Comparison of Two Types of Braces in the Treatment of Rockwood Type III AC-dislocations

January 12, 2021 updated by: Michael Finsterwald, Bürgerspital Solothurn

Conservative Treatment of Rockwood Type III Acromioclavicular Dislocation With Two Different Types of Braces: a Comparative Prospective Randomized Trial

In a randomised prospective comparative Trial the investigators aim to compare the conservative Treatment of acromioclavicular dislocations (Rockwood III) with a conventional sling versus a Acromion 2.0 brace, which exerts a direct Reposition force on the Joint.

The sling/brace will be worn for 6 weeks and the patients will be regularly checked clinically and radiologically.The investigators are interested in differences of shoulder function, Patient satisfaction as well as cosmetic and radiological results.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

35

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

  • Switzerland
      • Basel, Switzerland, 4031
        • Orthopädische Universitätsklinik Basel
      • Solothurn, Switzerland, 4500
        • Bürgerspital Solothurn, Department of Orthopaedics and Traumatology

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 99 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • First acute acromioclavicular dislocation Rockwood Type III

Exclusion Criteria:

  • Previous injury to acromioclavicular Joint
  • Previous surgery of acromioclavicular Joint
  • Known hypersensitivity or allergy to fabric of investigational product
  • Pregnancy
  • Known or suspected non-compliance, drug or alcohol abuse
  • Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant

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: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Acromion 2.0 Brace
Device: Acromion 2.0 Brace
Acromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling
Active Comparator: Mitella Sling
Device: Acromion 2.0 Brace
Acromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Shoulder function
Time Frame: at 6 weeks
Constant-Score
at 6 weeks
Shoulder function
Time Frame: at 12 weeks
Constant-Score
at 12 weeks
Shoulder function
Time Frame: at 1 week
ASES-Score (American Shoulder and Elbow Score)
at 1 week
Shoulder function
Time Frame: at 6 weeks
ASES-Score (American Shoulder and Elbow Score)
at 6 weeks
Shoulder function
Time Frame: at 12 weeks
ASES-Score (American Shoulder and Elbow Score)
at 12 weeks
Shoulder function
Time Frame: at 1 week
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
at 1 week
Shoulder function
Time Frame: at 6 weeks
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
at 6 weeks
Shoulder function
Time Frame: at 12 weeks
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
at 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of lateral clavicle dislocation
Time Frame: at initial presentation
Coracoclavicular distance on Panorama view in comparison to healthy side
at initial presentation
Degree of lateral clavicle dislocation
Time Frame: at 6 weeks
Coracoclavicular distance on Panorama view in comparison to healthy side
at 6 weeks
Degree of lateral clavicle dislocation
Time Frame: at 12 weeks
Coracoclavicular distance on Panorama view in comparison to healthy side
at 12 weeks

Collaborators and Investigators

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

Sponsor

Bürgerspital Solothurn

Collaborators

University Hospital, Basel, Switzerland

Investigators

  • Study Chair: Näder Helmy, PD, MD, Bürgerspital Solothurn, Department of Orthopaedics and Traumatology

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 (Actual)

September 1, 2017

Primary Completion (Actual)

December 31, 2020

Study Completion (Actual)

January 12, 2021

Study Registration Dates

First Submitted

August 18, 2017

First Submitted That Met QC Criteria

August 24, 2017

First Posted (Actual)

August 25, 2017

Study Record Updates

Last Update Posted (Actual)

January 13, 2021

Last Update Submitted That Met QC Criteria

January 12, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-00670

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

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.

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