Comparison of Two Types of Braces in the Treatment of Rockwood Type III AC-dislocations
NCT ID: NCT03261778
Last Updated: 2021-01-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
35 participants
INTERVENTIONAL
2017-09-01
2021-01-12
Brief Summary
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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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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Acromion 2.0 Brace
Acromion 2.0 Brace
Acromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling
Mitella Sling
Acromion 2.0 Brace
Acromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling
Interventions
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Acromion 2.0 Brace
Acromion 2.0 Brace will be worn for 6 weeks instead of the conventional Mitella sling
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
99 Years
ALL
Yes
Sponsors
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University Hospital, Basel, Switzerland
OTHER
Bürgerspital Solothurn
OTHER
Responsible Party
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Michael Finsterwald
Dr. med. Michael Finsterwald
Principal Investigators
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Näder Helmy, PD, MD
Role: STUDY_CHAIR
Bürgerspital Solothurn, Department of Orthopaedics and Traumatology
Locations
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Orthopädische Universitätsklinik Basel
Basel, , Switzerland
Bürgerspital Solothurn, Department of Orthopaedics and Traumatology
Solothurn, , Switzerland
Countries
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References
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Phillips AM, Smart C, Groom AF. Acromioclavicular dislocation. Conservative or surgical therapy. Clin Orthop Relat Res. 1998 Aug;(353):10-7.
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.
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.
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.
Other Identifiers
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2017-00670
Identifier Type: -
Identifier Source: org_study_id
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