Patient Response to an Integrated Orthotic and Rehabilitation Initiative for Traumatic Injuries: The PRIORITI-MTF Study.

Although limb salvage is now possible for many high-energy open fractures and crush injuries to the distal tibia, ankle, hindfoot, and midfoot, orthotic options are limited. The Intrepid Dynamic Exoskeletal Orthosis (IDEO) is a custom, energy-storing carbon fiber orthosis developed for trauma patients undergoing limb salvage. The IDEO differs from other orthoses in that it allows patients with ankle weakness to have more normal ankle biomechanics and increased ankle power. This article describes the design of a study to evaluate the effectiveness of the IDEO when delivered together with a high-intensity, sports medicine-based approach to rehabilitation. It builds on earlier studies by testing the program at military treatment facilities beyond the Brooke Army Medical Center and the Center for the Intrepid where the device was developed. The PRIORITI-MTF study is a multicenter before-after program evaluation where participants at least 1 year out from a traumatic lower extremity injury serve as their own controls. Participants are evaluated before receiving the IDEO, immediately after 4 weeks of physical therapy with the IDEO and at 6 and 12 months after the completion of physical therapy. Primary outcomes include functional performance, measured using well-validated assessments of speed, agility, power, and postural stability and self-reported functioning using the Short Musculoskeletal Function Assessment (SMFA) and the Veterans Health Survey (VR-12). Secondary outcomes include pain, depression, posttraumatic stress, and satisfaction with the IDEO.