Oxandrolone Multiligament Knee

March 26, 2026 updated by: George F. Hatch

Ability of Oral Oxandrolone to Aid in Rehabilitation and Outcomes of Multiligament Knee Reconstructions: A Double-Blind, Randomized Controlled Trial

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 Overview

Status

Suspended

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine of the University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Group
Placebo
Drug: Placebo
oral placebo for 12 weeks
Experimental: Treatment group
Oxandrolone
Drug: Oxandrolone
oral oxandrolone for 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
lean body mass
Time Frame: Change from baseline at 52 weeks
measured by bioelectrical impedance analysis
Change from baseline at 52 weeks
body fat percentage
Time Frame: Change from baseline at 52 weeksf
measured by bioelectrical impedance analysis
Change from baseline at 52 weeksf

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

George F. Hatch

Investigators

  • Principal Investigator: George Hatch, MD, University of Southern California

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2023

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Study Registration Dates

First Submitted

May 16, 2023

First Submitted That Met QC Criteria

May 30, 2023

First Posted (Actual)

June 7, 2023

Study Record Updates

Last Update Posted (Actual)

March 27, 2026

Last Update Submitted That Met QC Criteria

March 26, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HS-20-00161

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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