This trial is active, not recruiting.

Condition acromioclavicular joint dislocation.
Treatment surgical treatment of acromioclavicular dislocation.
Sponsor Helsingborgs Hospital
Start date January 2011
End date January 2013
Trial size 10 participants
Trial identifier NCT01759147, JNStudy01


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Surgical repair of acromioclavicular dislocation.
surgical treatment of acromioclavicular dislocation.
Coracoclavicular ligament repair using autogenous gracilis tendon implanted using an endobutton system containing fibrewires and a single transclavicular, transcoracoid bone tunnel.

Primary Outcomes

time frame: 12 months after surgery.
Disabilities of the Arm, Shoulder and Hand Score
time frame: 12 months after surgery.

Secondary Outcomes

Constant-Murley Score
time frame: 12 months after surgery

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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.

Additional Information

Official title Case Series to Evaluate Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.
Trial information was received from ClinicalTrials.gov and was last updated in December 2012.
Information provided to ClinicalTrials.gov by Helsingborgs Hospital.