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.
*Department of Orthopaedics, Carolinas Medical Center, Charlotte, NC; †San Antonio Military Medical Center, US Army Institute of Surgical Research, San Antonio, TX; ‡Department of Health Policy and Management, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD; §Naval Medical Center San Diego, San Diego, CA; ‖Walter Reed National Military Medical Center, Bethesda, MD; and ¶Department of Biostatistics, Johns Hopkins Bloomberg School of Public Health, Baltimore, MD.
Joseph R
JR
Hsu
Johnny G
JG
Owens
Jennifer
J
DeSanto
John R
JR
Fergason
Kevin M
KM
Kuhn
Benjamin K
BK
Potter
Daniel J
DJ
Stinner
Robert G
RG
Sheu
Sandra L
SL
Waggoner
Jason M
JM
Wilken
Yanjie
Y
Huang
Daniel O
DO
Scharfstein
Ellen J
EJ
MacKenzie
D000328:Adult; D016512:Ankle Injuries / Q000175:diagnosis* / Q000534:rehabilitation*; D001915:Braces; D019544:Equipment Failure Analysis; D000067190:Exoskeleton Device; D005260:Female; D018409:Foot Injuries / Q000175:diagnosis* / Q000534:rehabilitation*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D017060:Patient Satisfaction; D011474:Prosthesis Design; D018511:Systems Integration; D016896:Treatment Outcome; D014481:United States