Oxandrolone Rotator Cuff Trial

Summary

Participation Requirements

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 biolog...

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.

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