Oxandrolone Multiligament Knee

NCT ID: NCT05893069

Last Updated: 2025-05-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

SUSPENDED

Clinical Phase

PHASE4

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-01

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Ligament Tear Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
Randomized

Study Groups

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Treatment group

Oxandrolone

Group Type EXPERIMENTAL

Oxandrolone

Intervention Type DRUG

oral oxandrolone for 12 weeks

Placebo Group

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

oral placebo for 12 weeks

Interventions

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Oxandrolone

oral oxandrolone for 12 weeks

Intervention Type DRUG

Placebo

oral placebo for 12 weeks

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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George F. Hatch

OTHER

Sponsor Role lead

Responsible Party

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George F. Hatch

Associate Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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George Hatch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

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Keck School of Medicine of the University of Southern California

Los Angeles, California, United States

Site Status

Countries

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United States

Other Identifiers

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HS-20-00161

Identifier Type: -

Identifier Source: org_study_id

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