Oxandrolone Rotator Cuff Trial

NCT03091075 | Active Not Recruiting

• 1 other identifier: HS-17-00272
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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.

Conditions

Rotator Cuff Tear

Keywords

Rotator Cuff Tear; Rotator Cuff; Anabolic Steroid; Testosterone; Oxandrolone

Outcome Measures

Primary Outcomes (1)

• change in structural integrity of the rotator cuff/tendon healing

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

  baseline to 52 weeks

Secondary Outcomes (1)

• change in ASES shoulder score

  baseline to 104 weeks

Other Outcomes (4)

• change in VAS pain scale

  baseline to 104 weeks

• change in PASS Score

  baseline to 104 weeks

• change in Functional Outcome - Shoulder Strength

  baseline to 104 weeks

Study Arms (2)

Treatment Group

EXPERIMENTAL

Oxandrolone

Drug: Oxandrolone

Placebo Group

PLACEBO COMPARATOR

placebo

Drug: Placebo

Interventions

Oxandrolone DRUG

Treatment group will receive Oxandrolone daily for 12 weeks postoperatively

Treatment Group

Placebo DRUG

Placebo group will receive placebo for 12 weeks postoperative

Placebo Group

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Southern California: lead

Study Sites (1)

Keck School of Medicine of the University of Southern California

Los Angeles, California, 90033, United States

Location

Related Publications (32)

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MeSH Terms

Conditions

Rotator Cuff Injuries

Interventions

Oxandrolone

Condition Hierarchy (Ancestors)

Rupture; Wounds and Injuries; Shoulder Injuries; Tendon Injuries

Intervention Hierarchy (Ancestors)

Androstanols; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• George R Hatch, MD

  University of Southern California

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Allocation will be performed using computer software and will occur at the pharmacy to ensure that all investigators are blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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.

Study Record Dates

• First Submitted: March 13, 2017
• First Posted: March 27, 2017
• Study Start: September 23, 2018
• Primary Completion: July 1, 2025
• Study Completion: December 1, 2025
• Last Updated: May 18, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)