Oxandrolone Multiligament Knee

George F. Hatch

Status and phase: Active, not recruiting; Phase 4

Conditions: Ligament Tear Knee

Treatments: Drug: Placebo; Drug: Oxandrolone

Study type: Interventional

Funder types: Other

Identifiers

NCT05893069

HS-20-00161

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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60 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