Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures

Status Recruiting

Clinical Trial Summary

This prospective, multi-centre study aims to determine clinical, radiographic, and patient-reported outcomes (PROMs) following surgical fixation of displaced mid-diaphyseal clavicle fractures and to compare implant removal rates between techniques within 2-years of the procedure.

Clinical Trial Description

Given the substantially lower implant removal rate in combination with a high union rate with the dual mini-fragment technique, we do not believe there is clinical equipoise required for a randomized clinical trial. This study is a multi-centre, prospective cohort study (11 sites confirmed to date) of all operatively treated clavicle fractures, in order to objectively evaluate all current surgical techniques used across Canada. This pragmatic approach will allow us to observe surgical decision-making, rationale for implant removal, and report on clinical, radiographic, and patient-reported outcomes for all techniques over a 2-year follow-up timeframe, for the first time. All enrolled patients will be encouraged to begin immediate range of motion as tolerated and weightbearing as tolerated post-operatively. This will be assessed at each follow-up and any reason for delayed motion or weightbearing will be reported. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05867355
Study type	Observational
Source	University of Calgary
Contact
Status	Recruiting
Phase
Start date	March 22, 2021
Completion date	December 1, 2025

View Details

See also
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