Carbon Fiber Orthosis Cuff Design
Abstract
Conflicts associated with the War on Terror have resulted in many injuries, with more than half of evacuated Service Members, and two-thirds of Service Members who did not return to duty experiencing traumatic extremity injuries. Service Members who experience traumatic lower limb injuries often deal with persistent pain, stiffness, weakness, and functional limitation due to muscle loss, scarring, and post-traumatic osteoarthritis (PTOA) for the rest of their lives, negatively impacting their ability to return to work and leading to high long-term disability costs. Research has shown that carbon fiber custom dynamic orthoses (CDOs) dramatically improve function in Service Members following lower extremity trauma. CDOs consist of a proximal cuff wrapping around the leg just below the knee, a posterior carbon fiber strut that stores and returns energy, a carbon fiber footplate that supports and protects the foot, and a foam heel wedge placed in the shoe. The research team has previously investigated the effects of systematically altering CDO design characteristics, including the posterior strut, the heel wedge, and overall device alignment, on patient outcomes and device function. This work offers valuable insight into the effects of CDO design characteristics on patient outcomes, but there is a distinct lack of insight into the proximal cuff and its role in optimizing patient outcomes following lower extremity injury. The proximal cuff is a primary interface between the patient and the CDO, and multiple proximal cuff designs are widely used in clinical practice at this time. It is thought that each design offers unique advantages to the patient and the clinician, but there is little data supporting these claims. Currently, clinicians are forced to rely on previous experiences, trends in the field, and advice from colleagues, rather than objective data or guidelines when selecting the proximal cuff design. The goal of this project is to determine the effects of proximal cuff design on patient-reported outcomes, limb mechanics and loading, and CDO mechanical characteristics in order to inform the field and promote evidence-based medicine during future CDO prescription and fittings. Providing CDOs with the proper proximal cuff design is expected to result in a preferred device that better restores limb function while improving patient comfort and satisfaction. This proposal for the Orthotics and Prosthetics Outcomes Research Program Clinical Trial Award addresses the need to improve the health and well-being of individuals with limb impairment and aligns with the goal of focusing on devices currently used in clinical practice, rather than the development of new, or improvement of existing approaches, to optimize outcomes. This study builds on the team’s previous experience systematically evaluating CDO design characteristics to determine the effects of proximal cuff design on patient comfort, pain, physical function, preference, limb mechanics and loading, and CDO mechanical characteristics. Four proximal cuff designs representing currently available devices used with Service Members, Veterans, and civilians will be tested in a randomized order: (1) a patellar tendon bearing clamshell cuff secured with a mechanical ratcheting system, (2) an anterior/posterior patellar tendon bearing shell, with a fixed pivot point, secured with Velcro, (3) a rigid clamshell cuff secured with Velcro, and (4) a semi-rigid cuff with a flexible outer layer secured with Velcro. Participants will be cast and fit with each proximal cuff design by experienced clinicians and will be given time to accommodate to the CDO before testing. Participants will not be informed of the intent or name of the specific proximal cuff design being tested. Seventeen healthy able-bodied individuals and 17 individuals diagnosed with PTOA following extremity injury will be evaluated using multiple well-established tests. Participants will complete questionnaire
Document Details
- Document Type
- DoD Grant Award
- Publication Date
- Dec 28, 2022
- Source ID
- W81XWH2210464
Entities
People
- Jason M. Wilken
Organizations
- United States Army
- University of Iowa