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Oxandrolone Rotator Cuff Trial (ORCT)

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ClinicalTrials.gov Identifier: NCT03091075
Recruitment Status : Not yet recruiting
First Posted : March 27, 2017
Last Update Posted : January 17, 2018
Sponsor:
Information provided by (Responsible Party):
George F., University of Southern California

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rotator Cuff Tear Drug: Oxandrolone Pill Drug: Placebo Oral Tablet Phase 2

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  (Clinical Trial)
Estimated Enrollment : 144 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: 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 (males 12 mg BID (24 mg per day) and females 6 mg BID (12 mg per day)), with dosing beginning at time of surgery and continuing for 12 weeks postoperative.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Allocation will be performed using computer software and will occur at the pharmacy to ensure that all investigators are blinded.
Primary Purpose: Treatment
Official Title: Ability of Oral Steroid (Oxandrolone) to Halt Fatty Infiltration and Aid Rotator Cuff Healing: A Double-Blind, Randomized Clinical Trial
Estimated Study Start Date : May 1, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tears
Drug Information available for: Oxandrolone

Arm Intervention/treatment
Experimental: Treatment Group
receiving oral Oxandrolone 24 mg (12mg tablets) per day if male and 12 mg Oxandrolone per day if female, with dosing starting at time of surgery and continuing 12 weeks postoperative
Drug: Oxandrolone Pill
Treatment group will receive 24 mg Oxandrolone per day if male and 12 mg Oxandrolone per day if female, with dosing starting at time of surgery and continuing 12 weeks postoperative

Placebo Comparator: Placebo Group
receiving placebo medication (Placebo Oral Tablet), oral tablet, with dosing beginning at time of surgery and continuing for 12 weeks postoperative
Drug: Placebo Oral Tablet
Placebo group will receive a placebo oral tablet, beginning at the time of surgery and continuing 12 weeks postoperative




Primary Outcome Measures :
  1. change in structural integrity of the rotator cuff/tendon healing [ Time Frame: baseline, 12 weeks, 52 weeks and 104 weeks postoperative ]
    assessed by MRI, classified based on the Sugaya classification and Goutallier Grade


Secondary Outcome Measures :
  1. change in ASES shoulder score [ Time Frame: baseline; procedure day; 2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks ]
    American Shoulder Elbow Surgeon's Shoulder Score, Patient Questionnaire


Other Outcome Measures:
  1. change in VAS pain scale [ Time Frame: baseline; procedure day; 2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks ]
    Visual Analog Score - pain scale, patient questionnaire

  2. change in PASS Score [ Time Frame: baseline; procedure day; 2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks ]
    Patient Acceptabe Symptom State, patient questionnaire

  3. change in Functional Outcome - Shoulder Strength [ Time Frame: baseline; procedure day; 2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks ]
    isometric shoulder strength measures using a handheld dynamometer

  4. change in Body Composition [ Time Frame: baseline; procedure day; 2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks ]
    body composition testing by bioelectric impedence



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Ages Eligible for Study:   40 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  • 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
  • Any other condition or treatment interfering with completion of the trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091075


Contacts
Contact: George R Hatch, MD 323-442-5860 ghatch@med.usc.edu
Contact: Keemia Soraya Heidari, BA 323-442-5860 kheidari@usc.edu

Locations
United States, California
Keck School of Medicine of the University of Southern California Not yet recruiting
Los Angeles, California, United States, 90033
Contact: Keemia Soraya Heidari, BA    323-442-5680    kheidari@usc.edu   
Principal Investigator: George R Hatch, MD         
Sub-Investigator: Keemia Soraya Heidari, BA         
Sub-Investigator: Anthony Essilfie, MD         
Sub-Investigator: Seth Gamradt, MD         
Sub-Investigator: Alan Gurler, MS         
Sub-Investigator: Lori Michener, PhD         
Sub-Investigator: Reza Omid, MD         
Sub-Investigator: Todd Schroeder, PhD         
Sub-Investigator: James Tibone, MD         
Sub-Investigator: C. Thomas Vangsness, MD         
Sub-Investigator: Alexander Weber, MD         
Sponsors and Collaborators
University of Southern California
Investigators
Principal Investigator: George R Hatch, MD University of Southern California
  Study Documents (Full-Text)

Documents provided by George F., University of Southern California:
Informed Consent Form  [PDF] September 11, 2017


Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: APP-17-01020
Informed Consent Form  This link exits the ClinicalTrials.gov site
Identifier: APP-17-01020

Publications:

Responsible Party: George F., Associate Professor, University of Southern California
ClinicalTrials.gov Identifier: NCT03091075     History of Changes
Other Study ID Numbers: HS-17-00272
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: January 17, 2018
Last Verified: January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by George F., University of Southern California:
Rotator Cuff Tear
Rotator Cuff
Anabolic Steroid
Testosterone
Oxandrolone

Additional relevant MeSH terms:
Rotator Cuff Injuries
Rupture
Wounds and Injuries
Shoulder Injuries
Tendon Injuries
Oxandrolone
Androgens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anabolic Agents