Tendon repair compared with physiotherapy in the treatment of rotator cuff tears: a randomized controlled study in 103 cases with a five-year follow-up.

BACKGROUND: There is limited Level-I evidence that compares operative and nonoperative treatment of rotator cuff tears. We compared outcomes of patients treated with primary tendon repair with outcomes of those treated with physiotherapy and optional secondary tendon repair if needed. METHODS: A single-center, pragmatic, randomized controlled study with follow-ups after six months and one, two, and five years was conducted in a secondary-care institution. One hundred and three patients with a rotator cuff tear not exceeding 3 cm were randomized to primary tendon repair (n = 52) or physiotherapy (n = 51). The primary outcome measure was the Constant score. Secondary outcome measures included the self-report section of the American Shoulder and Elbow Surgeons score; the physical component summary measure of the Short Form 36 Health Survey; the measurement of pain, strength, and shoulder motion; patient satisfaction; and findings from magnetic resonance imaging and sonography. Analysis was by intention to treat. RESULTS: The five-year follow-up rate was 98%. Twelve of the fifty-one patients in the physiotherapy group were treated with secondary tendon repair. The results from primary tendon repair were superior to those from physiotherapy plus secondary repair, with between-group mean differences of 5.3 points on the Constant score (p = 0.05), 9.0 points on the American Shoulder and Elbow Surgeons score (p < 0.001), 1.1 cm on a 10-cm visual analog scale for pain (p < 0.001), and 1.0 cm on a 10-cm visual analog scale for patient satisfaction (p = 0.03). In 37% of tears treated with physiotherapy only, there were increasing tear sizes on ultrasound of >5 mm, over five years, associated with an inferior outcome. CONCLUSIONS: Although primary repair of small and medium-sized rotator cuff tears was associated with better outcome than physiotherapy treatment, the differences were small and may be below clinical importance. In the physiotherapy treatment group, there were increasing tear sizes and inferior outcomes in one-third of patients who did not undergo repair.