NCT05361980 Pediatric Orthopaedic Implant Safety & Efficacy
| NCT ID | NCT05361980 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of British Columbia |
| Condition | Fracture |
| Study Type | OBSERVATIONAL |
| Enrollment | 4,000 participants |
| Start Date | 2022-01-06 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 4,000 participants in total. It began in 2022-01-06 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Contact & Investigator
Bryn Zomar, PhD
STUDY DIRECTOR
University of British Columbia
Frequently Asked Questions
Who can join the NCT05361980 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 25 Years, studying Fracture. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05361980 currently recruiting?
Yes, NCT05361980 is actively recruiting participants. Contact the research team at bryn.zomar@cw.bc.ca for enrollment information.
Where is the NCT05361980 trial being conducted?
This trial is being conducted at Vancouver, Canada.
Who is sponsoring the NCT05361980 clinical trial?
NCT05361980 is sponsored by University of British Columbia. The principal investigator is Bryn Zomar, PhD at University of British Columbia. The trial plans to enroll 4,000 participants.