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

Acromioclavicular Joint Dislocation Clinical Trial

Official title:

Conservative Treatment of Rockwood Type III Acromioclavicular Dislocation With Two Different Types of Braces: a Comparative Prospective Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03261778
• Other study ID #: 2017-00670
• Status: Completed
• Phase: N/A
• Start date: September 1, 2017
• Est. completion date: January 12, 2021

Study information

• Verified date: January 2021
• Source: Bürgerspital Solothurn
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: January 12, 2021
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Acromioclavicular Joint Dislocation

Intervention

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

Locations

Country	Name	City	State
Switzerland	Orthopädische Universitätsklinik Basel	Basel
Switzerland	Bürgerspital Solothurn, Department of Orthopaedics and Traumatology	Solothurn

Sponsors (2)

Lead Sponsor	Collaborator
Bürgerspital Solothurn	University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (3)

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. Review. — View Citation

Phillips AM, Smart C, Groom AF. Acromioclavicular dislocation. Conservative or surgical therapy. Clin Orthop Relat Res. 1998 Aug;(353):10-7. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Shoulder function	Constant-Score	at 6 weeks
Primary	Shoulder function	Constant-Score	at 12 weeks
Primary	Shoulder function	ASES-Score (American Shoulder and Elbow Score)	at 1 week
Primary	Shoulder function	ASES-Score (American Shoulder and Elbow Score)	at 6 weeks
Primary	Shoulder function	ASES-Score (American Shoulder and Elbow Score)	at 12 weeks
Primary	Shoulder function	Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)	at 1 week
Primary	Shoulder function	Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)	at 6 weeks
Primary	Shoulder function	Subjective Shoulder value (scale 0-100% where 100% equals a healthy shoulder)	at 12 weeks
Secondary	Degree of lateral clavicle dislocation	Coracoclavicular distance on Panorama view in comparison to healthy side	at initial presentation
Secondary	Degree of lateral clavicle dislocation	Coracoclavicular distance on Panorama view in comparison to healthy side	at 6 weeks
Secondary	Degree of lateral clavicle dislocation	Coracoclavicular distance on Panorama view in comparison to healthy side	at 12 weeks