Actively Recruiting

Age: 0Years - 25Years
All Genders
Healthy Volunteers
NCT05361980

Pediatric Orthopaedic Implant Safety & Efficacy

Led by University of British Columbia · Updated on 2025-11-24

4000

Participants Needed

1

Research Sites

412 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

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).

CONDITIONS

Official Title

Pediatric Orthopaedic Implant Safety & Efficacy

Who Can Participate

Age: 0Years - 25Years
All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients indicated for the device-specific use as determined by a physician and device instructions for use
  • Patients able to follow the required length of follow-up to assess implant outcomes
  • Informed consent or assent provided by patient or guardian
Not Eligible

You will not qualify if you...

  • Patients with known sensitivity or allergy to metals
  • Patients unable to follow post-operative care instructions

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

BC Children's Hospital

Vancouver, British Columbia, Canada, V6H 3N1

Actively Recruiting

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Research Team

B

Bryn Zomar, PhD

CONTACT

H

Harpreet Chhina, PhD

CONTACT

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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