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OpenTrials
Completed

NCT Number: NCT03261778

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

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.

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Key information

Conditions

Acromioclavicular Joint Dislocation

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Orthopädische Universitätsklinik Basel, Basel, Switzerland

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Acromion 2.0 Brace

Device

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

Primary outcomes

  1. Shoulder function

    Time frame: at 6 weeks

    Constant-Score

  2. Shoulder function

    Time frame: at 12 weeks

    Constant-Score

  3. Shoulder function

    Time frame: at 1 week

    ASES-Score (American Shoulder and Elbow Score)

  4. Shoulder function

    Time frame: at 6 weeks

    ASES-Score (American Shoulder and Elbow Score)

  5. Shoulder function

    Time frame: at 12 weeks

    ASES-Score (American Shoulder and Elbow Score)

  6. Shoulder function

    Time frame: at 1 week

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

  7. Shoulder function

    Time frame: at 6 weeks

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

  8. Shoulder function

    Time frame: at 12 weeks

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

Secondary outcomes

  1. Degree of lateral clavicle dislocation

    Time frame: at initial presentation

    Coracoclavicular distance on Panorama view in comparison to healthy side

  2. Degree of lateral clavicle dislocation

    Time frame: at 6 weeks

    Coracoclavicular distance on Panorama view in comparison to healthy side

  3. Degree of lateral clavicle dislocation

    Time frame: at 12 weeks

    Coracoclavicular distance on Panorama view in comparison to healthy side

Sponsors and collaborators

Lead sponsor

Bürgerspital Solothurn

Other

Collaborators

  • University Hospital, Basel, Switzerland

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2020
Study completion
2021
First posted
Aug 25, 2017
Registry last updated
Jan 13, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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