Rotator Cuff Tear
Conditions
Keywords
Rotator Cuff Tear, Rotator Cuff, Anabolic Steroid, Testosterone, Oxandrolone
Brief summary
This study is about healing after a rotator cuff tear repair procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic derivative of the human hormone Testosterone (the principal male sex hormone and an anabolic steroid), given for 12 weeks following rotator cuff repair, is effective in aiding in the healing process and restoring muscle mass.
Interventions
DRUGOxandrolone
Treatment group will receive Oxandrolone daily for 12 weeks postoperatively
DRUGPlacebo
Placebo group will receive placebo for 12 weeks postoperative
Sponsors
University of Southern California
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Allocation will be performed using computer software and will occur at the pharmacy to ensure that all investigators are blinded.
Intervention model description
Men and women aged 40 - 75 scheduled for rotator cuff repair, who have failed nonoperative management of chronic, full thickness rotator cuff tears confirmed by MRI, will be randomized into one of two groups, a control group (receiving placebo medication) and an experimental group receiving oral Oxandrolone for 12 weeks postoperative.
Eligibility
Sex/Gender
ALL
Age
40 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* scheduled for rotator cuff repair * failed nonoperative management of chronic, full thickness rotator cuff tears * full thickness rotator cuff tear confirmed on MRI
Exclusion criteria
* patients with prior shoulder surgery or prior rotator cuff repair * tears larger than 5 cm * significant glenohumeral arthritis (Hamada Grade 2 or higher) * Untreated diabetes mellitus * Pituitary tumor * Rheumatoid arthritis * Uncontrolled hypertension * Congestive heart failure * Myocardial infarction within the past 6 months * End-stage renal disease * Liver enzymes two times the normal value * Deep Vein Thrombosis (DVT) within the past 6 months * Disorder of the coagulation system * Currently taking anticoagulation * Claustrophobia * Prior or current use of anabolic steroids * Chromosomal disorders * Prostate cancer * Breast cancer * Hypercalcemia * Medications that interfere with testosterone production or function, including but not limited to 5 alpha-reductase inhibitors * Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the Screening visit through 6 weeks after the last dose of study treatment * Any other condition or treatment interfering with completion of the trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| change in structural integrity of the rotator cuff/tendon healing | baseline to 52 weeks | assessed by MRI, classified based on the Sugaya classification and Goutallier Grade |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| change in ASES shoulder score | baseline to 104 weeks | American Shoulder Elbow Surgeon's Shoulder Score, Patient Questionnaire |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORGeorge R Hatch, MD
University of Southern California
Outcome results
None listed