Evaluating the safety and effectiveness of pediatric orthopedic implants
Official title: Global Pediatric Orthopaedic Implant Safety & Efficacy Clinical Follow-up Program
Run by University of British Columbia · NCT05361980 · Data updated 2026-11-12
This study is testing how safe and effective orthopedic implants are for kids with fractures and limb deformities to see how they perform over time.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 0 Years to 25 Years |
| Sex | All |
| Enrollment | 4000 (estimated) |
| Sponsor | University of British Columbia Academic / other |
| Locations | 1 site (Vancouver, British Columbia) |
| Status | Recruiting |
| Started | January 6, 2022 |
| Main results expected | December 2028 |
| Study ends | December 2029 |
| Registry record updated | November 9, 2026 |
| Trial ID | NCT05361980 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include pediatric patients indicated for specific orthopedic implants as determined by their physician.
✕Probably not a fit
Patients with metal sensitivities or those unable to adhere to post-operative care may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the safety and efficacy of pediatric orthopedic implants used for various conditions such as fractures and limb deformities. Patients will be screened for eligibility based on standard care assessments and will have their data collected in a secure database. The study will focus on understanding the long-term outcomes of these implants, particularly in light of new regulatory requirements for post-market clinical follow-up. Data will include demographic information, medical history, and pre-operative clinical details.
Why it matters
Potential benefit: If successful, this study could enhance the understanding of pediatric orthopedic implant performance, leading to improved patient outcomes.
How similar studies have gone: Other studies have shown success in evaluating orthopedic implants, but this specific approach to pediatric implants is relatively novel.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
BC Children's Hospital
Vancouver, British Columbia, Canada Recruiting
Study contacts
- Study coordinator: Bryn Zomar, PhD
- Email: bryn.zomar@cw.bc.ca
- Phone: 604-875-2359
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.