Standardized Approach to Quantitatively Measure Residual Limb Skin Health in Individuals with Lower Limb Amputation.

Objective: (1) Develop a standardized approach to quantitatively measure residual limb skin health. (2) Report reference residual limb skin health values in people with transtibial and transfemoral amputation. Approach: Residual limb health outcomes in individuals with transtibial (n = 5) and transfemoral (n = 5) amputation were compared to able-limb controls (n = 4) using noninvasive imaging (hyperspectral imaging and laser speckle flowmetry) and probe-based approaches (laser doppler flowmetry, transcutaneous oxygen, transepidermal water loss, surface electrical capacitance). Results: A standardized methodology that employs noninvasive imaging and probe-based approaches to measure residual limb skin health are described. Compared to able-limb controls, individuals with transtibial and transfemoral amputation have significantly lower transcutaneous oxygen tension, higher transepidermal water loss, and higher surface electrical capacitance in the residual limb. Innovation: Residual limb health as a critical component of prosthesis rehabilitation for individuals with lower limb amputation is understudied in part due to a lack of clinical measures. Here, we present a standardized approach to measure residual limb health in people with transtibial and transfemoral amputation. Conclusion: Technology advances in noninvasive imaging and probe-based measures are leveraged to develop a standardized approach to quantitatively measure residual limb health in individuals with lower limb loss. Compared to able-limb controls, resting residual limb physiology in people that have had transfemoral or transtibial amputation is characterized by lower transcutaneous oxygen tension and poorer skin barrier function.

Progress Toward Optimizing Prosthetic Socket Fit and Suspension Using Elevated Vacuum to Promote Residual Limb Health.

Objective: Prosthetic sockets are custom made for each amputee, yet there are no quantitative tools to determine the appropriateness of socket fit. Ensuring a proper socket fit can have significant effects on the health of residual limb soft tissues and overall function and acceptance of the prosthetic limb. Previous work found that elevated vacuum pressure data can detect movement between the residual limb and the prosthetic socket; however, the correlation between the two was specific to each user. The overall objective of this work is to determine the relationship between elevated vacuum pressure deviations and prosthetic socket fit. Approach: A tension compression machine was used to apply repeated controlled forces onto a residual limb model with sockets of different internal volume. Results: The vacuum pressure-displacement relationship was dependent on socket fit. The vacuum pressure data were sensitive enough to detect differences of 1.5% global volume and can likely detect differences even smaller. Limb motion was reduced as surface area of contact between the limb model and socket was maximized. Innovation: The results suggest that elevated vacuum pressure data provide information to quantify socket fit. Conclusions: This study provides evidence that the use of elevated vacuum pressure data may provide a method for prosthetists to quantify and monitor socket fit. Future studies should investigate the relationship between socket fit, limb motion, and limb health to define optimal socket fit parameters.

Elevated vacuum suspension preserves residual-limb skin health in people with lower-limb amputation: Randomized clinical trial.

A growing number of clinical trials and case reports support qualitative claims that use of an elevated vacuum suspension (EVS) prosthesis improves residual-limb health on the basis of self-reported questionnaires, clinical outcomes scales, and wound closure studies. Here, we report first efforts to quantitatively assess residual-limb circulation in response to EVS. Residual-limb skin health and perfusion of people with lower-limb amputation (N = 10) were assessed during a randomized crossover study comparing EVS with nonelevated vacuum suspension (control) over a 32 wk period using noninvasive probes (transepidermal water loss, laser speckle imaging, transcutaneous oxygen measurement) and functional hyperspectral imaging approaches. Regardless of the suspension system, prosthesis donning decreased perfusion in the residual limb under resting conditions. After 16 wk of use, EVS improved residual-limb oxygenation during treadmill walking. Likewise, prosthesis-induced reactive hyperemia was attenuated with EVS following 16 wk of use. Skin barrier function was preserved with EVS but disrupted after control socket use. Taken together, outcomes suggest chronic EVS use improves perfusion and preserves skin barrier function in people with lower-limb amputation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov; "Evaluation of limb health associated with a prosthetic vacuum socket system": NCT01839123; https://clinicaltrials.gov/ct2/show/NCT01839123?term=NCT01839123&rank=1.

Strength evaluation of prosthetic check sockets, copolymer sockets, and definitive laminated sockets.

A prosthesis encounters loading through forces and torques exerted by the person with amputation. International Organization for Standardization (ISO) standard 10328 was designed to test most lower-limb prosthetic components. However, this standard does not include prosthetic sockets. We measured static failure loads of prosthetic sockets using a modified ISO 10328 and then compared them with the criteria set by this standard for other components. Check socket (CS) strengths were influenced by thickness, material choice, and fabrication method. Copolymer socket (CP) strengths depended on thickness and fabrication methods. A majority of the CSs and all of the CPs failed to pass the ISO 10328 ductile loading criterion. In contrast, the strengths of definitive laminated sockets (DLs) were influenced more by construction material and technique. A majority of the DLs failed to pass the ISO 10328 brittle loading criterion. Analyzing prosthetic sockets from a variety of facilities demonstrated that socket performance varies considerably between and within facilities. The results from this article provide a foundation for understanding the quality of prosthetic sockets, some insight into possible routes for improving the current care delivered to patients, and a comparative basis for future technology.

Tensile strength and impact resistance properties of materials used in prosthetic check sockets, copolymer sockets, and definitive laminated sockets.

Prosthetic sockets serve as the interface between people with amputations and their prostheses. Although most materials used to make prosthetic sockets have been used for many years, knowledge of these materials' properties is limited, especially after they are subjected to fabrication processes. This study evaluated tensile and impact properties of the current state-of-the-art materials used to fabricate prosthetic check sockets, copolymer sockets, and definitive laminated sockets. Thermolyn Rigid and Orfitrans Stiff check socket materials produced significantly lower tensile strength and impact resistance than polyethylene terephthalate glycol (PETG). Copolymer socket materials exhibited greater resistance to impact forces than the check socket materials but lower tensile strengths than PETG. The heated molding processes, for the check socket and copolymer materials, reduced both tensile strength and elongation at break. Definitive laminated sockets were sorted according to fabrication techniques. Nyglass material had significantly higher elongation, indicating a more ductile material than carbon-based laminations. Carbon sockets with pigmented resin had higher tensile strength and modulus at break than nonpigmented carbon sockets. Elongation at yield and elongation at break were similar for both types of carbon-based laminations. The material properties determined in this study provide a foundation for understanding and improving the quality of prosthetic sockets using current fabrication materials and a basis for evaluating future technologies.