Oxandrolone Rotator Cuff Trial

• Status: Recruiting
• Trial end date: 2023-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Treatments: Oxandrolone

Criteria

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

• 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

• Any other condition or treatment interfering with completion of the trial