Oxandrolone Rotator Cuff Trial

Study Overview
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Brief Summary
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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.

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

Conditions
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Rotator Cuff Tear

Intervention / Treatment
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* Drug: Oxandrolone
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment Group<br>Oxandrolone | Drug: Oxandrolone<br>* Treatment group will receive Oxandrolone daily for 12 weeks postoperatively<br>|
| Placebo Comparator: Placebo Group<br>placebo | Drug: Placebo<br>* Placebo group will receive placebo for 12 weeks postoperative<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in ASES shoulder score | American Shoulder Elbow Surgeon's Shoulder Score, Patient Questionnaire | baseline to 104 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Oxandrolone, Rotator Cuff Tear, Rotator Cuff, Anabolic Steroid, Testosterone