Surgically Treated Displaced Mid-diaphyseal Clavicle Fractures

May 19, 2023 updated by: Prism Schneider, University of Calgary

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Skeletally mature, adult participants aged 18 years of age or older, who are treated with surgical fixation for a displaced mid-diaphyseal clavicle fracture. Exclusion criteria: Pathological fractures, clavicle non-unions, current or prior ipsilateral upper extremity injury that may impact functional outcomes, or an inability to consent or complete follow-up.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Determine implant removal rates
Time Frame: 4 years
To report implant removal rates in an appropriately powered prospective cohort study.
4 years
Identify rationale for implant removal
Time Frame: 4 years
To report rationale for implant removal in an appropriately powered prospective cohort study.
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Collaborators

Unity Health Toronto
Queen Elizabeth II Health Sciences Centre
Montreal General Hospital
Winnipeg Regional Health Authority
Thunder Bay Regional Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2021

Primary Completion (Anticipated)

June 1, 2025

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

May 4, 2023

First Submitted That Met QC Criteria

May 19, 2023

First Posted (Actual)

May 22, 2023

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 19, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REB20-2049

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Clavicle Fracture

Clinical Trials on surgical fixation

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Moldova

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe