CompletedNCT03261778Updated Jan 13, 2021

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

An interventional study of Acromion 2.0 Brace in Acromioclavicular Joint Dislocation, sponsored by Bürgerspital Solothurn. Completed at 2 sites in Switzerland. Open to participants aged 18 Years to 99 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-01-13.

Sponsored by Bürgerspital Solothurn · Not applicable, Interventional, and Treatment

Phase: Not applicable
Study type: Interventional
Enrollment: 35
Allocation: Randomized
Ages: 18 Years to 99 Years
Sex: All

Study summary

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.

Conditions studied

Acromioclavicular Joint Dislocation

Browse trials for

Joint Dislocations 189

Who can participate

Ages eligible: 18 Years to 99 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

First acute acromioclavicular dislocation Rockwood Type III

Exclusion criteria

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

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Single (Participant)
Enrollment: 35 participants (actual)

Study arms

Experimental
Acromion 2.0 Brace
Device: Acromion 2.0 Brace
Active comparator
Mitella Sling
Device: Acromion 2.0 Brace

Interventions

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

What researchers measure

Primary outcomes

Shoulder function
Constant-Score
Time frame: at 6 weeks
Shoulder function
Constant-Score
Time frame: at 12 weeks
Shoulder function
ASES-Score (American Shoulder and Elbow Score)
Time frame: at 1 week
Shoulder function
ASES-Score (American Shoulder and Elbow Score)
Time frame: at 6 weeks
Shoulder function
ASES-Score (American Shoulder and Elbow Score)
Time frame: at 12 weeks
Shoulder function
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
Time frame: at 1 week
Shoulder function
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
Time frame: at 6 weeks
Shoulder function
Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)
Time frame: at 12 weeks

Secondary outcomes

Degree of lateral clavicle dislocation
Coracoclavicular distance on Panorama view in comparison to healthy side
Time frame: at initial presentation
Degree of lateral clavicle dislocation
Coracoclavicular distance on Panorama view in comparison to healthy side
Time frame: at 6 weeks
Degree of lateral clavicle dislocation
Coracoclavicular distance on Panorama view in comparison to healthy side
Time frame: at 12 weeks

Study locations

2 sites

Orthopädische Universitätsklinik Basel
Basel, 4031, Switzerland
Bürgerspital Solothurn, Department of Orthopaedics and Traumatology
Solothurn, 4500, Switzerland

References and documents

Publications

Phillips AM, Smart C, Groom AF. Acromioclavicular dislocation. Conservative or surgical therapy. Clin Orthop Relat Res. 1998 Aug;(353):10-7. PubMed 9728155 ↗
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. PubMed 24178060 ↗
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. PubMed 21344264 ↗

Individual participant data

Plan to share: Undecided

Registry details

Key details

Study ID: NCT03261778
Lead sponsor: Bürgerspital Solothurn
Collaborators: University Hospital, Basel, Switzerland
Responsible party: Michael Finsterwald (Dr. med. Michael Finsterwald, Bürgerspital Solothurn) — Principal investigator
First posted: Aug 25, 2017
Start date: Sep 1, 2017
Primary completion: Dec 31, 2020
Completion: Jan 12, 2021
Last update: Jan 13, 2021

Study contacts

Näder Helmy, PD, MD

study chair · Bürgerspital Solothurn, Department of Orthopaedics and Traumatology

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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