Oxandrolone for Rotator Cuff Repair

(ORCT Trial)

Overseen By Alexis Rounds, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Must not be taking: Anticoagulants, Anabolic steroids, 5 alpha-reductase inhibitors

Disqualifiers: Diabetes, Hypertension, Heart failure, Cancer, others

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

116 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether Oxandrolone, a medication similar to a human hormone, aids in healing and restoring muscle after rotator cuff surgery. Participants will receive either Oxandrolone or a placebo (a substance with no active treatment) for 12 weeks. The trial targets individuals with a full rotator cuff tear confirmed by an MRI, scheduled for surgery after other treatments have failed. Those with previous shoulder surgery or certain health conditions may not qualify. As an unphased trial, this study allows participants to contribute to medical research and potentially gain new insights into muscle recovery.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are taking medications that interfere with testosterone production or function, like 5 alpha-reductase inhibitors.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Oxandrolone, a synthetic hormone similar to testosterone, aids in muscle healing. Studies have found that it can prevent muscle loss and even increase muscle size, particularly in areas like the shoulder. This effect could be beneficial for recovery after surgeries, such as rotator cuff repair.

The FDA has already approved Oxandrolone for other uses, indicating it has undergone safety testing in various situations. However, like any treatment, potential side effects exist. Some individuals using Oxandrolone have reported mood changes or liver issues. Consulting healthcare professionals about any concerns before starting a new treatment is crucial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for rotator cuff repair, which typically involves physical therapy and sometimes surgical intervention, Oxandrolone offers a unique approach by leveraging its anabolic steroid properties to potentially enhance muscle recovery and repair. Researchers are excited about Oxandrolone because it could accelerate healing and improve muscle strength, offering a promising alternative for patients looking for faster recovery times. Additionally, Oxandrolone's ability to promote protein synthesis might address underlying issues in tendon and muscle repair more effectively than traditional treatments.

What evidence suggests that Oxandrolone might be an effective treatment for rotator cuff repair?

Research has shown that Oxandrolone, which participants in this trial may receive, can help prevent muscle loss after surgery. A previous study found that Oxandrolone reduced scarring in shoulder muscles and increased muscle size, suggesting it might aid in healing and muscle recovery after rotator cuff repair. Additionally, steroids like Oxandrolone have improved recovery after other surgeries, such as ACL repair. These findings suggest Oxandrolone could effectively aid recovery and muscle strength after rotator cuff surgery. Participants in this trial will join either the Oxandrolone treatment group or a placebo group to evaluate its effectiveness. ^{1 2 3 4 6}

Who Is on the Research Team?

George R Hatch, MD

Principal Investigator

University of Southern California

Are You a Good Fit for This Trial?

This trial is for adults with confirmed full thickness rotator cuff tears, scheduled for repair surgery, and who have not improved with non-surgical treatments. It's not suitable for those with recent heart attacks, certain chronic diseases (like untreated diabetes or severe arthritis), a history of specific cancers, pregnant or breastfeeding individuals, or anyone on medications that affect testosterone.

Inclusion Criteria

I am scheduled for surgery to repair my rotator cuff.

My shoulder treatment without surgery didn’t work for a complete tear.

I have a complete tear in my shoulder's rotator cuff, confirmed by MRI.

Exclusion Criteria

Hypercalcemia

I have not had a heart attack in the last 6 months.

My kidneys are in the final stage of failure.

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 following rotator cuff repair

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of rotator cuff healing and shoulder function

52 weeks

Long-term follow-up

Participants are monitored for additional outcomes such as pain scale, PASS score, and body composition

104 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oxandrolone

Trial Overview The study tests if Oxandrolone, a synthetic hormone similar to testosterone, can help heal the rotator cuff after surgery and rebuild muscle mass. Participants will receive either Oxandrolone or a placebo for 12 weeks post-surgery to compare effectiveness in recovery.

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?

University of Southern California

Lead Sponsor

Trials

956

Recruited

1,609,000+

Published Research Related to This Trial

Anteroposterior tear length, hyperlipidemia, and muscle fatty degeneration are significant factors that contribute to the risk of retear after arthroscopic rotator cuff repair, potentially leading to the need for revision surgery.

Identifying these risk factors is crucial for developing preventive strategies to improve surgical outcomes and reduce the likelihood of complications following rotator cuff repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Revision Surgery After Symptomatic Failed Arthroscopic Rotator Cuff Repair: What Factors Affect Primary Surgery? Gotoh, M.[2020]

Corticosteroid injections, commonly used in nonoperative treatment for rotator cuff conditions, may negatively impact tissue quality, which could affect surgical outcomes.

The effectiveness of steroid injections as a treatment option is not strongly supported by evidence, and factors like chronicity of the tear and tobacco use also play significant roles in the success of rotator cuff repairs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Editorial Commentary: Steroid Injections Prior to Arthroscopic Rotator Cuff Repair-Is It Time to Rethink a Conservative Treatment Paradigm? Woolf, SK.[2019]

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S2666639125001610

Oxandrolone treatment prevents muscle atrophy and ... Oxandrolone treatment decreased the fibrosis fraction (%) of the infraspinatus origin in the surgery shoulder. Mean muscle fiber areas were increased in the ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03091075

Study Details | NCT03091075 | Oxandrolone Rotator Cuff ... This study is about healing after a rotator cuff tear repair procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic derivative of ...

3. withpower.com withpower.com/trial/phase-3-rotator-cuff-injuries-8-2018-94f00

Oxandrolone for Rotator Cuff Repair (ORCT Trial) This trial is testing if Oxandrolone, a man-made hormone like testosterone, can help patients heal and regain muscle after rotator cuff surgery.

4. 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.

5. ctv.veeva.com ctv.veeva.com/study/oxandrolone-rotator-cuff-trial

Oxandrolone Rotator Cuff Trial - ClinicalTrials.Veeva This study is about healing after a rotator cuff tear repair procedure. We hope to learn if a biologic medication: Oxandrolone, a synthetic derivative of the ...

6. arthroscopyjournal.org arthroscopyjournal.org/article/S0749-8063(22)00228-6/fulltext

Rotator Cuff Repairs Fail at an Alarmingly High Rate ... Rotator cuff repairs (RCR) frequently fail to heal, particularly those with advanced fatty infiltration, supraspinatus and infraspinatus atrophy.