Hsu Joseph R, Owens Johnny G, DeSanto Jennifer, Fergason John R, Kuhn Kevin M, Potter Benjamin K, Stinner Daniel J, Sheu Robert G, Waggoner Sandra L, Wilken Jason M, Huang Yanjie, Scharfstein Daniel O, MacKenzie Ellen J
*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.
J Orthop Trauma. 2017 Apr;31 Suppl 1:S56-S62. doi: 10.1097/BOT.0000000000000795.
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.
尽管对于许多高能开放性骨折以及胫骨远端、踝关节、后足和中足的挤压伤现在都可以进行保肢治疗，但矫形器的选择却很有限。无畏动态外骨骼矫形器（IDEO）是一种为接受保肢治疗的创伤患者定制的、储能碳纤维矫形器。IDEO与其他矫形器的不同之处在于，它能让踝关节无力的患者拥有更接近正常的踝关节生物力学特性并增强踝关节力量。本文描述了一项研究的设计，以评估IDEO与基于运动医学的高强度康复方法联合使用时的有效性。该研究基于早期研究，在布鲁克陆军医疗中心和研发该设备的无畏中心之外的军事治疗机构对该方案进行测试。PRIORITI-MTF研究是一项多中心前后方案评估，下肢创伤至少1年的参与者以自身作为对照。参与者在接受IDEO之前、使用IDEO进行4周物理治疗后立即以及物理治疗完成后的6个月和12个月接受评估。主要结局包括功能表现，通过对速度、敏捷性、力量和姿势稳定性进行充分验证的评估来衡量，以及使用简短肌肉骨骼功能评估（SMFA）和退伍军人健康调查（VR-12）进行自我报告的功能状况。次要结局包括疼痛、抑郁、创伤后应激以及对IDEO的满意度。
