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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Jonas Nordin, Helsingborgs Hospital
ClinicalTrials.gov Identifier:
NCT01759147
First received: December 23, 2012
Last updated: NA
Last verified: December 2012
History: No changes posted
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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. ] [ Designated as safety issue: Yes ]
    • Redislocations.
    • Other local complications, eg. infection.

  • Disabilities of the Arm, Shoulder and Hand Score [ Time Frame: 12 months after surgery. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Constant-Murley Score [ Time Frame: 12 months after surgery ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01759147

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

Publications:

Responsible Party: Jonas Nordin, Medical Intern, Helsingborgs Hospital
ClinicalTrials.gov Identifier: NCT01759147     History of Changes
Other Study ID Numbers: JNStudy01
Study First Received: December 23, 2012
Last Updated: December 23, 2012
Health Authority: Sweden: Regional Ethics Committee Lund

Additional relevant MeSH terms:
Dislocations
Wounds and Injuries

ClinicalTrials.gov processed this record on September 18, 2014