Pediatric Orthopaedic Implant Safety & Efficacy
Global Pediatric Orthopaedic Implant Safety & Efficacy Clinical Follow-up Program
University of British Columbia
4,000 participants
Jan 6, 2022
OBSERVATIONAL
Conditions
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
Inclusion Criteria3
- 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 Criteria2
- Patients with a demonstrated sensitivity to metals
- Patients with an inability to follow a post-operative regimen
Interventions
Patient receives a pediatric orthopaedic implant as a part of standard clinical care.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05361980