Recruiting

Orthopaedic Implant

Sponsor:

University of British Columbia

Code:

NCT05361980

Conditions

Fracture

Lengthening; Leg

Orthopedic Disorder

Deformity of Limb

Deformity; Bone

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Accepted

Interventions

Pediatric orthopaedic implant

Study Details

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).

Conditions

Fracture

Lengthening; Leg

Orthopedic Disorder

Deformity of Limb

Deformity; Bone

Study ID

NCT05361980

Start date

Jan 6, 2022

Status verified date

Nov, 2025

Completion date

Dec, 2029

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 25

Healthy Volunteers: Accepted

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

Study Design

Enrollment

4000 participants

Anticipated

Interventions and Outcome Measures

Arms

Longitudinal Observational Group

Pediatric patients indicated for the device-specific indication, per physician discretion and as indicated in the device IFU.

Interventions

Pediatric orthopaedic implant

Patient receives a pediatric orthopaedic implant as a part of standard clinical care.

Primary outcome measure

  • Device related adverse events [ Time Frame: 2 years post implant insertion ]
  • Implant survival [ Time Frame: 2 years post implant insertion ]
  • Implant efficacy [ Time Frame: 2 years post implant insertion ]

Central Contacts and Locations

Central contacts

Bryn Zomar, PhD

604-875-2359bryn.zomar@cw.bc.ca

Harpreet Chhina, PhD

604-875-2000hchhina@cw.bc.ca

Locations

BC Children's Hospital

Recruiting

Vancouver, British Columbia, Canada, V6H 3N1

Contacts

Emily Schaeffer, PhD

604-875-2359emily.schaeffer@cw.bc.ca

Principal Investigator:

Anthony Cooper, FRCSC

More Information

Sponsor

University of British Columbia

Last update posted

Nov 24, 2025

Last verified

Nov, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of British Columbia on 2025-11-24.