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Surgical or nonsurgical treatment for nontraumatic rotator cuff tears: Study protocol clinical trial
Ding-Gen Huang1, Ya-Li Wu, Peng-Fei Chen
1Traumatic Orthopedics, Longhua District Central Hospital, Shenzhen City, Guangdong Province, 518110, China.
Background:
The optimal treatment for symptomatic, nontraumatic rotator cuff tear is unknown. The primary aim of this randomized controlled trial is to compare functional improvement after surgical and conservative treatment of nontraumatic rotator cuff tears.
Methods:
This is a single-centre, randomized clinical trial with a follow-up of 12 months. Patients older than 18 years with magnetic resonance imaging - confirmed nontraumatic rotator cuff tears that are suitable for either surgery or nonsurgery treatment is enrolled. The primary outcome is Constant score. Secondary outcome measures include visual analog scale (VAS) score, patient satisfaction, and American Shoulder and Elbow Surgeons (ASES) score. All scores are assessed by an independent observer who is blinded to the allocation of groups.
Results:
The study will provide much needed data on surgical vs nonsurgical treatment for nontraumatic rotator cuff tears. Results of this study may help patients, clinicians, and policy makers assess the pivotal question on comparative effectiveness of surgery vs nonsurgical for rotator cuff tears.
Trial Registration:
This study protocol was registered in Research Registry (researchregistry5442).
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