Oxandrolone Rotator Cuff Trial

NCT ID: NCT03091075

Last Updated: 2025-05-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-09-23
• Study Completion Date: 2025-12-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Treatment Group

Oxandrolone

Group Type: EXPERIMENTAL

Oxandrolone

Intervention Type: DRUG

Treatment group will receive Oxandrolone daily for 12 weeks postoperatively

Placebo Group

placebo

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo group will receive placebo for 12 weeks postoperative

Interventions

Oxandrolone

Treatment group will receive Oxandrolone daily for 12 weeks postoperatively

Intervention Type: DRUG

Placebo

Placebo group will receive placebo for 12 weeks postoperative

Intervention Type: DRUG

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Southern California

OTHER

Sponsor Role: lead

Responsible Party

George F. Hatch

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

George R Hatch, MD

Role: PRINCIPAL_INVESTIGATOR

University of Southern California

Locations

Keck School of Medicine of the University of Southern California

Los Angeles, California, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

HS-17-00272

Identifier Type: -

Identifier Source: org_study_id