Global POISE
Research type
Research Study
Full title
Global Paediatric Orthopaedic Implant Safety & Efficacy (Global POISE) Clinical Follow-up Program
IRAS ID
337954
Contact name
Jonathan Wright
Contact email
Sponsor organisation
University of British Columbia
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NCT05361980, Registered on Clinicaltrials.gov website
Duration of Study in the UK
3 years, 10 months, 5 days
Research summary
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).
This study will be looking at orthopaedic implants used in children, placed for either fixation of fractures or used during surgery to correct a deformity (e.g. Osteotomy; cutting a bone to realign it)
Eligible participants would be any paediatric patient attending one of the study centres who requires surgery using any of the implants being studied. For the purposes of this study, all implants will be those manufactured by OrthoPediatrics. The study will be carried out in specialist children’s hospitals or specialist orthopaedic hospitals which carry out surgery for deformity correction or trauma in children.
This study will not make any changes to the normal care received by the patients or their parents, but will ask the families to complete questionnaires at the time of surgery and at the usual times of follow up clinic appointments, up until the point when: 1) the implant would be expected to be removed, 2) the patient has completed correction of alignment or 3) achieved skeletal maturity.
Anonymised data will be collected from the clinician about the patient demographics, type of surgery, any complications during the recovery (e.g. infection, delayed bone healing, failure of the implant).REC name
HSC REC B
REC reference
25/NI/0140
Date of REC Opinion
12 Dec 2025
REC opinion
Further Information Favourable Opinion