Oxandrolone for Rotator Cuff Repair

(ORCT Trial)

Overseen By Alexis Rounds, BS

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Southern California

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

116 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if Oxandrolone, a man-made hormone like testosterone, can help patients heal and regain muscle after rotator cuff surgery. The medication is given for a few months to see if it improves muscle recovery. Oxandrolone has been studied for its ability to increase muscle strength and lean body mass in various conditions, including severe burn injuries and muscle wasting in older adults.

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.

What data supports the effectiveness of the drug Oxandrolone for rotator cuff repair?

Oxandrolone, an anabolic steroid, has been shown to help improve muscle strength and recovery in conditions like HIV-related muscle wasting and severe injuries, suggesting it might aid in muscle repair and recovery after rotator cuff surgery. ^{1 2 3 4 5}

Is oxandrolone generally safe for humans?

Oxandrolone is generally used in burn patients but can cause liver issues, known as transaminitis (liver enzyme elevation), in some people. In studies, about 41% of burn patients experienced this side effect, especially those using certain other medications. It is important to monitor liver function during treatment. ^{6 7 8 9 10}

How does the drug oxandrolone differ from other treatments for rotator cuff repair?

Oxandrolone is unique because it is an anabolic steroid that can enhance tissue healing and muscle preservation, which may aid in rotator cuff repair. Unlike typical treatments that focus on surgical repair and physical therapy, oxandrolone's ability to improve wound healing and prevent muscle loss makes it a novel option for supporting recovery. ^{10 11 12 13 14}

Research Team

George R Hatch, MD

Principal Investigator

University of Southern California

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of corticosteroids injection in rotator cuff tears. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Corticosteroid Injections May Increase Retear and Revision Rates of Rotator Cuff Repair: A Systematic Review. [2021]

3. England pubmed.ncbi.nlm.nih.gov

Oxandrolone in AIDS-wasting myopathy. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

The anabolic androgenic steroid oxandrolone in the treatment of wasting and catabolic disorders: review of efficacy and safety. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

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

6. England pubmed.ncbi.nlm.nih.gov

Risk Factors Associated with the Development of Transaminitis in Oxandrolone-Treated Adult Burn Patients. [2020]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Incidence of oxandrolone induced hepatic transaminitis in patients with burn injury. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

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

9. England pubmed.ncbi.nlm.nih.gov

Incidence of hepatic dysfunction is equivalent in burn patients receiving oxandrolone and controls. [2018]

10. Denmark pubmed.ncbi.nlm.nih.gov

The effects of an anabolic steroid (oxandrolone) on reproductive development in the male rat. [2019]

11. England pubmed.ncbi.nlm.nih.gov

Quantitative Assay Validation for Oxandrolone in Human Plasma Using LC-MS-MS. [2019]

12. United States pubmed.ncbi.nlm.nih.gov

Oxandrolone, an anabolic steroid, enhances the healing of a cutaneous wound in the rat. [2019]

13. Italy pubmed.ncbi.nlm.nih.gov

Effects Of Oxandrolone On Lean Body Mass (Lbm) In Severe Burn Patients: A Randomized, Double Blind, Placebo-Controlled Trial. [2022]

14. England pubmed.ncbi.nlm.nih.gov

In vitro and in vivo metabolism of the anabolic-androgenic steroid oxandrolone in the horse. [2022]