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Orthopaedic Implant

Longitudinal Observational Group for Orthopedic Disorders (Global POISE Trial)

N/A
Recruiting
Research Sponsored by University of British Columbia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be younger than 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years post implant insertion
Awards & highlights
No Placebo-Only Group

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).

Eligible Conditions
  • Orthopedic Disorders
  • Implant Breakage
  • Hip Dislocation
  • Hip Dysplasia
  • Bone Deformity
  • Leg Lengthening
  • Broken Bones
  • Acute Lymphoblastic Leukemia
  • Implant Complication
  • Limb Deformity

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years post implant insertion
This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years post implant insertion for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Device related adverse events
Implant efficacy
Implant survival
Secondary study objectives
LIMB-Q Kids
Numeric pain rating scale (NPRS)
Pediatric Outcomes Data Collection Instrument (PODCI)

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Longitudinal Observational GroupExperimental Treatment1 Intervention
Pediatric patients indicated for the device-specific indication, per physician discretion and as indicated in the device IFU.

Find a Location

Who is running the clinical trial?

OrthoPediatricsIndustry Sponsor
University of British ColumbiaLead Sponsor
1,461 Previous Clinical Trials
2,481,198 Total Patients Enrolled
Emily Schaeffer, PhDStudy DirectorUniversity of British Columbia
1 Previous Clinical Trials
514 Total Patients Enrolled
~1724 spots leftby Dec 2026
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