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ID05361980

Global Follow-Up Program for Safety and Effectiveness of Pediatric Orthopaedic Implants

Led by University of British Columbia · Updated on 2025-11-24

4000

Participants Needed

1

Research Sites

52 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying the safety and effectiveness of pediatric orthopedic implants used in conditions such as hip disorders, fractures, limb deformities, and implant complications. These devices are essential for maintaining bone alignment, promoting healing, and preventing joint problems. New European regulations require careful follow-up to understand how well these implants perform over time and to monitor their safety. The study follows patients who receive pediatric orthopedic implants as part of their usual medical care. Data is collected both before and after surgery, including medical history, surgical details, and any device-related issues. Follow-up includes routine clinical visits where X-rays and other assessments help track bone healing, device condition, and any adverse events. Data is gathered through established registries and entered into a secure research database. Participants will be monitored for up to two years after their implant surgery. During this time, researchers collect information on device-related adverse effects, implant survival, and implant effectiveness. Additional measurements include pain levels and quality of life assessments. The study captures all scheduled and unscheduled visits, tracking any complications or implant removals to provide a comprehensive picture of implant outcomes and safety.

CONDITIONS

Brief Title

Pediatric Orthopaedic Implant Safety & Efficacy

Research Team

B

Bryn Zomar, PhD

H

Harpreet Chhina, PhD

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