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

Bürgerspital Solothurn35 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Acromioclavicular Joint Dislocation

Interventions

Acromion 2.0 BraceDEVICE

Acromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (2)

Orthopädische Universitätsklinik Basel

Basel, Switzerland

Bürgerspital Solothurn, Department of Orthopaedics and Traumatology

Solothurn, Switzerland

Outcomes

Primary Outcomes

Shoulder function

Constant-Score

Time frame: at 6 weeks

Shoulder function

Constant-Score

Time frame: at 12 weeks

Shoulder function

ASES-Score (American Shoulder and Elbow Score)

Time frame: at 1 week

Shoulder function

ASES-Score (American Shoulder and Elbow Score)

Time frame: at 6 weeks

Shoulder function

ASES-Score (American Shoulder and Elbow Score)

Time frame: at 12 weeks

Shoulder function

Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)

Time frame: at 1 week

Shoulder function

Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)

Time frame: at 6 weeks

Shoulder function

Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)

Time frame: at 12 weeks

Secondary Outcomes

Degree of lateral clavicle dislocation

Coracoclavicular distance on Panorama view in comparison to healthy side

Time frame: at initial presentation

Data from ClinicalTrials.gov

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