Orthopedics

"Children are not small adults” is a common saying among pediatric care providers across all specialties, including pediatric orthopedics. In addition to obvious size differences, children have physical features that are different from those in adults, such as growth plates, increased ligamentous laxity, and different levels of cognitive ability and neuromuscular control. In addition, growth can lead to progression of deformities (neuromuscular disease) or can be used to correct deformities (remodeling of fractures). Awareness of these factors, as well as emotional and social issues, is critical to provide the best outcome to pediatric patients.

The past decade has led to tremendous advances in pediatric orthopedics, including the development of highly specialized children’s hospitals with comprehensive multispecialty clinics, the use of genetic testing, and the use of computer-assisted technologies for deformity-correction and intraoperative navigation. While tremendous advances have been made, one area that has been lagging is the
development of pediatric-specific orthopedic implants. This problem is multifactorial and not unique to pediatric orthopedics. Adult devices such as defibrillators, pacemakers, heart valves, dialysis catheters/ports, and orthopedic implants are commonly used in children in an off-label fashion. For example, up to 60% of procedures performed in pediatric interventional cardiology are off-label.¹ Common
off-label uses in pediatric orthopedics involve the use of adult pedicle screws and trauma implants in skeletally immature patients.

Most experts say the biggest driver behind this lag is economics. The pediatric market is smaller than the adult market. Some pediatric conditions, such as genetic disorders, early onset scoliosis, and hip dysplasia are rare relative to adult musculoskeletal conditions such as osteoarthritis.

This makes it more difficult for companies to recover money spent on research and development. Probably the best example of this is in the joint arthroplasty market.
According to the CDC, in 2009, 676,000 and 327,000 total hip and knee replacements, respectively, were done in the US alone. This tremendous volume, and potential revenue for the manufacturers, has led to a host of innovations such as gender and activity-specific implants. An interesting contrast to this is the cast saw. Fracture care is one of the most common pediatric orthopedic procedures performed world-wide. Despite studies regarding cast saw complications,
including burns, patient/parental anxiety, and increased medico-legal risk when complications occur, little change has occurred to these devices since their invention by Dr. Homer Stryker in 1943.

In addition, it is becoming much more difficult and expensive to bring new products to market. Obtaining FDA approval usually requires large multicenter trials, which
are not possible given the rarity of some of the pediatric orthopedic conditions, as well as the reluctance of patients, parents, physicians, and institutions to enroll children in clinical trials. Some devices for rare conditions such as the VEPTR (vertical expandable prosthetic titanium rib) have been FDA-approved, but as a humanitarian device exemption.

In addition to off-label use, devices often are modified to provide a better fit. Some devices are available for children as a custom order, but they are not readily available when needed. In addition, only 30% of pediatric care in the US is provided in children’s hospitals where pediatric implants, if they even exist, as well as people experienced in their use, are most likely to be available.

To address this problem, Congress passed the Pediatric Device Safety and Improvement Act in 2007, which authorized the FDA to issue grants to stimulate the development of pediatric-specific devices. So far, approximately $11 million
has been awarded to 220 projects in various stages of completion across all areas of pediatric care, not just orthopedics. While a good first step, the overall amount spent is dwarfed by the amount spent on adults.

Despite these challenges, patient- and market-driven factors are increasing interest in the development of pediatric orthopedic devices. With increasing parental
demand for specialized pediatric care grows, so does the demand for pediatric-specific implants. Increased competition among device companies to be “full-service” to hospital systems has led to increased interest in developing pediatric-specific implants. While the implants themselves may not be profit leaders, their ability to make an implant company full-service to a hospital system may make it cost-effective, similar to the way retail companies use “loss leaders” to drive store traffic. Even now, there is only one pediatric specific orthopedic device company in
the marketplace.

Pediatric orthopedists have long recognized that children are not small adults, and it is time that the medical device manufacturers and regulatory agencies recognize it as well.

Reference
1. Sutherell JS, Hirsch R, Beekman RH 3rd. Pediatric interventional cardiology
in the United States is dependent on the off-label use of medical
devices. Congenit Heart Dis. 2010;5(1):2-7.

"Children are not small adults” is a common saying among pediatric care providers across all specialties, including pediatric orthopedics. In addition to obvious size differences, children have physical features that are different from those in adults, such as growth plates, increased ligamentous laxity, and different levels of cognitive ability and neuromuscular control. In addition, growth can lead to progression of deformities (neuromuscular disease) or can be used to correct deformities (remodeling of fractures). Awareness of these factors, as well as emotional and social issues, is critical to provide the best outcome to pediatric patients.

The past decade has led to tremendous advances in pediatric orthopedics, including the development of highly specialized children’s hospitals with comprehensive multispecialty clinics, the use of genetic testing, and the use of computer-assisted technologies for deformity-correction and intraoperative navigation. While tremendous advances have been made, one area that has been lagging is the
development of pediatric-specific orthopedic implants. This problem is multifactorial and not unique to pediatric orthopedics. Adult devices such as defibrillators, pacemakers, heart valves, dialysis catheters/ports, and orthopedic implants are commonly used in children in an off-label fashion. For example, up to 60% of procedures performed in pediatric interventional cardiology are off-label.¹ Common
off-label uses in pediatric orthopedics involve the use of adult pedicle screws and trauma implants in skeletally immature patients.

Most experts say the biggest driver behind this lag is economics. The pediatric market is smaller than the adult market. Some pediatric conditions, such as genetic disorders, early onset scoliosis, and hip dysplasia are rare relative to adult musculoskeletal conditions such as osteoarthritis.

This makes it more difficult for companies to recover money spent on research and development. Probably the best example of this is in the joint arthroplasty market.
According to the CDC, in 2009, 676,000 and 327,000 total hip and knee replacements, respectively, were done in the US alone. This tremendous volume, and potential revenue for the manufacturers, has led to a host of innovations such as gender and activity-specific implants. An interesting contrast to this is the cast saw. Fracture care is one of the most common pediatric orthopedic procedures performed world-wide. Despite studies regarding cast saw complications,
including burns, patient/parental anxiety, and increased medico-legal risk when complications occur, little change has occurred to these devices since their invention by Dr. Homer Stryker in 1943.

In addition, it is becoming much more difficult and expensive to bring new products to market. Obtaining FDA approval usually requires large multicenter trials, which
are not possible given the rarity of some of the pediatric orthopedic conditions, as well as the reluctance of patients, parents, physicians, and institutions to enroll children in clinical trials. Some devices for rare conditions such as the VEPTR (vertical expandable prosthetic titanium rib) have been FDA-approved, but as a humanitarian device exemption.

In addition to off-label use, devices often are modified to provide a better fit. Some devices are available for children as a custom order, but they are not readily available when needed. In addition, only 30% of pediatric care in the US is provided in children’s hospitals where pediatric implants, if they even exist, as well as people experienced in their use, are most likely to be available.

To address this problem, Congress passed the Pediatric Device Safety and Improvement Act in 2007, which authorized the FDA to issue grants to stimulate the development of pediatric-specific devices. So far, approximately $11 million
has been awarded to 220 projects in various stages of completion across all areas of pediatric care, not just orthopedics. While a good first step, the overall amount spent is dwarfed by the amount spent on adults.

Despite these challenges, patient- and market-driven factors are increasing interest in the development of pediatric orthopedic devices. With increasing parental
demand for specialized pediatric care grows, so does the demand for pediatric-specific implants. Increased competition among device companies to be “full-service” to hospital systems has led to increased interest in developing pediatric-specific implants. While the implants themselves may not be profit leaders, their ability to make an implant company full-service to a hospital system may make it cost-effective, similar to the way retail companies use “loss leaders” to drive store traffic. Even now, there is only one pediatric specific orthopedic device company in
the marketplace.

Pediatric orthopedists have long recognized that children are not small adults, and it is time that the medical device manufacturers and regulatory agencies recognize it as well.

Reference
1. Sutherell JS, Hirsch R, Beekman RH 3rd. Pediatric interventional cardiology
in the United States is dependent on the off-label use of medical
devices. Congenit Heart Dis. 2010;5(1):2-7.

"Children are not small adults” is a common saying among pediatric care providers across all specialties, including pediatric orthopedics. In addition to obvious size differences, children have physical features that are different from those in adults, such as growth plates, increased ligamentous laxity, and different levels of cognitive ability and neuromuscular control. In addition, growth can lead to progression of deformities (neuromuscular disease) or can be used to correct deformities (remodeling of fractures). Awareness of these factors, as well as emotional and social issues, is critical to provide the best outcome to pediatric patients.

The past decade has led to tremendous advances in pediatric orthopedics, including the development of highly specialized children’s hospitals with comprehensive multispecialty clinics, the use of genetic testing, and the use of computer-assisted technologies for deformity-correction and intraoperative navigation. While tremendous advances have been made, one area that has been lagging is the
development of pediatric-specific orthopedic implants. This problem is multifactorial and not unique to pediatric orthopedics. Adult devices such as defibrillators, pacemakers, heart valves, dialysis catheters/ports, and orthopedic implants are commonly used in children in an off-label fashion. For example, up to 60% of procedures performed in pediatric interventional cardiology are off-label.¹ Common
off-label uses in pediatric orthopedics involve the use of adult pedicle screws and trauma implants in skeletally immature patients.

Most experts say the biggest driver behind this lag is economics. The pediatric market is smaller than the adult market. Some pediatric conditions, such as genetic disorders, early onset scoliosis, and hip dysplasia are rare relative to adult musculoskeletal conditions such as osteoarthritis.

This makes it more difficult for companies to recover money spent on research and development. Probably the best example of this is in the joint arthroplasty market.
According to the CDC, in 2009, 676,000 and 327,000 total hip and knee replacements, respectively, were done in the US alone. This tremendous volume, and potential revenue for the manufacturers, has led to a host of innovations such as gender and activity-specific implants. An interesting contrast to this is the cast saw. Fracture care is one of the most common pediatric orthopedic procedures performed world-wide. Despite studies regarding cast saw complications,
including burns, patient/parental anxiety, and increased medico-legal risk when complications occur, little change has occurred to these devices since their invention by Dr. Homer Stryker in 1943.

In addition, it is becoming much more difficult and expensive to bring new products to market. Obtaining FDA approval usually requires large multicenter trials, which
are not possible given the rarity of some of the pediatric orthopedic conditions, as well as the reluctance of patients, parents, physicians, and institutions to enroll children in clinical trials. Some devices for rare conditions such as the VEPTR (vertical expandable prosthetic titanium rib) have been FDA-approved, but as a humanitarian device exemption.

In addition to off-label use, devices often are modified to provide a better fit. Some devices are available for children as a custom order, but they are not readily available when needed. In addition, only 30% of pediatric care in the US is provided in children’s hospitals where pediatric implants, if they even exist, as well as people experienced in their use, are most likely to be available.

To address this problem, Congress passed the Pediatric Device Safety and Improvement Act in 2007, which authorized the FDA to issue grants to stimulate the development of pediatric-specific devices. So far, approximately $11 million
has been awarded to 220 projects in various stages of completion across all areas of pediatric care, not just orthopedics. While a good first step, the overall amount spent is dwarfed by the amount spent on adults.

Despite these challenges, patient- and market-driven factors are increasing interest in the development of pediatric orthopedic devices. With increasing parental
demand for specialized pediatric care grows, so does the demand for pediatric-specific implants. Increased competition among device companies to be “full-service” to hospital systems has led to increased interest in developing pediatric-specific implants. While the implants themselves may not be profit leaders, their ability to make an implant company full-service to a hospital system may make it cost-effective, similar to the way retail companies use “loss leaders” to drive store traffic. Even now, there is only one pediatric specific orthopedic device company in
the marketplace.

Pediatric orthopedists have long recognized that children are not small adults, and it is time that the medical device manufacturers and regulatory agencies recognize it as well.

Reference
1. Sutherell JS, Hirsch R, Beekman RH 3rd. Pediatric interventional cardiology
in the United States is dependent on the off-label use of medical
devices. Congenit Heart Dis. 2010;5(1):2-7.

Dr. Bartolotta is an assistant professor of radiology at Weill Cornell Medical College in New York City and assistant attending radiologist at New York-Presbyterian Hospital/Weill Cornell Medical Center.

Post-traumatic hip pain is a common chief concern among ED patients. While routine radiography, the standard imaging modality for the initial evaluation of suspected hip fracture, detects most fractures, its sensitivity is decreased in the setting of osteoporosis—particularly with nondisplaced fractures. Thus, though elderly/osteoporotic patients are more likely to fracture, these fractures are harder to detect on radiography. In a study of 70 patients with negative radiographs but high clinical concern for fracture, magnetic resonance imaging (MRI) detected occult femoral fractures in 37% and occult pelvic fractures in 23%.¹

Hip fractures in elderly patients are associated with substantial mortality and morbidity, the risks for which increase with delayed diagnosis.² When there is high clinical suspicion for a radiographically occult hip fracture in this population, cross-sectional imaging should be considered for further evaluation (Figure). The decision of whether to use computed tomography (CT) or MRI for the cross-sectional examination must be made on both an institutional and patient-specific basis. CT is faster, less expensive, and more widely and temporally available. Although CT has increased sensitivity for fracture detection compared to radiography, studies have demonstrated false-negative CT examinations in the setting of nondisplaced proximal femoral fractures, especially in osteoporotic patients. Hakkarinen et al³ reported that among 235 hip fractures, 10% were occult radiographically; approximately 17% of these fractures (4 out of 24) were also occult on CT but visible on MRI. Moreover, while radiography and CT may demonstrate a seemingly isolated fracture at the femoral greater trochanter, a subset of these fractures exhibit intertrochanteric extension that is only evident on MRI (Figure). Isolated greater trochanteric fractures are typically treated conservatively, while some incomplete intertrochanteric fractures warrant internal fixation, especially fractures that cross the intertrochanteric midline on coronal MRI.^4,5

In addition to improved fracture detection, MRI also provides superior evaluation of the underlying bone marrow for coexisting conditions, such as osteomyelitis, osteonecrosis, and primary or metastatic neoplasm in the setting of pathologic fracture. Additional benefits of MRI over radiography and CT include its lack of ionizing radiation and improved evaluation of adjacent soft tissue injuries, such as labral and/or musculotendinous tears.

MRI, however, does require a longer examination time in which the patient must remain still. This may be difficult for acutely post-traumatic patients, notably those with baseline dementia and/or claustrophobia. For patients in whom MRI is indicated (eg, patients who do not have an implantable device such as a cardiac pacemaker) and where it is institutionally available, the decision to utilize it over CT is largely rooted in health-care economics. MRI is more expensive than radiography and CT, and even in the largest medical centers, the examination requires substantially more time than CT, which inherently decreases patient throughput in the ED. Cannon et al⁶ present an evidence-based algorithm for patient stratification, in which patients at high-risk for osteoporosis and low-energy trauma should be considered for immediate MRI rather than CT. These risk factors optimize MRI utilization by selecting those patients with the greatest likelihood of nondisplaced, radiographically occult fracture.

References

1. Bogost GA, Lizerbram EK, Crues JV 3rd. MR imaging in evaluation of suspected hip fracture: frequency of unsuspected bone and soft-tissue injury. Radiology. 1995;197(1):263-267.

2. Zuckerman JD, Skovron ML, Koval KJ, Aharonoff G, Frankel VH. Postoperative complications and mortality associated with operative delay in older patients who have a fracture of the hip. J Bone Joint Surg Am. 1995;77(10):1551-1556.

3. Hakkarinen DK, Banh KV, Hendey GW. Magnetic resonance imaging identifies occult hip fractures missed by 64-slice computed tomography. J Emerg Med. 2012;43(2):303-307.

4. Feldman F, Staron RB. MRI of seemingly isolated greater trochanteric fractures. AJR Am J Roentgenol. 2004;183(2):323-329.

5. Schultz E, Miller TT, Boruchov SD, Schmell EB, Toledano B. Incomplete intertrochanteric fractures: imaging features and clinical management. Radiology. 1999;211(1):237-240.

6. Cannon J, Silvestri S, Munro M. Imaging choices in occult hip fracture. J Emerg Med. 2009;37(2):144-152.

Dr. Bartolotta is an assistant professor of radiology at Weill Cornell Medical College in New York City and assistant attending radiologist at New York-Presbyterian Hospital/Weill Cornell Medical Center.

Post-traumatic hip pain is a common chief concern among ED patients. While routine radiography, the standard imaging modality for the initial evaluation of suspected hip fracture, detects most fractures, its sensitivity is decreased in the setting of osteoporosis—particularly with nondisplaced fractures. Thus, though elderly/osteoporotic patients are more likely to fracture, these fractures are harder to detect on radiography. In a study of 70 patients with negative radiographs but high clinical concern for fracture, magnetic resonance imaging (MRI) detected occult femoral fractures in 37% and occult pelvic fractures in 23%.¹

Hip fractures in elderly patients are associated with substantial mortality and morbidity, the risks for which increase with delayed diagnosis.² When there is high clinical suspicion for a radiographically occult hip fracture in this population, cross-sectional imaging should be considered for further evaluation (Figure). The decision of whether to use computed tomography (CT) or MRI for the cross-sectional examination must be made on both an institutional and patient-specific basis. CT is faster, less expensive, and more widely and temporally available. Although CT has increased sensitivity for fracture detection compared to radiography, studies have demonstrated false-negative CT examinations in the setting of nondisplaced proximal femoral fractures, especially in osteoporotic patients. Hakkarinen et al³ reported that among 235 hip fractures, 10% were occult radiographically; approximately 17% of these fractures (4 out of 24) were also occult on CT but visible on MRI. Moreover, while radiography and CT may demonstrate a seemingly isolated fracture at the femoral greater trochanter, a subset of these fractures exhibit intertrochanteric extension that is only evident on MRI (Figure). Isolated greater trochanteric fractures are typically treated conservatively, while some incomplete intertrochanteric fractures warrant internal fixation, especially fractures that cross the intertrochanteric midline on coronal MRI.^4,5

In addition to improved fracture detection, MRI also provides superior evaluation of the underlying bone marrow for coexisting conditions, such as osteomyelitis, osteonecrosis, and primary or metastatic neoplasm in the setting of pathologic fracture. Additional benefits of MRI over radiography and CT include its lack of ionizing radiation and improved evaluation of adjacent soft tissue injuries, such as labral and/or musculotendinous tears.

MRI, however, does require a longer examination time in which the patient must remain still. This may be difficult for acutely post-traumatic patients, notably those with baseline dementia and/or claustrophobia. For patients in whom MRI is indicated (eg, patients who do not have an implantable device such as a cardiac pacemaker) and where it is institutionally available, the decision to utilize it over CT is largely rooted in health-care economics. MRI is more expensive than radiography and CT, and even in the largest medical centers, the examination requires substantially more time than CT, which inherently decreases patient throughput in the ED. Cannon et al⁶ present an evidence-based algorithm for patient stratification, in which patients at high-risk for osteoporosis and low-energy trauma should be considered for immediate MRI rather than CT. These risk factors optimize MRI utilization by selecting those patients with the greatest likelihood of nondisplaced, radiographically occult fracture.

References

1. Bogost GA, Lizerbram EK, Crues JV 3rd. MR imaging in evaluation of suspected hip fracture: frequency of unsuspected bone and soft-tissue injury. Radiology. 1995;197(1):263-267.

2. Zuckerman JD, Skovron ML, Koval KJ, Aharonoff G, Frankel VH. Postoperative complications and mortality associated with operative delay in older patients who have a fracture of the hip. J Bone Joint Surg Am. 1995;77(10):1551-1556.

3. Hakkarinen DK, Banh KV, Hendey GW. Magnetic resonance imaging identifies occult hip fractures missed by 64-slice computed tomography. J Emerg Med. 2012;43(2):303-307.

4. Feldman F, Staron RB. MRI of seemingly isolated greater trochanteric fractures. AJR Am J Roentgenol. 2004;183(2):323-329.

5. Schultz E, Miller TT, Boruchov SD, Schmell EB, Toledano B. Incomplete intertrochanteric fractures: imaging features and clinical management. Radiology. 1999;211(1):237-240.

6. Cannon J, Silvestri S, Munro M. Imaging choices in occult hip fracture. J Emerg Med. 2009;37(2):144-152.

Dr. Bartolotta is an assistant professor of radiology at Weill Cornell Medical College in New York City and assistant attending radiologist at New York-Presbyterian Hospital/Weill Cornell Medical Center.

Post-traumatic hip pain is a common chief concern among ED patients. While routine radiography, the standard imaging modality for the initial evaluation of suspected hip fracture, detects most fractures, its sensitivity is decreased in the setting of osteoporosis—particularly with nondisplaced fractures. Thus, though elderly/osteoporotic patients are more likely to fracture, these fractures are harder to detect on radiography. In a study of 70 patients with negative radiographs but high clinical concern for fracture, magnetic resonance imaging (MRI) detected occult femoral fractures in 37% and occult pelvic fractures in 23%.¹

Hip fractures in elderly patients are associated with substantial mortality and morbidity, the risks for which increase with delayed diagnosis.² When there is high clinical suspicion for a radiographically occult hip fracture in this population, cross-sectional imaging should be considered for further evaluation (Figure). The decision of whether to use computed tomography (CT) or MRI for the cross-sectional examination must be made on both an institutional and patient-specific basis. CT is faster, less expensive, and more widely and temporally available. Although CT has increased sensitivity for fracture detection compared to radiography, studies have demonstrated false-negative CT examinations in the setting of nondisplaced proximal femoral fractures, especially in osteoporotic patients. Hakkarinen et al³ reported that among 235 hip fractures, 10% were occult radiographically; approximately 17% of these fractures (4 out of 24) were also occult on CT but visible on MRI. Moreover, while radiography and CT may demonstrate a seemingly isolated fracture at the femoral greater trochanter, a subset of these fractures exhibit intertrochanteric extension that is only evident on MRI (Figure). Isolated greater trochanteric fractures are typically treated conservatively, while some incomplete intertrochanteric fractures warrant internal fixation, especially fractures that cross the intertrochanteric midline on coronal MRI.^4,5

In addition to improved fracture detection, MRI also provides superior evaluation of the underlying bone marrow for coexisting conditions, such as osteomyelitis, osteonecrosis, and primary or metastatic neoplasm in the setting of pathologic fracture. Additional benefits of MRI over radiography and CT include its lack of ionizing radiation and improved evaluation of adjacent soft tissue injuries, such as labral and/or musculotendinous tears.

MRI, however, does require a longer examination time in which the patient must remain still. This may be difficult for acutely post-traumatic patients, notably those with baseline dementia and/or claustrophobia. For patients in whom MRI is indicated (eg, patients who do not have an implantable device such as a cardiac pacemaker) and where it is institutionally available, the decision to utilize it over CT is largely rooted in health-care economics. MRI is more expensive than radiography and CT, and even in the largest medical centers, the examination requires substantially more time than CT, which inherently decreases patient throughput in the ED. Cannon et al⁶ present an evidence-based algorithm for patient stratification, in which patients at high-risk for osteoporosis and low-energy trauma should be considered for immediate MRI rather than CT. These risk factors optimize MRI utilization by selecting those patients with the greatest likelihood of nondisplaced, radiographically occult fracture.

References

1. Bogost GA, Lizerbram EK, Crues JV 3rd. MR imaging in evaluation of suspected hip fracture: frequency of unsuspected bone and soft-tissue injury. Radiology. 1995;197(1):263-267.

2. Zuckerman JD, Skovron ML, Koval KJ, Aharonoff G, Frankel VH. Postoperative complications and mortality associated with operative delay in older patients who have a fracture of the hip. J Bone Joint Surg Am. 1995;77(10):1551-1556.

3. Hakkarinen DK, Banh KV, Hendey GW. Magnetic resonance imaging identifies occult hip fractures missed by 64-slice computed tomography. J Emerg Med. 2012;43(2):303-307.

4. Feldman F, Staron RB. MRI of seemingly isolated greater trochanteric fractures. AJR Am J Roentgenol. 2004;183(2):323-329.

5. Schultz E, Miller TT, Boruchov SD, Schmell EB, Toledano B. Incomplete intertrochanteric fractures: imaging features and clinical management. Radiology. 1999;211(1):237-240.

6. Cannon J, Silvestri S, Munro M. Imaging choices in occult hip fracture. J Emerg Med. 2009;37(2):144-152.