Clinical trial NCT03261778: Comparison of Two Types of Braces in the Treatment of Rockwood Type III AC-dislocations
Official title: Conservative Treatment of Rockwood Type III Acromioclavicular Dislocation With Two Different Types of Braces: a Comparative Prospective Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acromioclavicular Joint Dislocation
Lead sponsor: Bürgerspital Solothurn
Sponsor class: OTHER
Collaborators: name: University Hospital, Basel, Switzerland
First posted: 2017-08-25
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Shoulder function
timeFrame: at 6 weeks
measure: Shoulder function
timeFrame: at 12 weeks
measure: Shoulder function
timeFrame: at 1 week
measure: Shoulder function
timeFrame: at 6 weeks
measure: Shoulder function
timeFrame: at 12 weeks
measure: Shoulder function
timeFrame: at 1 week
measure: Shoulder function
timeFrame: at 6 weeks
measure: Shoulder function
timeFrame: at 12 weeks
Secondary outcomes:
measure: Degree of lateral clavicle dislocation
timeFrame: at initial presentation
measure: Degree of lateral clavicle dislocation
timeFrame: at 6 weeks
measure: Degree of lateral clavicle dislocation
timeFrame: at 12 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Orthopädische Universitätsklinik Basel
city: Solothurn
country: Switzerland
facility: Bürgerspital Solothurn, Department of Orthopaedics and Traumatology
Study officials:
affiliation: Bürgerspital Solothurn, Department of Orthopaedics and Traumatology
name: Näder Helmy, PD, MD
role: STUDY_CHAIR
References:
citation: Phillips AM, Smart C, Groom AF. Acromioclavicular dislocation. Conservative or surgical therapy. Clin Orthop Relat Res. 1998 Aug;(353):10-7.
citation: 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.
citation: 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.