Status:
RECRUITING
Pediatric Orthopaedic Implant Safety & Efficacy
Lead Sponsor:
University of British Columbia
Collaborating Sponsors:
OrthoPediatrics
Conditions:
Fracture
Lengthening; Leg
Eligibility:
All Genders
Up to 25 years
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 pla...
Detailed Description
STUDY PROCEDURES Screening Patients will be screened against basic inclusion/exclusion criteria to see if patients may be appropriate for study participation according to any standard of care assessme...
Eligibility Criteria
Inclusion
- 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
- Patients with a demonstrated sensitivity to metals
- Patients with an inability to follow a post-operative regimen
Key Trial Info
Start Date :
January 6 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2029
Estimated Enrollment :
4000 Patients enrolled
Trial Details
Trial ID
NCT05361980
Start Date
January 6 2022
End Date
December 1 2029
Last Update
November 24 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1