Rotator Cuff Tear
Conditions
Keywords
Rotator cuff, Arthroscopic surgery, Open surgery, Physiotherapy, Physical therapy, Effectiveness, RCT, cost-effectiveness
Brief summary
This study aims at determining the effectiveness and cost-effectiveness of surgical management of full-thickness rotator cuff tears compared to conservative treatment. The research setting is prospective, randomised, and controlled. The aim of the study is to search out evidence based data of indications for rotator cuff repair. The investigators also aim at offering patients the most efficient and effective treatment and reduce the number of operations that do not have sufficient effectiveness. The data obtained will facilitate developing guidelines for referrals to a specialist when rotator cuff tear is suspected. The investigators hypothesize that there are subgroups of patients suffering from rotator cuff tears that benefit from surgery whereas other subgroups are best treated conservatively.
Detailed description
Subgroup analyses: * age * sex * duration of symptoms * presence of trauma before symptoms * size of tear * degenerative findings * other findings in MRI or arthroscopy * type of operation * co-morbidities * occupation * pain (VAS) * objective shoulder function * activities of daily living
Interventions
PROCEDURERotator cuff repair
Rotator cuff repair + physical therapy according to a standardized protocol
PROCEDUREConservative treatment
Physiotherapy according to a standardized protocol
Sponsors
Academy of Finland
Oulu University Hospital
Central Finland Hospital District
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
35 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* age over 35 years old * duration of symptoms at least three months despite of non-operative treatment * the patient accepts both treatment options (operative and conservative) * a full-thickness rotator cuff tear in MRI arthrography
Exclusion criteria
* previous shoulder operations * too high risk for operation * any disease or social problem reducing the ability to co-operate * rheumatoid arthritis * severe arthrosis of the glenohumeral or acromioclavicular joint * irreparable rotator cuff tear (including rotator cuff tear arthropathy) * progressive malign disease * adhesive capsulitis * high-energy trauma before symptoms * cervical syndrome * shoulder instability
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain (VAS) and objective shoulder function (Constant score) | 24 months | VAS (0 to 100 mm), Constant score (0 to 100 points) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in pain (VAS) and objective shoulder function (Constant score) | 3 months | VAS (0 to 100 mm), Constant score (0 to 100 points) |
Countries
Finland
Outcome results
None listed