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

Quacinella, Michael, DO, MPH; Bernstein, Ethan, MD, MPH; Mazzone, Brittney, PT, DPT; Wyatt, Marilynn, PT, MA; Kuhn, Kevin M., MD

Clinical Orthopaedics and Related Research®: April 2019 - Volume 477 - Issue 4 - p 838–847
doi: 10.1097/CORR.0000000000000487
2017 SELECTED PROCEEDINGS OF SOMOS
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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.

M. Quacinella, E. Bernstein, K. M. Kuhn, Department of Orthopedic Surgery, Naval Medical Center San Diego, San Diego, CA, USA

B. Mazzone, Extremity Trauma and Amputation Center of Excellence, Naval Medical Center San Diego, San Diego, CA, USA

M. Wyatt, Department of Physical Therapy, Naval Medical Center San Diego, San Diego, CA, USA

M. Quacinella, Department of Orthopaedic Surgery, Naval Medical Center San Diego, 34800 Bob Wilson Drive, San Diego, CA 92134, USA, email: Elisea.e.avalos-reyes.civ@mail.mil

Each author certifies that neither he or she, nor any member of his or her immediate family, has funding or commercial associations (consultancies, stock ownership, equity interest, patent/licensing arrangements, etc) that might pose a conflict of interest in connection with the submitted article.

All ICMJE Conflict of Interest Forms for authors and Clinical Orthopaedics and Related Research® editors and board members are on file with the publication and can be viewed on request.

Clinical Orthopaedics and Related Research® neither advocates nor endorses the use of any treatment, drug, or device. Readers are encouraged to always seek additional information, including FDA approval status, of any drug or device before clinical use.

Each author certifies that his or her institution approved the human protocol for this investigation and that all investigations were conducted in conformity with ethical principles of research.

The views expressed herein are those of the author(s) and do not necessarily reflect the official policy or position of the Department of the Navy, Department of Defense, or the US Government.

Received April 03, 2018

Accepted August 22, 2018

© 2019 Lippincott Williams & Wilkins LWW
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