A Study to Evaluate Operative Versus Non-Operative Treatment for Atraumatic Rotator Cuff Tears
Overview
Tab Title Description
Study type
InterventionalDescribes the nature of a clinical study. Types include:
- Observational study — observes people and measures outcomes without affecting results.
- Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
- Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
Study IDs
Site IRB
- Scottsdale/Phoenix, Arizona: 19-003859
NCT ID: NCT03295994
Sponsor Protocol Number: 171863
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