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

Bürgerspital Solothurn

Status: Completed

Conditions: Acromioclavicular Joint Dislocation

Treatments: Device: Acromion 2.0 Brace

Study type: Interventional

Funder types: Other

Identifiers

NCT03261778

2017-00670

Details and patient eligibility

About

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.

Enrollment: 35 patients

Sex: All

Ages: 18 to 99 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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35 participants in 2 patient groups

Acromion 2.0 Brace

Experimental group

Treatment:

Device: Acromion 2.0 Brace

Mitella Sling

Active Comparator group

Treatment:

Device: Acromion 2.0 Brace