Conservative Treatment Compared to Osteosynthesis in Patients With a Fractured Collar Bone

January 21, 2016 updated by: Northern Orthopaedic Division, Denmark

Conservative Treatment Versus Plate Osteosynthesis Using Angular Stabile Screws and Precontoured Plates in Displaced Midshaft Clavicular Fractures. A Prospective Randomized Multicenter Study

This study will compare non-operative treatment of displaced midshaft collarbone fractures with operative treatment using a precontoured titanium plate and screws.

The study hypothesis is that operation will provide better pain relief, faster return to activities, better function of the involved upper limb, and lower the risk of a non healing fracture (non union).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

140

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

  • Denmark
    • Central Jutland
      • Randers, Central Jutland, Denmark, 8930
        • Orthopaedic Division, Randers Hospital

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 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • fracture located to the mid third of the collar bone where there is no contact between the fractured surface of the main fragments on x-ray in one or two of two levels.

Exclusion Criteria:

  • bilateral fracture
  • imminent skin perforation
  • open fracture
  • associated neurovascular effect
  • unstable fracture of neck of scapula "floating shoulder"
  • fracture of coincidental upper extremity distal for the shoulder
  • pathologic fracture
  • the patient states that there was a unilateral or bilateral shoulder problem before the fracture
  • fracture realized more than 14 days after it arose
  • circumstances which make it impossible to carry out one of the two regimes, i.e. mental illness and abuse
  • circumstances which make follow-up impossible, i.e. address far from the including departments and stays abroad of long duration
  • medical contraindication against surgery or general anaesthesia
  • former participation in the trial
  • former fracture contra/ipsilateral at the age of 15 or older

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
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Arm sling treatment
Displaced midshaft fracture of the collar bone treated with an arm sling
Procedure: Displaced midshaft fracture of the collar bone
Displaced midshaft fracture of the collar bone treated with an arm sling
Other Names:
  • No other names.
EXPERIMENTAL: Operation
Displaced midshaft fracture of the collar bone treated with operation using a pre contoured titanium plate and screws.
Procedure: Operation using a precontoured titanium plate and screws
Operation using a precontoured titanium plate and screws
Other Names:
  • No other names.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disabilities of the Arm, Shoulder and Hand (DASH) Score
Time Frame: 6 weeks, 3 months, 6 months, 1 year
The DASH Outcome Measure is a 30-item, self-report questionnaire designed to measure physical function and symptoms in people with any of several musculoskeletal disorders of the upper limb. The tool gives clinicians and researchers the advantage of having a single, reliable instrument that can be used to assess any or all joints in the upper extremity.
6 weeks, 3 months, 6 months, 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Constant-Murley Score
Time Frame: 6 weeks, 3 months, 6 months, 1 year
6 weeks, 3 months, 6 months, 1 year

Collaborators and Investigators

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

Sponsor

Northern Orthopaedic Division, Denmark

Collaborators

Vejle Hospital
Randers Regional Hospital
Central Jutland Regional Hospital
Swemac Orthopaedics ApS

Investigators

  • Principal Investigator: Carsten M Jensen, M.D.Sci., Orthopaedic Division, Central Jutland, Randers Hospital, Denmark

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.

General Publications

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

April 1, 2010

Primary Completion (ACTUAL)

December 1, 2015

Study Completion (ACTUAL)

December 1, 2015

Study Registration Dates

First Submitted

February 27, 2010

First Submitted That Met QC Criteria

March 1, 2010

First Posted (ESTIMATE)

March 2, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

January 22, 2016

Last Update Submitted That Met QC Criteria

January 21, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ON-001-CMJ

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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