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

Study Overview
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Brief Summary
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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.

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

Conditions
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Acromioclavicular Joint Dislocation

Intervention / Treatment
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* Device: Acromion 2.0 Brace


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 99 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder function | Constant-Score | at 6 weeks | 
| Shoulder function | Constant-Score | at 12 weeks | 
| Shoulder function | ASES-Score (American Shoulder and Elbow Score) | at 1 week | 
| Shoulder function | ASES-Score (American Shoulder and Elbow Score) | at 6 weeks | 
| Shoulder function | ASES-Score (American Shoulder and Elbow Score) | at 12 weeks | 
| Shoulder function | Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder) | at 1 week | 
| Shoulder function | Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder) | at 6 weeks | 
| Shoulder function | 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 | Coracoclavicular distance on Panorama view in comparison to healthy side | at initial presentation | 
| Degree of lateral clavicle dislocation | Coracoclavicular distance on Panorama view in comparison to healthy side | at 6 weeks | 
| Degree of lateral clavicle dislocation | Coracoclavicular distance on Panorama view in comparison to healthy side | at 12 weeks |