NCT03295994.

Trial name or title	Operative versus non‐operative treatment for atraumatic rotator cuff tears
Methods	Multi‐centre, randomised controlled trial.
Participants	Planned sample size = 700 Inclusion Criteria Aged =>50 years to <85 years Shoulder pain and/or loss of range of active motion, strength or function MRI‐confirmed partial‐ or full‐thickness supraspinatus and/or infraspinatus tear of 4cm or less in longitudinal dimension Medically fit for surgery, defined as Category I‐III per American Society of Anesthesiologists (ASA) Physical Status Classification Ability and willingness to provide informed consent Exclusion Criteria Primary diagnosis is something other than a rotator cuff tear History (in last 2 years) of shoulder fracture involving the humeral head on affected side Previous rotator cuff surgery on affected side Isolated subscapularis and/or teres minor tear on affected side Acute rotator cuff tear caused by a severe trauma Shoulder used as a weight‐bearing joint Contraindication to MRI (claustrophobia, pacemaker, pregnancy, shoulder implant, etc.) Glenohumeral osteoarthritis on X‐ray/MRI Grade 4 fatty infiltration of rotator cuff (any tendons) Candidate for shoulder arthroplasty at baseline Non‐English speaking
Interventions	Group 1: arthroscopic rotator cuff surgery followed by physical therapy. Group 2: non‐operative, physical therapy (without surgery).
Outcomes	Primary Outcome Shoulder Pain & Disability Index (SPADI) at 12 months Secondary Outcome American Shoulder and Elbow Surgeons (ASES)
Starting date	March 19, 2018
Contact information	Helen M Koudelkova, MA615‐936‐8343 helen.koudelkova@vanderbilt.edu
Notes	Updated 18th June, 2018. Recruitment status: recruiting. Estimated primary completion date: December 30, 2022. Last refreshed June 5, 2018.

MRI: magnetic resonance imaging; NRS: Numeric Rating Scale; RC: rotator cuff; VAS: visual analogue score; WCB: Workers' Compensation Board