Pediatric Orthopaedic Implant Safety & Efficacy

NCT05361980 | Recruiting FDA Device

• 1 other identifier: H21-03076
• Study Type: observational
• Target: 4,000
• Locations: 1 country
• Sites: 1

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; Implant Breakage; Implant Complication; Hip Dysplasia; Pediatric ALL; Hip Disease; Hip Dislocation

Outcome Measures

Primary Outcomes (3)

• Device related adverse events

  Determine the frequency and severity of device-related adverse events at device-specific end points. All adverse events will be recorded and followed during the study. The frequency and severity of device related adverse events will be analyzed to ensure the device risk profile has not changed.

  2 years post implant insertion

• Implant survival

  Determine the implant survival rate at post-operative end-point: (lack of revision)

  2 years post implant insertion

• Implant efficacy

  Efficacy will be assessed by post-operative clinical and radiographic evaluations at each follow-up end-point to assess bone fixation and/or deformity correction.

  2 years post implant insertion

Secondary Outcomes (3)

• Numeric pain rating scale (NPRS)

  2 years post implant insertion

• LIMB-Q Kids

  2 years post implant insertion

• PROMIS

  2 years post implant insertion

Study Arms (1)

Longitudinal Observational Group

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

Device: Pediatric orthopaedic implant

Interventions

Pediatric orthopaedic implant DEVICE

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

Longitudinal Observational Group

Eligibility Criteria

• Age: 0 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Anyone who meets the eligibility criteria and is within the age limits listed in the above sections can participate in this study.

You may qualify if:

• 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

You may not qualify if:

• Patients with a demonstrated sensitivity to metals
• Patients with an inability to follow a post-operative regimen

Sponsors & Collaborators

• University of British Columbia: lead
• OrthoPediatrics: collaborator

Study Sites (1)

BC Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

RECRUITING

MeSH Terms

Conditions

Fractures, Bone; Musculoskeletal Diseases; Congenital Abnormalities; Hip Dislocation; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Condition Hierarchy (Ancestors)

Wounds and Injuries; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Joint Dislocations; Joint Diseases; Hip Injuries; Leukemia, Lymphoid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Bryn Zomar, PhD

  University of British Columbia

  STUDY DIRECTOR

Central Study Contacts

Bryn Zomar, PhD

CONTACT

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

Harpreet Chhina, PhD

CONTACT

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: May 5, 2022
• Study Start: January 6, 2022
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2029
• Last Updated: November 24, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)