Do Spatiotemporal Gait Parameters Improve After Pilon Fracture in Patients Who Use the Intrepid Dynamic Exoskeletal Orthosis?

BACKGROUND: Pilon fractures are high-energy fractures about the ankle observed commonly in both civilian and military trauma populations. Despite surgical management, outcomes are predictably poorly characterized by functional deficits secondary to pain and stiffness. The Intrepid Dynamic Exoskeletal Orthosis (IDEO) and Return-to-Run clinical pathway were initially designed to treat military service members after complex battlefield lower extremity injuries. The IDEO has been used to treat nonbattlefield injuries, but, to our knowledge, it has not been studied specifically among patients with pilon fractures. By studying the use of the IDEO in this patient population, we hope to learn how it might improve ambulation in the community, relieve pain, and return patients to work to better identify patients who might benefit from its use. QUESTIONS/PURPOSES: The purpose of this study was to determine whether the IDEO would improve gait parameters including velocity, cadence, stride length, and single-leg stance duration in patients with pilon fractures. Our secondary endpoints of interest were reductions in pain and return to duty.
METHODS: A prospectively collected database of all active-duty IDEO users at a single institution was queried for all patients using the IDEO after a pilon fracture. Patients were included if they were using the IDEO after sustaining a surgically treated pilon fracture and had exhausted all nonoperative therapies. Exclusions were patients with an incomplete gait analysis at the two study time points. Seven patients meeting these criteria were identified. Three-dimensional gait analysis was performed two times: first wearing shoes at a self-selected speed and second after a custom-made IDEO was fabricated for the patient and completion of the Return-to-Run pathway. Patients reported their average pain while ambulating using a numeric rating scale. Gait variables of interest were velocity, cadence, stride length, and single stance time. Return to military service was assessed through the military medical record. To return to duty, a service-specific physical readiness test must be completed.
RESULTS: Median gait velocity improved from 1.1 (interquartile range [IQR], 0.9-1.2) to 1.3 m/s (IQR, 1.2-1.5; p = 0.01). All other variables did not change: cadence 98.4 (IQR, 93.0-107.2) to 104.5 steps/min (IQR, 103.0-109.0; p = 0.13), affected stride length 1.3 (IQR, 1.0-1.4 m) to 1.4 m (IQR, 1.3-1.6 m; p = 0.07), and affected single stance 0.42 (IQR, 0.41-0.47) to 0.43 (IQR, 0.42-0.44; p = 0.80). Pain did not change between time points: 3 (IQR, 2-3) to 2.5 (IQR, 1-3.5; p = 0.90). Three of seven patients returned to duty.
CONCLUSIONS: At self-selected walking speeds, we observed no improvements in gait parameters or pain after application of the IDEO that would likely be considered clinically important, and so the device is unlikely to be worth the cost in this setting. It is possible that for higher demand users such as elite athletes, the IDEO could have a role after severe lower extremity trauma; however, this must be considered speculative until or unless proven in future studies. LEVEL OF EVIDENCE: Level III, therapeutic study.