NCT02059473

Treatment of Small Acute Cuff Tears, a Randomized Study

Treatment of Small Acute Full-thickness tears-a Prospective Randomised Controlled Trial

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: University Hospital, Linkoeping · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Rotator Cuff Tear

Interventions

Type	Name	Description
PROCEDURE	Rotator cuff repair	Physiotherapy \& Surgery
PROCEDURE	Physiotherapy

Timeline

• Start date: 2013-11-01
• Primary completion: 2015-12-01
• Completion: 2017-11-01
• First posted: 2014-02-11
• Last updated: 2014-02-11

Locations

1 site across 1 country: Sweden