RecruitingNCT05361980

Pediatric Orthopaedic Implant Safety & Efficacy

Global Pediatric Orthopaedic Implant Safety & Efficacy Clinical Follow-up Program

Sponsor

University of British Columbia

Enrollment

4,000 participants

Start Date

Jan 6, 2022

Study Type

OBSERVATIONAL

Conditions

Pediatric ALL Fracture Lengthening; Leg Orthopedic Disorder Deformity of Limb Deformity; Bone Implant Breakage Implant Complication Hip Dysplasia Hip Disease Hip Dislocation

Summary

Implant devices are important tools - their use is essential across a number of orthopaedic indications, including hip conditions, trauma and limb deformity. Given the vital role fixation devices play in maintaining alignment, promoting healthy bone healing and preventing joint degeneration, it is essential to understand the expected lifetime outcomes of these implants, and evaluate their safety and efficacy. Prospective implant efficacy and safety registries are needed to support this endeavour, especially considering new regulatory requirements from the European Union Medical Devices Regulation (EU MDR) in relation to post-market clinical follow-up (PMCF).

Eligibility

Min Age: 0 YearsMax Age: 25 Years

Plain Language Summary

Simplified for easier understanding

This long-term registry study is collecting safety and effectiveness data on orthopedic implants and devices used in children and adolescents, to better understand how these devices perform over time in real-world settings. **You may be eligible if...** - You are a pediatric patient indicated for a specific orthopedic implant or device based on your doctor's judgment - You are able to return for required follow-up visits - You (and/or your parent or guardian) can provide informed consent **You may NOT be eligible if...** - You have a known sensitivity or allergy to metals - You are unable to follow the post-operative care and follow-up schedule - You have specific contraindications to the implant being used Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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