NCT05867355

Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures

A Multi-Centre Prospective Cohort Study of Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 111 (estimated)
• Sponsor: University of Calgary · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Clavicle Fracture

Interventions

Type	Name	Description
PROCEDURE	surgical fixation	compare implant removal rates between surgical fixation techniques.

Timeline

• Start date: 2021-03-22
• Primary completion: 2025-06-01
• Completion: 2025-12-01
• First posted: 2023-05-22
• Last updated: 2023-05-22

Locations

1 site across 1 country: Canada