NCT05361980Recruiting
Pediatric Orthopaedic Implant Safety & Efficacy
Global Pediatric Orthopaedic Implant Safety & Efficacy Clinical Follow-up Program
Source: ClinicalTrials.gov · Last updated 24 Nov 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 4000 (estimated)
- First submitted
- 17 Dec 2021
- Start date
- 6 Jan 2022
- Primary completion date
- Dec 2028
- Lead sponsor
- University of British Columbia
- NCT number
- NCT05361980
What you commit to
- Study type: Observational
- Planned participants: 4000
- From 6 Jan 2022 to the primary completion date, Dec 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- Patients with a demonstrated sensitivity to metals
- Patients with an inability to follow a post-operative regimen
Who the study is looking for
- 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
Age in the registry: 0 years to 25 years · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| BC Children ' s Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.