Rotator Cuff Tear Clinical Trial
Official title:
Treatment of Small Acute Full-thickness tears-a Prospective Randomised Controlled Trial
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.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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