Oxandrolone Supplementation in Trauma: The Post-Injury Trial

Project Details


High-energy lower extremity fractures (motor vehicle, fall from height, gunshot injuries) are unfortunately common among active Service Members, as well as civilians presenting to trauma centers worldwide. These injuries often require multiple surgeries followed by protracted rehabilitation. Despite the best efforts of surgeons and rehabilitation specialists, these injuries result in permanent limitations of function, ambulation, and ability to return to Service. This is due to the significant soft-tissue damage (muscles, tendons, nerves and blood vessels) these high-energy fractures sustain, which is compounded by the trauma of one or more surgeries. In addition, during recovery, there is a stress response resembling that seen in large surface area burn patients that contributes to muscle atrophy. This stress response is partly due to and compounded by soft-tissue disuse atrophy from post-injury immobilization and weight-bearing restrictions. The combined result is significantly reduced muscle volume and strength that persists long after bony healing.

The current standard of treatment for recovery from the significant soft-tissue damage associated with these injuries is physical therapy and rehabilitation, which may last years. Although patients make significant gains with prolonged physical therapy, many do not completely recover. The 5-year mortality rate for patients with these injuries is as high as 25%, despite an in-hospital mortality of only 8%, suggesting the presence of continued life-threatening morbidity. At least one third of patients are unable to return to work, and the majority are left with reduced quality of life, long-term pain and limited function. Currently, there are no efficacious interventions available to offset or treat the metabolic and mechanical sequalae associated with high-energy trauma and prolonged immobilization. Oxandrolone has been successfully utilized to accelerate muscular recovery, reduce muscle loss, and improve function in several populations including healthy elderly patients, patients with large surface area burns, neuromuscular diseases, HIV, congenital heart disease, and genetic diseases including Klinefelter's and Turner's Syndromes. The efficacy seen with Oxandrolone use in these populations may be translatable to high-energy, lower-extremity fracture patients.

Although there are risks of Oxandrolone supplementation, including behavioral, dermatological, reproductive, or endocrinological changes, they have not been prominent in previous large trials, and it has been shown to be safe in children. The major risk of Oxandrolone supplementation is slight increase in liver enzymes; however, these normalize with medication discontinuation and do not result in long-term damage. These risks are minimal compared to the potential benefit of improved function, increased return to duty, and decreased burden on families and caregivers caring for patients with these significant injuries. Oxandrolone supplementation may accelerate recovery of muscle mass and strength, resulting in reduced length of hospital stay, reduced readmission, and shorter rehabilitation course, which are among the largest expenditures in casualty care.

A randomized, placebo-controlled trial demonstrating improved and expedited muscle mass recovery and associated improvements in functional outcomes with Oxandrolone supplementation after high-energy lower extremity fractures will improve the function of patients with these injuries. Although current rehabilitation from these injuries may take several years, the majority of improvement is seen within the first year after injury. As seen in large surface area burns, supplementation with Oxandrolone can improve outcomes and function within the first year of supplementation.

The potential benefits of an improved early recovery will help these patients return to duty more rapidly. Just as importantly, this will minimize the burden on their families and allow these patients a high level of function in multiple aspects of their lives.

Effective start/end date1/01/20 → …


  • Congressionally Directed Medical Research Programs: $1,481,600.00


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