Clinical and Structural Outcome After Early Repair of the Traumatic Rotator Cuff Tear
Recruitment status was Recruiting
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.
Full Thickness Rotator Cuff Tear
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Arthroscopic Repair of Traumatic Rotator Cuff Tears. A Prospective Trial|
- Constant Shoulder Score (CS) [ Time Frame: twelve months ] [ Designated as safety issue: No ]
- Western Ontario Rotator Cuff Index (WORC) [ Time Frame: twelve months ] [ Designated as safety issue: No ]
- standardised measure of health status with EQ-5D [ Time Frame: twelve months ] [ Designated as safety issue: No ]
- cuff integrity [ Time Frame: twelve months ] [ Designated as safety issue: No ]cuff integrity using MRI at one year follow up
- Complications [ Time Frame: within one year ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Peroperatively retained rotator cuff biopsy.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||January 2015|
|Estimated Primary Completion Date:||October 2013 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01557309
|Contact: Knut Aagaard, MDfirstname.lastname@example.org|
|Contact: Karl Lunsjo, Ass. Prof.||+email@example.com|
|Department of Orthopaedic Surgery, Helsingborg Hospital||Recruiting|
|Helsingborg, Sweden, 25187|
|Contact: Knut Aagaard, MD +46-42-4063516 firstname.lastname@example.org|
|Contact: Karl Lunsjo, Ass. Prof +46-42-4063529 email@example.com|
|Study Director:||Karl Lunsjo, Associate Prof||Helsingborgs Hospital|