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
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)|
|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|
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.
- Complication [ Time Frame: 12 months after surgery. ]
- Other local complications, eg. infection.
- Disabilities of the Arm, Shoulder and Hand Score [ Time Frame: 12 months after surgery. ]
- Constant-Murley Score [ Time Frame: 12 months after surgery ]
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
|Hospital of Helsingborg|
|Helsingborg, Skåne, Sweden|
|Study Director:||Karl Lunsjö, Ass Prof||University of Lund|