Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures

Clavicle Fracture Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05867355
• Other study ID #: REB20-2049
• Status: Recruiting
• Start date: March 22, 2021
• Est. completion date: December 1, 2025

Study information

• Verified date: May 2023
• Source: University of Calgary
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 111
• Est. completion date: December 1, 2025
• Est. primary completion date: June 1, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Treated with surgical fixation for a displace mid-diaphyseal clavicle fracture.
• Aged 18 years of age or older and skeletally mature.
• Enrolled within 21 (+3 days) of injury.
• Willing and able to complete consent and study participation.

Exclusion Criteria:

• Pathological fractures.
• Clavicle non-unions.
• Current or prior ipsilateral upper extremity injury that may impact functional outcomes.
• Polytrauma patients with injuries projected to affect rehabilitation course.
• Active malignancy.
• Inability to provide consent or complete follow-up.
• Incarcerated patients.

Related Conditions & MeSH terms

• Clavicle Fracture
• Fractures, Bone

Intervention

Procedure:
• surgical fixation
compare implant removal rates between surgical fixation techniques.

Locations

Country	Name	City	State
Canada	Foothills Medical Centre	Calgary	Alberta

Sponsors (6)

Lead Sponsor	Collaborator
University of Calgary	Montreal General Hospital, Queen Elizabeth II Health Sciences Centre, Thunder Bay Regional Health Sciences Centre, Unity Health Toronto, Winnipeg Regional Health Authority

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine implant removal rates	To report implant removal rates in an appropriately powered prospective cohort study.	4 years
Primary	Identify rationale for implant removal	To report rationale for implant removal in an appropriately powered prospective cohort study.	4 years