Oxandrolone Multiligament Knee

George F. Hatch60 enrolled

Overview

This study is about healing after a rmultiligament knee reconstruction 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 is effective in aiding in the healing process and restoring muscle mass.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Ligament Tear Knee

Interventions

OxandroloneDRUG

oral oxandrolone for 12 weeks

PlaceboDRUG

oral placebo for 12 weeks

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: • Patients with MRI proven multiligament knee injury scheduled to undergo multiligament knee reconstruction Exclusion Criteria: * Patients with prior ipsilateral knee surgery * 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 * DVT within the past 6 months * Disorder of the coagulation system * Currently taking anticoagulation * Prior or current use of anabolic steroids * Chromosomal disorders * Prostate cancer * Breast cancer * Hypercalcemia * Patients with COPD not responsive to bronchodilators * Patients with known liver disease * Patients at risk for liver tumors * Severe hyperlipidemia * Patients taking medications that interfere with testosterone production or function, including but not limited to 5α-reductase inhibitors, acetaminophen (Tylenol, others), cholesterol lowering

Locations (1)

Keck School of Medicine of the University of Southern California

Los Angeles, California, United States

Outcomes

Primary Outcomes

lean body mass

measured by bioelectrical impedance analysis

Time frame: Change from baseline at 52 weeks

body fat percentage

measured by bioelectrical impedance analysis

Time frame: Change from baseline at 52 weeksf

Data from ClinicalTrials.gov

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