Treatment of Small Acute Cuff Tears, a Randomized Study

Not Applicable

• Conditions: Rotator Cuff Tear
• Interventions: Procedure: Rotator cuff repair; Procedure: Physiotherapy

• Registration Number: NCT02059473
• Lead Sponsor: University Hospital, Linkoeping

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.

Study Timeline

• Study Start: 2013-11
• Status Verified: 2014-02
• Study First Submitted: 2014-02-04
• Study First Submitted QC: 2014-02-07
• Last Update Submitted: 2014-02-07
• Study First Posted: 2014-02-11
• Last Update Posted: 2014-02-11
• Primary Completion: 2015-12
• Study Completion: 2017-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Physiotherapy & Surgery	Physiotherapy	Mini-open rotator cuff repair
Physiotherapy	Physiotherapy	Structured physiotherapy
Physiotherapy & Surgery	Rotator cuff repair	Mini-open rotator cuff repair

Primary Outcome Measures

Name	Time	Method
Constant-Murley Shoulder Assessment score	Twelve months

Secondary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Orthopedic Clinic, Linköping University Hospital; 🇸🇪 Linköping, Sweden