Oxandrolone Rotator Cuff Trial
Keywords
Abstract
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.
Dates
| Last Verified: | 05/31/2019 |
| First Submitted: | 03/12/2017 |
| Estimated Enrollment Submitted: | 03/19/2017 |
| First Posted: | 03/26/2017 |
| Last Update Submitted: | 06/19/2019 |
| Last Update Posted: | 06/23/2019 |
| Actual Study Start Date: | 09/22/2018 |
| Estimated Primary Completion Date: | 11/30/2020 |
| Estimated Study Completion Date: | 11/30/2022 |
Condition or disease
Intervention/treatment
Drug: Treatment Group
Drug: Placebo Group
Phase
Arm Groups
| Arm | Intervention/treatment |
|---|---|
| Experimental: Treatment Group receiving oral Oxandrolone 24 mg (12mg tablets) per day if male and 12 mg Oxandrolone per day if female, with dosing starting at time of surgery and continuing 12 weeks postoperative | Drug: Treatment Group Treatment group will receive 24 mg Oxandrolone per day if male and 12 mg Oxandrolone per day if female, with dosing starting at time of surgery and continuing 12 weeks postoperative |
| Placebo Comparator: Placebo Group receiving placebo medication (Placebo Oral Tablet), oral tablet, with dosing beginning at time of surgery and continuing for 12 weeks postoperative | Drug: Placebo Group Placebo group will receive a placebo oral tablet, beginning at the time of surgery and continuing 12 weeks postoperative |
Eligibility Criteria
| Ages Eligible for Study | 40 Years To 40 Years |
| Sexes Eligible for Study | All |
| Accepts Healthy Volunteers | Yes |
| 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 - 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 |
Outcome
Primary Outcome Measures
1. change in structural integrity of the rotator cuff/tendon healing [baseline, 12 weeks, 52 weeks and 104 weeks postoperative]
Secondary Outcome Measures
1. change in ASES shoulder score [baseline; procedure day; 2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks]
Other Outcome Measures
1. change in VAS pain scale [baseline; procedure day; 2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks]
2. change in PASS Score [baseline; procedure day; 2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks]
3. change in Functional Outcome - Shoulder Strength [baseline; procedure day; 2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks]
4. change in Body Composition [baseline; procedure day; 2 weeks, 6 weeks, 12 weeks, 24 weeks, 52 weeks, 104 weeks]
