Pediatric Orthopaedic Implant Safety & Efficacy

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

Sex: All

Ages: 0 Years – 25 Years

Healthy volunteers: Yes

Enrollment: 4000

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).

Eligibility Criteria

Inclusion Criteria: * Patients indicated for the device-specific indication, per physician discretion and as indicated in the device IFU. Off-label use is strongly discouraged; however, any and all on- and off-label indications for use of the products in this program will be collected and stratified accordingly * Patients must be able to adhere to the required length of follow-up for the endpoints of each individual product * Informed consent/assent is required Exclusion Criteria: * Patients with a demonstrated sensitivity to metals * Patients with an inability to follow a post-operative regimen

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05361980). StuddyBuddy aggregates publicly available trial information.