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The purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Physiotherapy & Surgery | Experimental | Mini-open rotator cuff repair |
|
| Physiotherapy | Active Comparator | Structured physiotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotator cuff repair | Procedure | Physiotherapy & Surgery |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Constant-Murley Shoulder Assessment score | Twelve months |
| Measure | Description | Time Frame |
|---|---|---|
| Western Ontario Rotator Cuff score | Shoulder specific, patient reported outcome score | Twelve months |
| MRI | Magnetic Resonance imaging. Gives a measure of muscle atrophy, fatty infiltration, rerupture and enlargement of the tendon rupture. |
| Measure | Description | Time Frame |
|---|---|---|
| Euro-Qol-five-Dimensions (EQ-5D) | Quality of life assessment | Twelve months |
| Patient Global Impression of Change (PGIC) | Patients Global impression of Change |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lars Adolfsson, Professor | Linkoeping University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Orthopedic Clinic, Linköping University Hospital | Recruiting | Linköping | 58185 | Sweden |
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| ID | Term |
|---|---|
| D000070636 | Rotator Cuff Injuries |
| ID | Term |
|---|---|
| D012421 | Rupture |
| D014947 | Wounds and Injuries |
| D000070599 | Shoulder Injuries |
| D013708 | Tendon Injuries |
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| ID | Term |
|---|---|
| D026741 | Physical Therapy Modalities |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Physiotherapy |
| Procedure |
|
| Twelve months |
| Twelve months |