Clinical and Structural Outcome After Early Repair of the Traumatic Rotator Cuff Tear
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT01557309|
Recruitment Status : Completed
First Posted : March 19, 2012
Last Update Posted : August 17, 2016
The optimal timing for surgical repair of traumatic rotator cuff tears is controversial. Today there are no prospective studies investigating the short to mid-term outcome after early arthroscopic repair of traumatic rotator cuff tears and the Swedish National Musculoskeletal Competence Centre requests more research to this subject. The investigators will follow 60 patients with acute rotator cuff tear undergoing early rotator cuff repair during the first year after surgery.
The investigators hypothesise that the outcome after rotator cuff repair is good.
|Condition or disease|
|Full Thickness Rotator Cuff Tear|
There exists controversy in the current literature regarding timing for surgical repair of traumatic rotator cuff tears. We have seen no prospective studies describing the progression of shoulder function improvement the first year after arthroscopic rotator cuff repair.
We hypothesize that early arthroscopic repair of traumatic rotator cuff tears yields successful functional and structural outcomes but there will be a progression of shoulder function improvement during the hole first postoperative year.
|Study Type :||Observational|
|Actual Enrollment :||60 participants|
|Official Title:||Arthroscopic Repair of Traumatic Rotator Cuff Tears. A Prospective Trial|
|Study Start Date :||November 2010|
|Primary Completion Date :||October 2013|
|Study Completion Date :||April 2014|
- Western Ontario Rotator Cuff Index (WORC) [ Time Frame: Two years ]
- Constant Shoulder Score (CS) [ Time Frame: One year ]
- standardised measure of health status with EQ-5D [ Time Frame: Two years ]
- cuff integrity [ Time Frame: One year ]
- Complications [ Time Frame: within one year ]
Biospecimen Retention: Samples Without DNA
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): NCT01557309
|Department of Orthopaedic Surgery, Helsingborg Hospital|
|Helsingborg, Sweden, 25187|
|Study Director:||Karl Lunsjo, Ass Prof||Helsingborgs Hospital|