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Pediatric Orthopaedic Implant Safety & Efficacy

NCT05361980 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 4000

Last updated 2025-11-24

No results posted yet for this study

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

Interventions

DEVICE

Pediatric orthopaedic implant

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

Sponsors & Collaborators

  • OrthoPediatrics

    collaborator INDUSTRY

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Bryn Zomar, PhD · University of British Columbia

Eligibility

Min Age
0 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-06
Primary Completion
2028-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05361980 on ClinicalTrials.gov