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| Name | Class |
|---|---|
| University Hospital, Basel, Switzerland | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acromion 2.0 Brace | Experimental |
| |
| Mitella Sling | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acromion 2.0 Brace | Device | Acromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Näder Helmy, PD, MD | Bürgerspital Solothurn, Department of Orthopaedics and Traumatology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopädische Universitätsklinik Basel | Basel | 4031 | Switzerland | |||
| Bürgerspital Solothurn, Department of Orthopaedics and Traumatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9728155 | Background | Phillips AM, Smart C, Groom AF. Acromioclavicular dislocation. Conservative or surgical therapy. Clin Orthop Relat Res. 1998 Aug;(353):10-7. | |
| 24178060 | Background | Korsten K, Gunning AC, Leenen LP. Operative or conservative treatment in patients with Rockwood type III acromioclavicular dislocation: a systematic review and update of current literature. Int Orthop. 2014 Apr;38(4):831-8. doi: 10.1007/s00264-013-2143-7. Epub 2013 Oct 31. |
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| at 6 weeks |
| Degree of lateral clavicle dislocation | Coracoclavicular distance on Panorama view in comparison to healthy side | at 12 weeks |
| Solothurn |
| 4500 |
| Switzerland |
| 21344264 | Background | Smith TO, Chester R, Pearse EO, Hing CB. Operative versus non-operative management following Rockwood grade III acromioclavicular separation: a meta-analysis of the current evidence base. J Orthop Traumatol. 2011 Mar;12(1):19-27. doi: 10.1007/s10195-011-0127-1. Epub 2011 Feb 23. |
| 36728233 | Derived | Duffett RW, Duralde XA, Marcus RE. CORR Synthesis: What Is the Most Effective Treatment for Rockwood Type III Acromioclavicular Joint Dislocations? Clin Orthop Relat Res. 2023 May 1;481(5):1008-1013. doi: 10.1097/CORR.0000000000002545. Epub 2023 Jan 13. No abstract available. |