Oxandrolone Rotator Cuff Trial
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 40 - 75 |
| Updated: | 1/19/2018 |
| Start Date: | May 1, 2018 |
| End Date: | December 2022 |
| Contact: | George R Hatch, MD |
| Email: | ghatch@med.usc.edu |
| Phone: | 323-442-5860 |
Ability of Oral Steroid (Oxandrolone) to Halt Fatty Infiltration and Aid Rotator Cuff Healing: A Double-Blind, Randomized Clinical Trial
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.
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.
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.
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.
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
We found this trial at
1
site
Los Angeles, California 90033
Principal Investigator: George R Hatch, MD
Phone: 323-442-5680
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