← Back to Search

Oxandrolone for Rotator Cuff Repair (ORCT Trial)

N/A

Waitlist Available

Led By George R Hatch, MD

Research Sponsored by University of Southern California

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Scheduled for rotator cuff repair

Failed nonoperative management of chronic, full thickness rotator cuff tears

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to 104 weeks

Awards & highlights

ORCT Trial Summary

This trial is testing a medication to see if it helps healing and restoring muscle mass after a rotator cuff repair.

Who is the study for?

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.Check my eligibility

What is being tested?

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.See study design

What are the potential side effects?

Oxandrolone may cause liver issues, changes in cholesterol levels, increased risk of heart disease, mood swings, hormonal imbalances like altered sex drive or menstrual irregularities and could potentially increase the risk of certain types of cancer.

ORCT Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am scheduled for surgery to repair my rotator cuff.

Select...

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

Select...

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

ORCT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to 104 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to 104 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to 104 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

change in structural integrity of the rotator cuff/tendon healing

Secondary outcome measures

change in ASES shoulder score

Other outcome measures

change in Body Composition

change in Functional Outcome - Shoulder Strength

change in PASS Score

+1 more

ORCT Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Treatment GroupExperimental Treatment1 Intervention

Oxandrolone

Group II: Placebo GroupPlacebo Group1 Intervention

placebo

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Oxandrolone

2004

Completed Phase 1

~60

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of Southern CaliforniaLead Sponsor

905 Previous Clinical Trials

1,596,202 Total Patients Enrolled

George R Hatch, MDPrincipal InvestigatorUniversity of Southern California

1 Previous Clinical Trials

12 Total Patients Enrolled

Media Library

Treatment Group Clinical Trial Eligibility Overview. Trial Name: NCT03091075 — N/A

Rotator Cuff Tears Research Study Groups: Placebo Group, Treatment Group

Rotator Cuff Tears Clinical Trial 2023: Treatment Group Highlights & Side Effects. Trial Name: NCT03091075 — N/A

Treatment Group 2023 Treatment Timeline for Medical Study. Trial Name: NCT03091075 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Can individuals aged 45 and over participate in this research?

"This medical trial is welcoming patients who are between 40 and 75 years of age."

Answered by AI

Who can sign on for this scientific examination?

"Those hoping for consideration must meet two criteria: be between the ages of 40 and 75, as well as possess a rotator cuff tear. This trial is seeking to recruit 144 participants."

Answered by AI

Are there any other investigations that have explored the efficacy of Oxandrolone Pill?

"Currently, two clinical trials are underway exploring Oxandrolone Pill. Neither of these active studies is in Phase 3 yet. Although most of the research centers for this medication are situated in Charleston, South carolina; 11 different sites across America are conducting investigations into its efficacy."

Answered by AI

What is the aggregate of persons participating in this clinical trial?

"Affirmatively, clinicaltrials.gov states that this research is currently enrolling participants with an original posting date of September 23rd 2018 and the latest edit occurring on September 10th 2021. A total of 144 people are needed across one primary site for participation in the trial."

Answered by AI

Can you elucidate what the risks of Oxandrolone Pill are for patients?

"The safety of Oxandrolone Pill was given a rating of 2, as it is currently undergoing phase 2 trials and thus has limited evidence for its efficacy but some data that suggests the drug's safety."

Answered by AI

Are participants being accepted for this research investigation currently?

"The public record on clinicaltrials.gov suggests this study is actively recruiting participants, with the initial listing posted back in September 2018 and most recently updated on September 10th 2021."

Answered by AI

What ailments does the Oxandrolone Pill typically address?

"Oxandrolone Pill is typically employed to administer corticosteroid therapy, but it may also be prescribed for patients with amino acid catabolism disorder or those who require weight gain support."

Answered by AI