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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Helsingborgs Hospital.
Recruitment status was:  Active, not recruiting
Information provided by (Responsible Party):
Jonas Nordin, Helsingborgs Hospital Identifier:
First received: December 23, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted

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 Intervention
Acromioclavicular Joint Dislocation.
Procedure: Surgical treatment of acromioclavicular dislocation.

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Case Series to Evaluate Clinical Outcome of Coracoclavicular Ligament Repair Using Autogenous Gracilis Tendon in Endobutton System.

Resource links provided by NLM:

Further study details as provided by Helsingborgs Hospital:

Primary Outcome Measures:
  • Complication [ Time Frame: 12 months after surgery. ]
    • Redislocations.
    • Other local complications, eg. infection.

  • Disabilities of the Arm, Shoulder and Hand Score [ Time Frame: 12 months after surgery. ]

Secondary Outcome Measures:
  • Constant-Murley Score [ Time Frame: 12 months after surgery ]

Enrollment: 10
Study Start Date: January 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
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.
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Please refer to this study by its identifier: NCT01759147

Hospital of Helsingborg
Helsingborg, Skåne, Sweden
Sponsors and Collaborators
Helsingborgs Hospital
Study Director: Karl Lunsjö, Ass Prof University of Lund
  More Information


Responsible Party: Jonas Nordin, Medical Intern, Helsingborgs Hospital Identifier: NCT01759147     History of Changes
Other Study ID Numbers: JNStudy01
Study First Received: December 23, 2012
Last Updated: December 23, 2012

Additional relevant MeSH terms:
Wounds and Injuries processed this record on May 24, 2017