Quantifying Bone and Skin Movement in the Residual Limb-Socket Interface of Individuals With Transtibial Limb Loss Using Dynamic Stereo X-Ray: Protocol for a Lower Limb Loss Cadaver and Clinical Study.

BACKGROUND: Relative motion between the residual limb and socket in individuals with transtibial limb loss can lead to substantial consequences that limit mobility. Although assessments of the relative motion between the residual limb and socket have been performed, there remains a substantial gap in understanding the complex mechanics of the residual limb-socket interface during dynamic activities that limits the ability to improve socket design. However, dynamic stereo x-ray (DSX) is an advanced imaging technology that can quantify 3D bone movement and skin deformation inside a socket during dynamic activities. OBJECTIVE: This study aims to develop analytical tools using DSX to quantify the dynamic, in vivo kinematics between the residual limb and socket and the mechanism of residual tissue deformation. METHODS: A lower limb cadaver study will first be performed to optimize the placement of an array of radiopaque beads and markers on the socket, liner, and skin to simultaneously assess dynamic tibial movement and residual tissue and liner deformation. Five cadaver limbs will be used in an iterative process to develop an optimal marker setup. Stance phase gait will be simulated during each session to induce bone movement and skin and liner deformation. The number, shape, size, and placement of each marker will be evaluated after each session to refine the marker set. Once an optimal marker setup is identified, 21 participants with transtibial limb loss will be fitted with a socket capable of being suspended via both elevated vacuum and traditional suction. Participants will undergo a 4-week acclimation period and then be tested in the DSX system to track tibial, skin, and liner motion under both suspension techniques during 3 activities: treadmill walking at a self-selected speed, at a walking speed 10% faster, and during a step-down movement. The performance of the 2 suspension techniques will be evaluated by quantifying the 3D bone movement of the residual tibia with respect to the socket and quantifying liner and skin deformation at the socket-residuum interface. RESULTS: This study was funded in October 2021. Cadaver testing began in January 2023. Enrollment began in February 2024. Data collection is expected to conclude in December 2025. The initial dissemination of results is expected in November 2026. CONCLUSIONS: The successful completion of this study will help develop analytical methods for the accurate assessment of residual limb-socket motion. The results will significantly advance the understanding of the complex biomechanical interactions between the residual limb and the socket, which can aid in evidence-based clinical practice and socket prescription guidelines. This critical foundational information can aid in the development of future socket technology that has the potential to reduce secondary comorbidities that result from complications of poor prosthesis load transmission. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/57329.

Effects of Prosthetic Socket Design on Residual Femur Motion Using Dynamic Stereo X-Ray - A Preliminary Analysis.

Individuals with transfemoral amputation experience relative motion between their residual limb and prosthetic socket, which can cause inefficient dynamic load transmission and secondary comorbidities that limit mobility. Accurately measuring the relative position and orientation of the residual limb relative to the prosthetic socket during dynamic activities can provide great insight into the complex mechanics of the socket/limb interface. Five participants with transfemoral amputation were recruited for this study. All participants had a well-fitting, ischial containment socket and were also fit with a compression/release stabilization socket. Participants underwent an 8-wk, randomized crossover trial to compare differences between socket types. Dynamic stereo x-ray was used to quantify three-dimensional residual bone kinematics relative to the prosthetic socket during treadmill walking at self-selected speed. Comfort, satisfaction, and utility were also assessed. There were no significant differences in relative femur kinematics between socket types in the three rotational degrees of freedom, as well as anterior-posterior and medial-lateral translation (p > 0.05). The ischial containment socket demonstrated significantly less proximal-distal translation (pistoning) of the femur compared to the compression/release stabilization socket during the gait cycle (p < 0.05), suggesting that the compression/release stabilization socket provided less control of the residual femur during distal translation. No significant differences in comfort and utility were found between socket types (p > 0.05). The quantitative, dynamic analytical tools used in the study were sensitive to distinguish differences in three-dimensional residual femur motion between two socket types, which can serve as a platform for future comparative effectiveness studies of socket technology.