The Treatment of Clavicular Fractures

January 3, 2023 updated by: University Hospital, Ghent

The Treatment of Displaced, Midshaft Clavicular Fractures: Operative vs Conservative. A Prospected, Randomized Study

Patients with a displaced, shortened, midshaft clavicular fracture are randomized in two groups: conservative or operative treatment. The conservative arm is treated with a sling for 6 weeks. The operative arm is treated with osteosynthesis, within 2 weeks.

Patients are clinically and radiologically evaluated during 1 year. A economical analysis is also done.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

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

  • Belgium
      • Aalst, Belgium, 9300
        • Stedelijk Ziekenhuis Aalst
      • Brugge, Belgium, 8000
        • AZ Sint Jan-Brugge
      • Ghent, Belgium, 9000
        • University Hospital Ghent
      • Ghent, Belgium, 9000
        • Jan Palfijnziekenhuis
      • Roeselare, Belgium, 8800
        • Stedelijk Ziekenhuis Roeselare
      • Tielt, Belgium, 8700
        • Sint-Andries Ziekenhuis

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 18 to 65 year
  • 100% displaced midshaft clavicular fracture

  • shortening

    • male: 18mm
    • female: 14mm

Exclusion Criteria:

  • pregnancy
  • pathological fracture
  • open fracture
  • history of frozen shoulder
  • ipsilateral fracture of shoulder or scapula
  • neurovascular injury
  • contraindication to anaesthesia

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
operative treatment
Procedure: osteosynthesis
operative treatment
Active Comparator: 2
conservative treatment
Other: sling
conservative treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Union
Time Frame: 1 year
1 year
Functionality
Time Frame: 1 year
1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Cost
Time Frame: 1 year
1 year
Complications
Time Frame: 1 year
1 year
Time to heal
Time Frame: 1 year
1 year
Relation with medication
Time Frame: 1 year
1 year
Relation with smoking
Time Frame: 1 year
1 year
Relation with job
Time Frame: 1 year
1 year

Collaborators and Investigators

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

Sponsor

University Hospital, Ghent

Collaborators

AZ Sint-Jan AV

Investigators

  • Principal Investigator: Lieven De Wilde, MD, PhD, University Hospital, Ghent
  • Principal Investigator: Bart Berghs, MD, AZ Sint-Jan AV
  • Principal Investigator: Pieter-Jan Vandekerckhove, MD, Sint-Andriesziekenhuis Tielt
  • Principal Investigator: J. Van Den Daele, MD, Stedelijk Ziekenhuis Roeselare
  • Principal Investigator: J. Vanonverschelde, MD, Stedelijk Ziekenhuis Aalst
  • Principal Investigator: G. Vandendriessche, MD, Jan Palfijnziekenhuis Ghent

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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)

April 1, 2008

Primary Completion (Actual)

May 27, 2009

Study Completion (Actual)

May 27, 2009

Study Registration Dates

First Submitted

March 14, 2008

First Submitted That Met QC Criteria

March 24, 2008

First Posted (Estimate)

March 25, 2008

Study Record Updates

Last Update Posted (Actual)

January 4, 2023

Last Update Submitted That Met QC Criteria

January 3, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2007/573

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.

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