Orthopedics

Eating a Mediterranean diet full of fruits, vegetables, fish, nuts, legumes, and whole grains is associated with a slightly lower risk of hip fracture in women, according to a study published online ahead of print in JAMA Internal Medicine.

Researchers analyzed data on diet and fracture risk in more than 90,000 postmenopausal women (average age, 63.6 years) who were followed for an average of almost 16 years. Diet quality and adherence were assessed by scores on 4 scales: the alternate Mediterranean Diet (aMED); the Healthy Eating Index 2010 (HEI-2010); the Alternate Healthy Eating Index 2010 (AHEI-2010); and the Dietary Approaches to Stop Hypertension (DASH) diet.

Women who scored the highest for adherence to a Mediterranean diet were at lower risk for hip fractures, although the absolute risk reduction was 0.29%. There was no association between a Mediterranean diet and total fracture risk.

A higher HEI-2010 or DASH score was inversely related to the risk of hip fracture, but the finding was not statistically significant. There was no association between HEI-2010, DASH and total fracture risk. The highest scores for AHEI-2010 were not significantly associated with hip or total fracture risk.

Eating a Mediterranean diet full of fruits, vegetables, fish, nuts, legumes, and whole grains is associated with a slightly lower risk of hip fracture in women, according to a study published online ahead of print in JAMA Internal Medicine.

Researchers analyzed data on diet and fracture risk in more than 90,000 postmenopausal women (average age, 63.6 years) who were followed for an average of almost 16 years. Diet quality and adherence were assessed by scores on 4 scales: the alternate Mediterranean Diet (aMED); the Healthy Eating Index 2010 (HEI-2010); the Alternate Healthy Eating Index 2010 (AHEI-2010); and the Dietary Approaches to Stop Hypertension (DASH) diet.

Women who scored the highest for adherence to a Mediterranean diet were at lower risk for hip fractures, although the absolute risk reduction was 0.29%. There was no association between a Mediterranean diet and total fracture risk.

A higher HEI-2010 or DASH score was inversely related to the risk of hip fracture, but the finding was not statistically significant. There was no association between HEI-2010, DASH and total fracture risk. The highest scores for AHEI-2010 were not significantly associated with hip or total fracture risk.

Eating a Mediterranean diet full of fruits, vegetables, fish, nuts, legumes, and whole grains is associated with a slightly lower risk of hip fracture in women, according to a study published online ahead of print in JAMA Internal Medicine.

Researchers analyzed data on diet and fracture risk in more than 90,000 postmenopausal women (average age, 63.6 years) who were followed for an average of almost 16 years. Diet quality and adherence were assessed by scores on 4 scales: the alternate Mediterranean Diet (aMED); the Healthy Eating Index 2010 (HEI-2010); the Alternate Healthy Eating Index 2010 (AHEI-2010); and the Dietary Approaches to Stop Hypertension (DASH) diet.

Women who scored the highest for adherence to a Mediterranean diet were at lower risk for hip fractures, although the absolute risk reduction was 0.29%. There was no association between a Mediterranean diet and total fracture risk.

A higher HEI-2010 or DASH score was inversely related to the risk of hip fracture, but the finding was not statistically significant. There was no association between HEI-2010, DASH and total fracture risk. The highest scores for AHEI-2010 were not significantly associated with hip or total fracture risk.

An increasing number of adolescents are undergoing ulnar lateral ligament (UCL) surgery to repair a pitching-related elbow injury, according to a study published online ahead of print in the March issue of the American Journal of Sports Medicine.

Analyzing a database of all ambulatory discharges in New York state, researchers found that 444 patients underwent surgery to repair their UCL between 2002 and 2011. The median age of study participants was 21; most were male.

The total volume of UCL surgeries increased nearly 200% during that time, while the number of UCL reconstructions per 100,000 people tripled from 0.15 to 0.45. Almost all of the growth occurred in two age groups, 17- to 18-year-olds and 19- to 20-year-olds. Patients who had private insurance were 25 times more likely to undergo UCL construction than those with Medicaid.

An increasing number of adolescents are undergoing ulnar lateral ligament (UCL) surgery to repair a pitching-related elbow injury, according to a study published online ahead of print in the March issue of the American Journal of Sports Medicine.

Analyzing a database of all ambulatory discharges in New York state, researchers found that 444 patients underwent surgery to repair their UCL between 2002 and 2011. The median age of study participants was 21; most were male.

The total volume of UCL surgeries increased nearly 200% during that time, while the number of UCL reconstructions per 100,000 people tripled from 0.15 to 0.45. Almost all of the growth occurred in two age groups, 17- to 18-year-olds and 19- to 20-year-olds. Patients who had private insurance were 25 times more likely to undergo UCL construction than those with Medicaid.

An increasing number of adolescents are undergoing ulnar lateral ligament (UCL) surgery to repair a pitching-related elbow injury, according to a study published online ahead of print in the March issue of the American Journal of Sports Medicine.

Analyzing a database of all ambulatory discharges in New York state, researchers found that 444 patients underwent surgery to repair their UCL between 2002 and 2011. The median age of study participants was 21; most were male.

The total volume of UCL surgeries increased nearly 200% during that time, while the number of UCL reconstructions per 100,000 people tripled from 0.15 to 0.45. Almost all of the growth occurred in two age groups, 17- to 18-year-olds and 19- to 20-year-olds. Patients who had private insurance were 25 times more likely to undergo UCL construction than those with Medicaid.

Children and adolescents who take medication for attention-deficit hyperactivity disorder (ADHD) show decreased bone density, according to a large cross-sectional study presented at the 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons in Orlando.

Researchers identified 5,315 pediatric patients in the Center for Disease Control and Prevention’s National Health and Nutrition Examination Survey (NHANES) and compared children who were taking an ADHD medication (methylphenidate, desmethylphenidate, dextroamphetamine, atomoxetine, or lisdexamfetamine) with those who were not.

Children taking ADHD medication had lower bone mineral density in the femur, femoral neck, and lumbar spine. Approximately 25% of survey participants who were taking ADHD medication met criteria for osteopenia.

Researchers were able to rule out other potential causes of low bone density in these children, including age, sex, race/ethnicity, and poverty levels. However, the study did not include information on dose, duration of use, or changes in therapy because of the limitations of the NHANES survey data.

Children and adolescents who take medication for attention-deficit hyperactivity disorder (ADHD) show decreased bone density, according to a large cross-sectional study presented at the 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons in Orlando.

Researchers identified 5,315 pediatric patients in the Center for Disease Control and Prevention’s National Health and Nutrition Examination Survey (NHANES) and compared children who were taking an ADHD medication (methylphenidate, desmethylphenidate, dextroamphetamine, atomoxetine, or lisdexamfetamine) with those who were not.

Children taking ADHD medication had lower bone mineral density in the femur, femoral neck, and lumbar spine. Approximately 25% of survey participants who were taking ADHD medication met criteria for osteopenia.

Researchers were able to rule out other potential causes of low bone density in these children, including age, sex, race/ethnicity, and poverty levels. However, the study did not include information on dose, duration of use, or changes in therapy because of the limitations of the NHANES survey data.

Children and adolescents who take medication for attention-deficit hyperactivity disorder (ADHD) show decreased bone density, according to a large cross-sectional study presented at the 2016 Annual Meeting of the American Academy of Orthopaedic Surgeons in Orlando.

Researchers identified 5,315 pediatric patients in the Center for Disease Control and Prevention’s National Health and Nutrition Examination Survey (NHANES) and compared children who were taking an ADHD medication (methylphenidate, desmethylphenidate, dextroamphetamine, atomoxetine, or lisdexamfetamine) with those who were not.

Children taking ADHD medication had lower bone mineral density in the femur, femoral neck, and lumbar spine. Approximately 25% of survey participants who were taking ADHD medication met criteria for osteopenia.

Researchers were able to rule out other potential causes of low bone density in these children, including age, sex, race/ethnicity, and poverty levels. However, the study did not include information on dose, duration of use, or changes in therapy because of the limitations of the NHANES survey data.

IN THIS ARTICLE

• Diagnosis
• Management
• Newborn hip evaluation algorithm

Developmental dysplasia of the hip (DDH), previously known as congenital dislocation of the hip, follows a spectrum of irregular anatomic hip development spanning from acetabular dysplasia to irreducible dislocation at birth. Early detection is critical to improve the overall prognosis. Prompt diagnosis requires understanding of potential risk factors, proficiency in physical examination techniques, and implementation of appropriate screening tools when indicated. Although current guidelines direct timing for physical exam screenings, imaging, and treatment, it is ultimately up to the provider to determine the best course of action on a case-by-case basis. This article provides a review of these topics and more.

CURRENT GUIDELINES

In 2000, the American Academy of Pediatrics (AAP) developed guidelines for detection of hip dysplasia, including recommendation of relevant physical exam screenings for all newborns.¹ In 2007, the Pediatric Orthopaedic Society of North America (POSNA) encouraged providers to follow the AAP guidelines with a continued recommendation to perform newborn screening for hip instability and routine follow-up evaluations until the child achieves walking.² The American Academy of Orthopaedic Surgeons (AAOS) also established clinical guidelines in 2014 that are endorsed by both AAP and POSNA.³ These guidelines support routine clinical screening; research evaluated infants up to 6 months old, however, limiting the recommendations to that age-group.

Failure to treat DDH early has been associated with serious negative sequelae that include chronic pain, degenerative arthritis, postural scoliosis, and early gait disturbances.⁴ Primary care providers are expected to perform thorough newborn hip exams with associated specialized tests (ie, Ortolani and Barlow, which are discussed in “Physical exam”) at each routine follow-up. Heightened clinical suspicion and risk factor awareness are key for primary care providers to promptly identify patients requiring orthopedic referral. With early diagnosis, a removable soft abduction brace can be applied as the initial treatment. When treatment is delayed, however, closed reduction under anesthesia or complex surgical intervention may be required.

EPIDEMIOLOGY

The etiology for DDH remains unknown. Hip dysplasia typically presents unilaterally but can also occur bilaterally. DDH is more likely to affect the left hip than the right.⁵

Reported incidence varies, ranging from 0.06 to 76.1 per 1,000 live births, and is largely affected by race and geographic location.⁵ Incidence is higher in countries where routine screening is required, by either physical examination or ultrasound (1.6 to 28.5 and 34.0 to 60.3 per 1,000, respectively), compared with countries not requiring routine screening (1.3 per 1,000). This may suggest that the majority of hip dysplasia cases are transient and resolve spontaneously without treatment.^6,7

RISK FACTORS AND PATIENT HISTORY

Known risk factors for DDH include breech presentation (see Figure 1), positive family history, and female gender.^5,8-10 Female infants are eight times more likely than males to develop DDH.¹⁰ Firstborn status is also recognized as an associated risk factor, which may be attributable to space constraints in utero. This hypothesis is further supported by the relative DDH-protective effect of prematurity and low birth weight. Other potential risk factors include advanced maternal age, birth weight that is high for gestational age, decreased hip abduction, and joint laxity. However, the majority of patients with hip dysplasia have no identifiable risk ­factors.^3,5,9,11,12

Swaddling, which often maintains the hips in an adducted and/or extended position, has also been strongly associated with hip dysplasia.^5,13 Multiple organizations, including the AAOS,AAP, POSNA, and the International Hip Dysplasia Institute, have developed or endorsed hip-healthy swaddling recommendations to minimize the risk for DDH in swaddled infants.^13-15 Such practices allow the infant’s legs to bend up and out at the hips, promoting free hip movement, flexion, and abduction.^13,15 Swaddling has demonstrated multiple benefits (including improved sleep and relief of excessive crying¹³) and continues to be recommended by many US providers; however, those caring for infants at risk for DDH should avoid traditional swaddling and/or practice hip-healthy swaddling techniques.^10,13,14 Early diagnosis starts with the clinician’s knowledge of DDH risk factors and the recommended screening protocols. The presence of multiple risk factors will increase the likelihood of this condition and should lower the clinician’s threshold for ordering additional screening, regardless of hip exam findings.

PHYSICAL EXAM

Both AAP and AAOS guidelines recommend clinical screening for DDH with physical exam in all newborns.^1,3 A head-to-toe musculoskeletal exam is warranted during the initial evaluation of every newborn in order to assess for any known DDH-associated conditions, which may include neuromuscular disorders, torticollis, and metatarsus adductus.⁵

Initial evaluation of an infant with DDH may reveal nonspecific findings, including asymmetric skin folds and limb-length inequality. The Galeazzi sign should be sought by aligning flexed knees with the child in the supine position and assessing for uneven knee heights (see Figure 2). Unilateral posterior hip dislocation or femoral shortening represents a positive Galeazzi sign.¹⁶ Joint laxity and limited hip abduction have also been associated with DDH.^1,10

Barlow and Ortolani exams are more specific to DDH and should be completed at newborn screening and each subsequent well-baby exam.¹ The Barlow maneuver is a provocative test with flexion, adduction, and posterior pressure through the infant’s hip (Figure 3). A palpable clunk during the Barlow maneuver indicates positive instability with posterior displacement. The Ortolani test is a reductive maneuver requiring abduction with posterior pressure to lift the greater trochanter (Figure 4). A clunk sensation with this test is positive for reduction of the hip.

The infant’s diaper should be removed during the hip evaluation. These exams are more reliable when each hip is evaluated separately with the pelvis stabilized.¹⁰ All physical exam findings must be carefully documented at each encounter.^1,17

It is critical for the examiner to understand the appropriate technique and potential results when conducting each of these specialized hip exams. A true positive finding is the clunking sensation that occurs with the dislocation or relocation of the affected hip; this finding is better felt than heard. In contrast, a benign hip click with these maneuvers is a more subtle sensation—typically, a soft-tissue snapping or catching—and is not diagnostic of DDH. A click is not a clunk and is not indicative of DDH.^1,3

DDH may present later in infancy or early childhood; therefore, DDH should remain within the differential diagnosis for gait asymmetry, unequal hip motion, or limb-length discrepancy. It may be beneficial to continue to evaluate for these developments during routine exams as part of a thorough pediatric musculoskeletal assessment, particularly in patients with documented risk factors for DDH.^1,3,4 Delay in diagnosis of DDH, it should be noted, is a relatively common complaint in pediatric medical malpractice lawsuits; until the early 2000s, this condition represented about 75% of claims in one medical malpractice database.The decrease in claims has been attributed to better awareness and earlier diagnosis of DDH. ¹⁷

Continue for the diagnosis >>

DIAGNOSIS

A positive Ortolani or Barlow sign is diagnostic and warrants prompt orthopedic referral (Figure 5). If physical examination results are equivocal or inconclusive, follow-up at two weeks is recommended, with continued routine follow-up until walking is achieved. Patients with persistent equivocal findings at the two-week follow-up warrant ultrasound at age 3 to 4 weeks or orthopedic referral. Infants with significant risk factors, particularly breech presentation at birth, should also undergo imaging.¹⁸ AAP recommends ultrasound at age 6 weeks or radiograph after 4 months of age.^1,18 AAOS recommends performing an imaging study before age 6 months when at least one of the following risk factors is present: breech presentation, positive family history of DDH, or previous clinical instability (moderate level of evidence).³

IMAGING

Ultrasound is the diagnostic test of choice for infants because radiographs have limited value until the femoral heads begin to ossify at age 4 to 6 months.¹⁸ Ultrasonography allows for visualization of the cartilaginous portion of the acetabulum and femoral head.¹ Dynamic stressing is performed during ultrasound to assess the level of hip stability. A provider trained in ultrasound will measure the depth of the acetabulum and identify any potential laxity or instability of the hip joint. Accuracy of these findings is largely dependent on the experience and skill of the examiner.

Ultrasound evaluation is not recommended until after age 3 to 4 weeks. Earlier findings may include mild laxity and immature morphology of the acetabulum, which often resolve spontaneously.^1,18 Use of ultrasound is currently recommended only to confirm diagnostic suspicion, based on clinical findings, or for infants with significant risk factors.¹⁸ Universal ultrasound screening in newborns is not recommended and would incur unnecessary costs.^1,3,9 Plain radiographs are used after age 4 months to confirm a diagnosis of DDH or to assess for residual dysplasia.^3,18

Continue for management >>

MANAGEMENT

Once hip dysplasia is suggested by physical exam or imaging study, the child’s subsequent care should be provided by an orthopedic specialist with experience in treating this condition. Treatment is preferably initiated before age 6 weeks.¹² The specifics of treatment are largely based on age at diagnosis and the severity of dysplasia.

The goal of treatment is to maintain the hips in a stable position with the femoral head well covered by the acetabulum. This will improve anatomic development and function. Early clinical diagnosis is often sufficient to justify initiating conservative treatment; additionally, early detection of DDH can considerably reduce the need for surgical intervention.¹² Although the potential for spontaneous resolution is high, the consequences associated with delay in care can be significant.

Preferred initial management, which can be initiated before confirmation of DDH by ultrasound, involves implementation of soft abduction support.¹⁹ The Pavlik harness is the support design of choice (Figure 6).¹² This harness maintains hip flexion and abduction, creating concentric reduction of the femoral head. The brace is highly successful when its use is initiated early. Treatment in a Pavlik harness requires nearly full-time wear and close monitoring by a clinician. Unlikely potential risks associated with this treatment include avascular necrosis and femoral nerve palsy.⁴

Ultrasonography is used to further monitor treatment and to determine length of wear. Long-term results suggest a success rate exceeding 90%.^20,21 However, this rate may be falsely elevated due to the number of hips that likely would have improved spontaneously without treatment.^6,19

The Pavlik harness becomes less effective with increasing age, and a more rigid abduction brace may be considered in infants older than 6 months.²⁰ Overall outcomes improve once the femoral head is consistently maintained in the acetabulum. Delay in treatment is associated with an increase in the long-term complications associated with residual hip dysplasia.²²

Once an infant is undergoing treatment for DDH in a Pavlik harness, there is no need for primary care providers to continue to perform provocative testing, such as the Ortolani or Barlow test, at routine well-baby checks. Unnecessary stress to the hips is not beneficial, and any new results will not change the treatment being provided by the orthopedic specialist. Adjustments to the fit of the harness should be made only by the orthopedist, unless femoral nerve palsy is noted on exam. This development warrants immediate discontinuation of harness use until symptoms resolve.²¹

Abduction bracing may not be suitable for all cases of hip dysplasia. Newborns with irreducible hips, more advanced dysplasia, or associated neuromuscular or syndromic disorder may require closed versus open reduction and casting. More invasive surgical options may also be considered in advanced dysplasia in order to reshape the joint and improve function.^20,22

Continue for patient education >>

PATIENT EDUCATION

Parents should be fully educated on the options for managing hip dysplasia. Once DDH is diagnosed, prompt referral to an orthopedic specialist is critical in order to weigh the treatment options and to develop the appropriate individualized plan for each child. Once treatment is initiated, parental compliance is essential; frequent meetings between parents and the specialist are important.

Parents of infants with known risk factors for and/or suspicion of hip dysplasia should also be educated on hip-healthy swaddling to allow for free motion of the hips and knees.^10,13 Advise them that some commercial baby carriers and slings may maintain the hips in an undesirable extended position. In both swaddling and with baby carriers, care should be taken to allow for hip abduction and flexion. Caution should also be taken during diaper changes to avoid lifting the legs and thereby causing unnecessary stress to the hips.

CONCLUSION

Developmental dysplasia of the hip can be a disabling pediatric condition. Early diagnosis improves the likelihood of successful treatment during infancy and can prevent serious complications. If untreated, DDH can lead to joint degeneration and premature arthritis. Recognition and treatment within the first six weeks of life is crucial to the overall outcome.

The role of a primary care provider is to identify hip dysplasia risk factors and recognize associated physical exam findings in order to refer to an orthopedic specialist in a timely manner. Guidelines from the AAP, POSNA, and AAOS help direct this process in order to effectively identify infants at risk and in need of treatment.

REFERENCES
1. American Academy of Pediatrics. Committee on Quality Improvement, Subcommittee on Developmental Dysplasia of the Hip. Clinical practice guideline: early detection of developmental dysplasia of the hip. Pediatrics. 2000;105(4 pt 1):896-905.
2. Schwend RM, Schoenecker P, Richards BS, et al. Screening the newborn for developmental dysplasia of the hip: now what do we do? J Pediatr Orthop. 2007;27(6):607-610.
3. Mulpuri K, Song KM, Goldberg MJ, Sevarino K. Detection and nonoperative management of pediatric developmental dysplasia of the hip in infants up to six months of age. J Am Acad Orthop Surg. 2015;23(3):202-205.
4. Thomas SRYW. A review of long-term outcomes for late presenting developmental hip dysplasia. Bone Joint J. 2015;97-B(6):729-733.
5. Loder RT, Skopelja EN. The epidemiology and demographics of hip dysplasia. ISRN Orthop. 2011;2011:238607.
6. US Preventive Services Task Force. Screening for developmental dysplasia of the hip: recommendation statement. Pediatrics. 2006;117(3):898-902.
7. Shorter D, Hong T, Osborn DA. Screening programmes for developmental dysplasia of the hip in newborn infants. Cochrane Database Syst Rev. 2011;(9):CD004595.
8. Loder RT, Shafer C. The demographics of developmental hip dysplasia in the Midwestern United States (Indiana). J Child Orthop. 2015;9(1):93-98.
9. Paton RW, Hinduja K, Thomas CD. The significance of at-risk factors in ultrasound surveillance of developmental dysplasia of the hip: a ten-year prospective study. J Bone Joint Surg Br. 2005;87(9):1264-1266.
10. Alsaleem M, Set KK, Saadeh L. Developmental dysplasia of hip: a review. Clin Pediatr (Phila). 2015;54(10):921-928.
11. Chan A, McCaul KA, Cundy PJ, et al. Perinatal risk factors for developmental dysplasia of the hip. Arch Dis Child. 1997;76(2):F94-F100.
12. Godley DR. Assessment, diagnosis, and treatment of developmental dysplasia of the hip. JAAPA. 2013;26(3):54-58.
13. Van Sleuwen BE, Engelberts AC, Boere-Boonekamp MM, et al. Swaddling: a systematic review. Pediatrics. 2007;120(4):e1097-e1106.
14. American Academy of Orthopaedic Surgeons, American Association of Orthopaedic Surgeons. Position statement: swaddling and developmental hip dysplasia. www.aaos.org/uploadedFiles/PreProduction/About/Opinion_Statements/position/1186%20Swaddling%20and%20Developmental%20Hip%20Dysplasia.pdf. Accessed January 22, 2016.
15. Clarke NM. Swaddling and hip dysplasia: an orthopaedic perspective. Arch Dis Child. 2014;99(1):5-6.
16. Storer SK, Skaggs DL. Developmental dysplasia of the hip. Am Fam Physician. 2006;74(8):1310-1316.
17. McAbee GN, Donn SM, Mendelson RA, et al. Medical diagnoses commonly associated with pediatric malpractice lawsuits in the United States. Pediatrics. 2008;122(6):e1282-e1286.
18. Imrie M, Scott V, Stearns P, et al. Is ultrasound screening for DDH in babies born breech sufficient? J Child Orthop. 2010;4(1):3-8.
19. Chen HW, Chang CH, Tsai ST, et al. Natural progression of hip dysplasia in newborns: a reflection of hip ultrasonographic screenings in newborn nurseries. J Pediatr Orthop B. 2010;19(5):418-423.
20. Gans I, Flynn JM, Sankar WN. Abduction bracing for residual acetabular dysplasia in infantile DDH. J Pediatr Orthop. 2013;33(7):714-718.
21. Murnaghan ML, Browne RH, Sucato DJ, Birch J. Femoral nerve palsy in Pavlik harness treatment for developmental dysplasia of the hip. J Bone Joint Surg Am. 2011;93(5):493-499.
22. Dezateux C, Rosendahl K. Developmental dysplasia of the hip. Lancet. 2007;369(9572):1541-1552.

IN THIS ARTICLE

• Diagnosis
• Management
• Newborn hip evaluation algorithm

Developmental dysplasia of the hip (DDH), previously known as congenital dislocation of the hip, follows a spectrum of irregular anatomic hip development spanning from acetabular dysplasia to irreducible dislocation at birth. Early detection is critical to improve the overall prognosis. Prompt diagnosis requires understanding of potential risk factors, proficiency in physical examination techniques, and implementation of appropriate screening tools when indicated. Although current guidelines direct timing for physical exam screenings, imaging, and treatment, it is ultimately up to the provider to determine the best course of action on a case-by-case basis. This article provides a review of these topics and more.

CURRENT GUIDELINES

In 2000, the American Academy of Pediatrics (AAP) developed guidelines for detection of hip dysplasia, including recommendation of relevant physical exam screenings for all newborns.¹ In 2007, the Pediatric Orthopaedic Society of North America (POSNA) encouraged providers to follow the AAP guidelines with a continued recommendation to perform newborn screening for hip instability and routine follow-up evaluations until the child achieves walking.² The American Academy of Orthopaedic Surgeons (AAOS) also established clinical guidelines in 2014 that are endorsed by both AAP and POSNA.³ These guidelines support routine clinical screening; research evaluated infants up to 6 months old, however, limiting the recommendations to that age-group.

Failure to treat DDH early has been associated with serious negative sequelae that include chronic pain, degenerative arthritis, postural scoliosis, and early gait disturbances.⁴ Primary care providers are expected to perform thorough newborn hip exams with associated specialized tests (ie, Ortolani and Barlow, which are discussed in “Physical exam”) at each routine follow-up. Heightened clinical suspicion and risk factor awareness are key for primary care providers to promptly identify patients requiring orthopedic referral. With early diagnosis, a removable soft abduction brace can be applied as the initial treatment. When treatment is delayed, however, closed reduction under anesthesia or complex surgical intervention may be required.

EPIDEMIOLOGY

The etiology for DDH remains unknown. Hip dysplasia typically presents unilaterally but can also occur bilaterally. DDH is more likely to affect the left hip than the right.⁵

Reported incidence varies, ranging from 0.06 to 76.1 per 1,000 live births, and is largely affected by race and geographic location.⁵ Incidence is higher in countries where routine screening is required, by either physical examination or ultrasound (1.6 to 28.5 and 34.0 to 60.3 per 1,000, respectively), compared with countries not requiring routine screening (1.3 per 1,000). This may suggest that the majority of hip dysplasia cases are transient and resolve spontaneously without treatment.^6,7

RISK FACTORS AND PATIENT HISTORY

Known risk factors for DDH include breech presentation (see Figure 1), positive family history, and female gender.^5,8-10 Female infants are eight times more likely than males to develop DDH.¹⁰ Firstborn status is also recognized as an associated risk factor, which may be attributable to space constraints in utero. This hypothesis is further supported by the relative DDH-protective effect of prematurity and low birth weight. Other potential risk factors include advanced maternal age, birth weight that is high for gestational age, decreased hip abduction, and joint laxity. However, the majority of patients with hip dysplasia have no identifiable risk ­factors.^3,5,9,11,12

Swaddling, which often maintains the hips in an adducted and/or extended position, has also been strongly associated with hip dysplasia.^5,13 Multiple organizations, including the AAOS,AAP, POSNA, and the International Hip Dysplasia Institute, have developed or endorsed hip-healthy swaddling recommendations to minimize the risk for DDH in swaddled infants.^13-15 Such practices allow the infant’s legs to bend up and out at the hips, promoting free hip movement, flexion, and abduction.^13,15 Swaddling has demonstrated multiple benefits (including improved sleep and relief of excessive crying¹³) and continues to be recommended by many US providers; however, those caring for infants at risk for DDH should avoid traditional swaddling and/or practice hip-healthy swaddling techniques.^10,13,14 Early diagnosis starts with the clinician’s knowledge of DDH risk factors and the recommended screening protocols. The presence of multiple risk factors will increase the likelihood of this condition and should lower the clinician’s threshold for ordering additional screening, regardless of hip exam findings.

PHYSICAL EXAM

Both AAP and AAOS guidelines recommend clinical screening for DDH with physical exam in all newborns.^1,3 A head-to-toe musculoskeletal exam is warranted during the initial evaluation of every newborn in order to assess for any known DDH-associated conditions, which may include neuromuscular disorders, torticollis, and metatarsus adductus.⁵

Initial evaluation of an infant with DDH may reveal nonspecific findings, including asymmetric skin folds and limb-length inequality. The Galeazzi sign should be sought by aligning flexed knees with the child in the supine position and assessing for uneven knee heights (see Figure 2). Unilateral posterior hip dislocation or femoral shortening represents a positive Galeazzi sign.¹⁶ Joint laxity and limited hip abduction have also been associated with DDH.^1,10

Barlow and Ortolani exams are more specific to DDH and should be completed at newborn screening and each subsequent well-baby exam.¹ The Barlow maneuver is a provocative test with flexion, adduction, and posterior pressure through the infant’s hip (Figure 3). A palpable clunk during the Barlow maneuver indicates positive instability with posterior displacement. The Ortolani test is a reductive maneuver requiring abduction with posterior pressure to lift the greater trochanter (Figure 4). A clunk sensation with this test is positive for reduction of the hip.

The infant’s diaper should be removed during the hip evaluation. These exams are more reliable when each hip is evaluated separately with the pelvis stabilized.¹⁰ All physical exam findings must be carefully documented at each encounter.^1,17

It is critical for the examiner to understand the appropriate technique and potential results when conducting each of these specialized hip exams. A true positive finding is the clunking sensation that occurs with the dislocation or relocation of the affected hip; this finding is better felt than heard. In contrast, a benign hip click with these maneuvers is a more subtle sensation—typically, a soft-tissue snapping or catching—and is not diagnostic of DDH. A click is not a clunk and is not indicative of DDH.^1,3

DDH may present later in infancy or early childhood; therefore, DDH should remain within the differential diagnosis for gait asymmetry, unequal hip motion, or limb-length discrepancy. It may be beneficial to continue to evaluate for these developments during routine exams as part of a thorough pediatric musculoskeletal assessment, particularly in patients with documented risk factors for DDH.^1,3,4 Delay in diagnosis of DDH, it should be noted, is a relatively common complaint in pediatric medical malpractice lawsuits; until the early 2000s, this condition represented about 75% of claims in one medical malpractice database.The decrease in claims has been attributed to better awareness and earlier diagnosis of DDH. ¹⁷

Continue for the diagnosis >>

DIAGNOSIS

A positive Ortolani or Barlow sign is diagnostic and warrants prompt orthopedic referral (Figure 5). If physical examination results are equivocal or inconclusive, follow-up at two weeks is recommended, with continued routine follow-up until walking is achieved. Patients with persistent equivocal findings at the two-week follow-up warrant ultrasound at age 3 to 4 weeks or orthopedic referral. Infants with significant risk factors, particularly breech presentation at birth, should also undergo imaging.¹⁸ AAP recommends ultrasound at age 6 weeks or radiograph after 4 months of age.^1,18 AAOS recommends performing an imaging study before age 6 months when at least one of the following risk factors is present: breech presentation, positive family history of DDH, or previous clinical instability (moderate level of evidence).³

IMAGING

Ultrasound is the diagnostic test of choice for infants because radiographs have limited value until the femoral heads begin to ossify at age 4 to 6 months.¹⁸ Ultrasonography allows for visualization of the cartilaginous portion of the acetabulum and femoral head.¹ Dynamic stressing is performed during ultrasound to assess the level of hip stability. A provider trained in ultrasound will measure the depth of the acetabulum and identify any potential laxity or instability of the hip joint. Accuracy of these findings is largely dependent on the experience and skill of the examiner.

Ultrasound evaluation is not recommended until after age 3 to 4 weeks. Earlier findings may include mild laxity and immature morphology of the acetabulum, which often resolve spontaneously.^1,18 Use of ultrasound is currently recommended only to confirm diagnostic suspicion, based on clinical findings, or for infants with significant risk factors.¹⁸ Universal ultrasound screening in newborns is not recommended and would incur unnecessary costs.^1,3,9 Plain radiographs are used after age 4 months to confirm a diagnosis of DDH or to assess for residual dysplasia.^3,18

Continue for management >>

MANAGEMENT

Once hip dysplasia is suggested by physical exam or imaging study, the child’s subsequent care should be provided by an orthopedic specialist with experience in treating this condition. Treatment is preferably initiated before age 6 weeks.¹² The specifics of treatment are largely based on age at diagnosis and the severity of dysplasia.

The goal of treatment is to maintain the hips in a stable position with the femoral head well covered by the acetabulum. This will improve anatomic development and function. Early clinical diagnosis is often sufficient to justify initiating conservative treatment; additionally, early detection of DDH can considerably reduce the need for surgical intervention.¹² Although the potential for spontaneous resolution is high, the consequences associated with delay in care can be significant.

Preferred initial management, which can be initiated before confirmation of DDH by ultrasound, involves implementation of soft abduction support.¹⁹ The Pavlik harness is the support design of choice (Figure 6).¹² This harness maintains hip flexion and abduction, creating concentric reduction of the femoral head. The brace is highly successful when its use is initiated early. Treatment in a Pavlik harness requires nearly full-time wear and close monitoring by a clinician. Unlikely potential risks associated with this treatment include avascular necrosis and femoral nerve palsy.⁴

Ultrasonography is used to further monitor treatment and to determine length of wear. Long-term results suggest a success rate exceeding 90%.^20,21 However, this rate may be falsely elevated due to the number of hips that likely would have improved spontaneously without treatment.^6,19

The Pavlik harness becomes less effective with increasing age, and a more rigid abduction brace may be considered in infants older than 6 months.²⁰ Overall outcomes improve once the femoral head is consistently maintained in the acetabulum. Delay in treatment is associated with an increase in the long-term complications associated with residual hip dysplasia.²²

Once an infant is undergoing treatment for DDH in a Pavlik harness, there is no need for primary care providers to continue to perform provocative testing, such as the Ortolani or Barlow test, at routine well-baby checks. Unnecessary stress to the hips is not beneficial, and any new results will not change the treatment being provided by the orthopedic specialist. Adjustments to the fit of the harness should be made only by the orthopedist, unless femoral nerve palsy is noted on exam. This development warrants immediate discontinuation of harness use until symptoms resolve.²¹

Abduction bracing may not be suitable for all cases of hip dysplasia. Newborns with irreducible hips, more advanced dysplasia, or associated neuromuscular or syndromic disorder may require closed versus open reduction and casting. More invasive surgical options may also be considered in advanced dysplasia in order to reshape the joint and improve function.^20,22

Continue for patient education >>

PATIENT EDUCATION

Parents should be fully educated on the options for managing hip dysplasia. Once DDH is diagnosed, prompt referral to an orthopedic specialist is critical in order to weigh the treatment options and to develop the appropriate individualized plan for each child. Once treatment is initiated, parental compliance is essential; frequent meetings between parents and the specialist are important.

Parents of infants with known risk factors for and/or suspicion of hip dysplasia should also be educated on hip-healthy swaddling to allow for free motion of the hips and knees.^10,13 Advise them that some commercial baby carriers and slings may maintain the hips in an undesirable extended position. In both swaddling and with baby carriers, care should be taken to allow for hip abduction and flexion. Caution should also be taken during diaper changes to avoid lifting the legs and thereby causing unnecessary stress to the hips.

CONCLUSION

Developmental dysplasia of the hip can be a disabling pediatric condition. Early diagnosis improves the likelihood of successful treatment during infancy and can prevent serious complications. If untreated, DDH can lead to joint degeneration and premature arthritis. Recognition and treatment within the first six weeks of life is crucial to the overall outcome.

The role of a primary care provider is to identify hip dysplasia risk factors and recognize associated physical exam findings in order to refer to an orthopedic specialist in a timely manner. Guidelines from the AAP, POSNA, and AAOS help direct this process in order to effectively identify infants at risk and in need of treatment.

REFERENCES
1. American Academy of Pediatrics. Committee on Quality Improvement, Subcommittee on Developmental Dysplasia of the Hip. Clinical practice guideline: early detection of developmental dysplasia of the hip. Pediatrics. 2000;105(4 pt 1):896-905.
2. Schwend RM, Schoenecker P, Richards BS, et al. Screening the newborn for developmental dysplasia of the hip: now what do we do? J Pediatr Orthop. 2007;27(6):607-610.
3. Mulpuri K, Song KM, Goldberg MJ, Sevarino K. Detection and nonoperative management of pediatric developmental dysplasia of the hip in infants up to six months of age. J Am Acad Orthop Surg. 2015;23(3):202-205.
4. Thomas SRYW. A review of long-term outcomes for late presenting developmental hip dysplasia. Bone Joint J. 2015;97-B(6):729-733.
5. Loder RT, Skopelja EN. The epidemiology and demographics of hip dysplasia. ISRN Orthop. 2011;2011:238607.
6. US Preventive Services Task Force. Screening for developmental dysplasia of the hip: recommendation statement. Pediatrics. 2006;117(3):898-902.
7. Shorter D, Hong T, Osborn DA. Screening programmes for developmental dysplasia of the hip in newborn infants. Cochrane Database Syst Rev. 2011;(9):CD004595.
8. Loder RT, Shafer C. The demographics of developmental hip dysplasia in the Midwestern United States (Indiana). J Child Orthop. 2015;9(1):93-98.
9. Paton RW, Hinduja K, Thomas CD. The significance of at-risk factors in ultrasound surveillance of developmental dysplasia of the hip: a ten-year prospective study. J Bone Joint Surg Br. 2005;87(9):1264-1266.
10. Alsaleem M, Set KK, Saadeh L. Developmental dysplasia of hip: a review. Clin Pediatr (Phila). 2015;54(10):921-928.
11. Chan A, McCaul KA, Cundy PJ, et al. Perinatal risk factors for developmental dysplasia of the hip. Arch Dis Child. 1997;76(2):F94-F100.
12. Godley DR. Assessment, diagnosis, and treatment of developmental dysplasia of the hip. JAAPA. 2013;26(3):54-58.
13. Van Sleuwen BE, Engelberts AC, Boere-Boonekamp MM, et al. Swaddling: a systematic review. Pediatrics. 2007;120(4):e1097-e1106.
14. American Academy of Orthopaedic Surgeons, American Association of Orthopaedic Surgeons. Position statement: swaddling and developmental hip dysplasia. www.aaos.org/uploadedFiles/PreProduction/About/Opinion_Statements/position/1186%20Swaddling%20and%20Developmental%20Hip%20Dysplasia.pdf. Accessed January 22, 2016.
15. Clarke NM. Swaddling and hip dysplasia: an orthopaedic perspective. Arch Dis Child. 2014;99(1):5-6.
16. Storer SK, Skaggs DL. Developmental dysplasia of the hip. Am Fam Physician. 2006;74(8):1310-1316.
17. McAbee GN, Donn SM, Mendelson RA, et al. Medical diagnoses commonly associated with pediatric malpractice lawsuits in the United States. Pediatrics. 2008;122(6):e1282-e1286.
18. Imrie M, Scott V, Stearns P, et al. Is ultrasound screening for DDH in babies born breech sufficient? J Child Orthop. 2010;4(1):3-8.
19. Chen HW, Chang CH, Tsai ST, et al. Natural progression of hip dysplasia in newborns: a reflection of hip ultrasonographic screenings in newborn nurseries. J Pediatr Orthop B. 2010;19(5):418-423.
20. Gans I, Flynn JM, Sankar WN. Abduction bracing for residual acetabular dysplasia in infantile DDH. J Pediatr Orthop. 2013;33(7):714-718.
21. Murnaghan ML, Browne RH, Sucato DJ, Birch J. Femoral nerve palsy in Pavlik harness treatment for developmental dysplasia of the hip. J Bone Joint Surg Am. 2011;93(5):493-499.
22. Dezateux C, Rosendahl K. Developmental dysplasia of the hip. Lancet. 2007;369(9572):1541-1552.

IN THIS ARTICLE

• Diagnosis
• Management
• Newborn hip evaluation algorithm

Developmental dysplasia of the hip (DDH), previously known as congenital dislocation of the hip, follows a spectrum of irregular anatomic hip development spanning from acetabular dysplasia to irreducible dislocation at birth. Early detection is critical to improve the overall prognosis. Prompt diagnosis requires understanding of potential risk factors, proficiency in physical examination techniques, and implementation of appropriate screening tools when indicated. Although current guidelines direct timing for physical exam screenings, imaging, and treatment, it is ultimately up to the provider to determine the best course of action on a case-by-case basis. This article provides a review of these topics and more.

CURRENT GUIDELINES

In 2000, the American Academy of Pediatrics (AAP) developed guidelines for detection of hip dysplasia, including recommendation of relevant physical exam screenings for all newborns.¹ In 2007, the Pediatric Orthopaedic Society of North America (POSNA) encouraged providers to follow the AAP guidelines with a continued recommendation to perform newborn screening for hip instability and routine follow-up evaluations until the child achieves walking.² The American Academy of Orthopaedic Surgeons (AAOS) also established clinical guidelines in 2014 that are endorsed by both AAP and POSNA.³ These guidelines support routine clinical screening; research evaluated infants up to 6 months old, however, limiting the recommendations to that age-group.

Failure to treat DDH early has been associated with serious negative sequelae that include chronic pain, degenerative arthritis, postural scoliosis, and early gait disturbances.⁴ Primary care providers are expected to perform thorough newborn hip exams with associated specialized tests (ie, Ortolani and Barlow, which are discussed in “Physical exam”) at each routine follow-up. Heightened clinical suspicion and risk factor awareness are key for primary care providers to promptly identify patients requiring orthopedic referral. With early diagnosis, a removable soft abduction brace can be applied as the initial treatment. When treatment is delayed, however, closed reduction under anesthesia or complex surgical intervention may be required.

EPIDEMIOLOGY

The etiology for DDH remains unknown. Hip dysplasia typically presents unilaterally but can also occur bilaterally. DDH is more likely to affect the left hip than the right.⁵

Reported incidence varies, ranging from 0.06 to 76.1 per 1,000 live births, and is largely affected by race and geographic location.⁵ Incidence is higher in countries where routine screening is required, by either physical examination or ultrasound (1.6 to 28.5 and 34.0 to 60.3 per 1,000, respectively), compared with countries not requiring routine screening (1.3 per 1,000). This may suggest that the majority of hip dysplasia cases are transient and resolve spontaneously without treatment.^6,7

RISK FACTORS AND PATIENT HISTORY

Known risk factors for DDH include breech presentation (see Figure 1), positive family history, and female gender.^5,8-10 Female infants are eight times more likely than males to develop DDH.¹⁰ Firstborn status is also recognized as an associated risk factor, which may be attributable to space constraints in utero. This hypothesis is further supported by the relative DDH-protective effect of prematurity and low birth weight. Other potential risk factors include advanced maternal age, birth weight that is high for gestational age, decreased hip abduction, and joint laxity. However, the majority of patients with hip dysplasia have no identifiable risk ­factors.^3,5,9,11,12

Swaddling, which often maintains the hips in an adducted and/or extended position, has also been strongly associated with hip dysplasia.^5,13 Multiple organizations, including the AAOS,AAP, POSNA, and the International Hip Dysplasia Institute, have developed or endorsed hip-healthy swaddling recommendations to minimize the risk for DDH in swaddled infants.^13-15 Such practices allow the infant’s legs to bend up and out at the hips, promoting free hip movement, flexion, and abduction.^13,15 Swaddling has demonstrated multiple benefits (including improved sleep and relief of excessive crying¹³) and continues to be recommended by many US providers; however, those caring for infants at risk for DDH should avoid traditional swaddling and/or practice hip-healthy swaddling techniques.^10,13,14 Early diagnosis starts with the clinician’s knowledge of DDH risk factors and the recommended screening protocols. The presence of multiple risk factors will increase the likelihood of this condition and should lower the clinician’s threshold for ordering additional screening, regardless of hip exam findings.

PHYSICAL EXAM

Both AAP and AAOS guidelines recommend clinical screening for DDH with physical exam in all newborns.^1,3 A head-to-toe musculoskeletal exam is warranted during the initial evaluation of every newborn in order to assess for any known DDH-associated conditions, which may include neuromuscular disorders, torticollis, and metatarsus adductus.⁵

Initial evaluation of an infant with DDH may reveal nonspecific findings, including asymmetric skin folds and limb-length inequality. The Galeazzi sign should be sought by aligning flexed knees with the child in the supine position and assessing for uneven knee heights (see Figure 2). Unilateral posterior hip dislocation or femoral shortening represents a positive Galeazzi sign.¹⁶ Joint laxity and limited hip abduction have also been associated with DDH.^1,10

Barlow and Ortolani exams are more specific to DDH and should be completed at newborn screening and each subsequent well-baby exam.¹ The Barlow maneuver is a provocative test with flexion, adduction, and posterior pressure through the infant’s hip (Figure 3). A palpable clunk during the Barlow maneuver indicates positive instability with posterior displacement. The Ortolani test is a reductive maneuver requiring abduction with posterior pressure to lift the greater trochanter (Figure 4). A clunk sensation with this test is positive for reduction of the hip.

The infant’s diaper should be removed during the hip evaluation. These exams are more reliable when each hip is evaluated separately with the pelvis stabilized.¹⁰ All physical exam findings must be carefully documented at each encounter.^1,17

It is critical for the examiner to understand the appropriate technique and potential results when conducting each of these specialized hip exams. A true positive finding is the clunking sensation that occurs with the dislocation or relocation of the affected hip; this finding is better felt than heard. In contrast, a benign hip click with these maneuvers is a more subtle sensation—typically, a soft-tissue snapping or catching—and is not diagnostic of DDH. A click is not a clunk and is not indicative of DDH.^1,3

DDH may present later in infancy or early childhood; therefore, DDH should remain within the differential diagnosis for gait asymmetry, unequal hip motion, or limb-length discrepancy. It may be beneficial to continue to evaluate for these developments during routine exams as part of a thorough pediatric musculoskeletal assessment, particularly in patients with documented risk factors for DDH.^1,3,4 Delay in diagnosis of DDH, it should be noted, is a relatively common complaint in pediatric medical malpractice lawsuits; until the early 2000s, this condition represented about 75% of claims in one medical malpractice database.The decrease in claims has been attributed to better awareness and earlier diagnosis of DDH. ¹⁷

Continue for the diagnosis >>

DIAGNOSIS

A positive Ortolani or Barlow sign is diagnostic and warrants prompt orthopedic referral (Figure 5). If physical examination results are equivocal or inconclusive, follow-up at two weeks is recommended, with continued routine follow-up until walking is achieved. Patients with persistent equivocal findings at the two-week follow-up warrant ultrasound at age 3 to 4 weeks or orthopedic referral. Infants with significant risk factors, particularly breech presentation at birth, should also undergo imaging.¹⁸ AAP recommends ultrasound at age 6 weeks or radiograph after 4 months of age.^1,18 AAOS recommends performing an imaging study before age 6 months when at least one of the following risk factors is present: breech presentation, positive family history of DDH, or previous clinical instability (moderate level of evidence).³

IMAGING

Ultrasound is the diagnostic test of choice for infants because radiographs have limited value until the femoral heads begin to ossify at age 4 to 6 months.¹⁸ Ultrasonography allows for visualization of the cartilaginous portion of the acetabulum and femoral head.¹ Dynamic stressing is performed during ultrasound to assess the level of hip stability. A provider trained in ultrasound will measure the depth of the acetabulum and identify any potential laxity or instability of the hip joint. Accuracy of these findings is largely dependent on the experience and skill of the examiner.

Ultrasound evaluation is not recommended until after age 3 to 4 weeks. Earlier findings may include mild laxity and immature morphology of the acetabulum, which often resolve spontaneously.^1,18 Use of ultrasound is currently recommended only to confirm diagnostic suspicion, based on clinical findings, or for infants with significant risk factors.¹⁸ Universal ultrasound screening in newborns is not recommended and would incur unnecessary costs.^1,3,9 Plain radiographs are used after age 4 months to confirm a diagnosis of DDH or to assess for residual dysplasia.^3,18

Continue for management >>

MANAGEMENT

Once hip dysplasia is suggested by physical exam or imaging study, the child’s subsequent care should be provided by an orthopedic specialist with experience in treating this condition. Treatment is preferably initiated before age 6 weeks.¹² The specifics of treatment are largely based on age at diagnosis and the severity of dysplasia.

The goal of treatment is to maintain the hips in a stable position with the femoral head well covered by the acetabulum. This will improve anatomic development and function. Early clinical diagnosis is often sufficient to justify initiating conservative treatment; additionally, early detection of DDH can considerably reduce the need for surgical intervention.¹² Although the potential for spontaneous resolution is high, the consequences associated with delay in care can be significant.

Preferred initial management, which can be initiated before confirmation of DDH by ultrasound, involves implementation of soft abduction support.¹⁹ The Pavlik harness is the support design of choice (Figure 6).¹² This harness maintains hip flexion and abduction, creating concentric reduction of the femoral head. The brace is highly successful when its use is initiated early. Treatment in a Pavlik harness requires nearly full-time wear and close monitoring by a clinician. Unlikely potential risks associated with this treatment include avascular necrosis and femoral nerve palsy.⁴

Ultrasonography is used to further monitor treatment and to determine length of wear. Long-term results suggest a success rate exceeding 90%.^20,21 However, this rate may be falsely elevated due to the number of hips that likely would have improved spontaneously without treatment.^6,19

The Pavlik harness becomes less effective with increasing age, and a more rigid abduction brace may be considered in infants older than 6 months.²⁰ Overall outcomes improve once the femoral head is consistently maintained in the acetabulum. Delay in treatment is associated with an increase in the long-term complications associated with residual hip dysplasia.²²

Once an infant is undergoing treatment for DDH in a Pavlik harness, there is no need for primary care providers to continue to perform provocative testing, such as the Ortolani or Barlow test, at routine well-baby checks. Unnecessary stress to the hips is not beneficial, and any new results will not change the treatment being provided by the orthopedic specialist. Adjustments to the fit of the harness should be made only by the orthopedist, unless femoral nerve palsy is noted on exam. This development warrants immediate discontinuation of harness use until symptoms resolve.²¹

Abduction bracing may not be suitable for all cases of hip dysplasia. Newborns with irreducible hips, more advanced dysplasia, or associated neuromuscular or syndromic disorder may require closed versus open reduction and casting. More invasive surgical options may also be considered in advanced dysplasia in order to reshape the joint and improve function.^20,22

Continue for patient education >>

PATIENT EDUCATION

Parents should be fully educated on the options for managing hip dysplasia. Once DDH is diagnosed, prompt referral to an orthopedic specialist is critical in order to weigh the treatment options and to develop the appropriate individualized plan for each child. Once treatment is initiated, parental compliance is essential; frequent meetings between parents and the specialist are important.

Parents of infants with known risk factors for and/or suspicion of hip dysplasia should also be educated on hip-healthy swaddling to allow for free motion of the hips and knees.^10,13 Advise them that some commercial baby carriers and slings may maintain the hips in an undesirable extended position. In both swaddling and with baby carriers, care should be taken to allow for hip abduction and flexion. Caution should also be taken during diaper changes to avoid lifting the legs and thereby causing unnecessary stress to the hips.

CONCLUSION

Developmental dysplasia of the hip can be a disabling pediatric condition. Early diagnosis improves the likelihood of successful treatment during infancy and can prevent serious complications. If untreated, DDH can lead to joint degeneration and premature arthritis. Recognition and treatment within the first six weeks of life is crucial to the overall outcome.

The role of a primary care provider is to identify hip dysplasia risk factors and recognize associated physical exam findings in order to refer to an orthopedic specialist in a timely manner. Guidelines from the AAP, POSNA, and AAOS help direct this process in order to effectively identify infants at risk and in need of treatment.

REFERENCES
1. American Academy of Pediatrics. Committee on Quality Improvement, Subcommittee on Developmental Dysplasia of the Hip. Clinical practice guideline: early detection of developmental dysplasia of the hip. Pediatrics. 2000;105(4 pt 1):896-905.
2. Schwend RM, Schoenecker P, Richards BS, et al. Screening the newborn for developmental dysplasia of the hip: now what do we do? J Pediatr Orthop. 2007;27(6):607-610.
3. Mulpuri K, Song KM, Goldberg MJ, Sevarino K. Detection and nonoperative management of pediatric developmental dysplasia of the hip in infants up to six months of age. J Am Acad Orthop Surg. 2015;23(3):202-205.
4. Thomas SRYW. A review of long-term outcomes for late presenting developmental hip dysplasia. Bone Joint J. 2015;97-B(6):729-733.
5. Loder RT, Skopelja EN. The epidemiology and demographics of hip dysplasia. ISRN Orthop. 2011;2011:238607.
6. US Preventive Services Task Force. Screening for developmental dysplasia of the hip: recommendation statement. Pediatrics. 2006;117(3):898-902.
7. Shorter D, Hong T, Osborn DA. Screening programmes for developmental dysplasia of the hip in newborn infants. Cochrane Database Syst Rev. 2011;(9):CD004595.
8. Loder RT, Shafer C. The demographics of developmental hip dysplasia in the Midwestern United States (Indiana). J Child Orthop. 2015;9(1):93-98.
9. Paton RW, Hinduja K, Thomas CD. The significance of at-risk factors in ultrasound surveillance of developmental dysplasia of the hip: a ten-year prospective study. J Bone Joint Surg Br. 2005;87(9):1264-1266.
10. Alsaleem M, Set KK, Saadeh L. Developmental dysplasia of hip: a review. Clin Pediatr (Phila). 2015;54(10):921-928.
11. Chan A, McCaul KA, Cundy PJ, et al. Perinatal risk factors for developmental dysplasia of the hip. Arch Dis Child. 1997;76(2):F94-F100.
12. Godley DR. Assessment, diagnosis, and treatment of developmental dysplasia of the hip. JAAPA. 2013;26(3):54-58.
13. Van Sleuwen BE, Engelberts AC, Boere-Boonekamp MM, et al. Swaddling: a systematic review. Pediatrics. 2007;120(4):e1097-e1106.
14. American Academy of Orthopaedic Surgeons, American Association of Orthopaedic Surgeons. Position statement: swaddling and developmental hip dysplasia. www.aaos.org/uploadedFiles/PreProduction/About/Opinion_Statements/position/1186%20Swaddling%20and%20Developmental%20Hip%20Dysplasia.pdf. Accessed January 22, 2016.
15. Clarke NM. Swaddling and hip dysplasia: an orthopaedic perspective. Arch Dis Child. 2014;99(1):5-6.
16. Storer SK, Skaggs DL. Developmental dysplasia of the hip. Am Fam Physician. 2006;74(8):1310-1316.
17. McAbee GN, Donn SM, Mendelson RA, et al. Medical diagnoses commonly associated with pediatric malpractice lawsuits in the United States. Pediatrics. 2008;122(6):e1282-e1286.
18. Imrie M, Scott V, Stearns P, et al. Is ultrasound screening for DDH in babies born breech sufficient? J Child Orthop. 2010;4(1):3-8.
19. Chen HW, Chang CH, Tsai ST, et al. Natural progression of hip dysplasia in newborns: a reflection of hip ultrasonographic screenings in newborn nurseries. J Pediatr Orthop B. 2010;19(5):418-423.
20. Gans I, Flynn JM, Sankar WN. Abduction bracing for residual acetabular dysplasia in infantile DDH. J Pediatr Orthop. 2013;33(7):714-718.
21. Murnaghan ML, Browne RH, Sucato DJ, Birch J. Femoral nerve palsy in Pavlik harness treatment for developmental dysplasia of the hip. J Bone Joint Surg Am. 2011;93(5):493-499.
22. Dezateux C, Rosendahl K. Developmental dysplasia of the hip. Lancet. 2007;369(9572):1541-1552.

Therapeutic goals set the tone for the American College of Rheumatology National Research Agenda 2016-2020 by calling for the discovery and development of new therapies for rheumatic disease; finding predictors of response and nonresponse to, and adverse events from therapy; and improving the understanding of how therapies should be used.

Those are the top 3 out of 15 goals facilitated by the ACR’s Committee on Research, which finalized the agenda after seeking input from members of the ACR and Association of Rheumatology Health Professionals (ARHP) living in the United States, and going through several rounds of refining and prioritizing the importance of goals through the input of clinicians, researchers, patients, and stakeholders. The Committee on Research uses the agenda to “set the compass for the organization in terms of research initiatives and facilitate the ACR’s advocacy for the research goals identified.”

©Tashatuvango/Thinkstock

Dr. Alexis R. Ogdie-Beatty, who jointly led the development of the agenda for the Committee on Research along with Dr. S. Louis Bridges, said that while the goals for 2016-2020 had a great deal of overlap with those of 2011-2015, “some of the topics that came up were different. Some of the topics were more specific than in the previous agenda. We have some idea how important these issues were to rheumatologists, given that rheumatologists (and patients) rated the importance of the items. Defining new therapeutic targets and developing new therapies for rheumatic diseases was by far the most highly rated goal by rheumatologists. Next most highly rated was to advocate for increased support for rheumatology research and rheumatology investigators – this was included as a supplementary goal that supports the rest of the agenda. Other newer items were those around determining how the changing health care landscape affects rheumatology patients and clinicians. In addition, nonpharmacologic therapy, adult outcomes of pediatric disease, and optimizing patient engagement were topics that were felt to be important. I think these highlight the input of clinicians in identifying research objectives.”

The 2016-2020 agenda is the third set of goals developed by the committee since 2005, and the first to “crowdsource” the important questions to ACR and ARHP members rather than be assembled solely by the committee.

The agenda arose from a multistage process that began with a web-based survey to the ACR/ARHP membership that asked respondents to “list the five most important research questions that need to be addressed over the next 5 years in order to improve the care for patients with rheumatic disease.” A selected group of 100 individuals representing patients, clinicians (academic and community), research (all types with diverse areas/diseases of interest), allied health professionals, pediatric and adult rheumatology, men and women, all career stages, and all regions of the country, used a Delphi exercise to rate 30 statements generated from the survey on a scale from 1 (not important) to 10 (very important). They had the option to provide comments. At a Leadership Summit, stakeholders from various nonprofit foundations associated with rheumatic diseases, the National Institutes of Health, and the president of the Rheumatology Research Foundation gave comments on a draft agenda to the Committee on Research, after which the committee discussed the results and input and then solicited further 1-10 ratings and comments on preliminary agenda goals from the same group of 100 individuals as in the second phase, plus an additional 17 clinicians.

Up next in the rank-ordering after therapeutic goals were three goals about understanding:

• The etiology, pathogenesis, and genetic basis of rheumatic diseases.

• Early disease states to improve early diagnosis, develop biomarkers for early detection, and determine how earlier treatment changes outcomes.

• The immune system and autoimmunity by defining autoimmunity triggers and determining how epigenetics affect disease susceptibility and inflammation.

The 5-year plan proposed developing improved outcome measures that incorporate patient self-reports, imaging, and measures of clinical response and disease activity. The agenda also seeks to gain better understanding of how patients with rheumatic disease, rheumatologists, and rheumatology health professionals are being affected by the changing U.S. health care landscape.

The plan calls for determining the role of nonpharmacologic therapy in the management of rheumatic disease (promoting and improving adherence to physical activity, finding optimal exercise prescriptions, and determining the role of diet on disease activity), as well as evaluating the role of regenerative medicine.

The agenda spells out the need for better engagement of patients in their care as well as for understanding how comorbidities are influenced by rheumatic disease and how pain and fatigue arise in rheumatic disease.

In two separate goals, committee members listed the importance of determining adult outcomes of pediatric rheumatic diseases and the effect of aging on the development, progression, and management of rheumatic diseases.

The Committee on Research identified three supplemental goals that support the others:

• Advocating for increased support for rheumatology research and rheumatology investigators.

• Harmonizing data from existing cohorts and registries to optimize research capabilities.

• Improving patient research partner involvement in research protocols.

[email protected]

Therapeutic goals set the tone for the American College of Rheumatology National Research Agenda 2016-2020 by calling for the discovery and development of new therapies for rheumatic disease; finding predictors of response and nonresponse to, and adverse events from therapy; and improving the understanding of how therapies should be used.

Those are the top 3 out of 15 goals facilitated by the ACR’s Committee on Research, which finalized the agenda after seeking input from members of the ACR and Association of Rheumatology Health Professionals (ARHP) living in the United States, and going through several rounds of refining and prioritizing the importance of goals through the input of clinicians, researchers, patients, and stakeholders. The Committee on Research uses the agenda to “set the compass for the organization in terms of research initiatives and facilitate the ACR’s advocacy for the research goals identified.”

©Tashatuvango/Thinkstock

Dr. Alexis R. Ogdie-Beatty, who jointly led the development of the agenda for the Committee on Research along with Dr. S. Louis Bridges, said that while the goals for 2016-2020 had a great deal of overlap with those of 2011-2015, “some of the topics that came up were different. Some of the topics were more specific than in the previous agenda. We have some idea how important these issues were to rheumatologists, given that rheumatologists (and patients) rated the importance of the items. Defining new therapeutic targets and developing new therapies for rheumatic diseases was by far the most highly rated goal by rheumatologists. Next most highly rated was to advocate for increased support for rheumatology research and rheumatology investigators – this was included as a supplementary goal that supports the rest of the agenda. Other newer items were those around determining how the changing health care landscape affects rheumatology patients and clinicians. In addition, nonpharmacologic therapy, adult outcomes of pediatric disease, and optimizing patient engagement were topics that were felt to be important. I think these highlight the input of clinicians in identifying research objectives.”

The 2016-2020 agenda is the third set of goals developed by the committee since 2005, and the first to “crowdsource” the important questions to ACR and ARHP members rather than be assembled solely by the committee.

The agenda arose from a multistage process that began with a web-based survey to the ACR/ARHP membership that asked respondents to “list the five most important research questions that need to be addressed over the next 5 years in order to improve the care for patients with rheumatic disease.” A selected group of 100 individuals representing patients, clinicians (academic and community), research (all types with diverse areas/diseases of interest), allied health professionals, pediatric and adult rheumatology, men and women, all career stages, and all regions of the country, used a Delphi exercise to rate 30 statements generated from the survey on a scale from 1 (not important) to 10 (very important). They had the option to provide comments. At a Leadership Summit, stakeholders from various nonprofit foundations associated with rheumatic diseases, the National Institutes of Health, and the president of the Rheumatology Research Foundation gave comments on a draft agenda to the Committee on Research, after which the committee discussed the results and input and then solicited further 1-10 ratings and comments on preliminary agenda goals from the same group of 100 individuals as in the second phase, plus an additional 17 clinicians.

Up next in the rank-ordering after therapeutic goals were three goals about understanding:

• The etiology, pathogenesis, and genetic basis of rheumatic diseases.

• Early disease states to improve early diagnosis, develop biomarkers for early detection, and determine how earlier treatment changes outcomes.

• The immune system and autoimmunity by defining autoimmunity triggers and determining how epigenetics affect disease susceptibility and inflammation.

The 5-year plan proposed developing improved outcome measures that incorporate patient self-reports, imaging, and measures of clinical response and disease activity. The agenda also seeks to gain better understanding of how patients with rheumatic disease, rheumatologists, and rheumatology health professionals are being affected by the changing U.S. health care landscape.

The plan calls for determining the role of nonpharmacologic therapy in the management of rheumatic disease (promoting and improving adherence to physical activity, finding optimal exercise prescriptions, and determining the role of diet on disease activity), as well as evaluating the role of regenerative medicine.

The agenda spells out the need for better engagement of patients in their care as well as for understanding how comorbidities are influenced by rheumatic disease and how pain and fatigue arise in rheumatic disease.

In two separate goals, committee members listed the importance of determining adult outcomes of pediatric rheumatic diseases and the effect of aging on the development, progression, and management of rheumatic diseases.

The Committee on Research identified three supplemental goals that support the others:

• Advocating for increased support for rheumatology research and rheumatology investigators.

• Harmonizing data from existing cohorts and registries to optimize research capabilities.

• Improving patient research partner involvement in research protocols.

[email protected]

Therapeutic goals set the tone for the American College of Rheumatology National Research Agenda 2016-2020 by calling for the discovery and development of new therapies for rheumatic disease; finding predictors of response and nonresponse to, and adverse events from therapy; and improving the understanding of how therapies should be used.

Those are the top 3 out of 15 goals facilitated by the ACR’s Committee on Research, which finalized the agenda after seeking input from members of the ACR and Association of Rheumatology Health Professionals (ARHP) living in the United States, and going through several rounds of refining and prioritizing the importance of goals through the input of clinicians, researchers, patients, and stakeholders. The Committee on Research uses the agenda to “set the compass for the organization in terms of research initiatives and facilitate the ACR’s advocacy for the research goals identified.”

©Tashatuvango/Thinkstock

Dr. Alexis R. Ogdie-Beatty, who jointly led the development of the agenda for the Committee on Research along with Dr. S. Louis Bridges, said that while the goals for 2016-2020 had a great deal of overlap with those of 2011-2015, “some of the topics that came up were different. Some of the topics were more specific than in the previous agenda. We have some idea how important these issues were to rheumatologists, given that rheumatologists (and patients) rated the importance of the items. Defining new therapeutic targets and developing new therapies for rheumatic diseases was by far the most highly rated goal by rheumatologists. Next most highly rated was to advocate for increased support for rheumatology research and rheumatology investigators – this was included as a supplementary goal that supports the rest of the agenda. Other newer items were those around determining how the changing health care landscape affects rheumatology patients and clinicians. In addition, nonpharmacologic therapy, adult outcomes of pediatric disease, and optimizing patient engagement were topics that were felt to be important. I think these highlight the input of clinicians in identifying research objectives.”

The 2016-2020 agenda is the third set of goals developed by the committee since 2005, and the first to “crowdsource” the important questions to ACR and ARHP members rather than be assembled solely by the committee.

The agenda arose from a multistage process that began with a web-based survey to the ACR/ARHP membership that asked respondents to “list the five most important research questions that need to be addressed over the next 5 years in order to improve the care for patients with rheumatic disease.” A selected group of 100 individuals representing patients, clinicians (academic and community), research (all types with diverse areas/diseases of interest), allied health professionals, pediatric and adult rheumatology, men and women, all career stages, and all regions of the country, used a Delphi exercise to rate 30 statements generated from the survey on a scale from 1 (not important) to 10 (very important). They had the option to provide comments. At a Leadership Summit, stakeholders from various nonprofit foundations associated with rheumatic diseases, the National Institutes of Health, and the president of the Rheumatology Research Foundation gave comments on a draft agenda to the Committee on Research, after which the committee discussed the results and input and then solicited further 1-10 ratings and comments on preliminary agenda goals from the same group of 100 individuals as in the second phase, plus an additional 17 clinicians.

Up next in the rank-ordering after therapeutic goals were three goals about understanding:

• The etiology, pathogenesis, and genetic basis of rheumatic diseases.

• Early disease states to improve early diagnosis, develop biomarkers for early detection, and determine how earlier treatment changes outcomes.

• The immune system and autoimmunity by defining autoimmunity triggers and determining how epigenetics affect disease susceptibility and inflammation.

The 5-year plan proposed developing improved outcome measures that incorporate patient self-reports, imaging, and measures of clinical response and disease activity. The agenda also seeks to gain better understanding of how patients with rheumatic disease, rheumatologists, and rheumatology health professionals are being affected by the changing U.S. health care landscape.

The plan calls for determining the role of nonpharmacologic therapy in the management of rheumatic disease (promoting and improving adherence to physical activity, finding optimal exercise prescriptions, and determining the role of diet on disease activity), as well as evaluating the role of regenerative medicine.

The agenda spells out the need for better engagement of patients in their care as well as for understanding how comorbidities are influenced by rheumatic disease and how pain and fatigue arise in rheumatic disease.

In two separate goals, committee members listed the importance of determining adult outcomes of pediatric rheumatic diseases and the effect of aging on the development, progression, and management of rheumatic diseases.

The Committee on Research identified three supplemental goals that support the others:

• Advocating for increased support for rheumatology research and rheumatology investigators.

• Harmonizing data from existing cohorts and registries to optimize research capabilities.

• Improving patient research partner involvement in research protocols.

[email protected]

Patients are learning about health and disease more independently than before, but such self-education may pose a unique challenge for practicing physicians. Although educated patients can assist in the critical appraisal of treatment options,¹ misinformed patients may have preconceived treatment biases and unrealistic expectations. More than 66 million Americans use the Internet daily, and recent surveys have shown 86% have used the Internet for health-related information.^2,3 With Internet use increasing, the number of patients turning to the web for medical information is increasing as well.⁴ For many patients, this information can be useful in making decisions about their health and health care.⁵

Although accessing medical information from the Internet has grown exponentially, analysis of information quality has grown considerably slower.⁶ With no regulatory body monitoring content, there is easy circumvention of the peer review process, an essential feature of academic publishing.⁷ With no external regulation, the information retrieved may be incorrect, outdated, or misleading. Many orthopedic studies have analyzed Internet content about numerous diagnoses.^3-6,8-18 Most of these studies have found this information highly variable and of poor quality.

We conducted a study to evaluate and analyze rotator cuff repair information available to the general public through the Internet; to assess changes in the quality of information over time; to determine if sites sponsored by academic institutions offered higher-quality information; and to assess whether the readability of the material varied according to DISCERN scores.

Rotator cuff repairs are among the most common surgeries performed by orthopedic surgeons. To our knowledge, this is the first study to assess the quality of web information about rotator cuff repairs. We hypothesized that the quality of information would positively correlate with the reading level of the material presented, that academic institutions would present the highest-quality information, and that the type of information presented would change over time.

Materials and Methods

We used the search phrase rotator cuff repair on the 3 most popular search engines: Google, Yahoo!, and Bing. Google is the dominant engine, taking 83.06% of total market share, followed by Yahoo! (6.86%) and Bing (4.27%).5 The first 50 websites identified by each search engine were selected for evaluation, excluding duplicates or overlapping websites. Similarly, advertisements and strictly video results lacking text were excluded. After each engine was queried, a master list of 150 websites was created for individual evaluation and assessment. To assess changes in results over time, we performed 2 searches, on November 16, 2011, and May 18, 2014.

The content of each website was analyzed for authorship, ability to contact the author, discussion of disorder, surgical treatment, complications, surgical eligibility, rehabilitation, other treatment options, and use of peer-reviewed sources. Authorship was placed in 1 of 6 categories:

1. Academic—university-affiliated physician or research group.

2. Private—physician or group without stated affiliation to an academic organization.

3. Industry—manufacturing or marketing company advertising a product or service for profit.

4. News source—bulletin or article without affiliation to a hospital or an academic institution.

5. Public education—individual or organization with noncommercial website providing third-party information (eg, Wikipedia, About.com).

6. Blog—website publishing an individual’s personal experiences in diary or journal form.

Websites were also assessed for accuracy and validity based on presence or absence of Health On the Net code (HONcode) certification and DISCERN score. Designed by the Health On the Net Foundation in 1996, HONcode provides a framework for disseminating high-quality medical information over the web.¹⁹ Website owners can request that their sites be evaluated for HONcode certification; a site that qualifies can display the HONcode seal.²⁰ The DISCERN project, initially funded by the National Health Service in the United Kingdom, judges the quality of written information available on health-related websites.²¹ It determines the quality of a publication on the basis of 16 questions: The first 8 address the publication’s reliability, the next 7 involve specific details of treatment choices, and the last is an overall rating of the website.

Website readability was assessed with the Flesch-Kincaid test. This test, designed under contract with the US Navy in 1975, has been used in other orthopedic studies.¹⁹ Regression analysis was performed to check for correlation between website readability and DISCERN score. Analysis of variance was used to analyze differences between scores.

Results

We performed a comprehensive analysis of the top 50 websites from each of the 3 search engines (N = 150 websites) (Figures 1–5, Table). Regarding authorship, our 2 searches demonstrated similar values (Figure 1). In 2011, 21% of websites were associated with an academic institution, 38% were authored by private physicians or hospital or physician groups not associated with an academic institution, 11.5% were industry-sponsored, 5% were news bulletins or media reports, 21.5% were public education websites, and 3% were personal blogs. Our 2014 search found a similar distribution of contributors. Between 2011 and 2014, the largest change was in academic authors, which decreased by 7%, from 21% to 14%. Percentage of websites authored by private physicians remained constant from the first to the second search: 38%.

When the 2011 and 2014 website content was compared, several changes were noted. Percentage of websites providing an author contact method increased from 21% to 50% (Figure 2), percentage detailing rotator cuff repairs increased from 82% to 91%, and percentage introducing treatment options in addition to surgical management increased from 11.5% to 61%. Percentage discussing surgical eligibility, however, decreased from 43% to 18%. Percentage citing peer-reviewed sources remained relatively constant (28%, 26%), as did percentage discussing surgical technique for rotator cuff repair (55%, 59%) (Figure 3). A major decrease was found in percentage of websites discussing surgical complications, 42% in 2011 down to 25% in 2014, whereas a major increase was found in percentage discussing rehabilitation, from 39% in 2011 up to 73% in 2014. In 2014, no websites discussed double- versus single-row surgery—compared with 6% in 2011. False claims remained low between 2011 and 2014. In both searches, no website guaranteed a return to sport, and few made claims of painless or bloodless surgery.

DISCERN scores for websites found during the 2014 search were averaged for each of the 6 authorship groups (Figure 4). The highest DISCERN scores were given to academic institution websites (51.6) and public education websites (49). For the academic websites, this difference was significant relative to news, blog, and private physician websites (Ps = .012, .001, .001) The lowest DISCERN scores were given to news organization websites and personal blogs. DISCERN scores were 43.8 for industry sources and 40.7 for private physician groups; the difference was not significant (P = .229). Overall mean DISCERN score for all websites was 44. Eleven percent of websites were HONcode-certified.

No correlation was found between website readability and DISCERN score; correlation coefficient r was .01 (Figure 5). For the websites in 2014, mean Flesch-Kincaid readability score was 50.17, and mean grade level was 10.98; coefficient of determination r² was 0.00012.

The Table compares our data with data from other orthopedic studies that have analyzed the quality of Internet information about various orthopedic injuries, diseases, and procedures.^{3-6,8,9,11-18} With its mean DISCERN score of 44, the present rotator cuff tear study was ranked third of 6 studies that have used this scoring system to analyze website content. Of these 6 studies, those reviewing osteosarcoma and juvenile idiopathic arthritis were ranked highest (mean scores, 49.8 and 48.9, respectively), and the study reviewing scoliosis surgery was ranked lowest (38.9). Bruce-Brand and colleagues9 recently found a mean DISCERN score of 41 for anterior cruciate ligament (ACL) reconstruction. When considering HONcode-certified websites, our Internet search for rotator cuff tears found the third lowest percentage, 10.5%, compared with the other studies (Table); the highest percentage, 30%, was found for websites discussing concussions in athletes. When considering authorship, our rotator cuff study found the third highest percentage, 76%, authored by academic centers, physicians, and public education websites; the highest percentage was found in websites discussing ACL reconstruction. Websites discussing ACL reconstruction also had the highest percentage of websites authored by industry.⁹

Discussion

To our knowledge, this is the first study specifically analyzing the quality of Internet information about rotator cuff repairs. A similar study, conducted by Starman and colleagues¹⁵ in 2010, addressed the quality of web information about 10 common sports medicine diagnoses, one of which was rotator cuff tears. In that study, only 16 of the websites included discussed rotator cuff tears. In addition, the authors used a customized, HONcode-based grading system to analyze each website, making their data difficult to compare across studies.

Ideally, a high-quality medical website should be written by a credible source and should cover a disorder, treatment options, eligibility, rehabilitation, and complications. As there is no standard grading system for analyzing web content about rotator cuff repairs, we analyzed the websites for specific information we thought should be included in a high-quality website (Figures 2, 3). When considering authorship, we found academic centers, private physicians, and educational sources comprised 76% of the sources; industry sources made up only 12%. Similar findings were noted by investigators analyzing Internet information about other orthopedic topics, including ACL reconstruction, lumbar arthroplasty, osteosarcoma, and cervical spine surgery.^5,11,22 Studies analyzing websites for information on ACL tears and distal radius fractures found have a higher percentage of industry-sponsored websites.^9,10

DISCERN showed that the highest-quality information came from websites with academic affiliations, consistent with previous studies,^3,9,17 and its mean score (51.6) was significantly higher than the scores for private physician websites, news sites, and blogs (Ps = .001, .016, .001); the least reliable information was from personal blogs and news outlets. Of note, mean DISCERN score was higher for the industry websites we found than for private physician websites (43.8 vs 40.7), though the difference was not significant (P = .229). Previous investigators considered number of industry-sponsored websites as a marker of poor quality of information relating to a given topic; however, given the DISCERN scores in our study, this might not necessarily be true.⁶ Based on the present study’s data, websites affiliated with academic institutions would be recommended for patients searching for high-quality information about rotator cuff tears.

Given DISCERN scores across studies, information about rotator cuff tears ranked below information about osteosarcoma and juvenile idiopathic arthritis but above information about scoliosis, cervical spine surgery, and ACL reconstruction (Table). DISCERN scores must be compared across studies, as there are no definitions for good and poor DISCERN scores.

Of the 4 studies that analyzed percentage of websites citing peer-reviewed sources, only our study and the study of cervical spine surgery¹⁸ analyzed that percentage as well as DISCERN score. Percentage citing peer-reviewed sources was 26% for rotator cuff tears and 24% for cervical spine surgery; the respective DISCERN scores were 44 and 43.6. As only these 2 studies could be compared, no real correlation between percentage of websites citing peer-reviewed sources and the quality of the content on a given topic can be assessed. More research into this relationship is needed. One already delineated association is the correlation between HONcode-certified sites and high DISCERN scores.²¹ For high-quality medical information, physicians can direct their patients both to academic institution websites and to HONcode-certified websites.

When we compared the present study with previous investigations, we found a large difference between search results for a given topic. In 2013, Duncan and colleagues⁶ and Bruce-Brand and colleagues⁹ used similar study designs (eg, search terms, search engines) for their investigations of quality of web information. Their results, however, were widely different. For example, percentages of industry authorship were 4.5% (Duncan and colleagues⁶) and 64% (Bruce-Brand and colleagues⁹). This inconsistency between studies conducted during similar periods might be related to what appears at the top of the results queue for a search. Duncan and colleagues⁶ analyzed 200 websites, Bruce-Brand and colleagues⁹ only 45. Industries may have made financial arrangements and used search engine optimization techniques to have their websites listed first in search results.

In our study, we also analyzed how web information has changed over time. On the Internet, information changes daily, and we hypothesized that the content found during our 2 searches (2011, 2014) would yield different results. Surprisingly, the data were similar, particularly concerning authorship (Figures 1, 2). In both searches, the largest authorship source was private physician or physician groups (38% in 2011 and 2014). Other authorship sources showed little change in percentage between searches. As for content, we found both increases and decreases in specific web information. Ability to contact authors increased from 21% (2011) to 50% (2014). We think it is important that websites offer a communication channel to people who read the medical information the sites provide. Percentage of websites discussing nonoperative treatment options increased from 11.5% to 61%. Therefore, patients in 2014 were being introduced to more options (in addition to surgery) for managing shoulder pain—an improvement in quality of information between the searches. Percentage of websites discussing surgical eligibility, however, decreased from 43% to 18%—a negative development in information quality. Another decrease, from 42% to 25%, was found for websites discussing surgical complications. Given the data as a whole, and our finding both negative and positive changes, it appears the quality of web content has not improved significantly. Interestingly, no websites discussed double- versus single-row surgery in 2014, but 6% did so in 2011.

Lost in the discussion of quality and reliability of information is whether patients comprehend what they are reading.²³ Yi and colleagues¹⁹ recentlyassessed the readability level of arthroscopy information in articles published online by the American Academy of Orthopaedic Surgeons (AAOS) and the Arthroscopy Association of North America (AANA). The investigators used the Flesch-Kincaid readability test to determine readability level in terms of grade level. They found that the majority of the patient education articles on the AAOS and AANA sites had a readability level far above the national average; only 4 articles were written at or below the eighth-grade level, the current average reading level in the United States.²⁴ Information that is not comprehensible is of no use to patients, and information that physicians and researchers consider high-quality might not be what patients consider high-quality. As we pursue higher-quality web content, we need to consider that its audience includes nonmedical readers, our patients. In the present study, we found that the readability of a website had no correlation with the site’s DISCERN score (Figure 5). Therefore, for information about rotator cuff repairs, higher-quality websites are no harder than lower-quality sites for patients to comprehend. The Flesch-Kincaid readability test is flawed in that it considers only total number of syllables per word and words per sentence, not nontextual elements of patient education materials, such as illustrations on a website. The 10.98 mean grade level found in our study is higher than the levels found for most studies reviewed by Yi and colleagues.¹⁹

This study had several limitations. During an Internet search, the number of websites a user visits drops precipitously after the first page of results. Studies have shown the top 20 sites in a given search receive 97% of the views, and the top 3 receive 58.4%. Whether patients visit websites far down in the list of 150 we found in our given search is unknown. Last, the Flesch-Kincaid readability test is flawed in several ways but nevertheless is used extensively in research. Grading is based on number of words and syllables used in a given sentence; it does not take into account the complexity or common usage of a given word or definition. Therefore, websites may receive low Flesch-Kincaid scores—indicating ease of reading—despite their use of complex medical terminology and jargon that complicate patients’ comprehension of the material.

Conclusion

Numerous authors have evaluated orthopedic patients’ accessing of medical information from the Internet. Although the Internet makes access easier, unreliable content can lead patients to develop certain notions about the direction of their care and certain expectations regarding their clinical outcomes. With there being no regulatory body monitoring content, the peer review process, an essential feature of academic publishing, can be easily circumvented.²⁵

In this study, the highest-quality websites had academic affiliations. Quality of information about rotator cuff repairs was similar to what was found for other orthopedic topics in comparable studies. Surprisingly, there was little change in authorship and content of web information between our 2 search periods (2011, 2014). Although there has been a rapid increase in the number of medical websites, quality of content seems not to have changed significantly. Patients look to physicians for guidance but increasingly are accessing the Internet for additional information. It is essential that physicians understand the quality of information available on the Internet when counseling patients regarding surgery.

Patients are learning about health and disease more independently than before, but such self-education may pose a unique challenge for practicing physicians. Although educated patients can assist in the critical appraisal of treatment options,¹ misinformed patients may have preconceived treatment biases and unrealistic expectations. More than 66 million Americans use the Internet daily, and recent surveys have shown 86% have used the Internet for health-related information.^2,3 With Internet use increasing, the number of patients turning to the web for medical information is increasing as well.⁴ For many patients, this information can be useful in making decisions about their health and health care.⁵

Although accessing medical information from the Internet has grown exponentially, analysis of information quality has grown considerably slower.⁶ With no regulatory body monitoring content, there is easy circumvention of the peer review process, an essential feature of academic publishing.⁷ With no external regulation, the information retrieved may be incorrect, outdated, or misleading. Many orthopedic studies have analyzed Internet content about numerous diagnoses.^3-6,8-18 Most of these studies have found this information highly variable and of poor quality.

We conducted a study to evaluate and analyze rotator cuff repair information available to the general public through the Internet; to assess changes in the quality of information over time; to determine if sites sponsored by academic institutions offered higher-quality information; and to assess whether the readability of the material varied according to DISCERN scores.

Rotator cuff repairs are among the most common surgeries performed by orthopedic surgeons. To our knowledge, this is the first study to assess the quality of web information about rotator cuff repairs. We hypothesized that the quality of information would positively correlate with the reading level of the material presented, that academic institutions would present the highest-quality information, and that the type of information presented would change over time.

Materials and Methods

We used the search phrase rotator cuff repair on the 3 most popular search engines: Google, Yahoo!, and Bing. Google is the dominant engine, taking 83.06% of total market share, followed by Yahoo! (6.86%) and Bing (4.27%).5 The first 50 websites identified by each search engine were selected for evaluation, excluding duplicates or overlapping websites. Similarly, advertisements and strictly video results lacking text were excluded. After each engine was queried, a master list of 150 websites was created for individual evaluation and assessment. To assess changes in results over time, we performed 2 searches, on November 16, 2011, and May 18, 2014.

The content of each website was analyzed for authorship, ability to contact the author, discussion of disorder, surgical treatment, complications, surgical eligibility, rehabilitation, other treatment options, and use of peer-reviewed sources. Authorship was placed in 1 of 6 categories:

1. Academic—university-affiliated physician or research group.

2. Private—physician or group without stated affiliation to an academic organization.

3. Industry—manufacturing or marketing company advertising a product or service for profit.

4. News source—bulletin or article without affiliation to a hospital or an academic institution.

5. Public education—individual or organization with noncommercial website providing third-party information (eg, Wikipedia, About.com).

6. Blog—website publishing an individual’s personal experiences in diary or journal form.

Websites were also assessed for accuracy and validity based on presence or absence of Health On the Net code (HONcode) certification and DISCERN score. Designed by the Health On the Net Foundation in 1996, HONcode provides a framework for disseminating high-quality medical information over the web.¹⁹ Website owners can request that their sites be evaluated for HONcode certification; a site that qualifies can display the HONcode seal.²⁰ The DISCERN project, initially funded by the National Health Service in the United Kingdom, judges the quality of written information available on health-related websites.²¹ It determines the quality of a publication on the basis of 16 questions: The first 8 address the publication’s reliability, the next 7 involve specific details of treatment choices, and the last is an overall rating of the website.

Website readability was assessed with the Flesch-Kincaid test. This test, designed under contract with the US Navy in 1975, has been used in other orthopedic studies.¹⁹ Regression analysis was performed to check for correlation between website readability and DISCERN score. Analysis of variance was used to analyze differences between scores.

Results

We performed a comprehensive analysis of the top 50 websites from each of the 3 search engines (N = 150 websites) (Figures 1–5, Table). Regarding authorship, our 2 searches demonstrated similar values (Figure 1). In 2011, 21% of websites were associated with an academic institution, 38% were authored by private physicians or hospital or physician groups not associated with an academic institution, 11.5% were industry-sponsored, 5% were news bulletins or media reports, 21.5% were public education websites, and 3% were personal blogs. Our 2014 search found a similar distribution of contributors. Between 2011 and 2014, the largest change was in academic authors, which decreased by 7%, from 21% to 14%. Percentage of websites authored by private physicians remained constant from the first to the second search: 38%.

When the 2011 and 2014 website content was compared, several changes were noted. Percentage of websites providing an author contact method increased from 21% to 50% (Figure 2), percentage detailing rotator cuff repairs increased from 82% to 91%, and percentage introducing treatment options in addition to surgical management increased from 11.5% to 61%. Percentage discussing surgical eligibility, however, decreased from 43% to 18%. Percentage citing peer-reviewed sources remained relatively constant (28%, 26%), as did percentage discussing surgical technique for rotator cuff repair (55%, 59%) (Figure 3). A major decrease was found in percentage of websites discussing surgical complications, 42% in 2011 down to 25% in 2014, whereas a major increase was found in percentage discussing rehabilitation, from 39% in 2011 up to 73% in 2014. In 2014, no websites discussed double- versus single-row surgery—compared with 6% in 2011. False claims remained low between 2011 and 2014. In both searches, no website guaranteed a return to sport, and few made claims of painless or bloodless surgery.

DISCERN scores for websites found during the 2014 search were averaged for each of the 6 authorship groups (Figure 4). The highest DISCERN scores were given to academic institution websites (51.6) and public education websites (49). For the academic websites, this difference was significant relative to news, blog, and private physician websites (Ps = .012, .001, .001) The lowest DISCERN scores were given to news organization websites and personal blogs. DISCERN scores were 43.8 for industry sources and 40.7 for private physician groups; the difference was not significant (P = .229). Overall mean DISCERN score for all websites was 44. Eleven percent of websites were HONcode-certified.

No correlation was found between website readability and DISCERN score; correlation coefficient r was .01 (Figure 5). For the websites in 2014, mean Flesch-Kincaid readability score was 50.17, and mean grade level was 10.98; coefficient of determination r² was 0.00012.

The Table compares our data with data from other orthopedic studies that have analyzed the quality of Internet information about various orthopedic injuries, diseases, and procedures.^{3-6,8,9,11-18} With its mean DISCERN score of 44, the present rotator cuff tear study was ranked third of 6 studies that have used this scoring system to analyze website content. Of these 6 studies, those reviewing osteosarcoma and juvenile idiopathic arthritis were ranked highest (mean scores, 49.8 and 48.9, respectively), and the study reviewing scoliosis surgery was ranked lowest (38.9). Bruce-Brand and colleagues9 recently found a mean DISCERN score of 41 for anterior cruciate ligament (ACL) reconstruction. When considering HONcode-certified websites, our Internet search for rotator cuff tears found the third lowest percentage, 10.5%, compared with the other studies (Table); the highest percentage, 30%, was found for websites discussing concussions in athletes. When considering authorship, our rotator cuff study found the third highest percentage, 76%, authored by academic centers, physicians, and public education websites; the highest percentage was found in websites discussing ACL reconstruction. Websites discussing ACL reconstruction also had the highest percentage of websites authored by industry.⁹

Discussion

To our knowledge, this is the first study specifically analyzing the quality of Internet information about rotator cuff repairs. A similar study, conducted by Starman and colleagues¹⁵ in 2010, addressed the quality of web information about 10 common sports medicine diagnoses, one of which was rotator cuff tears. In that study, only 16 of the websites included discussed rotator cuff tears. In addition, the authors used a customized, HONcode-based grading system to analyze each website, making their data difficult to compare across studies.

Ideally, a high-quality medical website should be written by a credible source and should cover a disorder, treatment options, eligibility, rehabilitation, and complications. As there is no standard grading system for analyzing web content about rotator cuff repairs, we analyzed the websites for specific information we thought should be included in a high-quality website (Figures 2, 3). When considering authorship, we found academic centers, private physicians, and educational sources comprised 76% of the sources; industry sources made up only 12%. Similar findings were noted by investigators analyzing Internet information about other orthopedic topics, including ACL reconstruction, lumbar arthroplasty, osteosarcoma, and cervical spine surgery.^5,11,22 Studies analyzing websites for information on ACL tears and distal radius fractures found have a higher percentage of industry-sponsored websites.^9,10

DISCERN showed that the highest-quality information came from websites with academic affiliations, consistent with previous studies,^3,9,17 and its mean score (51.6) was significantly higher than the scores for private physician websites, news sites, and blogs (Ps = .001, .016, .001); the least reliable information was from personal blogs and news outlets. Of note, mean DISCERN score was higher for the industry websites we found than for private physician websites (43.8 vs 40.7), though the difference was not significant (P = .229). Previous investigators considered number of industry-sponsored websites as a marker of poor quality of information relating to a given topic; however, given the DISCERN scores in our study, this might not necessarily be true.⁶ Based on the present study’s data, websites affiliated with academic institutions would be recommended for patients searching for high-quality information about rotator cuff tears.

Given DISCERN scores across studies, information about rotator cuff tears ranked below information about osteosarcoma and juvenile idiopathic arthritis but above information about scoliosis, cervical spine surgery, and ACL reconstruction (Table). DISCERN scores must be compared across studies, as there are no definitions for good and poor DISCERN scores.

Of the 4 studies that analyzed percentage of websites citing peer-reviewed sources, only our study and the study of cervical spine surgery¹⁸ analyzed that percentage as well as DISCERN score. Percentage citing peer-reviewed sources was 26% for rotator cuff tears and 24% for cervical spine surgery; the respective DISCERN scores were 44 and 43.6. As only these 2 studies could be compared, no real correlation between percentage of websites citing peer-reviewed sources and the quality of the content on a given topic can be assessed. More research into this relationship is needed. One already delineated association is the correlation between HONcode-certified sites and high DISCERN scores.²¹ For high-quality medical information, physicians can direct their patients both to academic institution websites and to HONcode-certified websites.

When we compared the present study with previous investigations, we found a large difference between search results for a given topic. In 2013, Duncan and colleagues⁶ and Bruce-Brand and colleagues⁹ used similar study designs (eg, search terms, search engines) for their investigations of quality of web information. Their results, however, were widely different. For example, percentages of industry authorship were 4.5% (Duncan and colleagues⁶) and 64% (Bruce-Brand and colleagues⁹). This inconsistency between studies conducted during similar periods might be related to what appears at the top of the results queue for a search. Duncan and colleagues⁶ analyzed 200 websites, Bruce-Brand and colleagues⁹ only 45. Industries may have made financial arrangements and used search engine optimization techniques to have their websites listed first in search results.

In our study, we also analyzed how web information has changed over time. On the Internet, information changes daily, and we hypothesized that the content found during our 2 searches (2011, 2014) would yield different results. Surprisingly, the data were similar, particularly concerning authorship (Figures 1, 2). In both searches, the largest authorship source was private physician or physician groups (38% in 2011 and 2014). Other authorship sources showed little change in percentage between searches. As for content, we found both increases and decreases in specific web information. Ability to contact authors increased from 21% (2011) to 50% (2014). We think it is important that websites offer a communication channel to people who read the medical information the sites provide. Percentage of websites discussing nonoperative treatment options increased from 11.5% to 61%. Therefore, patients in 2014 were being introduced to more options (in addition to surgery) for managing shoulder pain—an improvement in quality of information between the searches. Percentage of websites discussing surgical eligibility, however, decreased from 43% to 18%—a negative development in information quality. Another decrease, from 42% to 25%, was found for websites discussing surgical complications. Given the data as a whole, and our finding both negative and positive changes, it appears the quality of web content has not improved significantly. Interestingly, no websites discussed double- versus single-row surgery in 2014, but 6% did so in 2011.

Lost in the discussion of quality and reliability of information is whether patients comprehend what they are reading.²³ Yi and colleagues¹⁹ recentlyassessed the readability level of arthroscopy information in articles published online by the American Academy of Orthopaedic Surgeons (AAOS) and the Arthroscopy Association of North America (AANA). The investigators used the Flesch-Kincaid readability test to determine readability level in terms of grade level. They found that the majority of the patient education articles on the AAOS and AANA sites had a readability level far above the national average; only 4 articles were written at or below the eighth-grade level, the current average reading level in the United States.²⁴ Information that is not comprehensible is of no use to patients, and information that physicians and researchers consider high-quality might not be what patients consider high-quality. As we pursue higher-quality web content, we need to consider that its audience includes nonmedical readers, our patients. In the present study, we found that the readability of a website had no correlation with the site’s DISCERN score (Figure 5). Therefore, for information about rotator cuff repairs, higher-quality websites are no harder than lower-quality sites for patients to comprehend. The Flesch-Kincaid readability test is flawed in that it considers only total number of syllables per word and words per sentence, not nontextual elements of patient education materials, such as illustrations on a website. The 10.98 mean grade level found in our study is higher than the levels found for most studies reviewed by Yi and colleagues.¹⁹

This study had several limitations. During an Internet search, the number of websites a user visits drops precipitously after the first page of results. Studies have shown the top 20 sites in a given search receive 97% of the views, and the top 3 receive 58.4%. Whether patients visit websites far down in the list of 150 we found in our given search is unknown. Last, the Flesch-Kincaid readability test is flawed in several ways but nevertheless is used extensively in research. Grading is based on number of words and syllables used in a given sentence; it does not take into account the complexity or common usage of a given word or definition. Therefore, websites may receive low Flesch-Kincaid scores—indicating ease of reading—despite their use of complex medical terminology and jargon that complicate patients’ comprehension of the material.

Conclusion

Numerous authors have evaluated orthopedic patients’ accessing of medical information from the Internet. Although the Internet makes access easier, unreliable content can lead patients to develop certain notions about the direction of their care and certain expectations regarding their clinical outcomes. With there being no regulatory body monitoring content, the peer review process, an essential feature of academic publishing, can be easily circumvented.²⁵

In this study, the highest-quality websites had academic affiliations. Quality of information about rotator cuff repairs was similar to what was found for other orthopedic topics in comparable studies. Surprisingly, there was little change in authorship and content of web information between our 2 search periods (2011, 2014). Although there has been a rapid increase in the number of medical websites, quality of content seems not to have changed significantly. Patients look to physicians for guidance but increasingly are accessing the Internet for additional information. It is essential that physicians understand the quality of information available on the Internet when counseling patients regarding surgery.

Patients are learning about health and disease more independently than before, but such self-education may pose a unique challenge for practicing physicians. Although educated patients can assist in the critical appraisal of treatment options,¹ misinformed patients may have preconceived treatment biases and unrealistic expectations. More than 66 million Americans use the Internet daily, and recent surveys have shown 86% have used the Internet for health-related information.^2,3 With Internet use increasing, the number of patients turning to the web for medical information is increasing as well.⁴ For many patients, this information can be useful in making decisions about their health and health care.⁵

Although accessing medical information from the Internet has grown exponentially, analysis of information quality has grown considerably slower.⁶ With no regulatory body monitoring content, there is easy circumvention of the peer review process, an essential feature of academic publishing.⁷ With no external regulation, the information retrieved may be incorrect, outdated, or misleading. Many orthopedic studies have analyzed Internet content about numerous diagnoses.^3-6,8-18 Most of these studies have found this information highly variable and of poor quality.

We conducted a study to evaluate and analyze rotator cuff repair information available to the general public through the Internet; to assess changes in the quality of information over time; to determine if sites sponsored by academic institutions offered higher-quality information; and to assess whether the readability of the material varied according to DISCERN scores.

Rotator cuff repairs are among the most common surgeries performed by orthopedic surgeons. To our knowledge, this is the first study to assess the quality of web information about rotator cuff repairs. We hypothesized that the quality of information would positively correlate with the reading level of the material presented, that academic institutions would present the highest-quality information, and that the type of information presented would change over time.

Materials and Methods

We used the search phrase rotator cuff repair on the 3 most popular search engines: Google, Yahoo!, and Bing. Google is the dominant engine, taking 83.06% of total market share, followed by Yahoo! (6.86%) and Bing (4.27%).5 The first 50 websites identified by each search engine were selected for evaluation, excluding duplicates or overlapping websites. Similarly, advertisements and strictly video results lacking text were excluded. After each engine was queried, a master list of 150 websites was created for individual evaluation and assessment. To assess changes in results over time, we performed 2 searches, on November 16, 2011, and May 18, 2014.

The content of each website was analyzed for authorship, ability to contact the author, discussion of disorder, surgical treatment, complications, surgical eligibility, rehabilitation, other treatment options, and use of peer-reviewed sources. Authorship was placed in 1 of 6 categories:

1. Academic—university-affiliated physician or research group.

2. Private—physician or group without stated affiliation to an academic organization.

3. Industry—manufacturing or marketing company advertising a product or service for profit.

4. News source—bulletin or article without affiliation to a hospital or an academic institution.

5. Public education—individual or organization with noncommercial website providing third-party information (eg, Wikipedia, About.com).

6. Blog—website publishing an individual’s personal experiences in diary or journal form.

Websites were also assessed for accuracy and validity based on presence or absence of Health On the Net code (HONcode) certification and DISCERN score. Designed by the Health On the Net Foundation in 1996, HONcode provides a framework for disseminating high-quality medical information over the web.¹⁹ Website owners can request that their sites be evaluated for HONcode certification; a site that qualifies can display the HONcode seal.²⁰ The DISCERN project, initially funded by the National Health Service in the United Kingdom, judges the quality of written information available on health-related websites.²¹ It determines the quality of a publication on the basis of 16 questions: The first 8 address the publication’s reliability, the next 7 involve specific details of treatment choices, and the last is an overall rating of the website.

Website readability was assessed with the Flesch-Kincaid test. This test, designed under contract with the US Navy in 1975, has been used in other orthopedic studies.¹⁹ Regression analysis was performed to check for correlation between website readability and DISCERN score. Analysis of variance was used to analyze differences between scores.

Results

We performed a comprehensive analysis of the top 50 websites from each of the 3 search engines (N = 150 websites) (Figures 1–5, Table). Regarding authorship, our 2 searches demonstrated similar values (Figure 1). In 2011, 21% of websites were associated with an academic institution, 38% were authored by private physicians or hospital or physician groups not associated with an academic institution, 11.5% were industry-sponsored, 5% were news bulletins or media reports, 21.5% were public education websites, and 3% were personal blogs. Our 2014 search found a similar distribution of contributors. Between 2011 and 2014, the largest change was in academic authors, which decreased by 7%, from 21% to 14%. Percentage of websites authored by private physicians remained constant from the first to the second search: 38%.

When the 2011 and 2014 website content was compared, several changes were noted. Percentage of websites providing an author contact method increased from 21% to 50% (Figure 2), percentage detailing rotator cuff repairs increased from 82% to 91%, and percentage introducing treatment options in addition to surgical management increased from 11.5% to 61%. Percentage discussing surgical eligibility, however, decreased from 43% to 18%. Percentage citing peer-reviewed sources remained relatively constant (28%, 26%), as did percentage discussing surgical technique for rotator cuff repair (55%, 59%) (Figure 3). A major decrease was found in percentage of websites discussing surgical complications, 42% in 2011 down to 25% in 2014, whereas a major increase was found in percentage discussing rehabilitation, from 39% in 2011 up to 73% in 2014. In 2014, no websites discussed double- versus single-row surgery—compared with 6% in 2011. False claims remained low between 2011 and 2014. In both searches, no website guaranteed a return to sport, and few made claims of painless or bloodless surgery.

DISCERN scores for websites found during the 2014 search were averaged for each of the 6 authorship groups (Figure 4). The highest DISCERN scores were given to academic institution websites (51.6) and public education websites (49). For the academic websites, this difference was significant relative to news, blog, and private physician websites (Ps = .012, .001, .001) The lowest DISCERN scores were given to news organization websites and personal blogs. DISCERN scores were 43.8 for industry sources and 40.7 for private physician groups; the difference was not significant (P = .229). Overall mean DISCERN score for all websites was 44. Eleven percent of websites were HONcode-certified.

No correlation was found between website readability and DISCERN score; correlation coefficient r was .01 (Figure 5). For the websites in 2014, mean Flesch-Kincaid readability score was 50.17, and mean grade level was 10.98; coefficient of determination r² was 0.00012.

The Table compares our data with data from other orthopedic studies that have analyzed the quality of Internet information about various orthopedic injuries, diseases, and procedures.^{3-6,8,9,11-18} With its mean DISCERN score of 44, the present rotator cuff tear study was ranked third of 6 studies that have used this scoring system to analyze website content. Of these 6 studies, those reviewing osteosarcoma and juvenile idiopathic arthritis were ranked highest (mean scores, 49.8 and 48.9, respectively), and the study reviewing scoliosis surgery was ranked lowest (38.9). Bruce-Brand and colleagues9 recently found a mean DISCERN score of 41 for anterior cruciate ligament (ACL) reconstruction. When considering HONcode-certified websites, our Internet search for rotator cuff tears found the third lowest percentage, 10.5%, compared with the other studies (Table); the highest percentage, 30%, was found for websites discussing concussions in athletes. When considering authorship, our rotator cuff study found the third highest percentage, 76%, authored by academic centers, physicians, and public education websites; the highest percentage was found in websites discussing ACL reconstruction. Websites discussing ACL reconstruction also had the highest percentage of websites authored by industry.⁹

Discussion

To our knowledge, this is the first study specifically analyzing the quality of Internet information about rotator cuff repairs. A similar study, conducted by Starman and colleagues¹⁵ in 2010, addressed the quality of web information about 10 common sports medicine diagnoses, one of which was rotator cuff tears. In that study, only 16 of the websites included discussed rotator cuff tears. In addition, the authors used a customized, HONcode-based grading system to analyze each website, making their data difficult to compare across studies.

Ideally, a high-quality medical website should be written by a credible source and should cover a disorder, treatment options, eligibility, rehabilitation, and complications. As there is no standard grading system for analyzing web content about rotator cuff repairs, we analyzed the websites for specific information we thought should be included in a high-quality website (Figures 2, 3). When considering authorship, we found academic centers, private physicians, and educational sources comprised 76% of the sources; industry sources made up only 12%. Similar findings were noted by investigators analyzing Internet information about other orthopedic topics, including ACL reconstruction, lumbar arthroplasty, osteosarcoma, and cervical spine surgery.^5,11,22 Studies analyzing websites for information on ACL tears and distal radius fractures found have a higher percentage of industry-sponsored websites.^9,10

DISCERN showed that the highest-quality information came from websites with academic affiliations, consistent with previous studies,^3,9,17 and its mean score (51.6) was significantly higher than the scores for private physician websites, news sites, and blogs (Ps = .001, .016, .001); the least reliable information was from personal blogs and news outlets. Of note, mean DISCERN score was higher for the industry websites we found than for private physician websites (43.8 vs 40.7), though the difference was not significant (P = .229). Previous investigators considered number of industry-sponsored websites as a marker of poor quality of information relating to a given topic; however, given the DISCERN scores in our study, this might not necessarily be true.⁶ Based on the present study’s data, websites affiliated with academic institutions would be recommended for patients searching for high-quality information about rotator cuff tears.

Given DISCERN scores across studies, information about rotator cuff tears ranked below information about osteosarcoma and juvenile idiopathic arthritis but above information about scoliosis, cervical spine surgery, and ACL reconstruction (Table). DISCERN scores must be compared across studies, as there are no definitions for good and poor DISCERN scores.

Of the 4 studies that analyzed percentage of websites citing peer-reviewed sources, only our study and the study of cervical spine surgery¹⁸ analyzed that percentage as well as DISCERN score. Percentage citing peer-reviewed sources was 26% for rotator cuff tears and 24% for cervical spine surgery; the respective DISCERN scores were 44 and 43.6. As only these 2 studies could be compared, no real correlation between percentage of websites citing peer-reviewed sources and the quality of the content on a given topic can be assessed. More research into this relationship is needed. One already delineated association is the correlation between HONcode-certified sites and high DISCERN scores.²¹ For high-quality medical information, physicians can direct their patients both to academic institution websites and to HONcode-certified websites.

When we compared the present study with previous investigations, we found a large difference between search results for a given topic. In 2013, Duncan and colleagues⁶ and Bruce-Brand and colleagues⁹ used similar study designs (eg, search terms, search engines) for their investigations of quality of web information. Their results, however, were widely different. For example, percentages of industry authorship were 4.5% (Duncan and colleagues⁶) and 64% (Bruce-Brand and colleagues⁹). This inconsistency between studies conducted during similar periods might be related to what appears at the top of the results queue for a search. Duncan and colleagues⁶ analyzed 200 websites, Bruce-Brand and colleagues⁹ only 45. Industries may have made financial arrangements and used search engine optimization techniques to have their websites listed first in search results.

In our study, we also analyzed how web information has changed over time. On the Internet, information changes daily, and we hypothesized that the content found during our 2 searches (2011, 2014) would yield different results. Surprisingly, the data were similar, particularly concerning authorship (Figures 1, 2). In both searches, the largest authorship source was private physician or physician groups (38% in 2011 and 2014). Other authorship sources showed little change in percentage between searches. As for content, we found both increases and decreases in specific web information. Ability to contact authors increased from 21% (2011) to 50% (2014). We think it is important that websites offer a communication channel to people who read the medical information the sites provide. Percentage of websites discussing nonoperative treatment options increased from 11.5% to 61%. Therefore, patients in 2014 were being introduced to more options (in addition to surgery) for managing shoulder pain—an improvement in quality of information between the searches. Percentage of websites discussing surgical eligibility, however, decreased from 43% to 18%—a negative development in information quality. Another decrease, from 42% to 25%, was found for websites discussing surgical complications. Given the data as a whole, and our finding both negative and positive changes, it appears the quality of web content has not improved significantly. Interestingly, no websites discussed double- versus single-row surgery in 2014, but 6% did so in 2011.

Lost in the discussion of quality and reliability of information is whether patients comprehend what they are reading.²³ Yi and colleagues¹⁹ recentlyassessed the readability level of arthroscopy information in articles published online by the American Academy of Orthopaedic Surgeons (AAOS) and the Arthroscopy Association of North America (AANA). The investigators used the Flesch-Kincaid readability test to determine readability level in terms of grade level. They found that the majority of the patient education articles on the AAOS and AANA sites had a readability level far above the national average; only 4 articles were written at or below the eighth-grade level, the current average reading level in the United States.²⁴ Information that is not comprehensible is of no use to patients, and information that physicians and researchers consider high-quality might not be what patients consider high-quality. As we pursue higher-quality web content, we need to consider that its audience includes nonmedical readers, our patients. In the present study, we found that the readability of a website had no correlation with the site’s DISCERN score (Figure 5). Therefore, for information about rotator cuff repairs, higher-quality websites are no harder than lower-quality sites for patients to comprehend. The Flesch-Kincaid readability test is flawed in that it considers only total number of syllables per word and words per sentence, not nontextual elements of patient education materials, such as illustrations on a website. The 10.98 mean grade level found in our study is higher than the levels found for most studies reviewed by Yi and colleagues.¹⁹

This study had several limitations. During an Internet search, the number of websites a user visits drops precipitously after the first page of results. Studies have shown the top 20 sites in a given search receive 97% of the views, and the top 3 receive 58.4%. Whether patients visit websites far down in the list of 150 we found in our given search is unknown. Last, the Flesch-Kincaid readability test is flawed in several ways but nevertheless is used extensively in research. Grading is based on number of words and syllables used in a given sentence; it does not take into account the complexity or common usage of a given word or definition. Therefore, websites may receive low Flesch-Kincaid scores—indicating ease of reading—despite their use of complex medical terminology and jargon that complicate patients’ comprehension of the material.

Conclusion

Numerous authors have evaluated orthopedic patients’ accessing of medical information from the Internet. Although the Internet makes access easier, unreliable content can lead patients to develop certain notions about the direction of their care and certain expectations regarding their clinical outcomes. With there being no regulatory body monitoring content, the peer review process, an essential feature of academic publishing, can be easily circumvented.²⁵

In this study, the highest-quality websites had academic affiliations. Quality of information about rotator cuff repairs was similar to what was found for other orthopedic topics in comparable studies. Surprisingly, there was little change in authorship and content of web information between our 2 search periods (2011, 2014). Although there has been a rapid increase in the number of medical websites, quality of content seems not to have changed significantly. Patients look to physicians for guidance but increasingly are accessing the Internet for additional information. It is essential that physicians understand the quality of information available on the Internet when counseling patients regarding surgery.

Nonopioid therapy is the preferred approach for managing chronic pain outside of active cancer, palliative, and end-of-life care, according to a new guideline released today by the Centers for Disease Control and Prevention.

The 12 recommendations included in the guideline center around this principle and two others: using the lowest possible effective dosage when opioids are used, and exercising caution and monitoring patients closely when prescribing opioids.

Specifically, the guideline states that “clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient,” and that “treatment should be combined with nonpharmacologic and nonopioid therapy, as appropriate.”

The guideline also addresses steps to take before starting or continuing opioid therapy, and drug selection, dosage, duration, follow-up, and discontinuation. Recommendations for assessing risk and addressing harms of opioid use are also included.

The CDC developed the guideline as part of the U.S. government’s urgent response to the epidemic of overdose deaths, which has been fueled by a quadrupling of the prescribing and sales of opioids since 1999, according to a CDC press statement. The guideline’s purpose is to help prevent opioid misuse and overdose.

“The CDC Guideline for Prescribing Opioids for Chronic Pain, United States, 2016 will help primary care providers ensure the safest and most effective treatment for their patients,” according to the statement. The CDC’s director, Dr. Tom Frieden, noted that “overprescribing opioids – largely for chronic pain – is a key driver of America’s drug-overdose epidemic.”

In a CDC teleconference marking the release of the guideline, Dr. Frieden said it has become increasingly clear that opioids “carry substantial risks but only uncertain benefits, especially compared with other treatments for chronic pain.

“Beginning treatment with an opioid is a momentous decision, and it should only be done with full understanding by both the clinician and the patient of the substantial risks and uncertain benefits involved,” Dr. Frieden said. He added that he knows of no other medication “that’s routinely used for a nonfatal condition [and] that kills patients so frequently.

“With more than 250 million prescriptions written each year, it’s so important that doctors understand that any one of those prescriptions could potentially end a patient’s life,” he cautioned.

A 2015 study showed that 1 of every 550 patients treated with opioids for noncancer pain – and 1 of 32 who received the highest doses (more than 200 morphine milligram equivalents per day) – died within 2.5 years of the first prescription.

Dr. Frieden noted that opioids do have a place when the potential benefits outweigh the potential harms. “But for most patients – the vast majority of patients – the risks will outweigh the benefits,” he said.

The opioid epidemic is one of the most pressing public health issues in the United States today, said Sylvia M. Burwell, secretary of the Department of Health & Human Services. A year ago, she announced an HHS initiative to reduce prescription opioid and heroin-related drug overdose, death, and dependence.

“Last year, more Americans died from drug overdoses than car crashes,” Ms. Burwell said during the teleconference, noting that families across the nation and from all walks of life have been affected.

Combating the opioid epidemic is a national priority, she said, and the CDC guideline will help in that effort.

“We believe this guideline will help health care professionals provide safer and more effective care for patients dealing with chronic pain, and we also believe it will help these providers drive down the rates of opioid use disorder, overdose, and ... death,” she said.

The American Medical Association greeted the guideline with cautious support.

“While we are largely supportive of the guidelines, we remain concerned about the evidence base informing some of the recommendations,” noted Dr. Patrice A. Harris, chair-elect of the AMA board and chair of the AMA Task Force to Reduce Opioid Abuse, in a statement.

The AMA also cited potential conflicts between the guideline and product labeling and state laws, as well as obstacles such as insurance coverage limits on nonpharmacologic treatments.

“If these guidelines help reduce the deaths resulting from opioids, they will prove to be valuable,” Dr. Harris said in the statement. “If they produce unintended consequences, we will need to mitigate them.”

Of note, the guideline stresses the right of patients with chronic pain to receive safe and effective pain management, and focuses on giving primary care providers – who account for about half of all opioid prescriptions – a road map for providing such pain management by increasing the use of effective nonopioid and nonpharmacologic therapies.

It was developed through a “rigorous scientific process using the best available scientific evidence, consulting with experts, and listening to comments from the public and partner organizations,” according to the CDC statement. The organization “is dedicated to working with partners to improve the evidence base and will refine the recommendations as new research becomes available.

”In conjunction with the release of the guideline, the CDC has provided a checklist for prescribing opioids for chronic pain, and a website with additional tools for implementing the recommendations within the guideline.

The CDC's opioid recommendations

The Centers for Disease Control and Prevention’s new opioid prescription guideline includes 12 recommendations. Here they are, modified slightly for style:

1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks.

2. Before starting opioid therapy for chronic pain, providers should establish treatment goals with all patients, including realistic goals for pain and function. Providers should not initiate opioid therapy without consideration of how therapy will be discontinued if unsuccessful. Providers should continue opioid therapy only if there is clinically meaningful improvement in pain and function.

3. Before starting and periodically during opioid therapy, providers should discuss with patients known risks and realistic benefits of opioid therapy, and patient and provider responsibilities for managing therapy.

4. When starting opioid therapy for chronic pain, providers should prescribe immediate-release opioids instead of extended-release/long-acting opioids.

5. When opioids are started, providers should prescribe the lowest effective dosage. Providers should use caution when prescribing opioids at any dosage, should implement additional precautions when increasing dosage to 50 or more morphine milligram equivalents (MME) per day, and generally should avoid increasing dosage to 90 or more MME per day.

6. When opioids are used for acute pain, providers should prescribe the lowest effective dose of immediate-release opioids. Three or fewer days often will be sufficient.

7. Providers should evaluate the benefits and harms with patients within 1-4 weeks of starting opioid therapy for chronic pain or of dose escalation. They should reevaluate continued therapy’s benefits and harms every 3 months or more frequently. If continued therapy’s benefits do not outweigh harms, providers should work with patients to reduce dosages or discontinue opioids.

8. During therapy, providers should evaluate risk factors for opioid-related harm. Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose – such as history of overdose, history of substance use disorder, or higher opioid dosage (50 MME or more) – are present.

9. Providers should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving high opioid dosages or dangerous combinations that put him or her at high risk for overdose. Providers should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

10. When prescribing opioids for chronic pain, providers should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications, as well as other controlled prescription drugs and illicit drugs.

11. Providers should avoid concurrent prescriptions of opioid pain medication and benzodiazepines whenever possible.

12. Providers should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

M. Alexander Otto contributed to this article.

[email protected]

Nonopioid therapy is the preferred approach for managing chronic pain outside of active cancer, palliative, and end-of-life care, according to a new guideline released today by the Centers for Disease Control and Prevention.

The 12 recommendations included in the guideline center around this principle and two others: using the lowest possible effective dosage when opioids are used, and exercising caution and monitoring patients closely when prescribing opioids.

Specifically, the guideline states that “clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient,” and that “treatment should be combined with nonpharmacologic and nonopioid therapy, as appropriate.”

The guideline also addresses steps to take before starting or continuing opioid therapy, and drug selection, dosage, duration, follow-up, and discontinuation. Recommendations for assessing risk and addressing harms of opioid use are also included.

The CDC developed the guideline as part of the U.S. government’s urgent response to the epidemic of overdose deaths, which has been fueled by a quadrupling of the prescribing and sales of opioids since 1999, according to a CDC press statement. The guideline’s purpose is to help prevent opioid misuse and overdose.

“The CDC Guideline for Prescribing Opioids for Chronic Pain, United States, 2016 will help primary care providers ensure the safest and most effective treatment for their patients,” according to the statement. The CDC’s director, Dr. Tom Frieden, noted that “overprescribing opioids – largely for chronic pain – is a key driver of America’s drug-overdose epidemic.”

In a CDC teleconference marking the release of the guideline, Dr. Frieden said it has become increasingly clear that opioids “carry substantial risks but only uncertain benefits, especially compared with other treatments for chronic pain.

“Beginning treatment with an opioid is a momentous decision, and it should only be done with full understanding by both the clinician and the patient of the substantial risks and uncertain benefits involved,” Dr. Frieden said. He added that he knows of no other medication “that’s routinely used for a nonfatal condition [and] that kills patients so frequently.

“With more than 250 million prescriptions written each year, it’s so important that doctors understand that any one of those prescriptions could potentially end a patient’s life,” he cautioned.

A 2015 study showed that 1 of every 550 patients treated with opioids for noncancer pain – and 1 of 32 who received the highest doses (more than 200 morphine milligram equivalents per day) – died within 2.5 years of the first prescription.

Dr. Frieden noted that opioids do have a place when the potential benefits outweigh the potential harms. “But for most patients – the vast majority of patients – the risks will outweigh the benefits,” he said.

The opioid epidemic is one of the most pressing public health issues in the United States today, said Sylvia M. Burwell, secretary of the Department of Health & Human Services. A year ago, she announced an HHS initiative to reduce prescription opioid and heroin-related drug overdose, death, and dependence.

“Last year, more Americans died from drug overdoses than car crashes,” Ms. Burwell said during the teleconference, noting that families across the nation and from all walks of life have been affected.

Combating the opioid epidemic is a national priority, she said, and the CDC guideline will help in that effort.

“We believe this guideline will help health care professionals provide safer and more effective care for patients dealing with chronic pain, and we also believe it will help these providers drive down the rates of opioid use disorder, overdose, and ... death,” she said.

The American Medical Association greeted the guideline with cautious support.

“While we are largely supportive of the guidelines, we remain concerned about the evidence base informing some of the recommendations,” noted Dr. Patrice A. Harris, chair-elect of the AMA board and chair of the AMA Task Force to Reduce Opioid Abuse, in a statement.

The AMA also cited potential conflicts between the guideline and product labeling and state laws, as well as obstacles such as insurance coverage limits on nonpharmacologic treatments.

“If these guidelines help reduce the deaths resulting from opioids, they will prove to be valuable,” Dr. Harris said in the statement. “If they produce unintended consequences, we will need to mitigate them.”

Of note, the guideline stresses the right of patients with chronic pain to receive safe and effective pain management, and focuses on giving primary care providers – who account for about half of all opioid prescriptions – a road map for providing such pain management by increasing the use of effective nonopioid and nonpharmacologic therapies.

It was developed through a “rigorous scientific process using the best available scientific evidence, consulting with experts, and listening to comments from the public and partner organizations,” according to the CDC statement. The organization “is dedicated to working with partners to improve the evidence base and will refine the recommendations as new research becomes available.

”In conjunction with the release of the guideline, the CDC has provided a checklist for prescribing opioids for chronic pain, and a website with additional tools for implementing the recommendations within the guideline.

The CDC's opioid recommendations

The Centers for Disease Control and Prevention’s new opioid prescription guideline includes 12 recommendations. Here they are, modified slightly for style:

1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks.

2. Before starting opioid therapy for chronic pain, providers should establish treatment goals with all patients, including realistic goals for pain and function. Providers should not initiate opioid therapy without consideration of how therapy will be discontinued if unsuccessful. Providers should continue opioid therapy only if there is clinically meaningful improvement in pain and function.

3. Before starting and periodically during opioid therapy, providers should discuss with patients known risks and realistic benefits of opioid therapy, and patient and provider responsibilities for managing therapy.

4. When starting opioid therapy for chronic pain, providers should prescribe immediate-release opioids instead of extended-release/long-acting opioids.

5. When opioids are started, providers should prescribe the lowest effective dosage. Providers should use caution when prescribing opioids at any dosage, should implement additional precautions when increasing dosage to 50 or more morphine milligram equivalents (MME) per day, and generally should avoid increasing dosage to 90 or more MME per day.

6. When opioids are used for acute pain, providers should prescribe the lowest effective dose of immediate-release opioids. Three or fewer days often will be sufficient.

7. Providers should evaluate the benefits and harms with patients within 1-4 weeks of starting opioid therapy for chronic pain or of dose escalation. They should reevaluate continued therapy’s benefits and harms every 3 months or more frequently. If continued therapy’s benefits do not outweigh harms, providers should work with patients to reduce dosages or discontinue opioids.

8. During therapy, providers should evaluate risk factors for opioid-related harm. Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose – such as history of overdose, history of substance use disorder, or higher opioid dosage (50 MME or more) – are present.

9. Providers should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving high opioid dosages or dangerous combinations that put him or her at high risk for overdose. Providers should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

10. When prescribing opioids for chronic pain, providers should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications, as well as other controlled prescription drugs and illicit drugs.

11. Providers should avoid concurrent prescriptions of opioid pain medication and benzodiazepines whenever possible.

12. Providers should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

M. Alexander Otto contributed to this article.

[email protected]

Nonopioid therapy is the preferred approach for managing chronic pain outside of active cancer, palliative, and end-of-life care, according to a new guideline released today by the Centers for Disease Control and Prevention.

The 12 recommendations included in the guideline center around this principle and two others: using the lowest possible effective dosage when opioids are used, and exercising caution and monitoring patients closely when prescribing opioids.

Specifically, the guideline states that “clinicians should consider opioid therapy only if expected benefits for both pain and function are anticipated to outweigh risks to the patient,” and that “treatment should be combined with nonpharmacologic and nonopioid therapy, as appropriate.”

The guideline also addresses steps to take before starting or continuing opioid therapy, and drug selection, dosage, duration, follow-up, and discontinuation. Recommendations for assessing risk and addressing harms of opioid use are also included.

The CDC developed the guideline as part of the U.S. government’s urgent response to the epidemic of overdose deaths, which has been fueled by a quadrupling of the prescribing and sales of opioids since 1999, according to a CDC press statement. The guideline’s purpose is to help prevent opioid misuse and overdose.

“The CDC Guideline for Prescribing Opioids for Chronic Pain, United States, 2016 will help primary care providers ensure the safest and most effective treatment for their patients,” according to the statement. The CDC’s director, Dr. Tom Frieden, noted that “overprescribing opioids – largely for chronic pain – is a key driver of America’s drug-overdose epidemic.”

In a CDC teleconference marking the release of the guideline, Dr. Frieden said it has become increasingly clear that opioids “carry substantial risks but only uncertain benefits, especially compared with other treatments for chronic pain.

“Beginning treatment with an opioid is a momentous decision, and it should only be done with full understanding by both the clinician and the patient of the substantial risks and uncertain benefits involved,” Dr. Frieden said. He added that he knows of no other medication “that’s routinely used for a nonfatal condition [and] that kills patients so frequently.

“With more than 250 million prescriptions written each year, it’s so important that doctors understand that any one of those prescriptions could potentially end a patient’s life,” he cautioned.

A 2015 study showed that 1 of every 550 patients treated with opioids for noncancer pain – and 1 of 32 who received the highest doses (more than 200 morphine milligram equivalents per day) – died within 2.5 years of the first prescription.

Dr. Frieden noted that opioids do have a place when the potential benefits outweigh the potential harms. “But for most patients – the vast majority of patients – the risks will outweigh the benefits,” he said.

The opioid epidemic is one of the most pressing public health issues in the United States today, said Sylvia M. Burwell, secretary of the Department of Health & Human Services. A year ago, she announced an HHS initiative to reduce prescription opioid and heroin-related drug overdose, death, and dependence.

“Last year, more Americans died from drug overdoses than car crashes,” Ms. Burwell said during the teleconference, noting that families across the nation and from all walks of life have been affected.

Combating the opioid epidemic is a national priority, she said, and the CDC guideline will help in that effort.

“We believe this guideline will help health care professionals provide safer and more effective care for patients dealing with chronic pain, and we also believe it will help these providers drive down the rates of opioid use disorder, overdose, and ... death,” she said.

The American Medical Association greeted the guideline with cautious support.

“While we are largely supportive of the guidelines, we remain concerned about the evidence base informing some of the recommendations,” noted Dr. Patrice A. Harris, chair-elect of the AMA board and chair of the AMA Task Force to Reduce Opioid Abuse, in a statement.

The AMA also cited potential conflicts between the guideline and product labeling and state laws, as well as obstacles such as insurance coverage limits on nonpharmacologic treatments.

“If these guidelines help reduce the deaths resulting from opioids, they will prove to be valuable,” Dr. Harris said in the statement. “If they produce unintended consequences, we will need to mitigate them.”

Of note, the guideline stresses the right of patients with chronic pain to receive safe and effective pain management, and focuses on giving primary care providers – who account for about half of all opioid prescriptions – a road map for providing such pain management by increasing the use of effective nonopioid and nonpharmacologic therapies.

It was developed through a “rigorous scientific process using the best available scientific evidence, consulting with experts, and listening to comments from the public and partner organizations,” according to the CDC statement. The organization “is dedicated to working with partners to improve the evidence base and will refine the recommendations as new research becomes available.

”In conjunction with the release of the guideline, the CDC has provided a checklist for prescribing opioids for chronic pain, and a website with additional tools for implementing the recommendations within the guideline.

The CDC's opioid recommendations

The Centers for Disease Control and Prevention’s new opioid prescription guideline includes 12 recommendations. Here they are, modified slightly for style:

1. Nonpharmacologic therapy and nonopioid pharmacologic therapy are preferred for chronic pain. Providers should only consider adding opioid therapy if expected benefits for both pain and function are anticipated to outweigh risks.

2. Before starting opioid therapy for chronic pain, providers should establish treatment goals with all patients, including realistic goals for pain and function. Providers should not initiate opioid therapy without consideration of how therapy will be discontinued if unsuccessful. Providers should continue opioid therapy only if there is clinically meaningful improvement in pain and function.

3. Before starting and periodically during opioid therapy, providers should discuss with patients known risks and realistic benefits of opioid therapy, and patient and provider responsibilities for managing therapy.

4. When starting opioid therapy for chronic pain, providers should prescribe immediate-release opioids instead of extended-release/long-acting opioids.

5. When opioids are started, providers should prescribe the lowest effective dosage. Providers should use caution when prescribing opioids at any dosage, should implement additional precautions when increasing dosage to 50 or more morphine milligram equivalents (MME) per day, and generally should avoid increasing dosage to 90 or more MME per day.

6. When opioids are used for acute pain, providers should prescribe the lowest effective dose of immediate-release opioids. Three or fewer days often will be sufficient.

7. Providers should evaluate the benefits and harms with patients within 1-4 weeks of starting opioid therapy for chronic pain or of dose escalation. They should reevaluate continued therapy’s benefits and harms every 3 months or more frequently. If continued therapy’s benefits do not outweigh harms, providers should work with patients to reduce dosages or discontinue opioids.

8. During therapy, providers should evaluate risk factors for opioid-related harm. Providers should incorporate into the management plan strategies to mitigate risk, including considering offering naloxone when factors that increase risk for opioid overdose – such as history of overdose, history of substance use disorder, or higher opioid dosage (50 MME or more) – are present.

9. Providers should review the patient’s history of controlled substance prescriptions using state prescription drug monitoring program (PDMP) data to determine whether the patient is receiving high opioid dosages or dangerous combinations that put him or her at high risk for overdose. Providers should review PDMP data when starting opioid therapy for chronic pain and periodically during opioid therapy for chronic pain, ranging from every prescription to every 3 months.

10. When prescribing opioids for chronic pain, providers should use urine drug testing before starting opioid therapy and consider urine drug testing at least annually to assess for prescribed medications, as well as other controlled prescription drugs and illicit drugs.

11. Providers should avoid concurrent prescriptions of opioid pain medication and benzodiazepines whenever possible.

12. Providers should offer or arrange evidence-based treatment (usually medication-assisted treatment with buprenorphine or methadone in combination with behavioral therapies) for patients with opioid use disorder.

M. Alexander Otto contributed to this article.

[email protected]

Immunizing surgical patients against seasonal influenza before they are discharged from the hospital appears safe and is a sound strategy for expanding vaccine coverage, especially among people at high risk, according to a report published online March 14 in Annals of Internal Medicine.

All health care contacts, including hospitalizations, are considered excellent opportunities for influenza vaccination, and current recommendations advise that eligible inpatients receive the immunization before discharge. However, surgical patients don’t often get the flu vaccine before they leave the hospital, likely because of concerns that potential adverse effects like fever and myalgia could be falsely attributed to surgical complications. This would lead to unnecessary patient evaluations and could interfere with postsurgical care, said Sara Y. Tartof, Ph.D., and her associates in the department of research and evaluation, Kaiser Permanente Southern California, Pasadena.

©CAP53/iStockphoto.com

“Although this concern is understandable, few clinical data support it,” they noted.

“To provide clinical evidence that would either substantiate or refute” these concerns about perioperative flu vaccination, the investigators analyzed data in the electronic health records for 81,647 surgeries. All the study participants were deemed eligible for flu vaccination. They were socioeconomically and ethnically diverse, ranged in age from 6 months to 106 years, and underwent surgery at 14 hospitals during three consecutive flu seasons. Operations included general, cardiac, eye, dermatologic, ENT, neurologic, ob.gyn., oral/maxillofacial, orthopedic, plastic, podiatric, urologic, and vascular procedures.

Patients received a flu vaccine in 6,420 hospital stays for surgery – only 15% of 42,777 eligible hospitalizations – usually on the day of discharge. (The remaining 38,870 patients either had been vaccinated before hospital admission or were vaccinated more than a week after discharge and were not included in further analyses.)

Compared with eligible patients who didn’t receive a flu vaccine during hospitalization for surgery, those who did showed no increased risk for subsequent inpatient visits, ED visits, or clinical work-ups for infection. Patients who received the flu vaccine before discharge showed a minimally increased risk for outpatient visits during the week following hospitalization, but this was considered unlikely “to translate into substantial clinical impact,” especially when balanced against the benefit of immunization, Dr. Tartof and her associates said (Ann Intern Med. 2016 Mar 14. doi: 10.7326/M15-1667).

Giving the flu vaccine during a surgical hospitalization “is an opportunity to protect a high-risk population,” because surgery patients tend to be of an age, and to have comorbid conditions, that raise their risk for flu complications. In addition, previous research has reported that 39%-46% of adults hospitalized for influenza-related disease in a given year had been hospitalized during the preceding autumn, indicating that recent hospitalization also raises the risk for flu complications, the investigators said.

“Our data support the rationale for increasing vaccination rates among surgical inpatients,” they said.

This study was funded by the U.S. Centers for Disease Control and Prevention through the Vaccine Safety Datalink program. Dr. Tartof reported receiving grants from Merck outside of this work; two of her associates reported receiving grants from Novartis and GlaxoSmithKline outside of this work.

Immunizing surgical patients against seasonal influenza before they are discharged from the hospital appears safe and is a sound strategy for expanding vaccine coverage, especially among people at high risk, according to a report published online March 14 in Annals of Internal Medicine.

All health care contacts, including hospitalizations, are considered excellent opportunities for influenza vaccination, and current recommendations advise that eligible inpatients receive the immunization before discharge. However, surgical patients don’t often get the flu vaccine before they leave the hospital, likely because of concerns that potential adverse effects like fever and myalgia could be falsely attributed to surgical complications. This would lead to unnecessary patient evaluations and could interfere with postsurgical care, said Sara Y. Tartof, Ph.D., and her associates in the department of research and evaluation, Kaiser Permanente Southern California, Pasadena.

©CAP53/iStockphoto.com

“Although this concern is understandable, few clinical data support it,” they noted.

“To provide clinical evidence that would either substantiate or refute” these concerns about perioperative flu vaccination, the investigators analyzed data in the electronic health records for 81,647 surgeries. All the study participants were deemed eligible for flu vaccination. They were socioeconomically and ethnically diverse, ranged in age from 6 months to 106 years, and underwent surgery at 14 hospitals during three consecutive flu seasons. Operations included general, cardiac, eye, dermatologic, ENT, neurologic, ob.gyn., oral/maxillofacial, orthopedic, plastic, podiatric, urologic, and vascular procedures.

Patients received a flu vaccine in 6,420 hospital stays for surgery – only 15% of 42,777 eligible hospitalizations – usually on the day of discharge. (The remaining 38,870 patients either had been vaccinated before hospital admission or were vaccinated more than a week after discharge and were not included in further analyses.)

Compared with eligible patients who didn’t receive a flu vaccine during hospitalization for surgery, those who did showed no increased risk for subsequent inpatient visits, ED visits, or clinical work-ups for infection. Patients who received the flu vaccine before discharge showed a minimally increased risk for outpatient visits during the week following hospitalization, but this was considered unlikely “to translate into substantial clinical impact,” especially when balanced against the benefit of immunization, Dr. Tartof and her associates said (Ann Intern Med. 2016 Mar 14. doi: 10.7326/M15-1667).

Giving the flu vaccine during a surgical hospitalization “is an opportunity to protect a high-risk population,” because surgery patients tend to be of an age, and to have comorbid conditions, that raise their risk for flu complications. In addition, previous research has reported that 39%-46% of adults hospitalized for influenza-related disease in a given year had been hospitalized during the preceding autumn, indicating that recent hospitalization also raises the risk for flu complications, the investigators said.

“Our data support the rationale for increasing vaccination rates among surgical inpatients,” they said.

This study was funded by the U.S. Centers for Disease Control and Prevention through the Vaccine Safety Datalink program. Dr. Tartof reported receiving grants from Merck outside of this work; two of her associates reported receiving grants from Novartis and GlaxoSmithKline outside of this work.

Immunizing surgical patients against seasonal influenza before they are discharged from the hospital appears safe and is a sound strategy for expanding vaccine coverage, especially among people at high risk, according to a report published online March 14 in Annals of Internal Medicine.

All health care contacts, including hospitalizations, are considered excellent opportunities for influenza vaccination, and current recommendations advise that eligible inpatients receive the immunization before discharge. However, surgical patients don’t often get the flu vaccine before they leave the hospital, likely because of concerns that potential adverse effects like fever and myalgia could be falsely attributed to surgical complications. This would lead to unnecessary patient evaluations and could interfere with postsurgical care, said Sara Y. Tartof, Ph.D., and her associates in the department of research and evaluation, Kaiser Permanente Southern California, Pasadena.

©CAP53/iStockphoto.com

“Although this concern is understandable, few clinical data support it,” they noted.

“To provide clinical evidence that would either substantiate or refute” these concerns about perioperative flu vaccination, the investigators analyzed data in the electronic health records for 81,647 surgeries. All the study participants were deemed eligible for flu vaccination. They were socioeconomically and ethnically diverse, ranged in age from 6 months to 106 years, and underwent surgery at 14 hospitals during three consecutive flu seasons. Operations included general, cardiac, eye, dermatologic, ENT, neurologic, ob.gyn., oral/maxillofacial, orthopedic, plastic, podiatric, urologic, and vascular procedures.

Patients received a flu vaccine in 6,420 hospital stays for surgery – only 15% of 42,777 eligible hospitalizations – usually on the day of discharge. (The remaining 38,870 patients either had been vaccinated before hospital admission or were vaccinated more than a week after discharge and were not included in further analyses.)

Compared with eligible patients who didn’t receive a flu vaccine during hospitalization for surgery, those who did showed no increased risk for subsequent inpatient visits, ED visits, or clinical work-ups for infection. Patients who received the flu vaccine before discharge showed a minimally increased risk for outpatient visits during the week following hospitalization, but this was considered unlikely “to translate into substantial clinical impact,” especially when balanced against the benefit of immunization, Dr. Tartof and her associates said (Ann Intern Med. 2016 Mar 14. doi: 10.7326/M15-1667).

Giving the flu vaccine during a surgical hospitalization “is an opportunity to protect a high-risk population,” because surgery patients tend to be of an age, and to have comorbid conditions, that raise their risk for flu complications. In addition, previous research has reported that 39%-46% of adults hospitalized for influenza-related disease in a given year had been hospitalized during the preceding autumn, indicating that recent hospitalization also raises the risk for flu complications, the investigators said.

“Our data support the rationale for increasing vaccination rates among surgical inpatients,” they said.

This study was funded by the U.S. Centers for Disease Control and Prevention through the Vaccine Safety Datalink program. Dr. Tartof reported receiving grants from Merck outside of this work; two of her associates reported receiving grants from Novartis and GlaxoSmithKline outside of this work.

Systemic cobalt toxicity has been reported in the literature after hip arthroplasty revisions for failed ceramic components secondary to third-body abrasive wear of cobalt-chrome (CoCr) components, as well as with metal-on-metal (MOM) hip arthroplasty designs. There have been several cases of systemic cobalt toxicity after revision for fractured ceramic components.^1,2 Of these 7 reported cases, all patients had neurologic complaints and 4 patients developed cardiomyopathy secondary to toxic cobalt levels, with 1 case being fatal.¹ MOM hip prostheses have also been associated with local and systemic problems secondary to metal debris. Adverse local tissue reactions have been reported to occur in up to 59% of patients, and, in some registries, the failure rate of MOM arthroplasty caused by these soft-tissue reactions is 2 to 3 times that of conventional metal-on-polyethylene design failures.^3,4 The occurrence of systemic complications from MOM total hip arthroplasty (THA) wear debris is much less common. There have been 6 cases of systemic cobalt toxicity reported in the literature resulting from MOM total hip prosthesis design.^1,2

We present a case of biopsy-confirmed cardiomyopathy secondary to cobalt toxicity from a MOM THA design with subsequent requirement for left ventricular assist device (LVAD) implantation despite prosthesis removal. To our knowledge, this is the first report in the literature of this specific implant design causing systemic cobalt toxicity. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

The patient was a healthy nondiabetic man age 54 years who presented to our clinic 6 years after undergoing left THA and 5 years after undergoing right THA with the Biomet M2a-Magnum MOM prosthesis at an outside facility. The left-side components placed at the index procedure were a size 50 cup, 44 magnum head, 10 Taperloc stem (Biomet), and +9 neck. The right-side components were a size 52 cup, 46 magnum head, 10 Taperloc stem, and +3 neck. The patient emphasized that he was very happy with his hip prostheses and denied groin or thigh pain. His medical history was significant for exogenous obesity, and he denied any history of alcohol, tobacco, steroid, or recreational drug use.

The patient’s review of systems suggested that, approximately 11 months prior to presentation at our facility, he began having difficulty with his activities of daily living secondary to chest pressure with exertion, fatigue, and associated diaphoresis. He complained of decreased sensation in his feet bilaterally but denied any hearing loss, tinnitus, or vision changes. He underwent evaluation of the new-onset chest discomfort with a cardiac stress test that suggested no active cardiac ischemia. An echocardiogram revealed mitral regurgitation, stage II diastolic dysfunction with a left ventricular ejection fraction of 55%. Additionally, during this time period, the patient was being followed by his local orthopedic surgeon for an elevated cobalt level of 120 ppb and a chromium level of 109 ppb. The patient was referred to our clinic for recommendations regarding the elevated metal-ion levels. Upon initial evaluation, the patient denied any hip or groin pain. His physical examination revealed a nonantalgic gait with full range of motion and no signs of instability, tenderness, or masses. The patient was also noted to have no vibratory sensation in his feet bilaterally. The plain radiographs indicated bilateral MOM THA with acetabular inclination levels of 55º on the right and left sides. No cystic changes or other worrisome signs that would suggest implant loosening or failure were present (Figure 1). The serum metal levels were repeated and showed a cobalt level of 189 ppb and a chromium level of 71 ppb. Whole venous blood samples were drawn at our request using trace element tubes and were sent to Medtox Laboratories Inc. for analysis. Other pertinent laboratory values, including hematocrit and thyroid levels, were within normal limits. Because of concerns of systemic toxicity from significantly elevated cobalt and chromium levels, the patient elected to proceed with revision of the MOM components.

During the preoperative medical evaluation, the patient’s cardiac status was a concern, and the etiology of the cardiac dysfunction was unclear. Cardiac magnetic resonance imaging (MRI), which was performed to evaluate the extent and etiology of cardiac dysfunction, showed biventricular dysfunction. To evaluate the underlying myocardial tissue characteristics, delayed contrast imaging was performed and showed diffuse myocardial hyperenhancement of the anterior, lateral, and apical walls, with sparing of the base and midseptum. This type of extensive hyperenhancement is commonly seen with cardiac amyloidosis; however, the blood-pool kinetics during contrast administration is unusual for amyloidosis, as well as the diffuse edema noted on T2-weighted MRI. Importantly, cardiac MRI is very specific in excluding alternative diagnoses, such as postinfarct, infiltrative, acquired, viral, or alcoholic/drugs of abuse etiologies. In the absence of amyloidosis, the only other pattern that would be consistent with symptoms was diffuse, fulminant myocarditis of toxic origin lacking clinical evidence for an infectious origin. The patient’s prior exposure to cobalt was noted. Thus, the hyperenhancement and edema could be strong supportive evidence of cobalt infiltration, despite no reported cases in the literature of cobalt cardiomyopathy found on cardiac MRI.

Additional workup was initiated, and cardiac catheterization showed that the patient continued to decompensate, with worsening global left ventricular dysfunction with an ejection fraction of 30% without evidence of coronary artery disease. Also, he was noted to have mild renal impairment with a blood urea nitrogen level of 31 mg/dL and a creatinine level of 1.7 mg/dL. The etiology of the renal impairment was unknown and had not been established, according to the patient and his wife. The renal impairment was not thought to be caused by the elevated metal ions levels but likely resulted from prerenal azotemia secondary to decreased cardiac output. During catheterization, an endomyocardial biopsy was performed and the tissue sent to the Mayo Clinic pathology department for analysis. The sample showed myocyte hypertrophy and interstitial fibrosis with scattered myofibers containing large cytoplasmic vacuoles. Also present was karyomegaly consistent with myocyte hypertrophy (Figures 2A, 2B). Trichrome stain confirmed replacement of myofibers by collagen (Figure 2C). Electron microscopy performed on a paraffin block showed reduced contractile elements, vacuolar spaces, and increased lipofuscin. The findings were very consistent with, but not specific for, cardiomyopathy from cobalt toxicity. No evidence of an inflammatory infiltrate was identified. The diagnosis was cobalt cardiomyopathy based on biopsy, presentation, cobalt levels, and intraoperative findings.

The patient was admitted to the cardiac intensive care unit preoperatively and optimized with inotropic agents. A multidisciplinary consultation with the cardiology and anesthesia departments was obtained. Both recommended cardiac anesthesia with intraoperative Swan-Ganz catheter and transesophageal echo monitoring. Assuming that the patient remained hemodynamically stable with limited blood loss and the first hip was timely performed, the cardiology department recommended a single surgery, because fewer risks and complications could be expected than from a staged procedure. Subsequently, surgery was performed on the left hip via a conservative anterior approach on the fracture table. The patient remained stable with limited blood loss. During the same operating room time, revision of the right hip was performed using an anterior approach. The intraoperative findings showed evidence of pseudotumors in the adjacent soft tissues and abundant brown, creamy fluid upon entering the joint capsule, consistent with a metallic appearance. Both hips showed similar prosthetic findings. There was no significant visible wear of the large diameter metal heads or gross abnormality of the acetabular components. The trunnion area on both femoral implants was abnormal, revealing a black coating suggestive of marked corrosion. The components were all well fixed, without visible damage, and, because of his fragile cardiac status, the patient’s acetabular components were not revised. The trunnions were cleaned and the femoral heads were revised to active articulation dual-mobility metal-on-polyethylene constructs using 28-mm Biolox Option ceramic (CeramTec). The tissue specimens from the operation showed chronic inflammation with areas of fibroconnective tissue and bland fibrinoid necrosis with extensive brown pigment-laden macrophage reaction. The intraoperative cultures were negative.

The patient tolerated the surgery without complication, and his postoperative period was without incident. Nine months after surgery, the patient’s cobalt and chromium levels had declined to 16 ppb and 32 ppb, respectively (normal, <1 ppb). However, his cardiac status continued to worsen with significant shortness of breath and bilateral lower extremity edema despite diuresis. Follow-up cardiac MRI indicated progressive left and right dysfunction with ejection fractions of 23% and 25%, respectively. After progressive heart-failure symptoms, the patient was admitted to the hospital for severe congestive heart failure and underwent implantation of a HeartWare LVAD with tricuspid valve repair using an Edwards annuloplasty ring. He has since had a cardiac transplant and is doing well.

Discussion

To our knowledge, this is the first reported case of cardiomyopathy in a patient with elevated cobalt ion levels and a Biomet M2a-Magnum hip prosthesis. This is also the first reported case of cardiac MRI–defined cobalt cardiomyopathy. The cobalt levels seen in this patient were similar to those of other cases with systemic cobalt toxicity from a MOM hip construct. Mao and colleagues⁵ reported 2 cases of systemic cobalt toxicity in 2 patients with articular surface replacement hip prostheses.One patient presented with mild groin pain, neurologic symptoms, and a cobalt level of 410 ppb 5 years after her index procedure. The other patient presented with cardiac and neurologic symptoms but no hip complaints. The patient’s cobalt levels ranged from 185 ppb to 210 ppb. Both patients improved after their revision surgery, and their cobalt levels decreased. The 2 patients in Tower’s report⁶ were 49-year-old men who had articular surface replacement implants (DePuy). One patient who presented with progressive hip pain 11 months postoperatively developed neurologic symptoms and cardiomyopathy, with cobalt levels of 83 ppb before revision surgery 43 months after his index procedure. The other patient presented with hip pain and vertigo, headaches, fatigue, and dyspnea. He underwent hip revision 40 months postoperatively and required closed reduction under sedation for dislocation. Finally, and most recently, Allen and colleagues² reported a 59-year-old woman with a cobalt level of 287 ppb whose symptoms did not resolve after implantation of an LVAD or cardiac transplantation but only after removal of her bilateral hip prosthesis. Our case is most similar to this report but significantly adds to the literature in 2 distinct manners: (1) Biomet M2a-Magnum has not been implicated in cobalt toxicity; and (2) this is the first reported use of dedicated cardiac MRI to noninvasively define underlying cardiac pathology.

The cardiac manifestations secondary to systemic cobalt toxicity in this patient represent a frightening consequence of MOM prosthetic wear. The effects of cobalt toxicity on cardiac tissues were first described in a series of alcoholic patients from Manchester in 1900;⁷ however, it was not until 1967, in a series of patients in Quebec, that cobalt was found to be the inciting factor. In the modern era, hip arthroplasty techniques resulting in excessive cobalt and chromium wear have demonstrated the same findings of myocyte hypertrophy, interstitial fibrosis, and scattered myofibers containing large cytoplasmic inclusions.^8,9 The patient presented here has pathologic findings consistent with previous cases of cobalt cardiomyopathy; however, in the other cases of cardiomyopathy due to MOM total hip components, the patients’ cardiac conditions improved after the prostheses were revised and the cobalt levels began to diminish.^5,6In our case, the patient has sustained permanent damage to his myocardium and a progressive decline in his cardiac status, which is a deviation from reported cases as of 2014.

While there is no guideline to unequivocally diagnose cobalt cardiomyopathy, the constellation of findings, including pathologic, biologic, blood levels, imaging, and surgical, all uniformly indicate a unifying diagnosis. The lack of improvement after prosthetic device removal supports a diagnosis of permanent myocardial damage, which is consistent with cardiomyopathy of advanced toxic etiology.

Conclusion

This case presents a patient with bilateral MOM THAs, acetabular cup inclinations of greater than 55º, renal impairment, and cobalt levels greater than 60 ppb, with occult cardiac failure leading to LVAD implantation as a prelude to cardiac transplantation in order to avoid certain death. These factors have been shown, in prior case reports, to be associated with cardiac damage that may be reversible.⁶ However; it is important for orthopedic surgeons to recognize that certain hip prostheses can be associated or lead to irreversible cardiac damage.

Systemic cobalt toxicity has been reported in the literature after hip arthroplasty revisions for failed ceramic components secondary to third-body abrasive wear of cobalt-chrome (CoCr) components, as well as with metal-on-metal (MOM) hip arthroplasty designs. There have been several cases of systemic cobalt toxicity after revision for fractured ceramic components.^1,2 Of these 7 reported cases, all patients had neurologic complaints and 4 patients developed cardiomyopathy secondary to toxic cobalt levels, with 1 case being fatal.¹ MOM hip prostheses have also been associated with local and systemic problems secondary to metal debris. Adverse local tissue reactions have been reported to occur in up to 59% of patients, and, in some registries, the failure rate of MOM arthroplasty caused by these soft-tissue reactions is 2 to 3 times that of conventional metal-on-polyethylene design failures.^3,4 The occurrence of systemic complications from MOM total hip arthroplasty (THA) wear debris is much less common. There have been 6 cases of systemic cobalt toxicity reported in the literature resulting from MOM total hip prosthesis design.^1,2

We present a case of biopsy-confirmed cardiomyopathy secondary to cobalt toxicity from a MOM THA design with subsequent requirement for left ventricular assist device (LVAD) implantation despite prosthesis removal. To our knowledge, this is the first report in the literature of this specific implant design causing systemic cobalt toxicity. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

The patient was a healthy nondiabetic man age 54 years who presented to our clinic 6 years after undergoing left THA and 5 years after undergoing right THA with the Biomet M2a-Magnum MOM prosthesis at an outside facility. The left-side components placed at the index procedure were a size 50 cup, 44 magnum head, 10 Taperloc stem (Biomet), and +9 neck. The right-side components were a size 52 cup, 46 magnum head, 10 Taperloc stem, and +3 neck. The patient emphasized that he was very happy with his hip prostheses and denied groin or thigh pain. His medical history was significant for exogenous obesity, and he denied any history of alcohol, tobacco, steroid, or recreational drug use.

The patient’s review of systems suggested that, approximately 11 months prior to presentation at our facility, he began having difficulty with his activities of daily living secondary to chest pressure with exertion, fatigue, and associated diaphoresis. He complained of decreased sensation in his feet bilaterally but denied any hearing loss, tinnitus, or vision changes. He underwent evaluation of the new-onset chest discomfort with a cardiac stress test that suggested no active cardiac ischemia. An echocardiogram revealed mitral regurgitation, stage II diastolic dysfunction with a left ventricular ejection fraction of 55%. Additionally, during this time period, the patient was being followed by his local orthopedic surgeon for an elevated cobalt level of 120 ppb and a chromium level of 109 ppb. The patient was referred to our clinic for recommendations regarding the elevated metal-ion levels. Upon initial evaluation, the patient denied any hip or groin pain. His physical examination revealed a nonantalgic gait with full range of motion and no signs of instability, tenderness, or masses. The patient was also noted to have no vibratory sensation in his feet bilaterally. The plain radiographs indicated bilateral MOM THA with acetabular inclination levels of 55º on the right and left sides. No cystic changes or other worrisome signs that would suggest implant loosening or failure were present (Figure 1). The serum metal levels were repeated and showed a cobalt level of 189 ppb and a chromium level of 71 ppb. Whole venous blood samples were drawn at our request using trace element tubes and were sent to Medtox Laboratories Inc. for analysis. Other pertinent laboratory values, including hematocrit and thyroid levels, were within normal limits. Because of concerns of systemic toxicity from significantly elevated cobalt and chromium levels, the patient elected to proceed with revision of the MOM components.

During the preoperative medical evaluation, the patient’s cardiac status was a concern, and the etiology of the cardiac dysfunction was unclear. Cardiac magnetic resonance imaging (MRI), which was performed to evaluate the extent and etiology of cardiac dysfunction, showed biventricular dysfunction. To evaluate the underlying myocardial tissue characteristics, delayed contrast imaging was performed and showed diffuse myocardial hyperenhancement of the anterior, lateral, and apical walls, with sparing of the base and midseptum. This type of extensive hyperenhancement is commonly seen with cardiac amyloidosis; however, the blood-pool kinetics during contrast administration is unusual for amyloidosis, as well as the diffuse edema noted on T2-weighted MRI. Importantly, cardiac MRI is very specific in excluding alternative diagnoses, such as postinfarct, infiltrative, acquired, viral, or alcoholic/drugs of abuse etiologies. In the absence of amyloidosis, the only other pattern that would be consistent with symptoms was diffuse, fulminant myocarditis of toxic origin lacking clinical evidence for an infectious origin. The patient’s prior exposure to cobalt was noted. Thus, the hyperenhancement and edema could be strong supportive evidence of cobalt infiltration, despite no reported cases in the literature of cobalt cardiomyopathy found on cardiac MRI.

Additional workup was initiated, and cardiac catheterization showed that the patient continued to decompensate, with worsening global left ventricular dysfunction with an ejection fraction of 30% without evidence of coronary artery disease. Also, he was noted to have mild renal impairment with a blood urea nitrogen level of 31 mg/dL and a creatinine level of 1.7 mg/dL. The etiology of the renal impairment was unknown and had not been established, according to the patient and his wife. The renal impairment was not thought to be caused by the elevated metal ions levels but likely resulted from prerenal azotemia secondary to decreased cardiac output. During catheterization, an endomyocardial biopsy was performed and the tissue sent to the Mayo Clinic pathology department for analysis. The sample showed myocyte hypertrophy and interstitial fibrosis with scattered myofibers containing large cytoplasmic vacuoles. Also present was karyomegaly consistent with myocyte hypertrophy (Figures 2A, 2B). Trichrome stain confirmed replacement of myofibers by collagen (Figure 2C). Electron microscopy performed on a paraffin block showed reduced contractile elements, vacuolar spaces, and increased lipofuscin. The findings were very consistent with, but not specific for, cardiomyopathy from cobalt toxicity. No evidence of an inflammatory infiltrate was identified. The diagnosis was cobalt cardiomyopathy based on biopsy, presentation, cobalt levels, and intraoperative findings.

The patient was admitted to the cardiac intensive care unit preoperatively and optimized with inotropic agents. A multidisciplinary consultation with the cardiology and anesthesia departments was obtained. Both recommended cardiac anesthesia with intraoperative Swan-Ganz catheter and transesophageal echo monitoring. Assuming that the patient remained hemodynamically stable with limited blood loss and the first hip was timely performed, the cardiology department recommended a single surgery, because fewer risks and complications could be expected than from a staged procedure. Subsequently, surgery was performed on the left hip via a conservative anterior approach on the fracture table. The patient remained stable with limited blood loss. During the same operating room time, revision of the right hip was performed using an anterior approach. The intraoperative findings showed evidence of pseudotumors in the adjacent soft tissues and abundant brown, creamy fluid upon entering the joint capsule, consistent with a metallic appearance. Both hips showed similar prosthetic findings. There was no significant visible wear of the large diameter metal heads or gross abnormality of the acetabular components. The trunnion area on both femoral implants was abnormal, revealing a black coating suggestive of marked corrosion. The components were all well fixed, without visible damage, and, because of his fragile cardiac status, the patient’s acetabular components were not revised. The trunnions were cleaned and the femoral heads were revised to active articulation dual-mobility metal-on-polyethylene constructs using 28-mm Biolox Option ceramic (CeramTec). The tissue specimens from the operation showed chronic inflammation with areas of fibroconnective tissue and bland fibrinoid necrosis with extensive brown pigment-laden macrophage reaction. The intraoperative cultures were negative.

The patient tolerated the surgery without complication, and his postoperative period was without incident. Nine months after surgery, the patient’s cobalt and chromium levels had declined to 16 ppb and 32 ppb, respectively (normal, <1 ppb). However, his cardiac status continued to worsen with significant shortness of breath and bilateral lower extremity edema despite diuresis. Follow-up cardiac MRI indicated progressive left and right dysfunction with ejection fractions of 23% and 25%, respectively. After progressive heart-failure symptoms, the patient was admitted to the hospital for severe congestive heart failure and underwent implantation of a HeartWare LVAD with tricuspid valve repair using an Edwards annuloplasty ring. He has since had a cardiac transplant and is doing well.

Discussion

To our knowledge, this is the first reported case of cardiomyopathy in a patient with elevated cobalt ion levels and a Biomet M2a-Magnum hip prosthesis. This is also the first reported case of cardiac MRI–defined cobalt cardiomyopathy. The cobalt levels seen in this patient were similar to those of other cases with systemic cobalt toxicity from a MOM hip construct. Mao and colleagues⁵ reported 2 cases of systemic cobalt toxicity in 2 patients with articular surface replacement hip prostheses.One patient presented with mild groin pain, neurologic symptoms, and a cobalt level of 410 ppb 5 years after her index procedure. The other patient presented with cardiac and neurologic symptoms but no hip complaints. The patient’s cobalt levels ranged from 185 ppb to 210 ppb. Both patients improved after their revision surgery, and their cobalt levels decreased. The 2 patients in Tower’s report⁶ were 49-year-old men who had articular surface replacement implants (DePuy). One patient who presented with progressive hip pain 11 months postoperatively developed neurologic symptoms and cardiomyopathy, with cobalt levels of 83 ppb before revision surgery 43 months after his index procedure. The other patient presented with hip pain and vertigo, headaches, fatigue, and dyspnea. He underwent hip revision 40 months postoperatively and required closed reduction under sedation for dislocation. Finally, and most recently, Allen and colleagues² reported a 59-year-old woman with a cobalt level of 287 ppb whose symptoms did not resolve after implantation of an LVAD or cardiac transplantation but only after removal of her bilateral hip prosthesis. Our case is most similar to this report but significantly adds to the literature in 2 distinct manners: (1) Biomet M2a-Magnum has not been implicated in cobalt toxicity; and (2) this is the first reported use of dedicated cardiac MRI to noninvasively define underlying cardiac pathology.

The cardiac manifestations secondary to systemic cobalt toxicity in this patient represent a frightening consequence of MOM prosthetic wear. The effects of cobalt toxicity on cardiac tissues were first described in a series of alcoholic patients from Manchester in 1900;⁷ however, it was not until 1967, in a series of patients in Quebec, that cobalt was found to be the inciting factor. In the modern era, hip arthroplasty techniques resulting in excessive cobalt and chromium wear have demonstrated the same findings of myocyte hypertrophy, interstitial fibrosis, and scattered myofibers containing large cytoplasmic inclusions.^8,9 The patient presented here has pathologic findings consistent with previous cases of cobalt cardiomyopathy; however, in the other cases of cardiomyopathy due to MOM total hip components, the patients’ cardiac conditions improved after the prostheses were revised and the cobalt levels began to diminish.^5,6In our case, the patient has sustained permanent damage to his myocardium and a progressive decline in his cardiac status, which is a deviation from reported cases as of 2014.

While there is no guideline to unequivocally diagnose cobalt cardiomyopathy, the constellation of findings, including pathologic, biologic, blood levels, imaging, and surgical, all uniformly indicate a unifying diagnosis. The lack of improvement after prosthetic device removal supports a diagnosis of permanent myocardial damage, which is consistent with cardiomyopathy of advanced toxic etiology.

Conclusion

This case presents a patient with bilateral MOM THAs, acetabular cup inclinations of greater than 55º, renal impairment, and cobalt levels greater than 60 ppb, with occult cardiac failure leading to LVAD implantation as a prelude to cardiac transplantation in order to avoid certain death. These factors have been shown, in prior case reports, to be associated with cardiac damage that may be reversible.⁶ However; it is important for orthopedic surgeons to recognize that certain hip prostheses can be associated or lead to irreversible cardiac damage.

Systemic cobalt toxicity has been reported in the literature after hip arthroplasty revisions for failed ceramic components secondary to third-body abrasive wear of cobalt-chrome (CoCr) components, as well as with metal-on-metal (MOM) hip arthroplasty designs. There have been several cases of systemic cobalt toxicity after revision for fractured ceramic components.^1,2 Of these 7 reported cases, all patients had neurologic complaints and 4 patients developed cardiomyopathy secondary to toxic cobalt levels, with 1 case being fatal.¹ MOM hip prostheses have also been associated with local and systemic problems secondary to metal debris. Adverse local tissue reactions have been reported to occur in up to 59% of patients, and, in some registries, the failure rate of MOM arthroplasty caused by these soft-tissue reactions is 2 to 3 times that of conventional metal-on-polyethylene design failures.^3,4 The occurrence of systemic complications from MOM total hip arthroplasty (THA) wear debris is much less common. There have been 6 cases of systemic cobalt toxicity reported in the literature resulting from MOM total hip prosthesis design.^1,2

We present a case of biopsy-confirmed cardiomyopathy secondary to cobalt toxicity from a MOM THA design with subsequent requirement for left ventricular assist device (LVAD) implantation despite prosthesis removal. To our knowledge, this is the first report in the literature of this specific implant design causing systemic cobalt toxicity. The patient provided written informed consent for print and electronic publication of this case report.

Case Report

The patient was a healthy nondiabetic man age 54 years who presented to our clinic 6 years after undergoing left THA and 5 years after undergoing right THA with the Biomet M2a-Magnum MOM prosthesis at an outside facility. The left-side components placed at the index procedure were a size 50 cup, 44 magnum head, 10 Taperloc stem (Biomet), and +9 neck. The right-side components were a size 52 cup, 46 magnum head, 10 Taperloc stem, and +3 neck. The patient emphasized that he was very happy with his hip prostheses and denied groin or thigh pain. His medical history was significant for exogenous obesity, and he denied any history of alcohol, tobacco, steroid, or recreational drug use.

The patient’s review of systems suggested that, approximately 11 months prior to presentation at our facility, he began having difficulty with his activities of daily living secondary to chest pressure with exertion, fatigue, and associated diaphoresis. He complained of decreased sensation in his feet bilaterally but denied any hearing loss, tinnitus, or vision changes. He underwent evaluation of the new-onset chest discomfort with a cardiac stress test that suggested no active cardiac ischemia. An echocardiogram revealed mitral regurgitation, stage II diastolic dysfunction with a left ventricular ejection fraction of 55%. Additionally, during this time period, the patient was being followed by his local orthopedic surgeon for an elevated cobalt level of 120 ppb and a chromium level of 109 ppb. The patient was referred to our clinic for recommendations regarding the elevated metal-ion levels. Upon initial evaluation, the patient denied any hip or groin pain. His physical examination revealed a nonantalgic gait with full range of motion and no signs of instability, tenderness, or masses. The patient was also noted to have no vibratory sensation in his feet bilaterally. The plain radiographs indicated bilateral MOM THA with acetabular inclination levels of 55º on the right and left sides. No cystic changes or other worrisome signs that would suggest implant loosening or failure were present (Figure 1). The serum metal levels were repeated and showed a cobalt level of 189 ppb and a chromium level of 71 ppb. Whole venous blood samples were drawn at our request using trace element tubes and were sent to Medtox Laboratories Inc. for analysis. Other pertinent laboratory values, including hematocrit and thyroid levels, were within normal limits. Because of concerns of systemic toxicity from significantly elevated cobalt and chromium levels, the patient elected to proceed with revision of the MOM components.

During the preoperative medical evaluation, the patient’s cardiac status was a concern, and the etiology of the cardiac dysfunction was unclear. Cardiac magnetic resonance imaging (MRI), which was performed to evaluate the extent and etiology of cardiac dysfunction, showed biventricular dysfunction. To evaluate the underlying myocardial tissue characteristics, delayed contrast imaging was performed and showed diffuse myocardial hyperenhancement of the anterior, lateral, and apical walls, with sparing of the base and midseptum. This type of extensive hyperenhancement is commonly seen with cardiac amyloidosis; however, the blood-pool kinetics during contrast administration is unusual for amyloidosis, as well as the diffuse edema noted on T2-weighted MRI. Importantly, cardiac MRI is very specific in excluding alternative diagnoses, such as postinfarct, infiltrative, acquired, viral, or alcoholic/drugs of abuse etiologies. In the absence of amyloidosis, the only other pattern that would be consistent with symptoms was diffuse, fulminant myocarditis of toxic origin lacking clinical evidence for an infectious origin. The patient’s prior exposure to cobalt was noted. Thus, the hyperenhancement and edema could be strong supportive evidence of cobalt infiltration, despite no reported cases in the literature of cobalt cardiomyopathy found on cardiac MRI.

Additional workup was initiated, and cardiac catheterization showed that the patient continued to decompensate, with worsening global left ventricular dysfunction with an ejection fraction of 30% without evidence of coronary artery disease. Also, he was noted to have mild renal impairment with a blood urea nitrogen level of 31 mg/dL and a creatinine level of 1.7 mg/dL. The etiology of the renal impairment was unknown and had not been established, according to the patient and his wife. The renal impairment was not thought to be caused by the elevated metal ions levels but likely resulted from prerenal azotemia secondary to decreased cardiac output. During catheterization, an endomyocardial biopsy was performed and the tissue sent to the Mayo Clinic pathology department for analysis. The sample showed myocyte hypertrophy and interstitial fibrosis with scattered myofibers containing large cytoplasmic vacuoles. Also present was karyomegaly consistent with myocyte hypertrophy (Figures 2A, 2B). Trichrome stain confirmed replacement of myofibers by collagen (Figure 2C). Electron microscopy performed on a paraffin block showed reduced contractile elements, vacuolar spaces, and increased lipofuscin. The findings were very consistent with, but not specific for, cardiomyopathy from cobalt toxicity. No evidence of an inflammatory infiltrate was identified. The diagnosis was cobalt cardiomyopathy based on biopsy, presentation, cobalt levels, and intraoperative findings.

The patient was admitted to the cardiac intensive care unit preoperatively and optimized with inotropic agents. A multidisciplinary consultation with the cardiology and anesthesia departments was obtained. Both recommended cardiac anesthesia with intraoperative Swan-Ganz catheter and transesophageal echo monitoring. Assuming that the patient remained hemodynamically stable with limited blood loss and the first hip was timely performed, the cardiology department recommended a single surgery, because fewer risks and complications could be expected than from a staged procedure. Subsequently, surgery was performed on the left hip via a conservative anterior approach on the fracture table. The patient remained stable with limited blood loss. During the same operating room time, revision of the right hip was performed using an anterior approach. The intraoperative findings showed evidence of pseudotumors in the adjacent soft tissues and abundant brown, creamy fluid upon entering the joint capsule, consistent with a metallic appearance. Both hips showed similar prosthetic findings. There was no significant visible wear of the large diameter metal heads or gross abnormality of the acetabular components. The trunnion area on both femoral implants was abnormal, revealing a black coating suggestive of marked corrosion. The components were all well fixed, without visible damage, and, because of his fragile cardiac status, the patient’s acetabular components were not revised. The trunnions were cleaned and the femoral heads were revised to active articulation dual-mobility metal-on-polyethylene constructs using 28-mm Biolox Option ceramic (CeramTec). The tissue specimens from the operation showed chronic inflammation with areas of fibroconnective tissue and bland fibrinoid necrosis with extensive brown pigment-laden macrophage reaction. The intraoperative cultures were negative.

The patient tolerated the surgery without complication, and his postoperative period was without incident. Nine months after surgery, the patient’s cobalt and chromium levels had declined to 16 ppb and 32 ppb, respectively (normal, <1 ppb). However, his cardiac status continued to worsen with significant shortness of breath and bilateral lower extremity edema despite diuresis. Follow-up cardiac MRI indicated progressive left and right dysfunction with ejection fractions of 23% and 25%, respectively. After progressive heart-failure symptoms, the patient was admitted to the hospital for severe congestive heart failure and underwent implantation of a HeartWare LVAD with tricuspid valve repair using an Edwards annuloplasty ring. He has since had a cardiac transplant and is doing well.

Discussion

To our knowledge, this is the first reported case of cardiomyopathy in a patient with elevated cobalt ion levels and a Biomet M2a-Magnum hip prosthesis. This is also the first reported case of cardiac MRI–defined cobalt cardiomyopathy. The cobalt levels seen in this patient were similar to those of other cases with systemic cobalt toxicity from a MOM hip construct. Mao and colleagues⁵ reported 2 cases of systemic cobalt toxicity in 2 patients with articular surface replacement hip prostheses.One patient presented with mild groin pain, neurologic symptoms, and a cobalt level of 410 ppb 5 years after her index procedure. The other patient presented with cardiac and neurologic symptoms but no hip complaints. The patient’s cobalt levels ranged from 185 ppb to 210 ppb. Both patients improved after their revision surgery, and their cobalt levels decreased. The 2 patients in Tower’s report⁶ were 49-year-old men who had articular surface replacement implants (DePuy). One patient who presented with progressive hip pain 11 months postoperatively developed neurologic symptoms and cardiomyopathy, with cobalt levels of 83 ppb before revision surgery 43 months after his index procedure. The other patient presented with hip pain and vertigo, headaches, fatigue, and dyspnea. He underwent hip revision 40 months postoperatively and required closed reduction under sedation for dislocation. Finally, and most recently, Allen and colleagues² reported a 59-year-old woman with a cobalt level of 287 ppb whose symptoms did not resolve after implantation of an LVAD or cardiac transplantation but only after removal of her bilateral hip prosthesis. Our case is most similar to this report but significantly adds to the literature in 2 distinct manners: (1) Biomet M2a-Magnum has not been implicated in cobalt toxicity; and (2) this is the first reported use of dedicated cardiac MRI to noninvasively define underlying cardiac pathology.

The cardiac manifestations secondary to systemic cobalt toxicity in this patient represent a frightening consequence of MOM prosthetic wear. The effects of cobalt toxicity on cardiac tissues were first described in a series of alcoholic patients from Manchester in 1900;⁷ however, it was not until 1967, in a series of patients in Quebec, that cobalt was found to be the inciting factor. In the modern era, hip arthroplasty techniques resulting in excessive cobalt and chromium wear have demonstrated the same findings of myocyte hypertrophy, interstitial fibrosis, and scattered myofibers containing large cytoplasmic inclusions.^8,9 The patient presented here has pathologic findings consistent with previous cases of cobalt cardiomyopathy; however, in the other cases of cardiomyopathy due to MOM total hip components, the patients’ cardiac conditions improved after the prostheses were revised and the cobalt levels began to diminish.^5,6In our case, the patient has sustained permanent damage to his myocardium and a progressive decline in his cardiac status, which is a deviation from reported cases as of 2014.

While there is no guideline to unequivocally diagnose cobalt cardiomyopathy, the constellation of findings, including pathologic, biologic, blood levels, imaging, and surgical, all uniformly indicate a unifying diagnosis. The lack of improvement after prosthetic device removal supports a diagnosis of permanent myocardial damage, which is consistent with cardiomyopathy of advanced toxic etiology.

Conclusion

This case presents a patient with bilateral MOM THAs, acetabular cup inclinations of greater than 55º, renal impairment, and cobalt levels greater than 60 ppb, with occult cardiac failure leading to LVAD implantation as a prelude to cardiac transplantation in order to avoid certain death. These factors have been shown, in prior case reports, to be associated with cardiac damage that may be reversible.⁶ However; it is important for orthopedic surgeons to recognize that certain hip prostheses can be associated or lead to irreversible cardiac damage.