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Three Factors Increase Risk for Hip Replacement Revision

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Three Factors Increase Risk for Hip Replacement Revision

SAN DIEGO – People who are overweight or younger than 75 years when they have a total hip replacement face an increased risk for revision within 12 years; the risk is also increased if cement was used to hold the femoral stem of the implant in place.

"Patients and physicians may wish to weave some of these findings into their decisions about whether to undergo primary [total hip replacement] because they inform the subsequent risk of revision," said the study’s lead author, Dr. Jeffrey Katz, professor of medicine and orthopedic surgery at Harvard Medical School, Boston.

Using hospital records and Medicare claims data, Dr. Katz and his associates examined the presurgery characteristics of 836 people who had initial total hip replacements (THRs) from July 1995 to June 1996 and subsequent revisions sometime before 2009. The researchers then compared those patients to 836 matched controls who also had THRs in the mid-1990s but whose prosthetic hip had not been revised by the time their case had a revision.

Patients who had a prior contralateral hip replacement, a prior history of other orthopedic surgery, and those who lived with others, instead of alone, also had a higher revision risk. Odds ratios were modest but statistically significant, ranging from 1.3 to 1.7.

"Age and weight were not surprising. We thought we might see an effect of sex [since] there is a literature of males being at higher risk, but we did not. There is also literature on comorbidity being associated with revision, which we did not see," Dr. Katz said at the World Congress on Osteoarthritis.

The cement finding adds "to what is a rather conflicted literature on the durability of cemented versus uncemented designs," he said. The odds ratio for the finding was 1.4.

Cement techniques – including techniques for reaming out the femur and applying the pressure to the cement – have improved since the mid-1990s, so "you have to be careful interpreting the [cement] data. They may not apply to the way cement is used now," Dr. Katz said.

Based on the findings, "when you talk to somebody who is in their mid to late 70s about hip replacement, I think you can say revision is not particularly likely. For a younger person, they should recognize that we may have to go back again. At that point, they’ll be older and have greater surgical risk," he said.

The manufacturer of the implants, the initial surgeon’s level of experience with the procedure, and the reasons for the revisions were not captured by the study.

The researchers also found a higher risk of revision if, at the time of their initial surgery, patients had a body mass index (BMI) greater than 30 kg/m2 (OR, 1.5) or were in the highest tertile for weight (OR, 1.7) or height (OR, 1.4).

Dr. Katz offered several interpretations. Height, weight, and BMI are likely related to the biomechanical load on the implant. Regarding the greater risk below age 75 years (OR, 1.5), younger, more active patients may be more likely to have a faulty THR fixed. Increased risk for prior contralateral hip replacements (OR, 1.4) or orthopedic surgery (OR, 1.5) may indicated a willingness and ability to undergo surgery.

The added risk from living with others (OR, 1.3) "may represent having the social support in place to deal with rehab and a temporary dependency," which facilitates elective surgery, he said.

There are about 280,000 primary THRs in the United States annually, and about 50,000 revisions. The revision rate is about 1% a year, "so 100 people who go out 20 years, you might expect 20 of them to be revised," Dr. Katz said at the congress, which was sponsored by the Osteoarthritis Research Society International.

The work was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Katz said he has no disclosures.

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SAN DIEGO – People who are overweight or younger than 75 years when they have a total hip replacement face an increased risk for revision within 12 years; the risk is also increased if cement was used to hold the femoral stem of the implant in place.

"Patients and physicians may wish to weave some of these findings into their decisions about whether to undergo primary [total hip replacement] because they inform the subsequent risk of revision," said the study’s lead author, Dr. Jeffrey Katz, professor of medicine and orthopedic surgery at Harvard Medical School, Boston.

Using hospital records and Medicare claims data, Dr. Katz and his associates examined the presurgery characteristics of 836 people who had initial total hip replacements (THRs) from July 1995 to June 1996 and subsequent revisions sometime before 2009. The researchers then compared those patients to 836 matched controls who also had THRs in the mid-1990s but whose prosthetic hip had not been revised by the time their case had a revision.

Patients who had a prior contralateral hip replacement, a prior history of other orthopedic surgery, and those who lived with others, instead of alone, also had a higher revision risk. Odds ratios were modest but statistically significant, ranging from 1.3 to 1.7.

"Age and weight were not surprising. We thought we might see an effect of sex [since] there is a literature of males being at higher risk, but we did not. There is also literature on comorbidity being associated with revision, which we did not see," Dr. Katz said at the World Congress on Osteoarthritis.

The cement finding adds "to what is a rather conflicted literature on the durability of cemented versus uncemented designs," he said. The odds ratio for the finding was 1.4.

Cement techniques – including techniques for reaming out the femur and applying the pressure to the cement – have improved since the mid-1990s, so "you have to be careful interpreting the [cement] data. They may not apply to the way cement is used now," Dr. Katz said.

Based on the findings, "when you talk to somebody who is in their mid to late 70s about hip replacement, I think you can say revision is not particularly likely. For a younger person, they should recognize that we may have to go back again. At that point, they’ll be older and have greater surgical risk," he said.

The manufacturer of the implants, the initial surgeon’s level of experience with the procedure, and the reasons for the revisions were not captured by the study.

The researchers also found a higher risk of revision if, at the time of their initial surgery, patients had a body mass index (BMI) greater than 30 kg/m2 (OR, 1.5) or were in the highest tertile for weight (OR, 1.7) or height (OR, 1.4).

Dr. Katz offered several interpretations. Height, weight, and BMI are likely related to the biomechanical load on the implant. Regarding the greater risk below age 75 years (OR, 1.5), younger, more active patients may be more likely to have a faulty THR fixed. Increased risk for prior contralateral hip replacements (OR, 1.4) or orthopedic surgery (OR, 1.5) may indicated a willingness and ability to undergo surgery.

The added risk from living with others (OR, 1.3) "may represent having the social support in place to deal with rehab and a temporary dependency," which facilitates elective surgery, he said.

There are about 280,000 primary THRs in the United States annually, and about 50,000 revisions. The revision rate is about 1% a year, "so 100 people who go out 20 years, you might expect 20 of them to be revised," Dr. Katz said at the congress, which was sponsored by the Osteoarthritis Research Society International.

The work was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Katz said he has no disclosures.

SAN DIEGO – People who are overweight or younger than 75 years when they have a total hip replacement face an increased risk for revision within 12 years; the risk is also increased if cement was used to hold the femoral stem of the implant in place.

"Patients and physicians may wish to weave some of these findings into their decisions about whether to undergo primary [total hip replacement] because they inform the subsequent risk of revision," said the study’s lead author, Dr. Jeffrey Katz, professor of medicine and orthopedic surgery at Harvard Medical School, Boston.

Using hospital records and Medicare claims data, Dr. Katz and his associates examined the presurgery characteristics of 836 people who had initial total hip replacements (THRs) from July 1995 to June 1996 and subsequent revisions sometime before 2009. The researchers then compared those patients to 836 matched controls who also had THRs in the mid-1990s but whose prosthetic hip had not been revised by the time their case had a revision.

Patients who had a prior contralateral hip replacement, a prior history of other orthopedic surgery, and those who lived with others, instead of alone, also had a higher revision risk. Odds ratios were modest but statistically significant, ranging from 1.3 to 1.7.

"Age and weight were not surprising. We thought we might see an effect of sex [since] there is a literature of males being at higher risk, but we did not. There is also literature on comorbidity being associated with revision, which we did not see," Dr. Katz said at the World Congress on Osteoarthritis.

The cement finding adds "to what is a rather conflicted literature on the durability of cemented versus uncemented designs," he said. The odds ratio for the finding was 1.4.

Cement techniques – including techniques for reaming out the femur and applying the pressure to the cement – have improved since the mid-1990s, so "you have to be careful interpreting the [cement] data. They may not apply to the way cement is used now," Dr. Katz said.

Based on the findings, "when you talk to somebody who is in their mid to late 70s about hip replacement, I think you can say revision is not particularly likely. For a younger person, they should recognize that we may have to go back again. At that point, they’ll be older and have greater surgical risk," he said.

The manufacturer of the implants, the initial surgeon’s level of experience with the procedure, and the reasons for the revisions were not captured by the study.

The researchers also found a higher risk of revision if, at the time of their initial surgery, patients had a body mass index (BMI) greater than 30 kg/m2 (OR, 1.5) or were in the highest tertile for weight (OR, 1.7) or height (OR, 1.4).

Dr. Katz offered several interpretations. Height, weight, and BMI are likely related to the biomechanical load on the implant. Regarding the greater risk below age 75 years (OR, 1.5), younger, more active patients may be more likely to have a faulty THR fixed. Increased risk for prior contralateral hip replacements (OR, 1.4) or orthopedic surgery (OR, 1.5) may indicated a willingness and ability to undergo surgery.

The added risk from living with others (OR, 1.3) "may represent having the social support in place to deal with rehab and a temporary dependency," which facilitates elective surgery, he said.

There are about 280,000 primary THRs in the United States annually, and about 50,000 revisions. The revision rate is about 1% a year, "so 100 people who go out 20 years, you might expect 20 of them to be revised," Dr. Katz said at the congress, which was sponsored by the Osteoarthritis Research Society International.

The work was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Katz said he has no disclosures.

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Major Finding: Patients had a higher revision risk after a total hip replacement if, at the time of their initial surgery, they had a BMI greater than 30 kg/m2 (OR, 1.5), a cemented femur implant stem (OR, 1.4), a prior contralateral THR (OR, 1.4), previous orthopedic surgery (OR, 1.5), or an age younger than 75 years (OR, 1.5).

Data Source: Case-control study involving 1,672 patients.

Disclosures: The work was funded by the National Institute of Arthritis and Musculoskeletal and Skin Diseases. Dr. Katz said he has no disclosures.

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Denosumab Effect Greater in Selected Patients : Patients with femoral neck osteoporosis had fewer fractures.

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Denosumab Effect Greater in Selected Patients : Patients with femoral neck osteoporosis had fewer fractures.

SAN FRANCISCO – The pivotal clinical trial of denosumab showed a 20% decrease in nonvertebral fractures compared with placebo treatment, but a new subgroup analysis shows the protective effect is significantly higher in patients with femoral neck osteoporosis.

The preplanned subgroup analysis of data from the FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) trial found that denosumab decreased nonvertebral fractures by 35% in patients with a femoral neck bone mineral density T score of −2.5 or lower and by only 3% in patients with higher femoral neck T scores, compared with patients in those subgroups who received placebo, Dr. Steven R. Cummings said.

The report of a 20% reduction in nonvertebral fractures in the overall trial for denosumab “underestimates its efficacy for those patients that we're most interested in treating with this drug – those with osteoporosis,” he said at a conference on osteoporosis sponsored by the University of California, San Francisco.

The findings have been submitted for publication. The analysis is one of several preplanned subgroup analyses being conducted, though this one is “the most interesting result for clinical care,” said Dr. Cummings, emeritus professor of medicine, epidemiology and biostatistics at the university.

The original FREEDOM study enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive every 6 months either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements. All of the subjects had bone mineral density T scores that were less than −2.5 but not less than −4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756–65).

The FREEDOM results were the basis of the Food and Drug Administration's approval of denosumab in June 2010.

Data for 2,343 patients who continued denosumab for another 2 years and 2,207 patients who switched from placebo to denosumab in an ongoing extension of the trial suggest that the incidence of nonvertebral fractures continues to decline in the first 5 years of denosumab use. The 5-year results have been submitted for publication, he said.

For nonvertebral fractures, the incidence decreased from 2.6% in the denosumab group in the first year of the FREEDOM trial to 2.1% in year 2 and 2.2% in year 3. Nonvertebral fractures were seen in 1.4% of patients in year 4 and 1.1% of patients in year 5, extension study data show. Similar rates were seen for vertebral fractures.

The extension study did not include a placebo comparison, so “we did a pretty rigorous estimate of what the rates would be if the placebo group had continued out to 5 years,” Dr. Cummings said. They estimated that nonvertebral or vertebral fracture rates would be 2.6% in the placebo group in years 4 and 5, more than twice that of patients on denosumab in the extension study.

A separate study highlighted another advantage of denosumab that it shares with zoledronic acid – greater adherence rates compared with oral therapies, he added. An open-label study of 250 women with untreated osteoporosis found an 87% adherence rate in the first year in patients randomized to get a denosumab injection every 6 months, compared with a 77% adherence rate for patients randomized to weekly oral alendronate therapy. Alendronate use was monitored by electronic bottle caps (Osteoporos. Int. 2011;22:1725–35).

The study's 2-year results, which have not yet been published, show that the difference in adherence rates between groups continues to widen, Dr. Cummings said.

Dr. Cummings has been a consultant to Amgen Pharmaceuticals, which markets denosumab; to Merck, which markets alendronate; and to Eli Lilly & Co.

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SAN FRANCISCO – The pivotal clinical trial of denosumab showed a 20% decrease in nonvertebral fractures compared with placebo treatment, but a new subgroup analysis shows the protective effect is significantly higher in patients with femoral neck osteoporosis.

The preplanned subgroup analysis of data from the FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) trial found that denosumab decreased nonvertebral fractures by 35% in patients with a femoral neck bone mineral density T score of −2.5 or lower and by only 3% in patients with higher femoral neck T scores, compared with patients in those subgroups who received placebo, Dr. Steven R. Cummings said.

The report of a 20% reduction in nonvertebral fractures in the overall trial for denosumab “underestimates its efficacy for those patients that we're most interested in treating with this drug – those with osteoporosis,” he said at a conference on osteoporosis sponsored by the University of California, San Francisco.

The findings have been submitted for publication. The analysis is one of several preplanned subgroup analyses being conducted, though this one is “the most interesting result for clinical care,” said Dr. Cummings, emeritus professor of medicine, epidemiology and biostatistics at the university.

The original FREEDOM study enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive every 6 months either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements. All of the subjects had bone mineral density T scores that were less than −2.5 but not less than −4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756–65).

The FREEDOM results were the basis of the Food and Drug Administration's approval of denosumab in June 2010.

Data for 2,343 patients who continued denosumab for another 2 years and 2,207 patients who switched from placebo to denosumab in an ongoing extension of the trial suggest that the incidence of nonvertebral fractures continues to decline in the first 5 years of denosumab use. The 5-year results have been submitted for publication, he said.

For nonvertebral fractures, the incidence decreased from 2.6% in the denosumab group in the first year of the FREEDOM trial to 2.1% in year 2 and 2.2% in year 3. Nonvertebral fractures were seen in 1.4% of patients in year 4 and 1.1% of patients in year 5, extension study data show. Similar rates were seen for vertebral fractures.

The extension study did not include a placebo comparison, so “we did a pretty rigorous estimate of what the rates would be if the placebo group had continued out to 5 years,” Dr. Cummings said. They estimated that nonvertebral or vertebral fracture rates would be 2.6% in the placebo group in years 4 and 5, more than twice that of patients on denosumab in the extension study.

A separate study highlighted another advantage of denosumab that it shares with zoledronic acid – greater adherence rates compared with oral therapies, he added. An open-label study of 250 women with untreated osteoporosis found an 87% adherence rate in the first year in patients randomized to get a denosumab injection every 6 months, compared with a 77% adherence rate for patients randomized to weekly oral alendronate therapy. Alendronate use was monitored by electronic bottle caps (Osteoporos. Int. 2011;22:1725–35).

The study's 2-year results, which have not yet been published, show that the difference in adherence rates between groups continues to widen, Dr. Cummings said.

Dr. Cummings has been a consultant to Amgen Pharmaceuticals, which markets denosumab; to Merck, which markets alendronate; and to Eli Lilly & Co.

SAN FRANCISCO – The pivotal clinical trial of denosumab showed a 20% decrease in nonvertebral fractures compared with placebo treatment, but a new subgroup analysis shows the protective effect is significantly higher in patients with femoral neck osteoporosis.

The preplanned subgroup analysis of data from the FREEDOM (Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months) trial found that denosumab decreased nonvertebral fractures by 35% in patients with a femoral neck bone mineral density T score of −2.5 or lower and by only 3% in patients with higher femoral neck T scores, compared with patients in those subgroups who received placebo, Dr. Steven R. Cummings said.

The report of a 20% reduction in nonvertebral fractures in the overall trial for denosumab “underestimates its efficacy for those patients that we're most interested in treating with this drug – those with osteoporosis,” he said at a conference on osteoporosis sponsored by the University of California, San Francisco.

The findings have been submitted for publication. The analysis is one of several preplanned subgroup analyses being conducted, though this one is “the most interesting result for clinical care,” said Dr. Cummings, emeritus professor of medicine, epidemiology and biostatistics at the university.

The original FREEDOM study enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive every 6 months either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements. All of the subjects had bone mineral density T scores that were less than −2.5 but not less than −4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756–65).

The FREEDOM results were the basis of the Food and Drug Administration's approval of denosumab in June 2010.

Data for 2,343 patients who continued denosumab for another 2 years and 2,207 patients who switched from placebo to denosumab in an ongoing extension of the trial suggest that the incidence of nonvertebral fractures continues to decline in the first 5 years of denosumab use. The 5-year results have been submitted for publication, he said.

For nonvertebral fractures, the incidence decreased from 2.6% in the denosumab group in the first year of the FREEDOM trial to 2.1% in year 2 and 2.2% in year 3. Nonvertebral fractures were seen in 1.4% of patients in year 4 and 1.1% of patients in year 5, extension study data show. Similar rates were seen for vertebral fractures.

The extension study did not include a placebo comparison, so “we did a pretty rigorous estimate of what the rates would be if the placebo group had continued out to 5 years,” Dr. Cummings said. They estimated that nonvertebral or vertebral fracture rates would be 2.6% in the placebo group in years 4 and 5, more than twice that of patients on denosumab in the extension study.

A separate study highlighted another advantage of denosumab that it shares with zoledronic acid – greater adherence rates compared with oral therapies, he added. An open-label study of 250 women with untreated osteoporosis found an 87% adherence rate in the first year in patients randomized to get a denosumab injection every 6 months, compared with a 77% adherence rate for patients randomized to weekly oral alendronate therapy. Alendronate use was monitored by electronic bottle caps (Osteoporos. Int. 2011;22:1725–35).

The study's 2-year results, which have not yet been published, show that the difference in adherence rates between groups continues to widen, Dr. Cummings said.

Dr. Cummings has been a consultant to Amgen Pharmaceuticals, which markets denosumab; to Merck, which markets alendronate; and to Eli Lilly & Co.

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Gastric Bypass May Increase Long-Term Fracture Risk

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Major Finding: The fracture risk for gastric bypass surgery patients was 2.3-fold greater than that for the general population.

Data Source: A retrospective study of 258 patients who underwent bariatric surgery between 1985 and 2004.

Disclosures: Dr. Kennel reported that he and his coinvestigators have no significant financial relationships to report.

BOSTON – Gastric bypass surgery appears to be linked to increased long-term fracture risk, based on a retrospective study of 258 bariatric surgery patients.

“Bariatric surgery results in an increased risk of fractures. We think the important take-home point here is that we need to start looking at the skeleton as one of those key areas for long-term follow-up,” Dr. Kurt Kennel said at the meeting.

The fracture risk for bariatric surgery patients in this study was 2.3 times greater than that for individuals who did not have bariatric surgery, reported Dr. Kennel of the endocrinology department at the Mayo Clinic in Rochester, Minn.

“We have questions about what this means in the long term,” said Dr. Kennel. In this study, the mean time to first fracture was 6 years, with a mean follow-up of 9 years. However, in much of the current literature on bariatric surgery, patients are followed only 1–2 years and the only issues addressed are related to surgery or weight.

“Some issues – like bone, for example – may not show the manifestations of these effects for many years and therefore we may be missing some of those effects,” said Dr. Kennel.

The researchers used data from the Rochester Epidemiology Project to conduct a retrospective study of fracture incidence. REP connects medical records from the Mayo Clinic, local hospitals, and local private practices. The study included data from 258 patients, who underwent a first bariatric surgery between 1985 and 2004 at the Mayo Clinic.

Fractures were expressed in standardized incidence ratios that compare the number of observed fractures to the number of expected fractures by skeletal site.

Expected fracture data were derived by applying age- and sex-specific incidence rates from the local population to the age- and sex-specific person-years of follow-up.

The average age of the bariatric surgery patients was 44 years and most (83%) were female. Following bariatric surgery, 79 patients experienced 132 fractures.

Bariatric surgery patients had an increased risk of fracture at nearly all of the skeletal sites studied, not just in weight-bearing bones.

Also of note, 94% of these patients had undergone gastric bypass procedures. Dr. Kennel attributed this to the time frame used in the study.

Other bariatric surgical procedures – such as adjustable gastric banding and sleeve gastrectomy – are more recent developments. Dr. Kennel acknowledged that different bariatric procedures might yield different fracture risks.

The increased rate of fractures “suggests that structural and biochemical changes in bone that are observed after bariatric surgery are clinically important.

Clinicians should discuss bone health with patients who have undergone or are considering bariatric surgery.”

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Major Finding: The fracture risk for gastric bypass surgery patients was 2.3-fold greater than that for the general population.

Data Source: A retrospective study of 258 patients who underwent bariatric surgery between 1985 and 2004.

Disclosures: Dr. Kennel reported that he and his coinvestigators have no significant financial relationships to report.

BOSTON – Gastric bypass surgery appears to be linked to increased long-term fracture risk, based on a retrospective study of 258 bariatric surgery patients.

“Bariatric surgery results in an increased risk of fractures. We think the important take-home point here is that we need to start looking at the skeleton as one of those key areas for long-term follow-up,” Dr. Kurt Kennel said at the meeting.

The fracture risk for bariatric surgery patients in this study was 2.3 times greater than that for individuals who did not have bariatric surgery, reported Dr. Kennel of the endocrinology department at the Mayo Clinic in Rochester, Minn.

“We have questions about what this means in the long term,” said Dr. Kennel. In this study, the mean time to first fracture was 6 years, with a mean follow-up of 9 years. However, in much of the current literature on bariatric surgery, patients are followed only 1–2 years and the only issues addressed are related to surgery or weight.

“Some issues – like bone, for example – may not show the manifestations of these effects for many years and therefore we may be missing some of those effects,” said Dr. Kennel.

The researchers used data from the Rochester Epidemiology Project to conduct a retrospective study of fracture incidence. REP connects medical records from the Mayo Clinic, local hospitals, and local private practices. The study included data from 258 patients, who underwent a first bariatric surgery between 1985 and 2004 at the Mayo Clinic.

Fractures were expressed in standardized incidence ratios that compare the number of observed fractures to the number of expected fractures by skeletal site.

Expected fracture data were derived by applying age- and sex-specific incidence rates from the local population to the age- and sex-specific person-years of follow-up.

The average age of the bariatric surgery patients was 44 years and most (83%) were female. Following bariatric surgery, 79 patients experienced 132 fractures.

Bariatric surgery patients had an increased risk of fracture at nearly all of the skeletal sites studied, not just in weight-bearing bones.

Also of note, 94% of these patients had undergone gastric bypass procedures. Dr. Kennel attributed this to the time frame used in the study.

Other bariatric surgical procedures – such as adjustable gastric banding and sleeve gastrectomy – are more recent developments. Dr. Kennel acknowledged that different bariatric procedures might yield different fracture risks.

The increased rate of fractures “suggests that structural and biochemical changes in bone that are observed after bariatric surgery are clinically important.

Clinicians should discuss bone health with patients who have undergone or are considering bariatric surgery.”

Major Finding: The fracture risk for gastric bypass surgery patients was 2.3-fold greater than that for the general population.

Data Source: A retrospective study of 258 patients who underwent bariatric surgery between 1985 and 2004.

Disclosures: Dr. Kennel reported that he and his coinvestigators have no significant financial relationships to report.

BOSTON – Gastric bypass surgery appears to be linked to increased long-term fracture risk, based on a retrospective study of 258 bariatric surgery patients.

“Bariatric surgery results in an increased risk of fractures. We think the important take-home point here is that we need to start looking at the skeleton as one of those key areas for long-term follow-up,” Dr. Kurt Kennel said at the meeting.

The fracture risk for bariatric surgery patients in this study was 2.3 times greater than that for individuals who did not have bariatric surgery, reported Dr. Kennel of the endocrinology department at the Mayo Clinic in Rochester, Minn.

“We have questions about what this means in the long term,” said Dr. Kennel. In this study, the mean time to first fracture was 6 years, with a mean follow-up of 9 years. However, in much of the current literature on bariatric surgery, patients are followed only 1–2 years and the only issues addressed are related to surgery or weight.

“Some issues – like bone, for example – may not show the manifestations of these effects for many years and therefore we may be missing some of those effects,” said Dr. Kennel.

The researchers used data from the Rochester Epidemiology Project to conduct a retrospective study of fracture incidence. REP connects medical records from the Mayo Clinic, local hospitals, and local private practices. The study included data from 258 patients, who underwent a first bariatric surgery between 1985 and 2004 at the Mayo Clinic.

Fractures were expressed in standardized incidence ratios that compare the number of observed fractures to the number of expected fractures by skeletal site.

Expected fracture data were derived by applying age- and sex-specific incidence rates from the local population to the age- and sex-specific person-years of follow-up.

The average age of the bariatric surgery patients was 44 years and most (83%) were female. Following bariatric surgery, 79 patients experienced 132 fractures.

Bariatric surgery patients had an increased risk of fracture at nearly all of the skeletal sites studied, not just in weight-bearing bones.

Also of note, 94% of these patients had undergone gastric bypass procedures. Dr. Kennel attributed this to the time frame used in the study.

Other bariatric surgical procedures – such as adjustable gastric banding and sleeve gastrectomy – are more recent developments. Dr. Kennel acknowledged that different bariatric procedures might yield different fracture risks.

The increased rate of fractures “suggests that structural and biochemical changes in bone that are observed after bariatric surgery are clinically important.

Clinicians should discuss bone health with patients who have undergone or are considering bariatric surgery.”

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Denosumab Reduces Fracture Incidence at All Risk Levels

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Denosumab Reduces Fracture Incidence at All Risk Levels

Denosumab reduced the incidence of new vertebral and hip fractures in postmenopausal women with osteoporosis at both higher and lower risk for fracture, in a post-hoc analysis of data from a 3-year, phase III randomized trial.

The monoclonal antibody denosumab (Prolia) was approved in June 2010 for treatment of postmenopausal women who have a high risk of osteoporotic fractures. In phase II and III trials, denosumab rapidly decreased bone resorption markers and increased bone mineral density at all skeletal sites, compared with placebo, said Dr. S. Boonen of Leuven (Belgium) University and his associates (J. Clin. Endocrinol. Metab. 2011;96 [doi:10.1210/jc.2010–2784]).

The Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) trial enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756–65).

The new analysis compared high-risk and low-risk groups within the FREEDOM population. High-risk groups included women with two or more preexisting vertebral fractures of any degree of deformity, or one or more vertebral fractures of moderate or severe deformity, or both; a femoral neck BMD T score of –2.5 or less; or both multiple and/or moderate or severe vertebral deformities and a femoral neck BMD T score of –2.5 or less.

For hip fractures, the higher-risk subgroups included women who were age 75 years or older; had a femoral neck BMD T score of –2.5 or less; or were 75 years or older with a femoral neck BMD T score of –2.5 or less. Women who did not have those specified risk factors were included in the lower-risk subgroups.

Over 3 years, denosumab treatment was equally effective at reducing the risk of new vertebral fractures in women at both higher and lower risk for those types of fractures, similar to the overall FREEDOM population. Compared with placebo, denosumab reduced the incidence of vertebral fracture in the subgroups at higher risk by prevalent vertebral fracture status by 9.2% (16.6% placebo vs. 7.5% denosumab) among those at risk via baseline femoral neck BMD T score of –2.5 by 6.8% (9.9% vs. 3.1%), and among those with both risk factors by 12.3% (20.1% vs. 8.1%).

The numbers needed to treat to prevent one vertebral fracture in each of these higher-risk subgroups were 11, 15, and 12, respectively, Dr. Boonen and his associates said.

Similar results were seen for the lower-risk groups, including a 4.4% absolute risk reduction in those without prevalent vertebral fracture, 3.7% for those with BMD T score greater than –2.5, and 4.5% for those with one or both risk factors.

Subgroup results for hip fractures were also consistent with the findings from the overall FREEDOM population, with the same efficacy of denosumab consistent across patients with different levels of risk. Compared with placebo, denosumab significantly reduced hip fracture incidence among those aged 75 years or older by 1.4% (2.3% placebo vs. 0.9% denosumab); those with a baseline femoral neck BMD T score of –2.5 or less by 1.4% (2.8% vs. 1.4%); and by 2.4% among those with both risk factors (4.1% vs. 1.7%).

Overall mortality was lower – but not significantly so – among all the subgroups with denosumab. However, there was a significantly lower incidence of fatal adverse events with denosumab vs. placebo in the higher-risk group with prevalent vertebral fracture (1.8% vs. 4.9%) and in those with both prevalent vertebral fracture and low femoral neck BMD (1.6% vs. 7.1%). The difference in mortality among the higher-risk subgroups was greater than that of the lower-risk groups, they noted.

“Our analyses highlight the consistency of the antifracture efficacy of denosumab across subjects with differences in a variety of major risk factors for fractures at baseline. Our analyses suggest that denosumab reduces both new vertebral and hip fractures, regardless of the underlying risk and that the higher absolute fracture risk observed in the higher-risk subgroups is associated with greater absolute risk reduction,” Dr. Boonen and his associates concluded.

The study was funded by Amgen. Dr. Boonen has received funding for serving as an investigator and as a member of the steering committee for Amgen, as well as consulting and lecture fees. He is also senior clinical investigator of the Fund for Scientific Research in Flanders, Belgium. Four of his coinvestigators are Amgen employees, and the others disclosed relationships with Amgen and several other pharmaceutical companies.

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Denosumab reduced the incidence of new vertebral and hip fractures in postmenopausal women with osteoporosis at both higher and lower risk for fracture, in a post-hoc analysis of data from a 3-year, phase III randomized trial.

The monoclonal antibody denosumab (Prolia) was approved in June 2010 for treatment of postmenopausal women who have a high risk of osteoporotic fractures. In phase II and III trials, denosumab rapidly decreased bone resorption markers and increased bone mineral density at all skeletal sites, compared with placebo, said Dr. S. Boonen of Leuven (Belgium) University and his associates (J. Clin. Endocrinol. Metab. 2011;96 [doi:10.1210/jc.2010–2784]).

The Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) trial enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756–65).

The new analysis compared high-risk and low-risk groups within the FREEDOM population. High-risk groups included women with two or more preexisting vertebral fractures of any degree of deformity, or one or more vertebral fractures of moderate or severe deformity, or both; a femoral neck BMD T score of –2.5 or less; or both multiple and/or moderate or severe vertebral deformities and a femoral neck BMD T score of –2.5 or less.

For hip fractures, the higher-risk subgroups included women who were age 75 years or older; had a femoral neck BMD T score of –2.5 or less; or were 75 years or older with a femoral neck BMD T score of –2.5 or less. Women who did not have those specified risk factors were included in the lower-risk subgroups.

Over 3 years, denosumab treatment was equally effective at reducing the risk of new vertebral fractures in women at both higher and lower risk for those types of fractures, similar to the overall FREEDOM population. Compared with placebo, denosumab reduced the incidence of vertebral fracture in the subgroups at higher risk by prevalent vertebral fracture status by 9.2% (16.6% placebo vs. 7.5% denosumab) among those at risk via baseline femoral neck BMD T score of –2.5 by 6.8% (9.9% vs. 3.1%), and among those with both risk factors by 12.3% (20.1% vs. 8.1%).

The numbers needed to treat to prevent one vertebral fracture in each of these higher-risk subgroups were 11, 15, and 12, respectively, Dr. Boonen and his associates said.

Similar results were seen for the lower-risk groups, including a 4.4% absolute risk reduction in those without prevalent vertebral fracture, 3.7% for those with BMD T score greater than –2.5, and 4.5% for those with one or both risk factors.

Subgroup results for hip fractures were also consistent with the findings from the overall FREEDOM population, with the same efficacy of denosumab consistent across patients with different levels of risk. Compared with placebo, denosumab significantly reduced hip fracture incidence among those aged 75 years or older by 1.4% (2.3% placebo vs. 0.9% denosumab); those with a baseline femoral neck BMD T score of –2.5 or less by 1.4% (2.8% vs. 1.4%); and by 2.4% among those with both risk factors (4.1% vs. 1.7%).

Overall mortality was lower – but not significantly so – among all the subgroups with denosumab. However, there was a significantly lower incidence of fatal adverse events with denosumab vs. placebo in the higher-risk group with prevalent vertebral fracture (1.8% vs. 4.9%) and in those with both prevalent vertebral fracture and low femoral neck BMD (1.6% vs. 7.1%). The difference in mortality among the higher-risk subgroups was greater than that of the lower-risk groups, they noted.

“Our analyses highlight the consistency of the antifracture efficacy of denosumab across subjects with differences in a variety of major risk factors for fractures at baseline. Our analyses suggest that denosumab reduces both new vertebral and hip fractures, regardless of the underlying risk and that the higher absolute fracture risk observed in the higher-risk subgroups is associated with greater absolute risk reduction,” Dr. Boonen and his associates concluded.

The study was funded by Amgen. Dr. Boonen has received funding for serving as an investigator and as a member of the steering committee for Amgen, as well as consulting and lecture fees. He is also senior clinical investigator of the Fund for Scientific Research in Flanders, Belgium. Four of his coinvestigators are Amgen employees, and the others disclosed relationships with Amgen and several other pharmaceutical companies.

Denosumab reduced the incidence of new vertebral and hip fractures in postmenopausal women with osteoporosis at both higher and lower risk for fracture, in a post-hoc analysis of data from a 3-year, phase III randomized trial.

The monoclonal antibody denosumab (Prolia) was approved in June 2010 for treatment of postmenopausal women who have a high risk of osteoporotic fractures. In phase II and III trials, denosumab rapidly decreased bone resorption markers and increased bone mineral density at all skeletal sites, compared with placebo, said Dr. S. Boonen of Leuven (Belgium) University and his associates (J. Clin. Endocrinol. Metab. 2011;96 [doi:10.1210/jc.2010–2784]).

The Fracture Reduction Evaluation of Denosumab in Osteoporosis Every 6 Months (FREEDOM) trial enrolled 7,808 postmenopausal women aged 60-80 years with osteoporosis to receive either a subcutaneous injection of denosumab (60 mg) or placebo along with daily calcium and vitamin D supplements every 6 months. All subjects had bone mineral density (BMD) T scores of less than –2.5 but not less than –4.0 at the lumbar spine or total hip. At 36 months, denosumab was associated with reductions of 68% in vertebral fracture and 40% in hip fracture (N. Engl. J. Med. 2009;361:756–65).

The new analysis compared high-risk and low-risk groups within the FREEDOM population. High-risk groups included women with two or more preexisting vertebral fractures of any degree of deformity, or one or more vertebral fractures of moderate or severe deformity, or both; a femoral neck BMD T score of –2.5 or less; or both multiple and/or moderate or severe vertebral deformities and a femoral neck BMD T score of –2.5 or less.

For hip fractures, the higher-risk subgroups included women who were age 75 years or older; had a femoral neck BMD T score of –2.5 or less; or were 75 years or older with a femoral neck BMD T score of –2.5 or less. Women who did not have those specified risk factors were included in the lower-risk subgroups.

Over 3 years, denosumab treatment was equally effective at reducing the risk of new vertebral fractures in women at both higher and lower risk for those types of fractures, similar to the overall FREEDOM population. Compared with placebo, denosumab reduced the incidence of vertebral fracture in the subgroups at higher risk by prevalent vertebral fracture status by 9.2% (16.6% placebo vs. 7.5% denosumab) among those at risk via baseline femoral neck BMD T score of –2.5 by 6.8% (9.9% vs. 3.1%), and among those with both risk factors by 12.3% (20.1% vs. 8.1%).

The numbers needed to treat to prevent one vertebral fracture in each of these higher-risk subgroups were 11, 15, and 12, respectively, Dr. Boonen and his associates said.

Similar results were seen for the lower-risk groups, including a 4.4% absolute risk reduction in those without prevalent vertebral fracture, 3.7% for those with BMD T score greater than –2.5, and 4.5% for those with one or both risk factors.

Subgroup results for hip fractures were also consistent with the findings from the overall FREEDOM population, with the same efficacy of denosumab consistent across patients with different levels of risk. Compared with placebo, denosumab significantly reduced hip fracture incidence among those aged 75 years or older by 1.4% (2.3% placebo vs. 0.9% denosumab); those with a baseline femoral neck BMD T score of –2.5 or less by 1.4% (2.8% vs. 1.4%); and by 2.4% among those with both risk factors (4.1% vs. 1.7%).

Overall mortality was lower – but not significantly so – among all the subgroups with denosumab. However, there was a significantly lower incidence of fatal adverse events with denosumab vs. placebo in the higher-risk group with prevalent vertebral fracture (1.8% vs. 4.9%) and in those with both prevalent vertebral fracture and low femoral neck BMD (1.6% vs. 7.1%). The difference in mortality among the higher-risk subgroups was greater than that of the lower-risk groups, they noted.

“Our analyses highlight the consistency of the antifracture efficacy of denosumab across subjects with differences in a variety of major risk factors for fractures at baseline. Our analyses suggest that denosumab reduces both new vertebral and hip fractures, regardless of the underlying risk and that the higher absolute fracture risk observed in the higher-risk subgroups is associated with greater absolute risk reduction,” Dr. Boonen and his associates concluded.

The study was funded by Amgen. Dr. Boonen has received funding for serving as an investigator and as a member of the steering committee for Amgen, as well as consulting and lecture fees. He is also senior clinical investigator of the Fund for Scientific Research in Flanders, Belgium. Four of his coinvestigators are Amgen employees, and the others disclosed relationships with Amgen and several other pharmaceutical companies.

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Treat Bone Injuries Early in Brain Trauma Patients

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Treat Bone Injuries Early in Brain Trauma Patients

BUENOS AIRES — Treatment of orthopedic injuries in patients with traumatic brain injury should not be delayed, Dr. Ivan Rubel said at the annual conference of the International Society of Orthopaedic Surgery and Traumatology.

A population-based study conducted in the Twin Cities area of Minnesota found that most patients who were seen in an emergency department for traumatic brain injury had received the injury from sports and recreational activities (Minn. Med. 2006;89:40–4). The traumatic brain injuries that trauma surgeons are more likely to encounter, however, come from falls or car accidents, said Dr. Rubel, director of the orthopedics and traumatology department at FLENI Institute in Buenos Aires.

Pelvic and extremity fractures are common in patients with traumatic brain injury. Many skeletal injuries are not given priority, or might even be missed. However, as the survival rate of patients with traumatic brain injury has increased, there is a greater emphasis on minimizing dysfunction and disability in these patients, particularly when the dysfunction and disability arise from concomitant orthopedic trauma.

In a study of health-related quality of life in pediatric patients during the first year following a traumatic brain injury, the treatment of associated injuries was shown to have a greater impact than other factors such as patient or family characteristics (Arch. Pediatr. Adolesc. Med. 2006;160:252–60). “With the recent advances in intensive care medicine, most of these patients survive,” said Dr. Rubel. “We have to focus on minimizing the dysfunction and disability.”

The main question concerns when to operate on orthopedic injuries in a patient with traumatic brain injury, explained Dr. Rubel. Early fracture fixation in blunt trauma patients is generally recommended, but many doctors are hesitant to perform early fixation in patients with severe brain trauma. There is a widespread view that fracture fixation should be postponed to protect the injured brain.

This view was challenged by a study examining the timing of fracture fixation in blunt trauma patients with severe head injuries (Am. J. Surg. 1998;176:324–9). Investigators reviewed records of 47 consecutive blunt trauma patients with both severe head injuries and long bone fractures requiring surgical fixation. Twenty-two patients had undergone early fracture fixation within 24 hours of hospital admission (mean time 17 hours), and 25 patients had undergone delayed treatment (mean time 143 hours). Review of patient records revealed that there were no significant differences between the two groups in terms of neurologic or orthopedic complications, length of hospital stay, or mortality. Thus, delay of fracture fixation did not protect the injured brain in this study population.

Dr. Rubel described a young patient who was treated at FLENI Institute for a severe traumatic head injury and multiple fractures. The head injury required decompression with a wide craniotomy. The patient remained in a coma for 6 weeks, and CT scans showed cerebral edema. Radiography revealed a huge intrapelvic calcification affecting the bladder and rectum, malunion of the pelvis, malunion of the tibia, and a radio-ulnar synostosis. She was placed in long arm and leg casts and was told that she could not have pelvic surgery because of the likelihood that she would die during the procedure.

“Once at our institution, the malunion of the tibia was corrected upon admission, and she was allowed to exercise on a rehabilitation bicycle,” said Dr. Rubel. The second step was resection of the forearm synostosis, which improved the position of the hand for daily activities and allowed her to rehabilitate her writing capabilities, he said. As the brain edema resolved, the patient gradually improved both in cognition and in function. Restoration of the pelvic malunion with serial osteotomies was the last surgical intervention.

“It's hard for patients to understand not to put weight on the leg, since the brain is still inflamed,” said Dr. Rubel. Rehabilitation was performed in a pool with chest-deep water. At 6 months from the accident, she returned to her normal activities.

Immediately after trauma, there is a window of opportunity when treatment of orthopedic injuries is optimal. Use that window of opportunity around trauma and start helping the patients right away to minimize their skeletal and psychological and cognitive dysfunction, advised Dr. Rubel.

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BUENOS AIRES — Treatment of orthopedic injuries in patients with traumatic brain injury should not be delayed, Dr. Ivan Rubel said at the annual conference of the International Society of Orthopaedic Surgery and Traumatology.

A population-based study conducted in the Twin Cities area of Minnesota found that most patients who were seen in an emergency department for traumatic brain injury had received the injury from sports and recreational activities (Minn. Med. 2006;89:40–4). The traumatic brain injuries that trauma surgeons are more likely to encounter, however, come from falls or car accidents, said Dr. Rubel, director of the orthopedics and traumatology department at FLENI Institute in Buenos Aires.

Pelvic and extremity fractures are common in patients with traumatic brain injury. Many skeletal injuries are not given priority, or might even be missed. However, as the survival rate of patients with traumatic brain injury has increased, there is a greater emphasis on minimizing dysfunction and disability in these patients, particularly when the dysfunction and disability arise from concomitant orthopedic trauma.

In a study of health-related quality of life in pediatric patients during the first year following a traumatic brain injury, the treatment of associated injuries was shown to have a greater impact than other factors such as patient or family characteristics (Arch. Pediatr. Adolesc. Med. 2006;160:252–60). “With the recent advances in intensive care medicine, most of these patients survive,” said Dr. Rubel. “We have to focus on minimizing the dysfunction and disability.”

The main question concerns when to operate on orthopedic injuries in a patient with traumatic brain injury, explained Dr. Rubel. Early fracture fixation in blunt trauma patients is generally recommended, but many doctors are hesitant to perform early fixation in patients with severe brain trauma. There is a widespread view that fracture fixation should be postponed to protect the injured brain.

This view was challenged by a study examining the timing of fracture fixation in blunt trauma patients with severe head injuries (Am. J. Surg. 1998;176:324–9). Investigators reviewed records of 47 consecutive blunt trauma patients with both severe head injuries and long bone fractures requiring surgical fixation. Twenty-two patients had undergone early fracture fixation within 24 hours of hospital admission (mean time 17 hours), and 25 patients had undergone delayed treatment (mean time 143 hours). Review of patient records revealed that there were no significant differences between the two groups in terms of neurologic or orthopedic complications, length of hospital stay, or mortality. Thus, delay of fracture fixation did not protect the injured brain in this study population.

Dr. Rubel described a young patient who was treated at FLENI Institute for a severe traumatic head injury and multiple fractures. The head injury required decompression with a wide craniotomy. The patient remained in a coma for 6 weeks, and CT scans showed cerebral edema. Radiography revealed a huge intrapelvic calcification affecting the bladder and rectum, malunion of the pelvis, malunion of the tibia, and a radio-ulnar synostosis. She was placed in long arm and leg casts and was told that she could not have pelvic surgery because of the likelihood that she would die during the procedure.

“Once at our institution, the malunion of the tibia was corrected upon admission, and she was allowed to exercise on a rehabilitation bicycle,” said Dr. Rubel. The second step was resection of the forearm synostosis, which improved the position of the hand for daily activities and allowed her to rehabilitate her writing capabilities, he said. As the brain edema resolved, the patient gradually improved both in cognition and in function. Restoration of the pelvic malunion with serial osteotomies was the last surgical intervention.

“It's hard for patients to understand not to put weight on the leg, since the brain is still inflamed,” said Dr. Rubel. Rehabilitation was performed in a pool with chest-deep water. At 6 months from the accident, she returned to her normal activities.

Immediately after trauma, there is a window of opportunity when treatment of orthopedic injuries is optimal. Use that window of opportunity around trauma and start helping the patients right away to minimize their skeletal and psychological and cognitive dysfunction, advised Dr. Rubel.

BUENOS AIRES — Treatment of orthopedic injuries in patients with traumatic brain injury should not be delayed, Dr. Ivan Rubel said at the annual conference of the International Society of Orthopaedic Surgery and Traumatology.

A population-based study conducted in the Twin Cities area of Minnesota found that most patients who were seen in an emergency department for traumatic brain injury had received the injury from sports and recreational activities (Minn. Med. 2006;89:40–4). The traumatic brain injuries that trauma surgeons are more likely to encounter, however, come from falls or car accidents, said Dr. Rubel, director of the orthopedics and traumatology department at FLENI Institute in Buenos Aires.

Pelvic and extremity fractures are common in patients with traumatic brain injury. Many skeletal injuries are not given priority, or might even be missed. However, as the survival rate of patients with traumatic brain injury has increased, there is a greater emphasis on minimizing dysfunction and disability in these patients, particularly when the dysfunction and disability arise from concomitant orthopedic trauma.

In a study of health-related quality of life in pediatric patients during the first year following a traumatic brain injury, the treatment of associated injuries was shown to have a greater impact than other factors such as patient or family characteristics (Arch. Pediatr. Adolesc. Med. 2006;160:252–60). “With the recent advances in intensive care medicine, most of these patients survive,” said Dr. Rubel. “We have to focus on minimizing the dysfunction and disability.”

The main question concerns when to operate on orthopedic injuries in a patient with traumatic brain injury, explained Dr. Rubel. Early fracture fixation in blunt trauma patients is generally recommended, but many doctors are hesitant to perform early fixation in patients with severe brain trauma. There is a widespread view that fracture fixation should be postponed to protect the injured brain.

This view was challenged by a study examining the timing of fracture fixation in blunt trauma patients with severe head injuries (Am. J. Surg. 1998;176:324–9). Investigators reviewed records of 47 consecutive blunt trauma patients with both severe head injuries and long bone fractures requiring surgical fixation. Twenty-two patients had undergone early fracture fixation within 24 hours of hospital admission (mean time 17 hours), and 25 patients had undergone delayed treatment (mean time 143 hours). Review of patient records revealed that there were no significant differences between the two groups in terms of neurologic or orthopedic complications, length of hospital stay, or mortality. Thus, delay of fracture fixation did not protect the injured brain in this study population.

Dr. Rubel described a young patient who was treated at FLENI Institute for a severe traumatic head injury and multiple fractures. The head injury required decompression with a wide craniotomy. The patient remained in a coma for 6 weeks, and CT scans showed cerebral edema. Radiography revealed a huge intrapelvic calcification affecting the bladder and rectum, malunion of the pelvis, malunion of the tibia, and a radio-ulnar synostosis. She was placed in long arm and leg casts and was told that she could not have pelvic surgery because of the likelihood that she would die during the procedure.

“Once at our institution, the malunion of the tibia was corrected upon admission, and she was allowed to exercise on a rehabilitation bicycle,” said Dr. Rubel. The second step was resection of the forearm synostosis, which improved the position of the hand for daily activities and allowed her to rehabilitate her writing capabilities, he said. As the brain edema resolved, the patient gradually improved both in cognition and in function. Restoration of the pelvic malunion with serial osteotomies was the last surgical intervention.

“It's hard for patients to understand not to put weight on the leg, since the brain is still inflamed,” said Dr. Rubel. Rehabilitation was performed in a pool with chest-deep water. At 6 months from the accident, she returned to her normal activities.

Immediately after trauma, there is a window of opportunity when treatment of orthopedic injuries is optimal. Use that window of opportunity around trauma and start helping the patients right away to minimize their skeletal and psychological and cognitive dysfunction, advised Dr. Rubel.

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Treat Bone Injuries Early in Brain Trauma Patients
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