Oxandrolone Rotator Cuff Trial

Not Applicable

Active, not recruiting

• Conditions: Rotator Cuff Tear
• Interventions: Drug: Placebo; Drug: Oxandrolone

• Registration Number: NCT03091075
• Lead Sponsor: University of Southern California

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-03-13
• Study First Submitted QC: 2017-03-20
• Study First Posted: 2017-03-27
• Study Start: 2018-09-23
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-15
• Last Update Posted: 2025-05-18
• Primary Completion: 2025-07-01
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 116

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo Group	Placebo	placebo
Treatment Group	Oxandrolone	Oxandrolone

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
change in ASES shoulder score	baseline to 104 weeks	American Shoulder Elbow Surgeon's Shoulder Score, Patient Questionnaire

Trial Locations

Locations (1)

Keck School of Medicine of the University of Southern California; 🇺🇸 Los Angeles, California, United States