Pediatric Orthopaedic Implant Safety & Efficacy

RECRUITING

NCT05361980

Sponsor: University of British Columbia

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).

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

Key Details

Gender

All

Age Range

0 Years - 25 Years

Study Type

OBSERVATIONAL

Enrollment

4000

Start Date

2022-01-06

Completion Date

2029-12

Last Updated

2025-11-24

Healthy Volunteers

Yes

Conditions

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

Interventions

DEVICE

Pediatric orthopaedic implant

Patient receives a pediatric orthopaedic implant as a part of standard clinical care.

Locations (1)

BC Children's Hospital

Vancouver, British Columbia, Canada

Clinical Research Directory