Clinical and Structural Outcome After Early Repair of the Traumatic Rotator Cuff Tear

Completed

• Conditions: Full Thickness Rotator Cuff Tear

• Registration Number: NCT01557309
• Lead Sponsor: Helsingborgs Hospital

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2010-11
• Study First Submitted: 2012-01-27
• Study First Submitted QC: 2012-03-16
• Study First Posted: 2012-03-19
• Primary Completion: 2013-10
• Study Completion: 2014-04
• Status Verified: 2016-08
• Last Update Submitted: 2016-08-16
• Last Update Posted: 2016-08-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• trauma to the shoulder with sudden onset of symptoms
• asymptomatic shoulder before trauma
• mr positive for full thickness rotator cuff tear

Exclusion Criteria

• fracture
• severe comorbidity
• more than 6 weeks after trauma
• glenohumeral degeneration signs or osteoarthritis on x-ray

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Western Ontario Rotator Cuff Index (WORC)	Two years

Secondary Outcome Measures

Name	Time	Method
standardised measure of health status with EQ-5D	Two years
Complications	within one year
Constant Shoulder Score (CS)	One year
cuff integrity	One year

Trial Locations

Locations (1)

Department of Orthopaedic Surgery, Helsingborg Hospital; 🇸🇪 Helsingborg, Sweden