Oxandrolone Rotator Cuff Trial (ORCT)

  • STATUS
    Recruiting
  • End date
    Dec 23, 2023
  • participants needed
    144
  • sponsor
    University of Southern California
Updated on 10 February 2022
rotator cuff repair
full thickness rotator cuff tear
oxandrolone pill

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.

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.

Details
Condition Rotator Cuff Tear
Treatment Placebo Oral Tablet, Oxandrolone Pill
Clinical Study IdentifierNCT03091075
SponsorUniversity of Southern California
Last Modified on10 February 2022

Eligibility

Yes No Not Sure

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
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