Oxandrolone Rotator Cuff Trial (ORCT)

University of Southern California

Status: Active, not recruiting

Conditions: Rotator Cuff Tear

Treatments: Drug: Placebo; Drug: Oxandrolone

Study type: Interventional

Funder types: Other

Identifiers

NCT03091075

HS-17-00272

Details and patient eligibility

About

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.

Enrollment: 116 estimated patients

Sex: All

Ages: 40 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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116 participants in 2 patient groups, including a placebo group

Treatment Group

Experimental group

Description:

Oxandrolone

Treatment:

Drug: Oxandrolone

Placebo Group

Placebo Comparator group

Description:

placebo

Treatment:

Drug: Placebo