Oxandrolone Rotator Cuff Trial

University of Southern California4 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Rotator Cuff Tear

Interventions

OxandroloneDRUG

Treatment group will receive Oxandrolone daily for 12 weeks postoperatively

PlaceboDRUG

Placebo group will receive placebo for 12 weeks postoperative

Eligibility

Sex: ALLMin age: 40 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Keck School of Medicine of the University of Southern California

Los Angeles, California, United States

Outcomes

Primary Outcomes

change in structural integrity of the rotator cuff/tendon healing

assessed by MRI, classified based on the Sugaya classification and Goutallier Grade

Time frame: baseline to 52 weeks

Secondary Outcomes

change in ASES shoulder score

American Shoulder Elbow Surgeon's Shoulder Score, Patient Questionnaire

Time frame: baseline to 104 weeks

Data from ClinicalTrials.gov

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