Oxandrolone Rotator Cuff Trial (ORCT)

February 27, 2024 updated by: George F. Hatch, University of Southern California

Ability of Oral Steroid (Oxandrolone) to Halt Fatty Infiltration and Aid Rotator Cuff Healing: A Double-Blind, Randomized Clinical Trial

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 human hormone Testosterone (the principal male sex hormone and an anabolic steroid), given for 12 weeks following rotator cuff repair, is effective in aiding in the healing process and restoring muscle mass.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

Rotator cuff tears are currently one of the most common causes of musculoskeletal pain and disability; the biologic sequelae of a chronic tear are muscle atrophy, fatty infiltration, and intercellular fibrosis of the torn muscle-tendon unit. Recently, researchers have attempted to address the biologic sequelae of chronic rotator cuff tearing with animal studies examining the effects of anabolic steroids on rotator cuff healing, demonstrating that when administered as an adjuvant to rotator cuff repair, anabolic steroids can halt fatty infiltration, decrease muscle atrophy, and promote healing. The purpose of this study will be to conduct the first clinical trial using an oral anabolic agent (Oxandrolone, an oral synthetic derivative of testosterone that has been shown to aid in beneficial tissue healing in burn patients) to promote rotator cuff healing. Men and women aged 40 - 75 scheduled for rotator cuff repair, who have failed nonoperative management of chronic, full thickness rotator cuff tears confirmed by MRI, will be randomized into one of two groups, a control group (receiving placebo medication) and an experimental group (receiving oral Oxandrolone), with dosing (males 12 mg BID, female 6 mg BID) beginning at time of surgery and continuing for 12 weeks postoperative. Allocation will be performed using computer software and will occur at the pharmacy to ensure that all investigators are blinded. All participants will undergo a standardized rehabilitation protocol for rotator cuff repair, supervised by a licensed physical therapist.

Study Type

Interventional

Enrollment (Estimated)

116

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • California
      • Los Angeles, California, United States, 90033
        • Keck School of Medicine of the University of Southern California

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • scheduled for rotator cuff repair
  • failed nonoperative management of chronic, full thickness rotator cuff tears
  • full thickness rotator cuff tear confirmed on MRI

Exclusion Criteria:

  • patients with prior shoulder surgery or prior rotator cuff repair
  • tears larger than 5 cm
  • significant glenohumeral arthritis (Hamada Grade 2 or higher)
  • 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
  • Deep Vein Thrombosis (DVT) within the past 6 months
  • Disorder of the coagulation system
  • Currently taking anticoagulation
  • Claustrophobia
  • Prior or current use of anabolic steroids
  • Chromosomal disorders
  • Prostate cancer
  • Breast cancer
  • Hypercalcemia
  • Medications that interfere with testosterone production or function, including but not limited to 5 alpha-reductase inhibitors
  • Pregnant or breastfeeding, or expecting to conceive or father children within the projected duration of the trial, starting with the Screening visit through 6 weeks after the last dose of study treatment
  • Any other condition or treatment interfering with completion of the trial

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment Group
Oxandrolone
Treatment group will receive Oxandrolone daily for 12 weeks postoperatively
Placebo Comparator: Placebo Group
placebo
Placebo group will receive placebo for 12 weeks postoperative

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in structural integrity of the rotator cuff/tendon healing
Time Frame: baseline to 52 weeks
assessed by MRI, classified based on the Sugaya classification and Goutallier Grade
baseline to 52 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in ASES shoulder score
Time Frame: baseline to 104 weeks
American Shoulder Elbow Surgeon's Shoulder Score, Patient Questionnaire
baseline to 104 weeks

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
change in VAS pain scale
Time Frame: baseline to 104 weeks
Visual Analog Score - pain scale, patient questionnaire
baseline to 104 weeks
change in PASS Score
Time Frame: baseline to 104 weeks
Patient Acceptable Symptom State, patient questionnaire
baseline to 104 weeks
change in Functional Outcome - Shoulder Strength
Time Frame: baseline to 104 weeks
isometric shoulder strength measures using a handheld dynamometer
baseline to 104 weeks
change in Body Composition
Time Frame: baseline to 104 weeks
body composition testing by bioelectric impedence
baseline to 104 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: George R Hatch, MD, University of Southern California

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 23, 2018

Primary Completion (Estimated)

May 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 13, 2017

First Submitted That Met QC Criteria

March 20, 2017

First Posted (Actual)

March 27, 2017

Study Record Updates

Last Update Posted (Actual)

March 1, 2024

Last Update Submitted That Met QC Criteria

February 27, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Data will be shared as required with the USC Health Sciences Institutional Review Board. Participant data will be coded with coding identifiers kept separately by research personnel only and destroyed upon completion of the study.

Study Data/Documents

  1. Study Protocol
    Information identifier: APP-17-01020
  2. Informed Consent Form
    Information identifier: APP-17-01020

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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