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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-09-01

Study Completion Date

2021-01-12

Brief Summary

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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.

Detailed Description

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Conditions

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Acromioclavicular Joint Dislocation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Acromion 2.0 Brace

Group Type EXPERIMENTAL

Acromion 2.0 Brace

Intervention Type DEVICE

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

Mitella Sling

Group Type ACTIVE_COMPARATOR

Acromion 2.0 Brace

Intervention Type DEVICE

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Basel, Switzerland

OTHER

Sponsor Role collaborator

Bürgerspital Solothurn

OTHER

Sponsor Role lead

Responsible Party

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Michael Finsterwald

Dr. med. Michael Finsterwald

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Bürgerspital Solothurn, Department of Orthopaedics and Traumatology

Solothurn, , Switzerland

Site Status

Countries

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Switzerland

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.

Reference Type BACKGROUND
PMID: 9728155 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24178060 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21344264 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36728233 (View on PubMed)

Other Identifiers

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2017-00670

Identifier Type: -

Identifier Source: org_study_id

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