Sawyer JR

In my 16 years of practice, there has been tremendous change in the field of pediatric orthopedics in both demographics and scope of practice. Because of scientific and technological advances, efforts of the Pediatric Orthopaedic Society of North America (POSNA), and a changing workforce, the nature of pediatric orthopedics is changing dramatically and will continue to do so.

In the late 1990s, a “typical” pediatric orthopedic surgeon was treating fractures, developmental dysplasia of the hip, clubfeet, and other congenital deformities. Surgery for adolescent idiopathic scoliosis was moving toward anterior instrumentation and correction of the spine. The concepts of early-onset scoliosis and thoracic insufficiency syndrome were in their infancy. Children with anterior cruciate ligament tears were treated with braces until skeletal maturity, often leading to life-altering meniscal pathology. Essential medical treatments for genetic conditions, including bisphosphonates for osteogenesis imperfecta and corticosteroids for Duchenne muscular dystrophy, were considered experimental.

The field itself also was at a crossroads. In 1993, there were 410 active members in POSNA (vs 653 in 2014), and the vast majority were male.¹ In the late 1990s, there were approximately 30 pediatric fellowship spots and 10 fellows being trained per year. Simultaneously, approximately 20 to 30 active POSNA members were retiring annually, leading to a projected shortage of pediatric orthopedic surgeons.¹ A 2007 American Orthopaedic Association survey found that 59% of members believed that pediatric orthopedics was the most underserved specialty for a variety of reasons, including perceived lower reimbursement, higher volume of nonoperative treatment, and lifestyle issues (such as on-call burden).²

Owing in part to efforts of POSNA in resident/fellow education and mentorship, the practice of pediatric orthopedics in 2016 is dramatically different from a decade ago. The number of fellowship programs has increased to 44 programs, offering a total of 71 fellowship spots, of which 60 were filled by US applicants in 2014. Interestingly, the current active membership of POSNA is 19% female, and the 2014 fellowship class was 34% female. This is in contrast to the 4.4% of all AAOS members who are female. If current trends continue, POSNA could be 40% female by 2025 as senior, predominantly male members retire.¹

Pediatric orthopedic practice in 2016 is also dramatically different owing to the development of subspecialization in areas of pediatric sports medicine, hand surgery, trauma, and the treatment of adolescent hip pathology. In fact, a recent survey of fellowship graduates showed that 30% of graduating fellows were going to do a second fellowship.³

While technological advances have driven the care of many pediatric orthopedic conditions such as spinal deformity and sports injuries, there also has been a resurgence of interest in the nonoperative treatment of clubfeet using the Ponseti method and of early-onset scoliosis using Mehta casting. Children with clubfeet even a decade ago were being treated with wide comprehensive releases and capsulotomies, leading to stiff painful feet as young adults. Now comprehensive releases are rarely used. Owing to advances in posterior spinal instrumentation as well as studies showing some decline in pulmonary function after thoracotomy and anterior spinal fusion, the treatment of adolescent scoliosis is predominantly done through the posterior approach. Advances in screening have led to a dramatic decrease in the surgical treatment of hip dysplasia. Medical treatment, such as corticosteroids for Duchenne muscular dystrophy, has prolonged length of life and improved quality of life as well as decreased the number of spinal fusions performed. Recombinant factor replacement for hemophilia has almost eliminated the horrible morbidity associated with hemophilic arthropathy and the need for synovectomy, arthrodesis, and arthroplasty, as well as the infectious issues, such as human immunodeficiency virus (HIV) and hepatitis, associated with the use of pooled blood products. The use of growth-friendly spinal implants, such as the Vertical Expandable Prosthetic Titanium Rib (VEPTR; DePuy Synthes), magnetically driven growing rods (MAGEC; Ellipse), and spinal tethers have improved pulmonary outcomes and presumably life expectancy in young patients with early-onset scoliosis who a decade ago may have had an in situ spinal fusion. These are just a few examples, and there are many more.

The articles in this issue highlight some of these changes. Tibial osteotomy and deformity correction, as described in the article by Burton and Hennrikus (pages 16-18), are classic techniques used by pediatric orthopedists over the past decades and will continue to be useful. The article by Hosseinzadeh and Talwalkar (pages 19-22) reviews unique aspects of pediatric compartment syndrome. While the basic concepts of compartment syndrome have not changed, the signs of compartment syndrome, the 5 Ps we all learned a decade ago (pain, paresthesia, paralysis, pallor, and pulselessness) have now been replaced in children with the 3 As (increasing analgesia, anxiety, and agitation). Finally, the article by Sferopoulos (pages 38-41) describing a case of a giant bone island in a child reminds us that we have a lot more to learn as pediatric orthopedists regarding the molecular nature and cause of disease.

The next few years will continue to be an exciting and dynamic time in the field of pediatric orthopedics. Not only is the workforce itself changing and growing, but so are the definitions of what a pediatric orthopedic surgeon is and does. While subspecialization is the trend in most aspects of medicine, it will be important to continue to monitor<hl name="1"/> this trend to ensure that pediatric orthopedics does not become too highly specialized. With the tremendous inflow of new talent, ideas, and technology, the future for pediatric orthopedics has never looked brighter.

References

In my 16 years of practice, there has been tremendous change in the field of pediatric orthopedics in both demographics and scope of practice. Because of scientific and technological advances, efforts of the Pediatric Orthopaedic Society of North America (POSNA), and a changing workforce, the nature of pediatric orthopedics is changing dramatically and will continue to do so.

In the late 1990s, a “typical” pediatric orthopedic surgeon was treating fractures, developmental dysplasia of the hip, clubfeet, and other congenital deformities. Surgery for adolescent idiopathic scoliosis was moving toward anterior instrumentation and correction of the spine. The concepts of early-onset scoliosis and thoracic insufficiency syndrome were in their infancy. Children with anterior cruciate ligament tears were treated with braces until skeletal maturity, often leading to life-altering meniscal pathology. Essential medical treatments for genetic conditions, including bisphosphonates for osteogenesis imperfecta and corticosteroids for Duchenne muscular dystrophy, were considered experimental.

The field itself also was at a crossroads. In 1993, there were 410 active members in POSNA (vs 653 in 2014), and the vast majority were male.¹ In the late 1990s, there were approximately 30 pediatric fellowship spots and 10 fellows being trained per year. Simultaneously, approximately 20 to 30 active POSNA members were retiring annually, leading to a projected shortage of pediatric orthopedic surgeons.¹ A 2007 American Orthopaedic Association survey found that 59% of members believed that pediatric orthopedics was the most underserved specialty for a variety of reasons, including perceived lower reimbursement, higher volume of nonoperative treatment, and lifestyle issues (such as on-call burden).²

Owing in part to efforts of POSNA in resident/fellow education and mentorship, the practice of pediatric orthopedics in 2016 is dramatically different from a decade ago. The number of fellowship programs has increased to 44 programs, offering a total of 71 fellowship spots, of which 60 were filled by US applicants in 2014. Interestingly, the current active membership of POSNA is 19% female, and the 2014 fellowship class was 34% female. This is in contrast to the 4.4% of all AAOS members who are female. If current trends continue, POSNA could be 40% female by 2025 as senior, predominantly male members retire.¹

Pediatric orthopedic practice in 2016 is also dramatically different owing to the development of subspecialization in areas of pediatric sports medicine, hand surgery, trauma, and the treatment of adolescent hip pathology. In fact, a recent survey of fellowship graduates showed that 30% of graduating fellows were going to do a second fellowship.³

While technological advances have driven the care of many pediatric orthopedic conditions such as spinal deformity and sports injuries, there also has been a resurgence of interest in the nonoperative treatment of clubfeet using the Ponseti method and of early-onset scoliosis using Mehta casting. Children with clubfeet even a decade ago were being treated with wide comprehensive releases and capsulotomies, leading to stiff painful feet as young adults. Now comprehensive releases are rarely used. Owing to advances in posterior spinal instrumentation as well as studies showing some decline in pulmonary function after thoracotomy and anterior spinal fusion, the treatment of adolescent scoliosis is predominantly done through the posterior approach. Advances in screening have led to a dramatic decrease in the surgical treatment of hip dysplasia. Medical treatment, such as corticosteroids for Duchenne muscular dystrophy, has prolonged length of life and improved quality of life as well as decreased the number of spinal fusions performed. Recombinant factor replacement for hemophilia has almost eliminated the horrible morbidity associated with hemophilic arthropathy and the need for synovectomy, arthrodesis, and arthroplasty, as well as the infectious issues, such as human immunodeficiency virus (HIV) and hepatitis, associated with the use of pooled blood products. The use of growth-friendly spinal implants, such as the Vertical Expandable Prosthetic Titanium Rib (VEPTR; DePuy Synthes), magnetically driven growing rods (MAGEC; Ellipse), and spinal tethers have improved pulmonary outcomes and presumably life expectancy in young patients with early-onset scoliosis who a decade ago may have had an in situ spinal fusion. These are just a few examples, and there are many more.

The articles in this issue highlight some of these changes. Tibial osteotomy and deformity correction, as described in the article by Burton and Hennrikus (pages 16-18), are classic techniques used by pediatric orthopedists over the past decades and will continue to be useful. The article by Hosseinzadeh and Talwalkar (pages 19-22) reviews unique aspects of pediatric compartment syndrome. While the basic concepts of compartment syndrome have not changed, the signs of compartment syndrome, the 5 Ps we all learned a decade ago (pain, paresthesia, paralysis, pallor, and pulselessness) have now been replaced in children with the 3 As (increasing analgesia, anxiety, and agitation). Finally, the article by Sferopoulos (pages 38-41) describing a case of a giant bone island in a child reminds us that we have a lot more to learn as pediatric orthopedists regarding the molecular nature and cause of disease.

The next few years will continue to be an exciting and dynamic time in the field of pediatric orthopedics. Not only is the workforce itself changing and growing, but so are the definitions of what a pediatric orthopedic surgeon is and does. While subspecialization is the trend in most aspects of medicine, it will be important to continue to monitor<hl name="1"/> this trend to ensure that pediatric orthopedics does not become too highly specialized. With the tremendous inflow of new talent, ideas, and technology, the future for pediatric orthopedics has never looked brighter.

References

In my 16 years of practice, there has been tremendous change in the field of pediatric orthopedics in both demographics and scope of practice. Because of scientific and technological advances, efforts of the Pediatric Orthopaedic Society of North America (POSNA), and a changing workforce, the nature of pediatric orthopedics is changing dramatically and will continue to do so.

In the late 1990s, a “typical” pediatric orthopedic surgeon was treating fractures, developmental dysplasia of the hip, clubfeet, and other congenital deformities. Surgery for adolescent idiopathic scoliosis was moving toward anterior instrumentation and correction of the spine. The concepts of early-onset scoliosis and thoracic insufficiency syndrome were in their infancy. Children with anterior cruciate ligament tears were treated with braces until skeletal maturity, often leading to life-altering meniscal pathology. Essential medical treatments for genetic conditions, including bisphosphonates for osteogenesis imperfecta and corticosteroids for Duchenne muscular dystrophy, were considered experimental.

The field itself also was at a crossroads. In 1993, there were 410 active members in POSNA (vs 653 in 2014), and the vast majority were male.¹ In the late 1990s, there were approximately 30 pediatric fellowship spots and 10 fellows being trained per year. Simultaneously, approximately 20 to 30 active POSNA members were retiring annually, leading to a projected shortage of pediatric orthopedic surgeons.¹ A 2007 American Orthopaedic Association survey found that 59% of members believed that pediatric orthopedics was the most underserved specialty for a variety of reasons, including perceived lower reimbursement, higher volume of nonoperative treatment, and lifestyle issues (such as on-call burden).²

Owing in part to efforts of POSNA in resident/fellow education and mentorship, the practice of pediatric orthopedics in 2016 is dramatically different from a decade ago. The number of fellowship programs has increased to 44 programs, offering a total of 71 fellowship spots, of which 60 were filled by US applicants in 2014. Interestingly, the current active membership of POSNA is 19% female, and the 2014 fellowship class was 34% female. This is in contrast to the 4.4% of all AAOS members who are female. If current trends continue, POSNA could be 40% female by 2025 as senior, predominantly male members retire.¹

Pediatric orthopedic practice in 2016 is also dramatically different owing to the development of subspecialization in areas of pediatric sports medicine, hand surgery, trauma, and the treatment of adolescent hip pathology. In fact, a recent survey of fellowship graduates showed that 30% of graduating fellows were going to do a second fellowship.³

While technological advances have driven the care of many pediatric orthopedic conditions such as spinal deformity and sports injuries, there also has been a resurgence of interest in the nonoperative treatment of clubfeet using the Ponseti method and of early-onset scoliosis using Mehta casting. Children with clubfeet even a decade ago were being treated with wide comprehensive releases and capsulotomies, leading to stiff painful feet as young adults. Now comprehensive releases are rarely used. Owing to advances in posterior spinal instrumentation as well as studies showing some decline in pulmonary function after thoracotomy and anterior spinal fusion, the treatment of adolescent scoliosis is predominantly done through the posterior approach. Advances in screening have led to a dramatic decrease in the surgical treatment of hip dysplasia. Medical treatment, such as corticosteroids for Duchenne muscular dystrophy, has prolonged length of life and improved quality of life as well as decreased the number of spinal fusions performed. Recombinant factor replacement for hemophilia has almost eliminated the horrible morbidity associated with hemophilic arthropathy and the need for synovectomy, arthrodesis, and arthroplasty, as well as the infectious issues, such as human immunodeficiency virus (HIV) and hepatitis, associated with the use of pooled blood products. The use of growth-friendly spinal implants, such as the Vertical Expandable Prosthetic Titanium Rib (VEPTR; DePuy Synthes), magnetically driven growing rods (MAGEC; Ellipse), and spinal tethers have improved pulmonary outcomes and presumably life expectancy in young patients with early-onset scoliosis who a decade ago may have had an in situ spinal fusion. These are just a few examples, and there are many more.

The articles in this issue highlight some of these changes. Tibial osteotomy and deformity correction, as described in the article by Burton and Hennrikus (pages 16-18), are classic techniques used by pediatric orthopedists over the past decades and will continue to be useful. The article by Hosseinzadeh and Talwalkar (pages 19-22) reviews unique aspects of pediatric compartment syndrome. While the basic concepts of compartment syndrome have not changed, the signs of compartment syndrome, the 5 Ps we all learned a decade ago (pain, paresthesia, paralysis, pallor, and pulselessness) have now been replaced in children with the 3 As (increasing analgesia, anxiety, and agitation). Finally, the article by Sferopoulos (pages 38-41) describing a case of a giant bone island in a child reminds us that we have a lot more to learn as pediatric orthopedists regarding the molecular nature and cause of disease.

The next few years will continue to be an exciting and dynamic time in the field of pediatric orthopedics. Not only is the workforce itself changing and growing, but so are the definitions of what a pediatric orthopedic surgeon is and does. While subspecialization is the trend in most aspects of medicine, it will be important to continue to monitor<hl name="1"/> this trend to ensure that pediatric orthopedics does not become too highly specialized. With the tremendous inflow of new talent, ideas, and technology, the future for pediatric orthopedics has never looked brighter.

References

"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.