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

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ClinicalTrials.gov Identifier: NCT01759147
Recruitment Status : Unknown
Verified December 2012 by Jonas Nordin, Helsingborgs Hospital.
Recruitment status was:  Active, not recruiting
First Posted : January 2, 2013
Last Update Posted : January 2, 2013
Sponsor:
Information provided by (Responsible Party):
Jonas Nordin, 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.


Condition or disease Intervention/treatment Phase
Acromioclavicular Joint Dislocation. Procedure: Surgical treatment of acromioclavicular dislocation. Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
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 : January 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : July 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dislocations
U.S. FDA Resources

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.



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

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

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


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01759147


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

Publications:

Responsible Party: Jonas Nordin, Medical Intern, Helsingborgs Hospital
ClinicalTrials.gov Identifier: NCT01759147     History of Changes
Other Study ID Numbers: JNStudy01
First Posted: January 2, 2013    Key Record Dates
Last Update Posted: January 2, 2013
Last Verified: December 2012

Additional relevant MeSH terms:
Joint Dislocations
Bone Diseases
Musculoskeletal Diseases
Wounds and Injuries