Rotator Cuff Tear
Conditions
Brief summary
The purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study.
Detailed description
In clinical practice most patients with a traumatic acute rotator cuff tear are treated with operative repair. The results of surgery are in most cases good but there are also good results in the literature from conservative treatment. So far there has been no prospective randomized comparison between the two treatments. When it comes to degenerative non-traumatic tears, level 1 and 2 studies have not been able to show the superiority of surgery. This study takes place in 2 clinics in Sweden (Linköping and Kalmar). Patients who have no previous shoulder conditions, a trauma to the shoulder and pain and/or inability to lift their arm will undergo magnetic resonance imaging (MRI). If this indicates a full-thickness rotator cuff tear of the cranial part of the rotator cuff the patient will be randomized to surgery or physiotherapy. Surgical intervention is mini-open repair. Follow-up takes place at 3 months, 6 months and 12 months with patient scores taken by a blinded independent physiotherapist. At 12 months a new MRI is conducted as well.
Interventions
PROCEDURERotator cuff repair
Physiotherapy & Surgery
PROCEDUREPhysiotherapy
Sponsors
University Hospital, Linkoeping
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Trauma to the shoulder * Full thickness cranial rotator cuff tear * Operation possible within 3 months
Exclusion criteria
* 2 or more rotator cuff tendons involved * Fracture * Dislocation * Previous shoulder condition (symptomatic osteoarthritis (Gleno-humeral (GH) joint, Acromial-Clavicular (AC) joint), frozen shoulder, instability, tumor) * Malignancy * Rheumatic disease * Inability to understand swedish * Substance abuse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Constant-Murley Shoulder Assessment score | Twelve months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario Rotator Cuff score | Twelve months | Shoulder specific, patient reported outcome score |
| MRI | Twelve months | Magnetic Resonance imaging. Gives a measure of muscle atrophy, fatty infiltration, rerupture and enlargement of the tendon rupture. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Euro-Qol-five-Dimensions (EQ-5D) | Twelve months | Quality of life assessment |
| Patient Global Impression of Change (PGIC) | Twelve months | Patients Global impression of Change |
Countries
Sweden
Outcome results
None listed