The purpose of this study is to compare treatment benefits from surgical treatment by tendon repair and from physiotherapy for small and medium-sized rotator cuff tears.
Surgical treatment by tendon repair or physiotherapy are accepted treatment options for small and medium-sized rotator cuff tears, but have never been compared in randomised, controlled studies. In this study, patients presenting clinical signs together with imaging findings (MRI and sonography) for a full-thickness rotator cuff tear will be randomly allocated to surgery (tendon repair) or physiotherapy. Outcome measuring will be performed by the Constant score, the self report section of the American Shoulder and Elbow Surgeons score (ASES), the Short Form 36 Health Survey (SF-36) and subscores for shoulder motion, pain, strength and patient satisfaction. Scores will be taken at baseline and after 6 months,1, 2, 5, 10 and 15 years by a blinded assessor. All operated shoulders will be controlled by MRI after one year. Patients with no effect from physiotherapy after at least 15 treatment sessions will be offered secondary surgical treatment, and scoring results from last follow-up before surgery will be carried forward to analysis, according to an intention to treat principle.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
103
Open or mini-open tendon repair in combination with an acromioplasty and eventually a tenodesis of the long head of the biceps
According to a rehabilitation program which was established prior to study start.
Martina Hansen's Hospital
Sandvika, Norway
Constant score
Time frame: baseline, 6 months, 1, 2, 5, 10, 15 years
self report section of the American Shoulder and Elbow Surgeons score (ASES)
Time frame: baseline, 6 months, 1, 2, 5, 10, 15 years
Short Form 36 Health Survey (SF-36)
Time frame: baseline, 6 months, 1, 2, 5, 10, 15 years
Patient satisfaction
Time frame: 1, 2, 5, 10, 15 years
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