A Study to Evaluate Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears

Overview

About this study

The purpose of this study is to compare pain and function in patients undergoing operative versus non-operative treatment of atraumatic rotator cuff tears at 12 months of follow-up, and to assess effects of rotator cuff tear size and age on comparative outcomes of operative versus non-operative treatments for atraumatic rotator cuff tears.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Aged ≥ 40 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 xrays/MRI.
  • Grade 4 fatty infiltration of rotator cuff (any tendons).
  • Candidate for shoulder arthroplasty at baseline.
  • Non-English speaking.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status

Scottsdale/Phoenix, Ariz.

Mayo Clinic principal investigator

John Tokish, M.D.

Closed for enrollment

More information

Publications

Publications are currently not available
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CLS-20472527

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