Actively Recruiting
Global Pediatric Orthopaedic Implant Safety & Efficacy Clinical Follow-up Program
Led by University of British Columbia · Updated on 2025-11-24
4000
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
Sponsors
U
University of British Columbia
Lead Sponsor
O
OrthoPediatrics
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of pediatric orthopedic implants used in conditions such as hip disorders, fractures, limb deformities, and implant complications. These devices are essential for maintaining bone alignment, promoting healing, and preventing joint problems. New European regulations require careful follow-up to understand how well these implants perform over time and to monitor their safety. The study follows patients who receive pediatric orthopedic implants as part of their usual medical care. Data is collected both before and after surgery, including medical history, surgical details, and any device-related issues. Follow-up includes routine clinical visits where X-rays and other assessments help track bone healing, device condition, and any adverse events. Data is gathered through established registries and entered into a secure research database. Participants will be monitored for up to two years after their implant surgery. During this time, researchers collect information on device-related adverse effects, implant survival, and implant effectiveness. Additional measurements include pain levels and quality of life assessments. The study captures all scheduled and unscheduled visits, tracking any complications or implant removals to provide a comprehensive picture of implant outcomes and safety.
CONDITIONS
Brief Title
Pediatric Orthopaedic Implant Safety & Efficacy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients indicated for the device-specific indication, as decided by their doctor and described in the device instructions for use
- Patients able to follow the required length of follow-up for each product's endpoints
- Informed consent or assent has been given
You will not qualify if you...
- Patients with known sensitivity to metals
- Patients unable to follow a post-operative care plan
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Screening and enrollment visit
Duration - Single event during standard care
Participants receive a pediatric orthopaedic implant as part of their standard clinical care.
1 visit (in-person) for implant procedure
Duration - Up to 2 years post implant insertion
Participants who undergo routine care are observed through data collection during standard follow-up visits, including assessments of radiographs, device-related adverse events, and implant survivorship.
Routine standard of care follow-up visits plus unscheduled visits if adverse events occur
Trial Site Locations
Total: 1 location
1
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
Actively Recruiting
Research Team
B
Bryn Zomar, PhD
H
Harpreet Chhina, PhD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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