Milestone Reached in Pediatric Implant Study

OrthoPediatrics Corp. announced its ongoing Global POISE (Pediatric Orthopedic Implant Safety and Efficacy) Study is analyzing more than 600 implants in 300-plus pediatric patients.

Global POISE is a multi-center, post-market, prospective clinical follow-up study designed to assess the safety and efficacy of various OrthoPediatrics’ implant devices. This international study is focused on verifying implant survival and identifying any device-related adverse events. Launched in 2023, Global POISE now includes 13 active sites and is still growing, with data currently being collected from Canada, the United States, Australia, New Zealand, and South Africa.

The insights generated from this study will help OrthoPediatrics refine its devices to meet the specific needs of growing children with orthopedic conditions. The sites involved in Global POISE are committed to broadening the study’s reach and continue to enroll additional patients across 17 different implant types to further enhance the understanding of their safety and long-term effectiveness.

“We are thrilled to see the Global POISE Study reach this significant milestone. This achievement is a testament to the dedication and collaboration of OrthoPediatrics and the research team at BC Children’s Hospital,” OrthoPediatrics Senior Vice President of Quality, Clinical and Regulatory Affairs Ray Garrison said. “As the study continues to expand, we are excited about the valuable insights it will generate that will ultimately improve the outcomes for children undergoing orthopedic procedures around the world. OrthoPediatrics remains committed to advancing pediatric orthopedic care through solutions designed to meet the unique needs of young patients.”

BC Children’s Hospital is a pediatric teaching and research hospital in Vancouver, British Columbia, that is recognized for its research in child health. The Global POISE study is spearheaded by principal investigators Dr. Anthony Cooper and Dr. Kishore Mulpuri, two orthopedic surgeons at the hospital.

Founded in 2006, OrthoPediatrics is focused exclusively on advancing pediatric orthopedics. As such, it currently markets more than 80 products that serve three of the largest categories within the pediatric orthopedic market. This product offering spans trauma and deformity, scoliosis, and sports medicine/other procedures. OrthoPediatrics’ global sales organization is focused exclusively on pediatric orthopedics and distributes its products in the United States and more than 70 countries outside the United States.