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

Sponsor
Helsingborgs Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT01759147
Collaborator
(none)
10
1
1
30
0.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Surgical treatment of acromioclavicular dislocation.
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
10 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Case Series to Evaluate Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.
Study Start Date :
Jan 1, 2011
Anticipated Primary Completion Date :
Jan 1, 2013
Anticipated Study Completion Date :
Jul 1, 2013

Arms and Interventions

Arm Intervention/Treatment
Experimental: Surgery

Surgical repair of acromioclavicular dislocation.

Procedure: 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.

Outcome Measures

Primary Outcome Measures

  1. Complication [12 months after surgery.]

    Redislocations. Other local complications, eg. infection.

  2. Disabilities of the Arm, Shoulder and Hand Score [12 months after surgery.]

Secondary Outcome Measures

  1. Constant-Murley Score [12 months after surgery]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital of Helsingborg Helsingborg Skåne Sweden

Sponsors and Collaborators

  • Helsingborgs Hospital

Investigators

  • Study Director: Karl Lunsjö, Ass Prof, University of Lund

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Jonas Nordin, Medical Intern, Helsingborgs Hospital
ClinicalTrials.gov Identifier:
NCT01759147
Other Study ID Numbers:
  • JNStudy01
First Posted:
Jan 2, 2013
Last Update Posted:
Jan 2, 2013
Last Verified:
Dec 1, 2012
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 2, 2013