Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.

Not Applicable

• Conditions: Acromioclavicular Joint Dislocation.
• Interventions: Procedure: Surgical treatment of acromioclavicular dislocation.

• Registration Number: NCT01759147
• Lead Sponsor: Helsingborgs Hospital

Brief Summary

There are many surgical methods available for the treatment of patients with acromioclavicular dislocations. No single method has yet proven to be superior to the others.

The purpose of this study is to evaluate the clinical outcome and complications associated with coracoclavicular ligament repair using autogenous gracilis tendon graft implanted in a single transclavicle transcoracoid bone tunnel. The implantation is performed using an endobutton system that augments the repair with fibrewires.

The investigators will prospecitvely follow 30 patients enrolled in the study.

The hypthesis is that this near anatomical repair of the coracoclavicular ligaments will result in good clinical outcome and few complications.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-01
• Status Verified: 2012-12
• Study First Submitted: 2012-12-23
• Study First Submitted QC: 2012-12-23
• Last Update Submitted: 2012-12-23
• Primary Completion: 2013-01
• Study First Posted: 2013-01-02
• Last Update Posted: 2013-01-02
• Study Completion: 2013-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• Age between 18 and 75 years old.
• Shoulder trauma within last 2 weeks.
• Pain from the acromioclavicular joint.

Exclusion Criteria

• Chronic or concomitant acromioclavicular joint pathology on injured side.
• Previous acromioclavicular joint dislocation on contralateral side.
• Major shoulder pathology on affected side.
• Mental inability to take part in rehabilitation.
• Non Swedish or English speaking patients.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Surgery	Surgical treatment of acromioclavicular dislocation.	Surgical repair of acromioclavicular dislocation.

Primary Outcome Measures

Name	Time	Method
Complication	12 months after surgery.	* Redislocations.; * Other local complications, eg. infection.
Disabilities of the Arm, Shoulder and Hand Score	12 months after surgery.

Secondary Outcome Measures

Name	Time	Method
Constant-Murley Score	12 months after surgery

Trial Locations

Locations (1)

Hospital of Helsingborg; 🇸🇪 Helsingborg, Skåne, Sweden