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Oxandrolone Rotator Cuff Trial (ORCT)

Primary Purpose

Rotator Cuff Tear

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Oxandrolone

Placebo

About this trial

This is an interventional treatment trial for Rotator Cuff Tear focused on measuring Rotator Cuff Tear, Rotator Cuff, Anabolic Steroid, Testosterone, Oxandrolone

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
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
Any other condition or treatment interfering with completion of the trial

Sites / Locations

Keck School of Medicine of the University of Southern CaliforniaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Treatment Group

Placebo Group

Arm Description

Oxandrolone

placebo

Outcomes

Primary Outcome Measures

change in structural integrity of the rotator cuff/tendon healing

assessed by MRI, classified based on the Sugaya classification and Goutallier Grade

Secondary Outcome Measures

change in ASES shoulder score

American Shoulder Elbow Surgeon's Shoulder Score, Patient Questionnaire

Full Information

NCT ID

NCT03091075

First Posted

March 13, 2017

Last Updated

May 16, 2023

Sponsor

University of Southern California

1. Study Identification

Unique Protocol Identification Number

NCT03091075

Brief Title

Oxandrolone Rotator Cuff Trial

Acronym

ORCT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

May 2023

Overall Recruitment Status

Recruiting

Study Start Date

September 23, 2018 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Southern California

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rotator Cuff Tear

Keywords

Rotator Cuff Tear, Rotator Cuff, Anabolic Steroid, Testosterone, Oxandrolone

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

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 for 12 weeks postoperative.

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Masking Description

Allocation will be performed using computer software and will occur at the pharmacy to ensure that all investigators are blinded.

Allocation

Randomized

Enrollment

116 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment Group

Arm Type

Experimental

Arm Description

Oxandrolone

Arm Title

Placebo Group

Arm Type

Placebo Comparator

Arm Description

placebo

Intervention Type

Drug

Intervention Name(s)

Oxandrolone

Intervention Description

Treatment group will receive Oxandrolone daily for 12 weeks postoperatively

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo group will receive placebo for 12 weeks postoperative

Primary Outcome Measure Information:

Title

change in structural integrity of the rotator cuff/tendon healing

Description

assessed by MRI, classified based on the Sugaya classification and Goutallier Grade

Time Frame

baseline to 52 weeks

Secondary Outcome Measure Information:

Title

change in ASES shoulder score

Description

American Shoulder Elbow Surgeon's Shoulder Score, Patient Questionnaire

Time Frame

baseline to 104 weeks

Other Pre-specified Outcome Measures:

Title

change in VAS pain scale

Description

Visual Analog Score - pain scale, patient questionnaire

Time Frame

baseline to 104 weeks

Title

change in PASS Score

Description

Patient Acceptable Symptom State, patient questionnaire

Time Frame

baseline to 104 weeks

Title

change in Functional Outcome - Shoulder Strength

Description

isometric shoulder strength measures using a handheld dynamometer

Time Frame

baseline to 104 weeks

Title

change in Body Composition

Description

body composition testing by bioelectric impedence

Time Frame

baseline to 104 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility 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 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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

George R Hatch, MD

Phone

323-442-5860

uscortho.sports@gmail.com

First Name & Middle Initial & Last Name or Official Title & Degree

George Hatch, MD

Phone

323-442-5860

ghatch@med.usc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

George R Hatch, MD

Organizational Affiliation

University of Southern California

Official's Role

Principal Investigator

Facility Information:

Facility Name

Keck School of Medicine of the University of Southern California

City

Los Angeles

State/Province

California

ZIP/Postal Code

90033

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

George F Hatch, MD

Phone

323-442-5680

uscortho.sports@gmail.com

First Name & Middle Initial & Last Name & Degree

George R Hatch, MD

First Name & Middle Initial & Last Name & Degree

Keemia Soraya Heidari, BA

First Name & Middle Initial & Last Name & Degree

Anthony Essilfie, MD

First Name & Middle Initial & Last Name & Degree

Seth Gamradt, MD

First Name & Middle Initial & Last Name & Degree

Alan Gurler, MS

First Name & Middle Initial & Last Name & Degree

Lori Michener, PhD

First Name & Middle Initial & Last Name & Degree

Reza Omid, MD

First Name & Middle Initial & Last Name & Degree

Todd Schroeder, PhD

First Name & Middle Initial & Last Name & Degree

James Tibone, MD

First Name & Middle Initial & Last Name & Degree

C. Thomas Vangsness, MD

First Name & Middle Initial & Last Name & Degree

Alexander Weber, MD

First Name & Middle Initial & Last Name & Degree

Alexis Rounds, BS

12. IPD Sharing Statement

Plan to Share IPD

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Oxandrolone Rotator Cuff Trial

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