Botulinum toxin and hyperhidrosis of the amputation stump in war amputees.

INTRODUCTION: Stump hyperhidrosis is a common condition after lower limb amputation. It affects the prosthesis use, and the quality of life of patients. Several case reports tried to prove benefit of using Botulinum toxin in its treatment. AIM: This study was to conduct a larger workforce clinical trial and to demonstrate benefits of botulinum toxin injection in the treatment of stump hyperhidrosis. METHODS: A prospective study was conducted. War amputees who complained of annoying excessive sweating of the stump were included. They received intradermal injection of botulinum toxin A in the residual limb area in contact with prosthetic socket. Abundance of sweating and degree of functional discomfort associated with it were assessed before, after 3 weeks, 6 and 12 months. RESULTS: Seventeen male patients, followed for post-traumatic limb amputation were included in the study. Discomfort and bothersome in relation to Hyperhidrosis did decrease after treatment (p<0,001). Reported satisfaction after 3 weeks was 73,33%. Improvement of prothesis loosening up after 3 weeks was 72,5% [±15,6]. Mean injection-induced pain on the visual analogue scale was 5.17/10 (±1.58). The mean interval after the onset of improvement was 5.13 days [min:3, max:8]. The mean time of improvement was 10.4 months after the injection [min:6, max:12]. No major adverse events were reported following treatment. CONCLUSION: Intradermal injections of botulinum toxin in the symptomatic treatment of stump hyperhidrosis are effective and have few adverse effects. It improves the quality of life of our patients thanks to a better tolerance of the prosthesis.

Active nerve management for above the knee amputation: A comparison of through the wound versus posterior approach.

Targeted muscle reinnervation (TMR) and regenerative peripheral nerve interface (RPNI) are used to prevent or treat neuromas in amputees. TMR for above-the-knee amputation (AKA) is most commonly performed through a posterior incision rather than the stump wound because recipient motor nerves are primarily located in the proximal third of the thigh. When preventative TMR is performed with concurrent AKA, a posterior approach requires intraoperative repositioning and an additional incision. The purpose of this study was to evaluate feasibility of TMR and operative times for nerve management performed through the wound compared to a posterior approach in AKA patients to guide surgical decision-making. Patients who underwent AKA with TMR between 2018-2023 were reviewed. Patients were divided into two groups: TMR performed through the wound (Group I) and TMR performed through a posterior approach (Group II). If a nerve was unable to undergo coaptation for TMR due to the lack of suitable donor motor nerves, RPNI was performed. Eighteen patients underwent AKA with nerve management were included from Group I (8 patients) and Group II (10 patients). TMR coaptations performed on distinct nerves was 1.5 ± 0.5 in Group I compared to 2.6 ± 0.5 in Group II (p = 0.001). Operative time for Group I was 200.7 ± 33.4 min compared to 326.5 ± 37.1 min in Group II (p = 0.001). TMR performed through the wound following AKA requires less operative time than a posterior approach. However, since recipient motor nerves are not consistently found near the stump, RPNI may be required with TMR whereas the posterior approach allows for more TMR coaptations.

Application of ultrasound to monitor in vivo residual bone movement within transtibial prosthetic sockets.

Transtibial prosthetic users do often struggle to achieve an optimal prosthetic fit, leading to residual limb pain and stump-socket instability. Prosthetists face challenges in objectively assessing the impact of prosthetic adjustments on residual limb loading. Understanding the mechanical behaviour of the pseudo-joint formed by the residual bone and prosthesis may facilitate prosthetic adjustments and achieving optimal fit. This study aimed to assess the feasibility of using B-mode ultrasound to monitor in vivo residual bone movement within a transtibial prosthetic socket during different stepping tasks. Five transtibial prosthesis users participated, and ultrasound images were captured using a Samsung HM70A system during five dynamic conditions. Bone movement relative to the socket was quantified by tracking the bone contour using Adobe After-Effect. During the study a methodological adjustment was made to improve data quality, and the first two participants were excluded from analysis. The remaining three participants exhibited consistent range of motion, with a signal to noise ratio ranging from 1.12 to 2.59. Medial-lateral and anterior-posterior absolute range of motion varied between 0.03 to 0.88 cm and 0.14 to 0.87 cm, respectively. This study demonstrated that it is feasible to use B-mode ultrasound to monitor in vivo residual bone movement inside an intact prosthetic socket during stepping tasks.

Botox in below knee amputation for the management of post-operative contracture: a systematic review.

During the 1970s, scientists first used botulinum toxin to treat strabismus. While testing on monkeys, they noticed that the toxin could also reduce wrinkles in the glabella area. This led to its widespread use in both medical and cosmetic fields. The objective of the study was to evaluate the potential use of Botox in managing post-operative contracture after below-knee amputation. We conducted a systematic review In Pubmed, Cochrane Library, Embase, and Google Scholar using the MESH terms Botox, botulinum toxin, post-operative contracture, amputation, and below knee amputation. Our goal was to evaluate the potential use of Botox to manage post-operative contracture in patients who have undergone below-knee amputation. Our findings show evidence in the literature that Botox can effectively manage stump hyperhidrosis, phantom pain, and jumping stump, but no clinical trial has been found that discusses the use of Botox for post-operative contracture. Botox has been used in different ways to manage spasticity. Further studies and clinical trials are needed to support the use of Botox to manage this complication.

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.

[Bionic Surgery Meets Bionic Reconstruction - First In-human use of Robotic Microsurgery in Targeted Muscle Reinnervation]. / Bionische Chirurgie trifft Bionische Rekonstruktion ­ erstes in-human Projekt von robotischer Mikrochirurgie zur Targeted Muscle Reinnervation.

Robotic microsurgery is an emerging field in reconstructive surgery, which provides benefits such as improved precision, optimal ergonomics, and reduced tremors. However, only a few robotic platforms are available for performing microsurgical procedures, and successful nerve coaptation is still a challenge. Targeted muscle reinnervation (TMR) is an innovative reconstructive procedure that rewires multiple nerves to remnant stump muscles, thereby reducing neuroma and phantom limb pain and improving the control of bionic prostheses. The precision of surgical techniques is critical in reducing axonal sprouting around the coaptation site to minimise the potential for neuroma formation. This study reports the first use of a microsurgical robotic platform for multiple nerve transfers in a patient undergoing TMR for bionic extremity reconstruction. The Symani robotic platform, combined with external microscope magnification, was successfully used, and precise handling of nerve tissue and coaptation was easily feasible even in anatomically challenging environments. While the precision and stability offered by robotic assistance may be especially useful for nerve surgery, the high economic costs of robotic microsurgery remain a major challenge for current healthcare systems. In conclusion, this study demonstrated the feasibility of using a robotic microsurgical platform for nerve surgery and transfers, where precise handling of tissue is crucial and limited space is available. Future studies will explore the full potential of robotic microsurgery in the future.

Challenges and Solutions in Prosthetic Fitting of Digits after Flap Reconstruction.

Surgical reconstruction can restore length and function, but cannot adequately resolve the problem of disfigurement. Prosthetic fitting can play a complementary role in enhancing the aesthetic outcomes post reconstruction. However, complex reconstruction involving flaps coupled with the surgical imperative for limb length preservation can lead to outcomes where the reconstructed stumps are challenging to fit with prosthesis. This article describes how prosthetic fitting was tackled in a case of a triple-digit amputation after reconstruction that presented with finger stumps that were bulky, long and stiff in extension contracture, compounded by the presence of substantive scar tissues. We discuss major prosthesis modifications that were unconventional but necessary to enable fitting, the techniques involved, as well as the aesthetic and functional considerations behind the modifications. The results showed that enhanced aesthetic appearance, together with a marginal improvement in hand function, was achieved post-prosthetically, meeting the patient's and the clinical team's fitting objective. Level of Evidence: Level V (Therapeutic).

[Prosthetic Fitting Concepts after Major Amputation in the Upper Limb - an Overview of Current Possibilities]. / Prothetische Versorgungskonzepte nach Majoramputation der oberen Extremität ­ eine Übersicht gegenwärtiger Möglichkeiten.

BACKGROUND: The upper extremity and particularly the hands are crucial for patients in interacting with their environment, therefore amputations or severe damage with loss of hand function significantly impact their quality of life. In cases where biological reconstruction is not feasible or does not lead to sufficient success, bionic reconstruction plays a key role in patient care. Classical myoelectric prostheses are controlled using two signals derived from surface electrodes in the area of the stump muscles. Prosthesis control, especially in high amputations, is then limited and cumbersome. The surgical technique of Targeted Muscle Reinnervation (TMR) offers an innovative solution: The major arm nerves that have lost their target organs due to amputation are rerouted to muscles in the stump area. This enables the establishment of cognitive control signals that allow significantly improved prosthesis control. PATIENTS/MATERIALS AND METHODS: A selective literature review on TMR and bionic reconstruction was conducted, incorporating relevant articles and discussing them considering the clinical experience of our research group. Additionally, a clinical case is presented. RESULTS: Bionic reconstruction combined with Targeted Muscle Reinnervation enables intuitive prosthetic control with simultaneous movement of various prosthetic degrees of freedom and the treatment of neuroma and phantom limb pain. Long-term success requires a high level of patient compliance and intensive signal training during the prosthetic rehabilitation phase. Despite technological advances, challenges persist, especially in enhancing signal transmission and integrating natural sensory feedback into bionic prostheses. CONCLUSION: TMR surgery represents a significant advancement in the bionic care of amputees. Employing selective nerve transfers for signal multiplication and amplification, opens up possibilities for improving myoelectric prosthesis function and thus enhancing patient care. Advances in the area of external prosthetic components, improvements in the skeletal connection due to osseointegration and more fluid signal transmission using wireless, fully implanted electrode systems will lead to significant progress in bionic reconstruction, both in terms of precision of movement and embodiment.

Quantitative analysis of interface pressures in transfemoral prosthetic sockets.

BACKGROUND: Among the different factors affecting socket comfort, the pressure applied on residual limb tissues is a crucial parameter for the success or failure of any prosthetic device. However, only a few incomplete data are available on people with transfemoral amputation, in this regard. This work aims at filling this gap in the literature. METHODS: Ten people with transfemoral amputation wearing 3 different socket designs were recruited in this study: 2 ischial containment sockets featured by proximal trim lines that contain the ischial tuberosity and ramus and greater trochanter, 2 subischial sockets with proximal trim lines under the ischium level, and 6 quadrilateral sockets with proximal trim lines that contain the greater trochanter and create a horizontal seat for the ischial tuberosity. The pressure values at the anterior, lateral, posterior, and medial areas of the socket interface were recorded during 5 locomotion tasks (ie, horizontal, ascent, and descent walking, upstairs and downstairs) by using an F-Socket System (Tekscan Inc., Boston, MA). Gait segmentation was performed by exploiting plantar pressure, which was acquired by an additional sensor under the foot. Mean and standard deviation of minimum and maximum values were calculated for each interface area, locomotion task, and socket design. The mean pressure patterns during different locomotion tasks were reported, as well. RESULTS: Considering all subjects irrespective of socket design, the mean pressure range resulted 45.3 (posterior)-106.7 (posterior) kPa in horizontal walking; 48.3 (posterior)-113.8 (posterior) kPa in ascent walking; 50.8 (posterior)-105.7 (posterior) kPa in descent walking; 47.9 (posterior)-102.9 (lateral) kPa during upstairs; and 41.8 (posterior)-84.5 (anterior) kPa during downstairs. Qualitative differences in socket designs have been found. CONCLUSIONS: These data allow for a comprehensive analysis of pressures acting at the tissue-socket interface in people with transfemoral amputation, thus offering essential information for the design of novel solutions or to improve existing ones, in this field.

Targeted Muscle Reinnervation at the Time of Amputation Decreases Recurrent Symptomatic Neuroma Formation.

BACKGROUND: Targeted muscle reinnervation (TMR) is an effective technique for the prevention and management of phantom limb pain (PLP) and residual limb pain (RLP) among amputees. The purpose of this study was to evaluate symptomatic neuroma recurrence and neuropathic pain outcomes between cohorts undergoing TMR at the time of amputation (ie, acute) versus TMR following symptomatic neuroma formation (ie, delayed). METHODS: A cross-sectional, retrospective chart review was conducted using patients undergoing TMR between 2015 and 2020. Symptomatic neuroma recurrence and surgical complications were collected. A subanalysis was conducted for patients who completed Patient-Reported Outcome Measurement Information System (PROMIS) pain intensity, interference, and behavior scales and an 11-point numeric rating scale (NRS) form. RESULTS: A total of 105 limbs from 103 patients were identified, with 73 acute TMR limbs and 32 delayed TMR limbs. Nineteen percent of the delayed TMR group had symptomatic neuromas recur in the distribution of original TMR compared with 1% of the acute TMR group ( P < 0.05). Pain surveys were completed at final follow-up by 85% of patients in the acute TMR group and 69% of patients in the delayed TMR group. Of this subanalysis, acute TMR patients reported significantly lower PLP PROMIS pain interference ( P < 0.05), RLP PROMIS pain intensity ( P < 0.05), and RLP PROMIS pain interference ( P < 0.05) scores in comparison to the delayed group. CONCLUSIONS: Patients who underwent acute TMR reported improved pain scores and a decreased rate of neuroma formation compared with TMR performed in a delayed fashion. These results highlight the promising role of TMR in the prevention of neuropathic pain and neuroma formation at the time of amputation. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.

Nerve Capping Techniques for Neuroma Management: A Comprehensive Literature Review.

BACKGROUND/AIM OF THE STUDY: Nerve capping is a method of neuroma treatment or prevention that consists of the transplantation of a proximal nerve stump into an autograft or other material cap, after surgical removal of the neuroma or transection of the nerve. The aim was to reduce neuroma formation and symptoms by preventing neuronal adhesions and scar tissue. In this narrative literature review, we summarize the studies that have investigated the effectiveness of nerve capping for neuroma management to provide clarity and update the clinician's knowledge on the topic. METHODS: A systematic electronic search following the Preferred Reporting Items for Systematic Reviews and Meta-Analyses criteria was performed in the PubMed database combining "neuroma," "nerve," "capping," "conduit," "treatment," "management," "wrap," "tube," and "surgery" as search terms. English-language clinical studies on humans and animals that described nerve capping as a treatment/prevention technique for neuromas were then selected based on a full-text article review. The data from the included studies were compiled based on the technique and material used for nerve capping, and technique and outcomes were reviewed. RESULTS: We found 10 applicable human studies from our literature search. Several capping materials were described: epineurium, nerve, muscle, collagen nerve conduit, Neurocap (synthetic copolymer of lactide and caprolactone, which is biocompatible and resorbable), silicone rubber, and collagen. Overall, 146 patients were treated in the clinical studies. After surgery, many patients were completely pain-free or had considerable improvement in pain scores, whereas some patients did not have improvement or were not satisfied after the procedure. Nerve capping was used in 18 preclinical animal studies, using a variety of capping materials including autologous tissues, silicone, and synthetic nanofibers. Preclinical studies demonstrated successful reduction in rates of neuroma formation. CONCLUSIONS: Nerve capping has undergone major advancements since its beginnings and is now a useful option for the treatment or prevention of neuromas. As knowledge of peripheral nerve injuries and neuroma prevention grows, the criterion standard neuroprotective material for enhancement of nerve regeneration can be identified and applied to produce reliable surgical outcomes.

Internal Iliac Artery Patency as a Predictor of Above-Knee Amputation Stump Healing.

BACKGROUND: The primary aim of this study was to assess the role of internal iliac patency in predicting outcomes of above-knee amputation (AKA) stump healing. The secondary objectives were to assess the accuracy of Wound, Ischemia, and Foot Infection (WIfI) classification system in predicting AKA stump healing and its association with delayed mortality. METHODS: This is a retrospective study performed in a vascular surgery unit in a tertiary hospital on patients who underwent AKAs over 1 year, from July 2021 until June 2022. Patient demographic data, WIfI scoring, outcome of AKAs, and patency of profunda femoris and internal iliac artery (IIA) were collected. To minimize confounding, a single vascular surgeon performed all computed tomography imaging reviews and arterial measurements. Approval for this study was obtained from the National Research Registry, NMRR ID-23-01865-KQ4 (investigator initiated research). RESULTS: Ninety patients underwent AKA over 1 year, from July 2021 until June 2022. Occluded IIA in the presence of patent profunda femoris did not affect the wound healing of the AKA stump. There was significant association between WIfI scoring and mortality. Patients with a WIfI scoring of 3 to 4 were observed to have a higher mortality rate compared with patients with normal healing: 47 (72.0%) vs. 4 (80.0%); P = 0.021. CONCLUSIONS: In this study, the IIA patency shows no statistically significant effect on AKA stump healing; however, the small number of patients is a drawback of the study. This study also demonstrates that the WIfI score can be a prognostic factor for mortality in patients undergoing AKA.

Socket-residuum coupling integrity affects perception of external stimuli: Effects of altering the transtibial interface using vacuum-assisted suspension.

BACKGROUND: Relative movement between the socket and residual limb can impair function in prosthesis users. It is plausible that, in addition to its mechanical effect, the integrity of the socket-residuum interface influences the ability of an individual to sense tactile cues through the prosthesis. Vacuum-assisted suspension (VAS) has been shown to reduce relative movement at this interface, providing a means to test this premise. The purpose of this pilot study was to assess the effects of altering socket-residuum interface integrity through the VAS pressure level on the thresholds of perception of an externally applied vibration stimulus. METHODS: Seven unilateral transtibial prosthesis users participated. Socket-residual limb integrity was altered using the VAS subatmospheric (vacuum) pressure level. Vibration perception tests were conducted at low, mid, and high vacuum levels, targeting 0, 8, and 19 in Hg respectively, and performed in partially loaded and fully loaded conditions. Vibration intensity was increased using a dial until participants delivered a verbal signal indicating it was perceptible, and the nominal intensity was recorded. RESULTS: Intensity thresholds decreased (ie, sensitivity increased) from low to high vacuum settings when fully loaded ( P = 0.008). Differences when partially loaded were nonsignificant and variable across participants. CONCLUSION: This study provides preliminary evidence that altering the integrity between the socket and residual limb by modifying the vacuum level affects sensation related to the external environment experienced through the prosthesis, although translation of these findings to real-world stimuli remains to be tested.

Beta Changes Induced by Acute Hand Loss Model during NMES.

Neuromuscular electrical stimulation (NMES) has been demonstrated to effectively modulate cortical activities by evoking muscle contraction in upper limb and generating joint movements, which showed an excellent performance in motor rehabilitation. However, due to hand loss and cortical function reorganization induced by hand amputation, how neural activities in sensorimotor cortex response to NMES-evoked muscle contraction in the end of an amputation stump is not clear. In this paper, Ischemic nerve block (INB) technique was used to build an acute hand loss model, and 64-channel EEG signals were recorded from 11 healthy subjects to perform a 2×2 factorial design protocol, with the INB state and the current intensity as factors. The changes of NMES-evoked sensorimotor cortical activities were quantified by computing Beta-band event-related desynchronization (Beta ERD) patterns and the time-varying functional connectivity using adaptive directed transfer function (ADTF) before and during INB. The acute hand "loss" resulted in ipsilateral dominance of Beta ERD induced by NMES with two current intensities in the topographic maps, that is, ipsilateral Beta ERD was significantly higher than that the contralateral one (p<0.05). However, before INB, Beta ERD in the contralateral sensorimotor cortex induced by NMES above motor threshold was significantly higher than that in the ipsilateral area (p< 0.01). Meanwhile, whatever before or during INB, clustering coefficients of the ADTF network in sensorimotor cortex showed temporal dynamics during two NMES tasks. During INB, NMES above motor threshold-evoked lower clustering coefficients of the time-varying network in sensorimotor cortex than that before INB (p<0.05). The present results suggest that the loss of the hand proprioception will degrade cortical activities in the contralateral area, and increase cortical activities in the ipsilateral area compensatively responding to NMES. This finding may be particularly important to improve the reconstruction of the proprioception function of hand prosthesis.

Reinervación muscular dirigida diferida en el manejo del dolor neuropático tras amputación de extremidad inferior / Delayed targeted muscle reinnervation in the management of neuropathic pain after lower limb amputation

Introducción y objetivo: El dolor neuropático es una de las complicaciones más comunes en la cirugía de amputación de extremidad inferior. En este contexto surge la Reinervación Muscular Dirigida (TMR) como técnica con resultados prometedores en el tratamiento del dolor neuropático tras amputación. En este artículo presentamos la técnica quirúrgica y nuestra experiencia clínica. Material y método: Entre enero de 2021 y diciembre de 2022 registramos los pacientes intervenidos para TMR diferida de extremidad inferior en el Servicio de Cirugía Plástica del Hospital Universitario Miguel Servet (Zaragoza, España) evaluando su capacidad de portar prótesis a los 6 meses de la intervención. Asimismo, exponemos la técnica quirúrgica empleada. Resultados: Intervenimos 9 pacientes, 7 amputaciones infracondíleas y 2 supracondíleas. A los 6 meses, 7 eran capaces de deambular con prótesis y en 2 persistía dolor de componente mixto que impedía la protetización. Ambos pacientes habían sido amputados por causas vasculares. Conclusiones: En nuestra serie clínica obtuvimos resultados prometedores que permitieron la protetización en una gran proporción de casos, si bien la selección de pacientes es un punto crucial en la aplicación de esta técnica.(AU)

Background and objective: Neuropathic pain is one of the most common complications in lower extremity amputation surgery. In this context, Targeted Muscle Reinnervation (TMR) emerges as a technique with promising results in the treatment of neuropathic pain after amputation and phantom limb.In this article we describe the surgical technique and our clinical experience. Methods: Between January 2021 and December 2022, we registered the patients operated on for delayed TMR of the lower extremity in the Plastic Surgery Service of the Miguel Servet University Hospital (Zaragoza, Spain) evaluating their ability to wear prostheses 6 months after the intervention. Likewise, we expose the surgical technique used. Results: A total of 9 patients were operated, being 7 infracondylar and 2 supracondylar amputations. Six months after surgery, 7 patients could walk with the prosthesis, while the other 2 ones still experienced pain that prevented fitting the prosthesis. Both patients had been amputated for vascular causes. Conclusions: In our clinical series, we obtained promising results which allow ambulation in a large proportion of patients although we consider that patient selection is a crucial point in the application of this technique.(AU)

Adjustable prosthetic sockets: a systematic review of industrial and research design characteristics and their justifications.

BACKGROUND: The prosthetic socket is a key component that influences prosthesis satisfaction, with a poorly fitting prosthetic socket linked to prosthesis abandonment and reduced community participation. This paper reviews adjustable socket designs, as they have the potential to improve prosthetic fit and comfort through accommodating residual limb volume fluctuations and alleviating undue socket pressure. METHODS: Systematic literature and patent searches were conducted across multiple databases to identify articles and patents that discussed adjustable prosthetic sockets. The patents were used to find companies, organisations, and institutions who currently sell adjustable sockets or who are developing devices. RESULTS: 50 literature articles and 63 patents were identified for inclusion, representing 35 different designs used in literature and 16 commercially available products. Adjustable sockets are becoming more prevalent with 73% of publications (literature, patents, and news) occurring within the last ten years. Two key design characteristics were identified: principle of adjustability (inflatable bladders, moveable panels, circumferential adjustment, variable length), and surface form (conformable, rigid multi-DOF, and rigid single DOF). Inflatable bladders contributed to 40% of literature used designs with only one identified commercially available design (n = 16) using this approach. Whereas circumferential adjustment designs covered 75% of identified industry designs compared to only 36% of literature devices. Clinical studies were generally small in size and only 17.6% of them assessed a commercially available socket. DISCUSSION: There are clear differences in the design focus taken by industry and researchers, with justification for choice of design and range of adjustment often being unclear. Whilst comfort is often reported as improved with an adjustable socket, the rationale behind this is not often discussed, and small study sizes reduce the outcome viability. Many adjustable sockets lack appropriate safety features to limit over or under tightening, which may present a risk of tissue damage or provide inadequate coupling, affecting function and satisfaction. Furthermore, the relationship between design and comfort or function are rarely investigated and remain a significant gap in the literature. Finally, this review highlights the need for improved collaboration between academia and industry, with a strong disconnect observed between commercial devices and published research studies.

Moisture mitigation using a vented liner and a vented socket system for individuals with transfemoral amputation.

Sweating and heat buildup at the skin-liner interface is a major challenge for persons with limb loss. Liners made of heat-non-conducting materials may cause sweating of the residual limb and may result in liners slipping off the skin surface especially on a warm day or during high activity, causing skin breakdown and affecting limb health. To address this, we evaluated the efficacy of the vented liner-socket system (VS, Össur) compared to Seal-In silicone liner and non-vented socket (nVS, Össur) in reducing relative humidity (RH) during increased sweat. Nine individuals with limb loss using nVS were randomized to VS or nVS and asked for activity in a 20-min treadmill walk. RH was significantly attenuated (p = 0.0002) and perceived sweating, as reported by prosthesis users, improved (p = 0.028) with VS, patient-reported comprehensive lower limb amputee socket survey (CLASS) outcomes to determine the suspension, stability, and comfort were not significantly different between VS and nVS. There are limited rigorous scientific studies that clearly provide evidence-based guidelines to the prosthetist in the selection of liners from numerous available options. The present study is innovative in clearly establishing objective measures for assessing humidity and temperatures at the skin-liner interface while performing activity. As shown by the measured data and perceived sweat scores provided by the subjects based on their daily experience, this study provided clear evidence establishing relative humidity at the skin-liner interface is reduced with the use of a vented liner-socket system when compared to a similar non-vented system.

Mapping lines of non-extension in persons with lower limb amputation to aid comfort-driven prosthetic socket design.

OBJECTIVE: This study aimed to develop a new technique to map the strain field for persons with lower-limb amputations to use for the design of comfortable prostheses. METHODS: Using a DSLR camera with stenciled 2D markers, we demonstrated a technique to measure skin strain around the residual limb of persons with lower limb amputations. We used open-source software programs to reconstruct a series of cloud points derived from the pictures of the marked residual limb into 3D models, then calculated the minimum, maximum, and non-extension lines from directional strain fields. RESULTS: A DSLR camera was successful in capturing 2D markers. The maximum mean principal strain was 68% ± 14%, observed around the patella. The minimum compressive mean principal strain of -31% ± 4% was observed posteriorly in the popliteal region of the knee. Although lines of non-extension (LoNE) appear separate in different participants, they are anatomically located in regions that could be generalized for the design of prostheses. CONCLUSIONS: Marker locations extracted from the video of different poses can be compared to calculate strains from which the position of LoNE can be generated. The use of LoNE could be valuable in reducing discomfort at the socket interface and informing future socket design.