Prototyping A Novel Foot And Ankle External Fixator To Improve Rehabilitation Outcomes In Patients Following Closed Reduction; Patient-Provider Decisions in Elderly Ankle Fracture Management

Ankle fractures are complex injuries affecting both patients’ health and everyday lives. A vast amount of research and medical technology surrounds repairing and maintaining the fracture region, particularly stabilizing the bone fragments so they can mend. New developments in early weightbearing and micromovements have shown promise improving patients’ physical outcomes after wrist fracture. Ankle fractures have a major impact on patients’ capabilities, so returning them to normal functionality is imperative. My Capstone Project is developing an ankle fracture external fixator that enables weightbearing and controlled micromovements to improve the physical outcomes of patients. However, patients are not solely defined by their physical function. They are made up of physical and non-physical needs (e.g. mental health), and lengthy rehabilitation processes play a major role in patients’ daily life beyond limiting their movement. Elderly patients with ankle fractures see more severe impairments due to their reduced healing potential and development of compounding conditions (e.g. diabetes). They are not treated as active decisionmakers in their own treatment, and the disconnect between provider and patient can lead to worse mental health and further complications during recovery. Therefore, my Science and Technology Studies (STS) research focuses on how patients can be empowered through understanding of their recovery and included in their treatment decision-making processes. Through these works, patients can be considered in a more wholistic perspective with improved functional capabilities after physical therapy, reducing the limitations and consequences of ankle fractures.

Current treatment methods focus on surgical intervention (e.g. open reduction and internal fixation a.k.a. ORIF), where rods, plates, or pins are inserted into the fracture site to stabilize the bone fragments, or non-surgical intervention (e.g. closed reduction and external fixation a.k.a. CREF), where the bone fragments are aligned then immobilized using a brace, cast, or similar device. Both options show concerns for poor bone healing and increased joint stiffness following fixation because the joint is unable to move until physical therapy begins. Enabling early joint micromovements and weightbearing has shown improvements in maintaining proper joint function and speeding up the healing process, yet there are no ankle fracture devices on the market that enable this functionality. Cambridge Orthopaedics Labs (COL) developed a wrist fracture external fixator that incorporates these techniques. Their device utilizes a connected series of modular cuffs that maximizes adaptability and patient comfort, and we aimed to translate those strengths into a novel ankle fracture external fixator. We first performed a literature review of key populations, biomechanics of fracture, and treatment recommendations for different fracture types. Next, we rapidly prototyped device designs based on the needs of our primary populations (young males and elderly females) and performed structural analysis to ensure the fixator could withstand 20% body weight loading, a common metric used in physical therapy. Through our development and testing, we determined that the device has a safety factor of 2 for 20% body weight loading and maintains ankle displacement under 1 mm, allowing bone healing to continue while loaded. This is an important step in modernizing ankle fracture treatment from traditional casts and braces that do not consider the dynamic nature of the ankle and surrounding tissues.

For patients with ankle fractures, the outcome most considered by healthcare providers for treatment and rehabilitation is fracture healing, but this does not account for humans being more than physical bodies. Person-centered care emphasizes that humans are a culmination of physical, mental, emotional, social, and spiritual identities, all of which may be of varying importance to patients and their desired outcomes. Patients often do not know what to expect in their recovery process, when they will reach sufficient outcomes, and how these outcomes align with their daily or non-physical needs. Following treatment, patients may disregard rehabilitation plans, physical activity restrictions, or serious complications because they do not have adequate resources that translate provider knowledge into patient understanding of the treatment and rehabilitation process. By incorporating patients into the decision-making process before treatment, providers can accommodate desired non-physical outcomes as well as translate expectations to the patient for their understanding. This research uses patient-centered care and patient knowledge theories in thematic analysis to determine how patient concerns and needs following treatment or rehabilitation can be addressed before they negatively impact the patient’s outcomes. The main decision themes identified are treatment method (ORIF vs. CREF), tailoring rehabilitation plans for patient-specific factors, patient autonomy in recovery, preferences for patient-provider communication, and social support during recovery. These themes and their patient-specific factors can be incorporated into a personalized tool that synthesizes patients’ holistic needs prior and details the recovery process while informing the patient of tailored expectations following treatment. This work will greatly improve elderly ankle fracture outcomes and could be applied to broader orthopedic patient experiences.

These projects are vital to improving the ankle fracture process from diverse perspectives. Focusing on injured humans poses a critical challenge that they are sensitive to influences from healthcare providers and decisions in their treatment and recovery processes. The intersection of physical and non-physical needs can have drastic impacts on the overall health of patients, but this cannot be seen from the scope of either project individually. Additionally, the thematic analysis in the STS research opens a valuable avenue for future patient feedback on the external fixator to understand what features should be improved in successive iterations. Technical and STS research are two sides of the same coin; without understanding the nuances of humans, we cannot develop sustainable and equitable solutions that consider all users. Therefore, this overall work serves to emphasize the necessary holistic approach to research and product development.