Treatment of Small Acute Cuff Tears, a Randomized Study

University Hospital, Linkoeping

Status: Unknown

Conditions: Rotator Cuff Tear

Treatments: Procedure: Rotator cuff repair; Procedure: Physiotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT02059473

acutecufftearhannahallgren

Details and patient eligibility

About

The purpose of this project is to compare operative repair of traumatically torn rotator cuff tendon with physiotherapy in a randomized prospective study.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Physiotherapy & Surgery

Experimental group

Description:

Mini-open rotator cuff repair

Treatment:

Procedure: Physiotherapy

Procedure: Rotator cuff repair

Physiotherapy

Active Comparator group

Description:

Structured physiotherapy

Treatment:

Procedure: Physiotherapy