Factors leading to falls in transfemoral prosthesis users: a case series of prosthesis-side stumble recovery responses.

BACKGROUND: Falls due to stumbling are prevalent for transfemoral prosthesis users and may lead to increased injury risk. This preliminary case series analyzes the transfemoral prosthesis user stumble recovery response to highlight key deficits in current commercially-available prostheses and proposes potential interventions to improve recovery outcomes. METHODS: Six transfemoral prosthesis users were perturbed on their prosthetic limb at least three times while walking on a treadmill using obstacle perturbations in early, mid and late swing. Kinematic data were collected to characterize the response, while fall rate and key kinematic recovery metrics were used to assess the quality of recovery and highlight functional deficits in current commercially-available prostheses. RESULTS: Across all participants, 13 (54%) of the 24 trials resulted in a fall (defined as > 50% body-weight support) with all but one participant (83%) falling at least once and two participants (33%) falling every time. In contrast, in a previous study of seven young, unimpaired, non-prosthesis users using the same experimental apparatus, no falls occurred across 190 trials. For the transfemoral prosthesis users, early swing had the highest rate of falling at 64%, followed by mid-swing at 57%, and then late swing at 33%. The trend in falls was mirrored by the kinematic recovery metrics (peak trunk angle, peak trunk angular velocity, forward reach of the perturbed limb, and knee angle at ground contact). In early swing all four metrics were deficient compared to non-prosthesis user controls. In mid swing, all but trunk angular velocity were deficient. In late swing only forward reach was deficient. CONCLUSION: Based on the stumble recovery responses, four potential deficiencies were identified in the response of the knee prostheses: (1) insufficient resistance to stance knee flexion upon ground contact; (2) insufficient swing extension after a perturbation; (3) difficulty initiating swing flexion following a perturbation; and (4) excessive impedance against swing flexion in early swing preventing the potential utilization of the elevating strategy. Each of these issues can potentially be addressed by mechanical or mechatronic changes to prosthetic design to improve quality of recovery and reduce the likelihood a fall.

The Overlay, a New Solution for Volume Variations in the Residual Limb for Individuals with a Transtibial Amputation.

BACKGROUND: The company Ethnocare has developed the Overlay, a new pneumatic solution for managing volumetric variations (VVs) of the residual limb (RL) in transtibial amputees (TTAs), which improves socket fitting. However, the impact of the Overlay during functional tasks and on the comfort and pain felt in the RL is unknown. METHODS: 8 TTAs participated in two evaluations, separated by two weeks. We measured compensatory strategies (CS) using spatio-temporal parameters and three-dimensional lower limb kinematics and kinetics during gait and sit-to-stand (STS) tasks. During each visit, the participant carried out our protocol while wearing the Overlay and prosthetic folds (PFs), the most common solution to VV. Between each task, comfort and pain felt were assessed using visual analog scales. RESULTS: While walking, the cadence with the Overlay was 105 steps/min, while it was 101 steps/min with PFs (p = 0.021). During 35% and 55% of the STS cycle, less hip flexion was observed while wearing the Overlay compared to PFs (p = 0.004). We found asymmetry coefficients of 13.9% with the Overlay and 17% with PFs during the STS (p = 0.016) task. Pain (p = 0.031), comfort (p = 0.017), and satisfaction (p = 0.041) were better with the Overlay during the second visit. CONCLUSION: The Overlay's impact is similar to PFs' but provides less pain and better comfort.

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.

Infection After Lower-Limb Osseointegration: A Single-Center Retrospective Evaluation of Pathogens, Management, and Outcomes.

PURPOSE: Osseointegration (OI) is a novel alternative to traditional socket-suspended prostheses for lower-limb amputees, eliminating the socket-skin interface and allowing for weight bearing directly on the skeletal system. However, the stoma through which the implant attaches to the external prosthesis creates an ingress route for bacteria, and infection rates as high as 66% have been reported. The aims of this study are to classify infection management and long-term outcomes in this patient population to maximize implant salvage. METHODS: An institutional review board-approved retrospective analysis was performed on all patients who underwent lower-limb OI at our institution between 2017 and 2022. Demographic, operative, and outcome data were collected for all patients. Patients were stratified by the presence and severity of infection. Chi-square and t tests were performed on categorical and continuous data, respectively, using an alpha of 0.05. RESULTS: One hundred two patients met our study criteria; 62 had transfemoral OI and 40 had transtibial OI. Patients were followed for 23.8 months on average (range, 3.5-63.7). Osteomyelitis was more likely than soft tissue infection to be polymicrobial in nature (71% vs 23%, P < 0.05). Infections at the stoma were mostly (96%) managed with oral antibiotics alone, whereas deeper soft tissue infections also required intravenous antibiotics (75%) or operative washout (19%). Osteomyelitis was managed with intravenous antibiotics and required operative attention; 5 (71%) underwent washout and 2 (29%) underwent explantation. Both implants were replaced an average of 3.5 months after explantation. There was no correlation between history of soft tissue infection and development of osteomyelitis (P > 0.05). The overall implant salvage rate after infection was 96%. CONCLUSIONS: This study describes our institution's experience managing infection after OI and soft tissue reconstruction. Although infections do occur, they are easily treatable and rarely require operative intervention. Explantation due to infection is rare and can be followed up with reimplantation, reaffirming that OI is a safe and effective treatment modality.

Bone-anchored prostheses for lower limb amputation in a French cohort with 1-15 years of follow-up: implant survival rates, mechanical complications, and reported outcomes.

PURPOSE: To evaluate the implant survival rate, mechanical complications, and reported patient outcomes of bone-anchored prostheses for patients with lower limb amputation in France after 1-15 years of follow-up. METHODS: This retrospective cohort study included patients who underwent surgery at a single center in France between 2007 and 2021. The primary outcomes were the implant survival rate and functional scores assessed by the Questionnaire for Transfemoral Amputees (Q-TFA). Secondary outcomes were adverse events that occurred during follow-up. RESULTS: The cohort consisted of 20 bone-anchored prostheses in 17 patients. The main level of amputation was transfemoral (82%, n = 14). The main reason for amputation was trauma (n = 15). The mean age at amputation was 32 (range 15-54) years, and the mean age at the first stage of osseointegration was 41 (range 21-58) years. The Kaplan-Meier survival curve showed respective survival rates of 90%, 70%, and 60% at 2, 10, and 15 years. All Q-TFA scores were significantly improved at last the follow-up. Eleven patients (65%) experienced mechanical complications. In total, 37 infectious events occurred in 13 patients (76%), mainly comprising stage 1 infections (68%, n = 25). Only two cases of septic loosening occurred (12%), leading to implant removal. CONCLUSION: This is the first French cohort of bone-anchored prostheses and among the series with the longest follow-up periods. The findings indicate that bone-anchored prostheses are safe and reliable for amputee patients who have difficulties with classic prostheses.

Trochlear Ridge Prostheses for Reshaping Femoral Trochlear Ridges in Dogs with Patellar Luxation.

OBJECTIVES: To describe the implant characteristics and surgical application of a custom-made trochlear ridge prosthesis (TRP) and to report clinical outcomes in dogs affected by patellar luxation treated with TRP. STUDY DESIGN: Dogs affected by patellar luxation underwent computed tomography. A specific canine bone anatomical replica, a cutting guide, and a TRP were designed and provided for surgery. Surgical records, clinical and radiographic reassessments, complications, pre- and postoperative lameness, type and degree of patellar luxation, and TRP and patellar position after surgery were reviewed. Clinical outcomes were defined as full, acceptable, or unacceptable function. RESULTS: The TRP was implanted in 60 femoral trochleae: 48 unilateral and 12 bilateral. Successful correction of patellar luxation was achieved in 59/60 cases. TRP was applied with other surgical techniques in 36/60 of the cases and as the only surgical procedure in 24/60 cases. Overall, three complications were observed: two minor and one major (patellar luxation recurrence). Neither implant loosening nor infection was observed. The mean radiographic follow-up was 3.8 months. At the time of the final follow-up, 57/60 cases were scored as fully functional. CONCLUSION: The TRP application either alone or in combination with other surgical techniques allowed for correction of patellar luxation and improvement in preoperative lameness with nominal complications. TRP could represent a potentially reliable alternative to trochleoplasty.

Osseointegrated prostheses for femur amputees.

Osseointegrated implants is a surgical treatment permitting a direct skeletal attachment of an external prosthesis. It is a treatment for healthy transfemoral amputated patients who cannot tolerate or use a socket prosthesis, thereby alleviating related issues with poor fit, skin problems or discomfort. This review provides a summary of the indications and contraindications for surgery, the most common implants and reported outcomes.

What Are the MSTS Scores and Complications Associated With the Use of Three-dimensional Printed, Custom-made Prostheses in Patients Who Had Resection of Tumors of the Hand and Foot?

BACKGROUND: There are a few good options for restoring bone defects in the hand and foot. 3D-printed implants have been used in the pelvis and elsewhere, but to our knowledge, they have not been evaluated in the hand and foot. The functional outcome, complications, and longevity of 3D-printed prostheses in small bones are not well known. QUESTIONS/PURPOSES: (1) What are the functional outcomes of patients with hand or foot tumors who were treated with tumor resection and reconstruction with a 3D-printed custom prosthesis? (2) What complications are associated with using these prostheses? (3) What is the 5-year Kaplan-Meier cumulative incidence of implant breakage and reoperation? METHODS: Between January 2017 and October 2020, we treated 276 patients who had tumors of the hands or feet. Of those, we considered as potentially eligible patients who might have extensive loss in their joint that could not be fixed with a bone graft, cement, or any prostheses available on the market. Based on this, 93 patients were eligible; a further 77 were excluded because they received nonoperative treatment such as chemoradiation, resection without reconstruction, reconstruction using other materials, or ray amputation; another three were lost before the minimum study follow-up of 2 years and two had incomplete datasets, leaving 11 for analysis in this retrospective study. There were seven women and four men. The median age was 29 years (range 11 to 71 years). There were five hand tumors and six tumors of the feet. Tumor types were giant cell tumor of bone (five), chondroblastoma (two), osteosarcoma (two), neuroendocrine tumor (one), and squamous cell carcinoma (one). Margin status after resection was ≥ 1 mm. All patients were followed for a minimum of 24 months. The median follow-up time was 47 months (range 25 to 67 months). Clinical data; function according to the Musculoskeletal Tumor Society, DASH, and American Orthopedic Foot and Ankle Society scores; complications; and survivorship of implants were recorded during follow-up in the clinic, or patients with complete charts and recorded data were interviewed on the telephone by our research associates, orthopaedic oncology fellows, or the surgeons who performed the surgery. The cumulative incidence of implant breakage and reoperation was assessed using a Kaplan-Meier analysis. RESULTS: The median Musculoskeletal Tumor Society score was 28 of 30 (range 21 to 30). Seven of 11 patients experienced postoperative complications, primarily including hyperextension deformity and joint stiffness (three patients), joint subluxation (two), aseptic loosening (one), broken stem (one), and broken plate (one), but no infection or local recurrence occurred. Subluxations of the metacarpophalangeal and proximal interphalangeal joints in two patients' hands were caused by the design of the prosthesis without a joint or stem. These prostheses were revised to a second-generation prosthesis with joint and stem, leading to improved dexterity. The cumulative incidence of implant breakage and reoperation in the Kaplan-Meier analysis was 35% (95% CI 6% to 69%) and 29% (95% CI 3% to 66%) at 5 years, respectively. CONCLUSION: These preliminary findings suggest that 3D implants may be an option for reconstruction after resections that leave large bone and joint defects in the hand and foot. Although the functional results generally appeared to be good to excellent, complications and reoperations were frequent; thus, we believe this approach could be considered when patients have few or no alternatives other than amputation. Future studies will need to compare this approach to bone grafting or bone cementation. LEVEL OF EVIDENCE: Level IV, therapeutic study.

Unilateral transfemoral osseointegrated prostheses improve joint loading during walking.

People with unilateral transfemoral amputation using socket prostheses are at increased risk for developing osteoarthritis in both the residual hip and intact lower-limb joints. Osseointegrated prostheses are a surgical alternative to socket prostheses that directly attach to the residual femur via a bone-anchored implant, however their multi-joint loading effect is largely unknown. Our objective was to establish how osseointegrated prostheses influence joint loading during walking. Motion capture data (kinematics, ground reaction forces) were collected from 12 participants at baseline, with socket prostheses, and 12-months after prosthesis osseointegration during overground walking at self-selected speeds. Subject-specific musculoskeletal models were developed at each timepoint relative to osseointegration. Internal joint moments were calculated using inverse dynamics, muscle and joint reaction forces (JRFs) were estimated with static optimization. Changes in internal joint moments, JRFs, and joint loading-symmetry were compared using statistical parametric mapping (p≤ 0.05) before and after osseointegration. Amputated limb hip flexion moments and anterior JRFs decreased during terminal stance (p = 0.002, <0.001; respectively), while amputated limb hip abduction moments increased during mid-stance (p < 0.001), amputated hip rotation moment changed from internal to external throughout early stance (p < 0.001). Intact limb hip extension and knee flexion moments (p = 0.028, 0.032; respectively), superior and resultant knee JRFs (p = 0.046, 0.049; respectively) decreased during the loading response following prosthesis osseointegration. These results may indicate that the direct loading transmission of these novel prostheses create a more typical mechanical environment in bilateral joints, which is comparable with loading observed in able-bodied individuals and could decrease the risk of development or progression of osteoarthritis.

Biomechanical and clinical studies on lumbar spine fusion surgery: a review.

Low back pain is associated with degenerative disc diseases of the spine. Surgical treatment includes fusion and non-fusion types. The gold standard is fusion surgery, wherein the affected vertebral segment is fused. The common complication of fusion surgery is adjacent segment degeneration (ASD). The ASD often leads to revision surgery, calling for a further fusion of adjacent segments. The existing designs of nonfusion type implants are associated with clinical problems such as subsidence, difficulty in implantation, and the requirement of revision surgeries. Various surgical approaches have been adopted by the surgeons to insert the spinal implants into the affected segment. Over the years, extensive biomechanical investigations have been reported on various surgical approaches and prostheses to predict the outcomes of lumbar spine implantations. Computer models have been proven to be very effective in identifying the best prosthesis and surgical procedure. The objective of the study was to review the literature on biomechanical studies for the treatment of lumbar spinal degenerative diseases. A critical review of the clinical and biomechanical studies on fusion spine surgeries was undertaken. The important modeling parameters, challenges, and limitations of the current studies were identified, showing the future research directions.

Osseointegrated prostheses improve balance and balance confidence in individuals with unilateral transfemoral limb loss.

BACKGROUND: More than half of patients with lower-limb amputation who use socket prostheses experience at least one fall annually. These falls are primarily attributed to reduced proprioception which negatively affects balance. A promising alternative to socket prostheses are osseointegrated prostheses that involve direct fixation of the prosthetic limb to the residual limb through a bone-anchored implant, yet its effect on balance remains unknown. RESEARCH QUESTION: Do osseointegrated prostheses change static and dynamic balance, as well as patient reported measures of balance confidence, compared to a socket prosthesis? METHODS: A sample of 10 patients with unilateral transfemoral amputation scheduled to undergo prosthesis osseointegration were enrolled (6 F/4 M, BMI: 26.7 ± 2.9 kg/m2, Age: 46.1 ± 6.3 years). Motion capture data during quiet standing (eyes opened and eyes closed) and overground walking at a self-selected speed, and the Activities-Specific Balance Confidence (ABC) scale, were collected before (with socket prosthesis) and 12-months following osseointegration. Postural sway via the center of pressure (COP), variability of spatiotemporal parameters, and ABC scores were compared using a repeated measures design before and after osseointegration. RESULTS: Following prosthesis osseointegration, COP path length and 95 % confidence ellipse area were reduced during quiet standing (d = 0.75, P = 0.09; d = 0.52, P = 0.29, respectively) and the variability of step width and length were reduced during overground walking (d = 0.50, P = 0.06; d = 0.72, P = 0.06, respectively). Furthermore, patients reported significantly improved ABC scores with an osseointegrated prosthesis compared to a socket prosthesis (d = -1.36, P = 0.01). SIGNIFICANCE: Improvements in postural sway, reductions in gait variability, and greater balance confidence indicate that osseointegrated prostheses improve balance for people with unilateral transfemoral amputation.

The number of falls recalled in the past year and balance confidence predict the frequency of injurious falls by unilateral lower limb prosthesis users.

INTRODUCTION: Several personal characteristics have been associated with an increased risk of injurious falls by lower limb prosthesis (LLP) users. To date, however, none have been used to effectively predict the occurrence of injurious falls. OBJECTIVE: To develop a model that could predict the number of injurious falls over the next 6 months and identify fall-related circumstances that may increase the odds of a fall being injurious in unilateral LLP users. DESIGN: A secondary analysis of a prospective observational study. SETTING: Research laboratory. PARTICIPANTS: Sixty unilateral LLP users with a transtibial or transfemoral amputation. INTERVENTION: Not applicable. MAIN OUTCOME MEASURE(S): Participants' characteristics were recorded at baseline. Falls and their circumstances and consequences were collected prospectively over 6 months via monthly telephone calls. Multivariate negative binomial regression was used to predict the number of injurious falls over the next 6 months in LLP users. Incidence rate ratios (IRRs) were derived to determine the risk of an injurious fall. Bivariate logistic regression was used to identify the associations between injurious falls and fall-related circumstances. Odds ratios (ORs) were derived to characterize the odds that a fall would be injurious. RESULTS: The final multivariate model, which included the number of falls recalled in the past year (IRR = 1.31, 95% confidence interval [CI]: 1.01-1.71, p = .045) and balance confidence (p = .120), predicted the number of injurious falls in the next 6 months (χ2 (2) = 8.15, p = .017). Two fall-related circumstances were found to increase the odds that a fall would be injurious, fatigue due to activity (OR = 13.5, 95% CI: 3.50-52.3, p  = .001), and tiredness from a lack of sleep (OR = 5.36, 95% CI: 1.22-23.6, p = .026). CONCLUSION: The results suggest that the number of falls recalled in the past year and balance confidence scores predict the number of injurious falls an LLP user will experience in the next 6 months.

Stability and Falls Evaluations in AMPutees (SAFE-AMP 2): Reduced functional mobility is associated with a history of injurious falls in lower limb prosthesis users.

BACKGROUND: Injurious falls have a high cost and economic impact on an individual and the health system. Several studies have assessed performance-based functional mobility in lower limb prosthesis (LLP) users and fall risk including fall history. However, limited data exist regarding the relationship between functional mobility and a history of injurious falls in individuals who use a LLP. Such information could inform clinical practice and decision making from prosthesis design to policy. The purpose of this study was to identify factors associated with a history of injurious falls among LLP users using a clinical outcomes database. METHODS: Retrospective (2016-2018) observational study. Logistic regression applied. RESULTS: A final sample of 12,044 LLP users was included for analysis. Within the sample, 1,529 individuals reported a history of an injurious fall within the previous 6 months. Self-reported functional mobility was stratified into low, middle, and high levels: differences were found between levels for history of an injurious fall. The lowest mobility level was associated with 2.29 higher odds of a history of an injurious fall (95% CI: 1.96-2.69) indicating a potentially greater serious fall risk compared to those with higher mobility levels while controlling for covariates (sex, cause of amputation and level of amputation). CONCLUSION(S): Self-reported functional mobility was associated with a history of injurious falls in LLP users. The Prosthetic Limb Users Survey of Mobility is an accessible tool that prosthetists could use to identify individuals with a high risk of falls; this can inform care planning. Rehabilitation plans and prosthesis designs that target LLP users who report low functional mobility may positively impact health outcomes.

Association Between Osseointegration of Lower Extremity Amputation and Mortality Among Adults.

Importance: Transcutaneous osseointegration post amputation (TOPA) creates a direct linkage between residual bone and an external prosthetic limb, providing superior mobility and quality of life compared with a socket prosthesis. The causes and potential risks of mortality after TOPA have not been investigated. Objective: To investigate the association between TOPA and mortality and assess the potential risk factors. Design, Setting, and Participants: This observational cohort study included all patients with amputation of a lower extremity who underwent TOPA between November 1, 2010, and October 31, 2021, at a specialty orthopedic practice and tertiary referral hospital in a major urban center. Patients lived on several continents and were followed up as long as 10 years. Exposures: Transcutaneous osseointegration post amputation, consisting of a permanent intramedullary implant passed transcutaneously through a stoma and connected to an external prosthetic limb. Main Outcomes and Measures: Death due to any cause. The hypotheses tested-that patient variables (sex, age, level of amputation, postosseointegration infection, and amputation etiology) may be associated with subsequent mortality-were formulated after initial data collection identifying which patients had died. Results: A total of 485 patients were included in the analysis (345 men [71.1%] and 140 women [28.9%]), with a mean (SD) age at osseointegration of 49.1 (14.6) years among living patients or 61.2 (12.4) years among patients who had died. Nineteen patients (3.9%) died a mean (SD) of 2.2 (1.7) years (range, 58 days to 5 years) after osseointegration, including 17 (3.5%) who died of causes unrelated to osseointegration (most commonly cardiac issues) and 2 (0.4%) who died of direct osseointegration-related complications (infectious complications), of which 1 (0.2%) was coclassified as a preexisting health problem exacerbated by osseointegration (myocardial infarction after subsequent surgery to manage infection). No deaths occurred intraoperatively or during inpatient recuperation or acute recovery after index osseointegration (eg, cardiopulmonary events). Kaplan-Meier survival analysis with log-rank comparison and Cox proportional hazards regression modeling identified increased age (hazard ratio, 1.06 [95% CI, 1.02-1.09]) and vascular (odds ratio [OR], 4.73 [95% CI, 1.35-16.56]) or infectious (OR, 3.87 [95% CI, 1.31-11.40]) amputation etiology as risk factors. Notable factors not associated with mortality risk included postosseointegration infection and male sex. Conclusions and Relevance: These findings suggest that patients who have undergone TOPA rarely die of problems associated with the procedure but instead usually die of unrelated causes.

The First FDA Approved Early Feasibility Study of a Novel Percutaneous Bone Anchored Prosthesis for Transfemoral Amputees: A Prospective 1-year Follow-up Cohort Study.

OBJECTIVE: Evaluate the safety and efficacy of a novel press-fit bone-anchored prosthesis in an FDA approved study. DESIGN: Single-center, prospective 1-year follow-up cohort study of a percutaneous bone anchored prosthesis. SETTING: Veterans Health Administration Hospital. PARTICIPANTS: Ten male Veterans with unilateral transfemoral amputation that occurred at least 6 months prior to enrollment and was not the result of dysvascular disease (N=10). INTERVENTIONS: All participants received the novel press-fit Percutaneous Osseointegrated Prosthesis (POP) and a minimum of 10 days supervised rehabilitation therapy. OUTCOME MEASURES: Adverse events and radiographs were collected to assess device safety. Temporal assessments of bone density, stomal skin, prosthetic don/doff, functional ambulation, and patient-reported outcome compared our POP to a socket suspension system. RESULTS: Ten male participants mean age 48.8±12.1 years (range, 32-68 y) with mean time since amputation of 9.4± years (range 1-18 y) completed a two-staged implantation protocol and progressed to ambulation with an assistive device by post-operative day 14. Eight of 10 completed all study procedures. One implant loosened at 5 weeks, requiring removal. A second was removed after periprosthetic fracture from a non-device-related fall at 28 weeks. One patient required oral antibiotics for superficial infection. There were significant (P<.05) increases in bone density in the lumbar spine and adjacent to the distal porous coating with no radiographic evidence of bone resorption. Compared to the socket system, the use of POP significantly (P<.05) reduced prosthetic don and doff times and patient-reported prosthetic problem scores. Significant improvements (P<.05) in mean mobility, global health, and walking test scores were also observed. CONCLUSIONS: Improvements in bone density, function, and patient reported outcomes were observed with the POP device when compared to a socket suspension system. This Early Feasibility Study established initial safety and effectiveness of the POP device, supporting expanded investigation as an alternative to socket prostheses.

Treatment of acute intraoperative Budd-Chiari syndrome by placement of silicone prosthesis.

Complete liver mobilization for major resections sometimes causes liver tilting due to the release of the suspensory elements of the liver. Rarely this may take to a liver abnormal position with acute obstruction to venous flow at the suprahepatic level (Budd-Chiari syndrome). To avoid this complication, techniques such as post-operative stent implantation have been described. The case of a patient who underwent a complete mobilization of the liver for resection of the inferior venous cava and a right renal tumor, was reported. After that, an acute Budd-Chiari Syndrome was observed caused of the liver malposition, which was solved with the placement of two silicone prostheses in the liver cell.

Within-subject effects of standardized prosthetic socket modifications on physical function and patient-reported outcomes.

BACKGROUND: Among the challenges of living with lower limb loss is the increased risk of long-term health problems that can be either attributed directly to the amputation surgery and/or prosthetic rehabilitation or indirectly to a disability-induced sedentary lifestyle. These problems are exacerbated by poorly fit prosthetic sockets. There is a knowledge gap regarding how the socket design affects in-socket mechanics and how in-socket mechanics affect patient-reported comfort and function. The objectives of this study are (1) to gain a better understanding of how in-socket mechanics of the residual limb in transfemoral amputees are related to patient-reported comfort and function, (2) to identify clinical tests that can streamline the socket design process, and (3) to evaluate the efficacy and cost of a novel, quantitatively informed socket optimization process. METHODS: Users of transfemoral prostheses will be asked to walk on a treadmill wearing their current socket plus 8 different check sockets with designed changes in different structural measurements that are likely to induce changes in residual limb motion, skin strain, and pressure distribution within the socket. Dynamic biplane radiography and pressure sensors will be used to measure in-socket residual limb mechanics. Patient-reported outcomes will also be collected after wearing each socket. The effects of in-socket mechanics on both physical function and patient-reported outcomes (aim 1) will be assessed using a generalized linear model. Partial correlation analysis will be used to examine the association between research-grade measurements and readily available clinical measurements (aim 2). In order to compare the new quantitative design method to the standard of care, patient-reported outcomes and cost will be compared between the two methods, utilizing the Wilcoxon-Mann-Whitney non-parametric test (aim 3). DISCUSSION: Knowledge on how prosthetic socket modifications affect residual bone and skin biomechanics itself can be applied to devise future socket designs, and the methodology can be used to investigate and improve such designs, past and present. Apart from saving time and costs, this may result in better prosthetic socket fit for a large patient population, thus increasing their mobility, participation, and overall health-related quality of life. TRIAL REGISTRATION: ClinicalTrials.gov NCT05041998 . Date of registration: Sept 13, 2021.

A low-cost easily implementable physiotherapy intervention clinically improves gait implying better adaptation to lower limb prosthesis: a randomized clinical trial.

Lower limb amputation highly impacts the lives of individuals. The inability to walk due to difficulties in adapting to wearing prosthesis can potentially result in physical degeneration and comorbidity in this population. In this randomized clinical trial study, we investigated if a low-cost and easily implementable physiotherapy intervention was effective in improving gait performance and adaptation to lower limb prosthesis in individuals with an amputation. A total of 26 individuals participated in the study, 16 with lower limb amputation and 10 without amputation. Participants with amputation were further divided in intervention and control groups. The intervention group underwent a rehabilitation protocol aimed at strengthening muscles and improving prosthesis adaptation. Muscle strengthening targeted the hip segment, prioritizing the abdominal muscles, hip flexors, extensors, adductors and abductors, followed by cicatricial mobilization and weight-bearing on the stump for desensitization. Assessment and measures were performed across the kinetic and kinematic parameters of gait. In the comparison between pre-and post-intervention, a significant increase in gait speed (0.68-2.98, 95% CI, 1.83, effect size ES) and cadence (0.56-2.69, 95% CI, 1.63, ES) was found between groups and time points. Step (0.73-3.11, 95% CI, 1.92, ES) and stride length (0.62-2.84, 95% CI, 1.73) increased between pre- and post-intervention, while in the control group both variables remained smaller. The intervention group decreased stance phase as a percentage of gait cycle between pre- and post-intervention (- 1.33-0.62, 95% CI, - 36, ES), while it increased in the control group. Improvement in a combination of important gait parameters indicates that the intervention protocol promoted the adaptation to prosthesis and the functional independence of individuals with lower limb amputation. It is recommended that the participants continue receiving follow-up assessments and rehabilitation interventions.