Rotator Cuff Tear
Conditions
Keywords
arthroscopy, physical therapy, rehabilitation, surgery, rotator cuff tear
Brief summary
Rotator cuff tears are one of the most common reasons to seek musculoskeletal care in the United States and one of the fastest growing ambulatory surgery procedures. However, data on comparison of operative versus non-operative treatment is lacking and urgently needed.
Detailed description
This is non-blinded, randomized controlled trial. Patients will be randomly assigned to either an operative or non-operative course of treatment and will be followed for 12 months from baseline. Aim 1: To compare pain and function in patients undergoing operative versus non-operative treatment of atraumatic rotator cuff tears at 12 months of follow-up Aim 2: To assess effects of rotator cuff tear size and age on comparative outcomes of operative versus non-operative treatments for atraumatic rotator cuff tears 5U34AR069201-02 NIH grant funded the preparatory work for the trial but not the trial itself.
Interventions
PROCEDUREArthroscopic Rotator Cuff Surgery
Arthroscopic rotator cuff surgery
PROCEDUREPhysical Therapy
Physical therapy
Sponsors
University of Michigan
Patient-Centered Outcomes Research Institute
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
40 Years to 84 Years
Healthy volunteers
No
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 \&/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, as determined by recruiting MD * Grade 4 fatty infiltration of rotator cuff (any tendons) * Candidate for shoulder arthroplasty at baseline * Non-English speaking * Severe problems with maintaining follow-up expected (such as, but not limited to, history of substance abuse, homelessness/incarceration, dementia, brain injury, and psychotic disorders)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Shoulder Pain & Disability Index (SPADI) | Study participants will be followed for 12 months | SPADI is a composite pain and function measure. The scale range is from 0 to 100, with 0 being best, and 100 being worst. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| American Shoulder and Elbow Surgeons (ASES) | Study participants will be followed for 12 months | ASES is a pain and activity of daily living questionnaire. The range is from 0 to 100, with 0 being worst, and 100 being best. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORNitin B Jain, MD,MSPH
University of Michigan
Outcome results
None listed