Oxandrolone for Torn Knee Ligaments

Overseen By George Hatch, MD

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: George F. Hatch

Must not be taking: Anticoagulants, Anabolic steroids, Testosterone blockers

Disqualifiers: Diabetes, Hypertension, Heart failure, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Oxandrolone, a medication related to testosterone, improves healing of knee injuries after major surgery that repairs multiple torn ligaments. Researchers aim to determine if it can restore muscle mass and accelerate recovery. Participants will receive either Oxandrolone or a placebo (a non-active treatment) for 12 weeks. This trial suits individuals with MRI-confirmed multiple knee ligament injuries who are scheduled for reconstruction surgery. As a Phase 4 trial, Oxandrolone is already FDA-approved and proven effective, and this research seeks to understand its benefits for more patients.

Will I have to stop taking my current medications?

The trial does not specify if you must stop all current medications, but you cannot participate if you are taking medications that interfere with testosterone production or function, such as 5α-reductase inhibitors or certain cholesterol-lowering drugs.

What is the safety track record for Oxandrolone?

Research has shown that Oxandrolone, a synthetic form of testosterone, is generally safe for use. Studies have found that drugs like Oxandrolone can aid recovery after surgeries, such as ligament repairs or joint replacements. The FDA has approved Oxandrolone for other uses, indicating its general safety.

Evidence suggests it can be used safely for several weeks. For instance, a study on an Oxandrolone implant under the skin found it was safe and well-tolerated for 24 weeks. This indicates that using Oxandrolone after knee surgery might not pose major safety concerns.

Consult a healthcare professional about potential risks and benefits before deciding to join a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike standard treatments for torn knee ligaments, which often include surgery or physical therapy, Oxandrolone offers a novel approach by promoting muscle growth and tissue repair through its anabolic steroid properties. This treatment is unique because it works by enhancing protein synthesis, potentially speeding up recovery and strengthening the knee more effectively than traditional methods. Researchers are excited about Oxandrolone's potential to reduce recovery time significantly and improve outcomes for patients with torn knee ligaments.

What is the effectiveness track record for Oxandrolone in aiding healing after multiligament knee reconstruction?

Research has shown that oxandrolone, a type of anabolic steroid, can prevent muscle loss and promote muscle growth. One study found that just two weeks of oxandrolone use reduced muscle shrinking and increased muscle size. Anabolic steroids like oxandrolone have also helped people recover better after knee surgeries and joint replacements. In this trial, participants in the treatment group will receive oxandrolone to study its potential to aid healing after knee ligament surgeries. ^{1 2 5 6 7}

Who Is on the Research Team?

George Hatch, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for individuals with MRI-confirmed multiple ligament injuries in the knee who are scheduled for reconstruction surgery. It's designed to see if taking Oxandrolone, a synthetic hormone, helps heal and rebuild muscle after surgery.

Inclusion Criteria

I am scheduled for surgery to repair multiple ligaments in my knee.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive Oxandrolone or placebo for 12 weeks to aid in healing and muscle mass restoration

12 weeks

Follow-up

Participants are monitored for changes in lean body mass and body fat percentage

52 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oxandrolone

Trial Overview

The study tests whether Oxandrolone can aid healing post-multiligament knee surgery compared to a placebo. Participants will receive either the medication or placebo for 12 weeks to assess effectiveness in recovery and muscle mass restoration.

How Is the Trial Designed?

Group I: Treatment group Experimental Treatment 1 Intervention

Oxandrolone

Group II: Placebo Group Placebo Group 1 Intervention

Placebo

Who Is Running the Clinical Trial?

George F. Hatch

Lead Sponsor

Trials

1

Recruited

60+

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05893069

NCT05893069 | Oxandrolone Multiligament Knee

It identifies the role of the intervention that participants receive. Types of arms include experimental arm, active comparator arm, placebo comparator arm, ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2666639125001610

Oxandrolone treatment prevents muscle atrophy and ...

Conclusion. Two-week oxandrolone treatment prevents muscle retraction and muscle atrophy by reducing fibrosis and increasing muscle fiber cross-sectional area ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC8735789/

Anabolic Androgenic Steroids in Orthopaedic Surgery

There is evidence to suggest that AASs may improve postoperative recovery after anterior cruciate ligament reconstruction and total joint arthroplasty.

4.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06974526

Subdermal Implant-bioabsorbable Oxandrolone Pellet For ...

The use of anabolic steroids, such as oxandrolone, may aid in the recovery of muscle mass and strength, as well as functional capacity.

5.

ctv.veeva.com

ctv.veeva.com/study/oxandrolone-multiligament-knee

Oxandrolone Multiligament Knee - ClinicalTrials.Veeva

This study is about healing after a rmultiligament knee reconstruction procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic ...

6.

withpower.com

withpower.com/trial/phase-4-ligament-tear-knee-5-2023-d6682

Oxandrolone for Torn Knee Ligaments · Info for Participants

This trial is for individuals with MRI-confirmed multiple ligament injuries in the knee who are scheduled for reconstruction surgery. It's designed to see ...

7.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06974526

Subdermal Implant-bioabsorbable Oxandrolone Pellet For ...

This study evaluates the safety and tolerability of the absorbable subdermal oxandrolone implant for 24 weeks versus placebo implant in both men and women as ...