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Prosthetic manufacturers have marketed shock-absorbing pylons (SAPs) for attenuation of injurious loads from foot-ground contact. In this study, we compared a commonly prescribed SAP with a conventional rigid pylon, using a within-subject design (n = 15 unilateral transtibial amputees), to assess effect on gait mechanics, measure transmitted accelerations in situ, and determine functional outcomes using step counts and questionnaires. No differences were found across pylons for self-selected walking speed, prosthetic-side step length, prosthetic-side loading rate and decelerative peak of the vertical ground reaction force, peak pylon acceleration, step count per week, or questionnaire results that examined pylon performance and subjects' pain and fatigue levels. The only statistically significant finding was for the prosthetic-side knee angle at initial contact, where subjects displayed an average of 2.6 degrees more flexion with the rigid pylon than the SAP while walking at a controlled speed (p = 0.004); this result indicates that transtibial amputees are able to modulate the effective stiffness of their residual limb in response to changes in prosthetic component stiffness. The results from the laboratory, field, and subjective outcome measurements suggest that the SAP in this study is as effective as a rigid pylon for unilateral transtibial amputees. [ABSTRACT FROM AUTHOR]

PURPOSE: (1) To describe one aspect of social support, social integration, longitudinally for 2 years following lower limb amputation and (2) to explore the impact of social support on depression, pain interference, life satisfaction, mobility, and occupational functioning. METHOD: Eighty-nine adults recruited from consecutive admissions to an orthopaedic surgery service completed telephone interviews 1, 6, 12 and 24 months following amputation surgery. Dependent variables included the Social Integration (SI) sub-scale of the Craig Handicap Assessment and Reporting Technique (CHART) and the Multidimensional Scale of Perceived Social Support (MSPSS). RESULTS: There was a high level of SI among most persons following lower limb amputations that was relatively unchanged in the 2 years following surgery. However, mean levels of SI were lower in this group compared to a sample without disabilities. MSPSS scores were highly variable, ranging from almost no support to the maximum amount of support. MSPSS was an important concurrent predictor of pain interference, life satisfaction, and mobility, controlling for demographic and amputation-related factors. Baseline MSPSS predicted mobility and occupational functioning 6 months post-amputation, controlling for demographic and amputation-related factors. CONCLUSIONS: Findings suggest that interventions aimed at improving the quality of social relationships after amputation may facilitate participation in activities. [ABSTRACT FROM AUTHOR]

Pain is a common sequela of lower extremity amputation. Phantom limb pain is probably the most common pain syndrome that comes to mind when considering the spectrum of pain disorders experienced by amputees. However, in addition to this, residual limb pain and pain related to secondary musculoskeletal disorders are increasingly being recognized as important sources of nociception and pain-related disability in amputees. Although considerable research is still required to fully understand pain after amputation, this review article presents both a current understanding and a multidimensional perspective of pain in amputees and its epidemiology, pathophysiology, clinical presentation, biopsychosocial interrelationships, and management. [ABSTRACT FROM AUTHOR]

Amputees lack movement and control mechanisms at the foot and ankle that result in different strategies for locomotion than nonamputees. The torsion adapter is a prosthetic device designed to minimize shear stress at the residual limb by facilitating rotation in the transverse plane. This study determined if the addition of a torsion adapter alters lower-limb joint rotation moments of transtibial amputees walking in a straight line and turning. Ten transtibial amputees wore either a torsion adapter or a rigid adapter for an acclimation period of 3 weeks in random order. Ten nonamputees were also included for comparison. Kinetics were collected as participants walked in a straight line and around a 1 m-radius circular path at their self-selected turning walking speed. When amputee participants wore the torsion adapter, they demonstrated decreased prosthetic-limb peak internal rotation moments at the inside limb knee and hip compared with when they wore the rigid adapter, which may facilitate changes in orientation by not actively resisting the turn. Nonamputees exhibited larger moments compared with the prosthetic limb for both the amputee participants wearing either the torsion or rigid adapters. No differences were found in the moments for the intact limb between torsion and rigid adapter conditions during turning and for both limbs during straight-line walking. [ABSTRACT FROM AUTHOR]

Prosthetic devices that can store and return energy during gait enhance the mobility and functionality of lower-limb amputees. The process of selecting and fitting such devices is complicated, partly because of confusing literature on the topic. Gait analysis methods for measuring energy characteristics are often incomplete, leading to inconsistencies in the energy classifications of different products. These inconsistencies are part of the reason for the lack of universally accurate terminology in the field. Inaccurate terminology perpetuates misunderstanding. In this paper, important prosthetic energy concepts and methods for measuring energy characteristics are reviewed. Then a technically accurate nomenclature and a method of functional classification are proposed. This review and proposed classification scheme should help to alleviate confusion and should facilitate enhancement of the design, selection, and fitting of prosthetic limbs for amputee patients. [ABSTRACT FROM AUTHOR]

Ninety-two (92) persons with lower-limb amputations who regularly used prostheses responded to a survey that included questions about preferred recreational activities. This article describes the variety of activities selected by these men and women aged 20 to 87 years. Of the activities that were of high importance, 74% to 88% could be performed. Those activities assigned moderate to low importance were less often reported as able to be performed. The activities that require high energy level were more problematic for performance. The diversity of identified activities (n= 166) underscores the value of learning about amputees' activity preferences when making prosthetic prescription decisions. [ABSTRACT FROM AUTHOR]

The condition in which ankle dorsiflexion is restricted is known as equinus contracture (EC). Equinus contracture is purported to be associated with a number of clinical conditions. However, there are no data to support or refute a clinician's ability to diagnose EC by clinical exam. We prospectively evaluated the maximum ankle dorsiflexion with the knee fully extended in 68 people (34 patients with isolated fore- or midfoot pain and 34 asymptomatic subjects) both by clinical exam and by a custom-designed ankle goniometer. We compared the likelihood of agreement of the clinical impression (equinus, no equinus) to the maximum ankle dorsiflexion measured with the instrument at two different numerical definitions of EC (< or =5 degrees and < or =10 degrees of maximum dorsiflexion). When all subjects were included and equinus defined as < or =5 degrees of ankle dorsiflexion, a clinician's ability to detect the equinus when it is truly present is 77.8%. If equinus is defined as < or =10 degrees, this ability increases to 97.2%. Alternatively, if equinus is not present, as defined by < or =5 degrees, then a clinician's ability to correctly diagnose no equinus is 93.8%. If equinus is defined to < or =10 degrees, this ability decreases to 68.8%. [ABSTRACT FROM AUTHOR]

Lower-limb amputees have identified comfort and mobility as the two most important characteristics of a prosthesis. While these in turn depend on a multitude of factors, they are strongly influenced by the biomechanical performance of the prosthesis and the loading it imparts to the residual limb. Recent years have seen improvements in several prosthetic components that are designed to improve patient comfort and mobility. In this paper, we discuss two of these: VSAP and prosthetic foot-ankle systems; specifically, their mechanical properties and impact on amputee gait are presented. [ABSTRACT FROM AUTHOR]

The C-Leg(R) (Otto Bock, Duderstadt, Germany) is a microprocessor-controlled prosthetic knee that may enhance amputee gait. This intrasubject randomized study compared the gait biomechanics of transfemoral amputees wearing the C-Leg with those wearing a common noncomputerized prosthesis, the Mauch SNS (Ossur, Reykjavik, Iceland). After subjects had a 3-month acclimation period with each prosthetic knee, typical gait biomechanical data were collected in a gait laboratory. At a controlled walking speed (CWS), peak swing phase knee-flexion angle decreased for the C-Leg group compared with the Mauch SNS group (55.2 degrees +/- 6.5 degrees vs 64.41 degrees +/- 5.8 degrees, respectively; p = 0.005); the C-Leg group was similar to control subjects' peak swing knee-flexion angle (56.0 degrees +/- 3.4 degrees). Stance knee-flexion moment increased for the C-Leg group compared with the Mauch SNS group (0.142 +/- 0.05 vs 0.067 +/- 0.07 N* m, respectively; p = 0.01), but remained significantly reduced compared with control subjects (0.477 +/- 0.1 N* m). Prosthetic limb step length at CWS was less for the C-Leg group compared with the Mauch SNS group (0.66 +/- 0.04 vs 0.70 +/- 0.06 m, respectively; p = 0.005), which resulted in increased symmetry between limbs for the C-Leg group. Subjects also walked faster with the C-Leg versus the Mauch SNS (1.30 +/- 0.1 vs 1.21 +/- 0.1 m/s, respectively; p = 0.004). The C-Leg prosthetic limb vertical ground reaction force decreased compared with the Mauch SNS (96.3 +/- 4.7 vs 100.3 +/- 7.5% body weight, respectively; p = 0.0092). [ABSTRACT FROM AUTHOR]

Microprocessor-controlled prosthetic knees are claimed to improve gait efficiency in transfemoral (TF) amputees.This hypothesis was tested in a prospective randomized crossover trial that compared the Mauch SNS knee and the C-Leg microprocessor-controlled knee in eight TF amputees. The subjects were given a 3-month acclimation period in each knee. Then, their net oxygen cost (mL/kg/m) was measured while they walked over ground at four speeds in random order: 0.8 m/s, 1.0 m/s, 1.3 m/s, and self-selected walking speed (SSWS). The C-Leg caused small reductions in net oxygen cost that were not statistically significant compared with the Mauch SNS at any of the walking speeds (p > 0.190). Subjects chose higher SSWSs with the C-Leg compared with the Mauch SNS (mean +/- standard deviation =1.31 +/- 0.12 m/s vs 1.21 +/- 0.10 m/s, respectively, p = 0.046) but did not incur higher oxygen costs (p = 0.270), which suggests greater efficiency only at their SSWS. [ABSTRACT FROM AUTHOR]

Twenty-four adults with phantom limb pain (PLP) and/or residual limb pain (RLP) participated in a double-blind crossover trial. Participants were randomly assigned to receive gabapentin or placebo and later crossed over to the other treatment, with a 5-week washout interval in which they did not receive medication. Gabapentin was titrated from 300 mg to the maximum dose of 3,600 mg. Measures of pain intensity, pain interference, depression, life satisfaction, and functioning were collected throughout the study. Analyses revealed no significant group differences in pre- to posttreatment change scores on any of the outcome measures. More than half of the participants reported a meaningful decrease in pain during the gabapentin phase compared with about one-fifth who reported a meaningful decrease in pain during the placebo phase. In this trial, gabapentin did not substantially affect pain. More research on the efficacy of gabapentin to treat chronic PLP and RLP is needed. [ABSTRACT FROM AUTHOR]

Postamputation management is an important determinant of recovery from amputation. However, consensus on the most effective postoperative management strategies for individuals undergoing transtibial amputation (TTA) is lacking. Dressings can include simple soft gauze dressings, thigh-high rigid cast dressings, shorter removable rigid dressings, and prefabricated pneumatic dressings. Postoperative prosthetic attachments can be added to all but simple soft dressings. These dressings address the need to cleanly cover a fresh surgical wound, but not all postoperative dressings are designed to facilitate the strategic goals of preventing knee contractures, reducing edema, protecting from external trauma, or facilitating early weight bearing. The type of dressing and management strategy often overlap and are certainly interrelated. Current protocols and decisions are based on local practice, skill, and intuition. The current available literature is challenging, and difficulties include variations in healing potential, in comorbidity, in surgical-level selection, in techniques and skill, in experience with postoperative strategies, and with poorly defined outcome criteria. This paper reviews the published literature and compares measures of safety, efficacy, and clinical outcomes of the various techniques. Analysis of 10 controlled studies supported only 4 of the 14 claims cited in uncontrolled, descriptive studies. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To assess trends in peripheral vascular procedures performed in Veterans Health Administration (VHA) facilities. METHODS: All discharges with peripheral vascular procedures recorded for 1989-1998 were analyzed. The VHA user population was used to calculate age-specific rates. Trends were evaluated using frequency tables and Poisson regression. RESULTS: The VHA had 55,916 discharges with peripheral vascular procedures performed almost exclusively in men. Indications included peripheral vascular disease (53.7%), gangrene (19.3%), surgical complications (13.3%), and ulcers and infection (9.6%). The VHA age-specific rates were higher than US population rates for persons 45 to 64 years, similar for those 65 to 74 years, and lower for those 75 years and older. The age-specific rates declined slightly over the 10 years of observation, with the greatest decline noted in men age 45 to 65. CONCLUSION: The VHA provides almost 8% of all US peripheral vascular procedures in males. The VHA age-specific rates differ from the US rates with a shift to younger patients. The rates decreased for all age groups between 1989-1998. [ABSTRACT FROM AUTHOR]

GOAL: We sought to describe the common demographic and comorbid conditions that affect survival following nontraumatic amputation. METHODS: Veterans Administration hospital discharge records for 1992 were linked with death records. The most proximal level during the first hospitalization in 1992 was used for analysis. Demographic information (age, race) and comorbid diagnosis (cardiovascular, cerebrovascular, and renal disease) were used for Kaplan-Meier curves to describe survival following amputation. MAIN OUTCOME MEASURE: Death. RESULTS: Mortality risk increased with advanced age, more proximal amputation level, and renal and cardiovascular disease, and decreased for African Americans. No increased risk for persons with diabetes was noted in the first year following amputation but the risk increased thereafter. A higher risk of mortality in the first year was noted for renal disease, cardiovascular disease, and proximal amputation level. CONCLUSION: Survival following lower-limb amputation is impaired by advancing age, cardiovascular and renal disease, and proximal amputation level. Also, a small survival advantage is seen for African Americans and those with diabetes. [ABSTRACT FROM AUTHOR]

Rigid plaster dressings and immediate postoperative prostheses (IPOP) in patients undergoing transtibial amputations have been reported to reduce pain and healing time, prevent knee flexion contractures, and expedite early ambulation compared to soft dressings. Yet, despite the reported benefits, surgical adoption of (conventional) rigid dressings and IPOP has been inconsistent. The purpose of this study was to determine the current postoperative transtibial amputation dressing practices in VA hospitals. A six-item questionnaire was sent to 134 surgeons at the 117 VA hospitals where transtibial amputations were performed in fiscal year 1999. Responses were received from 83% of the surgeons. During the 1999 study year, surgeons performing transtibial amputations used soft dressings on 67% of patients, conventional rigid dressings with no intent to apply a foot attachment on 14% of patients, removable rigid dressings on 14% of patients, and IPOP (almost exclusively without a foot) on 5% of patients. The application of a rigid dressing or IPOP did not correlate well with the total number of transtibial amputations performed by the surgeon, hospital bed size, or academic affiliation. [ABSTRACT FROM AUTHOR]

OBJECTIVE: To assess trends in lower limb amputation performed in Veterans Health Administration (VHA) facilities. METHODS: All lower limb amputations recorded in the Patient Treatment File for 1989-1998 were analyzed using the hospital discharge as the unit of analysis. Age-specific rates were calculated using the VHA user-population as the denominator. Frequency tables and linear, logistic, and Poisson regression were used respectively to assess trends in amputation numbers, reoperation rates, and age-specific amputation rates. RESULTS: Between 1989-1998, there were 60,324 discharges with amputation in VHA facilities. Over 99.9% of these were in men and constitute 10 percent of all US male amputations. The major indications were diabetes (62.9%) and peripheral vascular disease alone (23.6%). The age-specific rates of major amputation in the VHA are higher than US rates of major amputation. VHA rates of major and minor amputation declined an average of 5% each year, while the number of diabetes-associated amputations remained the same. CONCLUSION: The number and age-specific rates of amputations decreased over 10 years despite an increase in the number of veterans using VHA care. [ABSTRACT FROM AUTHOR]

Lower limb prosthesis users are at an increased risk of developing osteoarthritis in their intact knee. There is a scarcity of literature examining how the stiffness properties of commercially available prosthetic feet impact gait mechanics, including knee loading biomechanical variables that have been associated with the development of osteoarthritis. This study aimed to isolate the effect of commercial prosthetic foot stiffness on intact knee loading, prosthetic foot-ankle biomechanics, and user perception. Seventeen males with unilateral transtibial amputation were fit with three consecutive foot stiffness categories of a standardized energy-storing prosthetic foot in a randomized order and while blinded to foot condition. Biomechanical and self-report data were collected during level-ground walking in a motion analysis laboratory. As prosthetic foot stiffness increased, contralateral knee external adduction moment significantly decreased between stiff vs. medium and stiff vs. soft foot conditions. Prosthetic foot rollover radius increased as foot stiffness increased. However, prosthetic foot-ankle push-off peak power and work decreased as foot stiffness increased. On average, users favored the medium stiffness condition and were able to correctly identify the foot stiffness condition. Overall, these results raise questions about the relative contributions of foot stiffness and ankle push-off power to changes in contralateral knee loading. The findings contribute to our understanding of the relationships between prosthetic foot mechanical properties and gait biomechanical variables at the contralateral knee when prosthetic foot stiffness is modified without a corresponding alignment adjustment., Competing Interests: Declaration of competing interest The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper., (Published by Elsevier Ltd.)

Objective: To determine the prevalence of peripheral neuropathy (PN) and its effect on mobility in patients who were prescribed a lower limb prosthesis (LLP) after an incident dysvascular transtibial (TT) or transfemoral (TF) lower extremity amputation (LEA). We also sought to determine if the effect of PN on mobility was modified by amputation level or depression., Design: Participants were identified retrospectively through the Veterans Affairs (VA) Corporate Data Warehouse (CDW) from March 1, 2018, to November 30, 2020, then were contacted prospectively to obtain their self-reported mobility. Multiple logistic regression was used to control for potential confounders and identify potential effect modifiers., Setting: The VA CDW, the National Prosthetics Patient Database, participant mailings and phone calls., Participants: Three hundred fifty-seven individuals who underwent a TT or TF amputation due to diabetes and/or peripheral arterial disease and were fitted with a qualifying LLP., Interventions: Not applicable., Main Outcomes Measures: The Locomotor Capabilities Index basic and advanced mobility subscale scores., Results: Two-hundred thirty seven participants (66%) had a diagnosis of PN prior to prosthesis prescription. The detrimental effect of PN on achieving basic and advanced mobility was significant after adjusting for potential confounding factors (adjusted odds ratio [aOR], 0.53; 95% confidence interval [CI], 0.30-0.94; p = .03 and aOR, 0.43; 95% CI, 0.24-0.77; p = .005, respectively). The detrimental effect of PN was more pronounced in patients with depression, especially for advanced mobility (aOR, 0.36; 95% CI, 0.14-0.95; p = .04) versus no depression (aOR, 0.53; 95% CI, 0.27-1.0; p = .07)., Conclusions: PN is common in patients who have undergone an LEA due to diabetes and/or vascular disease and patients with this diagnosis should be carefully evaluated. Targeted rehabilitation programs to mitigate its potential detrimental effects on mobility are important and should specifically include mental health assessment and treatment., (Published 2024. This article is a U.S. Government work and is in the public domain in the USA.)

Introduction: We developed a patient decision aid to enhance patient participation in amputation level decision making when there is a choice between a transmetatarsal or transtibial amputation., Methods: In accordance with International Patient Decision Aid Standards, we developed an amputation level patient decision aid for patients who are being considered for either a transmetatarsal or transtibial amputation, incorporating qualitative literature data, quantitative literature data, qualitative provider and patient interviews, expert panel input and iterative patient feedback., Results: The rapid qualitative literature review and qualitative interviews identified five domains outcome priority domains important to patients facing amputation secondary to chronic limb threatening ischemia: 1) the ability to walk, 2) healing and risk for reamputation, 3) rehabilitation program intensity, 4) ease of prosthetic use, and 5) limb length after amputation. The rapid quantitative review identified only two domains with adequate evidence comparing differences in outcomes between the two amputation levels: mobility and reamputation. Patient, surgeon, rehabilitation and decision aid expert feedback allowed us to integrate critical facets of the decision including addressing the emotional context of loss of limb, fear and anxiety as an obstacle to decision making, shaping the decision in the context of remaining life years, and how to facilitate patient knowledge of value tradeoffs., Conclusions: Amputation level choice is associated with significant outcome trade-offs. The AMPDECIDE patient decision aid can facilitate acknowledgment of patient fears, enhance knowledge of amputation level outcomes, assist patients in determining their personal outcome priorities, and facilitate shared amputation level decision making., (Published by Elsevier Inc.)

Objective: To determine if lower limb prosthesis (LLP) sophistication is associated with patient-reported mobility and/or mobility satisfaction, and if these associations differ by amputation level., Design: Cohort study that identified participants through a large national database and prospectively collected self-reported patient outcomes., Setting: The Veterans Administration (VA) Corporate Data Warehouse, the National Prosthetics Patient Database, participant mailings, and phone calls., Participants: 347 Veterans who underwent an incident transtibial (TT) or transfemoral (TF) amputation due to diabetes and/or peripheral artery disease and received a qualifying LLP between March 1, 2018, and November 30, 2020., Interventions: Basic, intermediate, and advanced prosthesis sophistication was measured by the accurate and reliable PROClass system., Main Outcome Measure: Patient-reported mobility using the advanced mobility subscale of the Locomotor Capabilities Index-5; mobility satisfaction using a 0-10-point Likert scale., Results: Lower limb amputees who received intermediate or advanced prostheses were more likely to achieve advanced mobility than those who received basic prostheses, with intermediate nearing statistical significance at nearly twice the odds (adjusted odds ratio (aOR)=1.8, 95% confidence interval (CI), .98-3.3; P=.06). The association was strongest in TF amputees with over 10 times the odds (aOR=10.2, 95% CI, 1.1-96.8; P=.04). The use of an intermediate sophistication prosthesis relative to a basic prosthesis was significantly associated with mobility satisfaction (adjusted β coefficient (aβ)=.77, 95% CI, .11-1.4; P=.02). A statistically significant association was only observed in those who underwent a TT amputation (aβ=.79, 95% CI, .09-1.5; P=.03)., Conclusions: Prosthesis sophistication was not associated with achieving advanced mobility in TT amputees but was associated with greater mobility satisfaction. In contrast, prosthesis sophistication was associated with achieving advanced mobility in TF amputees but was not associated with an increase in mobility satisfaction., (Published by Elsevier Inc.)

Background: Women with lower extremity amputations (LEAs) tend to have poorer prosthesis-related outcomes than men, although the literature is sparse. To our knowledge, there are no prior studies examining prosthesis-related outcomes of women veterans with LEAs., Objective: To examine gender differences (overall and by type of amputation) among veterans who underwent LEAs between 2005 and 2018, received care at the Veterans Health Administration (VHA) prior to undergoing amputation, and were prescribed a prosthesis. It was hypothesized that compared to men, women would report lower satisfaction with prosthetic services, poorer prosthesis fit, lower prosthesis satisfaction, less prosthesis use, and worse self-reported mobility. Furthermore, it was hypothesized that gender differences in outcomes would be more pronounced among individuals with transfemoral than among those with transtibial amputations., Design: Cross-sectional survey. Linear regressions were used to assess overall gender differences in outcomes and gender differences based on type of amputation in a national sample of veterans., Setting: VHA medical centers., Participants: The sample consisted of 449 veterans who self-identified their gender (women = 165, men = 284) with transtibial (n = 236), transfemoral (n = 135), and bilateral LEAs (n = 68) including all amputation etiologies., Interventions: Not applicable., Main Outcome Measures: The Orthotics and Prosthetics User's Survey, Trinity Amputation and Prosthesis Experiences Scale, and Prosthetic Limb Users Survey of Mobility-Short Form were used to assess satisfaction with prosthetic services, prosthesis fit, prosthesis satisfaction, prosthesis use, and self-reported mobility., Results: Women had poorer self-reported mobility than men (d = -0.26, 95% confidence interval -0.49 to -0.02, p < .05); this difference was small. There were no statistically significant gender differences in satisfaction with prosthetic services, prosthesis fit, prosthesis satisfaction, daily hours of prosthesis use, or by amputation type., Conclusions: Contrary to the hypothesis, prosthesis-related outcomes were similar between men and women with LEAs. Minimal differences may in part be due to receiving care from the VHA's integrated Amputation System of Care., (© 2023 American Academy of Physical Medicine and Rehabilitation.)

Purpose: To determine gender disparities and potential factors that modify prosthesis prescription practices in veteran patients who have undergone their first major unilateral amputation due to diabetes or peripheral arterial disease., Materials and Methods: A retrospective cohort study using the VA Corporate Data Warehouse to compare prosthesis prescription rates and time to prescription between men and women veterans. The primary exposure was gender. The primary outcome was a qualifying prosthesis prescription within 12 months of the incident amputation. The secondary outcome was time to prosthesis prescription. Multiple logistic and linear regression was used to control for potential confounders and identify potential effect modification., Results: 2,862 individuals met study criteria, with 1690 (60%) prescribed a qualifying prosthesis. Men were more likely to receive a prosthesis prescription than women (59% versus 45%, respectively; p  = 0.03). This difference was observed primarily among those with a diagnosis of major depressive disorder. In this subgroup, the odds of men receiving a prosthesis over women was over 3 times (adjusted odds ratio = 3.3; 95% Confidence Interval, 1.5, 7.4). Men had a mean shorter time to prescription compared to women (112 ± 72 versus 136 ± 79 days, respectively, p  = 0.08)., Depression in women negatively impacts their prosthesis prescription rates and time to prescription compared to men. This disparity may have significant impacts on future function and quality of life.Implications for RehabilitationThis study found that men more commonly received a prosthesis prescription and received it earlier than women.This disparity was most extreme among women who had been diagnosed with major depressive disorder.Providers should identify at risk patients early and consider targeted interventions to address depression during the preoperative and immediate postoperative phases.Future research should continue to work to identify gender-specific needs that exacerbate disparity.

Objective: To evaluate whether prosthetic prescription differed by gender and the extent to which differences were mediated by measured factors., Design: Retrospective longitudinal cohort study using data from Veterans Health Administration (VHA) administrative databases., Setting: VHA patients throughout the United States., Participants: The sample included 20,889 men and 324 women who had an incident transtibial or transfemoral amputation between 2005 and 2018., Interventions: Not applicable., Main Outcome Measures: Time to prosthetic prescription (up to 1 year). We used parametric survival analysis (an accelerated failure time model) to assess gender differences. We estimated mediation effects of amputation level, pain comorbidity burden, medical comorbidities, depression, and marital status on time to prescription., Results: In the 1 year after amputation, the proportion of women (54.3%) and men (55.7%) prescribed a prosthesis was similar. However, after we controlled for age, race, ethnicity, enrollment priority, VHA region, and service-connected disability, the time to prosthetic prescription was significantly faster among men compared with women (acceleration factor=0.73; 95% confidence interval, 0.61-0.87). The difference in time to prosthetic prescription between men and women was significantly mediated by amputation level (23%), pain comorbidity burden (-14%), and marital status (5%) but not medical comorbidities or depression., Conclusions: Although the proportion of patients with prosthetic prescription at 1-year postamputation was similar between men and women, women received prosthetic prescriptions more slowly than men, suggesting that more work is needed to understand barriers to timely prosthetic prescriptions among women, and how to intervene to reduce those barriers., (Published by Elsevier Inc.)

Objective: To develop a lower limb prosthesis (LLP) sophistication classification system that categorizes prosthetic component prescriptions into "basic," "intermediate," and "advanced" and assess its content validity, reliability, and accuracy., Design: Classification development and validation study., Setting: The Veterans Affairs (VA) Corporate Data Warehouse database and National Prosthetics Patient Database were used to identify patients undergoing their first amputation at the transtibial or transfemoral level due to diabetes or peripheral artery disease and to identify the associated codes for each LLP., Participants: An expert panel of 6 nationally recognized certified prosthetists, a national expert in VA prosthetics data and coding, a physical medicine and rehabilitation physician, and an epidemiologist developed an LLP classification system ( PROClass ) using 30 transfemoral and transtibial lower limb amputees., Main Outcome Measures: The expert panel reviewed 20 consecutive participants meeting study criteria for the development of the PROClass system and a subsequent 30 consecutive cases for assessing the inter- and intra-rater reliability and accuracy., Results: The interrater and intrarater reliability was almost perfect with Gwet's AC1 values ranging from .82 to .96 for both expert panel members and research assistants. The accuracy of the research assistant's classifications to the "criterion standard" was excellent with Gwet's AC1 values ranging between .75 and .92., Conclusions: PROClass is a pragmatic, reliable, and accurate prosthetic classification system with strong face validity that will enable the classification of prosthetic components used for large data set research aimed at evaluating important clinical questions such as the effects of sophistication on patient outcomes., (© 2023 The Authors.)

Background: Among patients facing lower extremity amputation due to dysvascular disease, the mortality risk is very high. Given this, as well as the importance of a patient-centered approach to medical care, informing patients about their possible risk of dying may be important during preoperative shared decision-making. The goal of this investigation was to gain an understanding of patient and provider experiences discussing mortality within the context of amputation within the Veterans Health Administration., Methods: Semistructured interviews were performed with Veterans with peripheral arterial disease and/or diabetes, vascular and podiatric surgeons, and physical medicine and rehabilitation physicians. Interviews were analyzed using team-based content analysis to identify themes related to amputation-level decisions., Results: We interviewed 22 patients and 21 surgeons and physicians and identified 3 themes related to conversations around mortality: (1) both patients and providers report that mortality conversations are not common prior to amputation; (2) while most providers find value in mortality conversations, some express concerns around engaging in these discussions with patients; and (3) some patients perceive mortality conversations as unnecessary, but many are open to engaging in the conversation., Conclusions: Providers may benefit from introducing the topic with patients, including providing the context for why mortality conversations may be valuable, with the understanding that patients can always decline to participate should they not be interested or comfortable discussing this issue., (Published by Elsevier Inc.)

Background: Achieving mobility with a prosthesis is a common post-amputation rehabilitation goal and primary outcome in prosthetic research studies. Patient-reported outcome measures (PROMs) available to measure prosthetic mobility have practical and psychometric limitations that inhibit their use in clinical care and research., Objective: To develop a brief, clinically meaningful, and psychometrically robust PROM to measure prosthetic mobility., Design: A cross-sectional study was conducted to administer previously developed candidate items to a national sample of lower limb prosthesis users. Items were calibrated to an item response theory model and two fixed-length short forms were created. Instruments were assessed for readability, effective range of measurement, agreement with the full item bank, ceiling and floor effects, convergent validity, and known groups validity., Setting: Participants were recruited using flyers posted in hospitals and prosthetics clinics across the United States, magazine advertisements, notices posted to consumer websites, and direct mailings., Participants: Adult prosthesis users (N = 1091) with unilateral lower limb amputation due to traumatic or dysvascular causes., Interventions: Not applicable., Main Outcome Measures: Candidate items (N = 105) were administered along with the Patient Reported Outcome Measurement Information System Brief Profile, Prosthesis Evaluation Questionnaire - Mobility Subscale, and Activities-Specific Balance Confidence Scale, and questions created to characterize respondents., Results: A bank of 44 calibrated self-report items, termed the Prosthetic Limb Users Survey of Mobility (PLUS-M), was produced. Clinical and statistical criteria were used to select items for 7- and 12-item short forms. PLUS-M instruments had an 8th grade reading level, measured with precision across a wide range of respondents, exhibited little-to-no ceiling or floor effects, correlated expectedly with scores from existing PROMs, and differentiated between groups of respondents expected to have different levels of mobility., Conclusion: The PLUS-M appears to be well suited to measuring prosthetic mobility in people with lower limb amputation. PLUS-M instruments are recommended for use in clinical and research settings., (© 2023 The Authors. PM&R published by Wiley Periodicals LLC on behalf of American Academy of Physical Medicine and Rehabilitation.)

Objective: To develop and validate a patient-specific multivariable prediction model that uses variables readily available in the electronic medical record to predict 12-month mobility at the time of initial post-amputation prosthetic prescription. The prediction model is designed for patients who have undergone their initial transtibial (TT) or transfemoral (TF) amputation because of complications of diabetes and/or peripheral artery disease., Design: Multi-methodology cohort study that identified patients retrospectively through a large Veteran's Affairs (VA) dataset then prospectively collected their patient-reported mobility., Setting: The VA Corporate Data Warehouse, the National Prosthetics Patient Database, participant mailings, and phone calls., Participants: Three-hundred fifty-seven veterans who underwent an incident dysvascular TT or TF amputation and received a qualifying lower limb prosthesis between March 1, 2018, and November 30, 2020 (N=357)., Interventions: Not applicable., Main Outcome Measure: The Amputee Single Item Mobility Measure (AMPSIMM) was divided into a 4-category outcome to predict wheelchair mobility (0-2), and household (3), basic community (4), or advanced community ambulation (5-6)., Results: Multinomial logistic lasso regression, a machine learning methodology designed to select variables that most contribute to prediction while controlling for overfitting, led to a final model including 23 predictors of the 4-category AMPSIMM outcome that effectively discriminates household ambulation from basic community ambulation and from advanced community ambulation-levels of key clinical importance when estimating future prosthetic demands. The overall model performance was modest as it did not discriminate wheelchair from household mobility as effectively., Conclusions: The AMPREDICT PROsthetics model can assist providers in estimating individual patients' future mobility at the time of prosthetic prescription, thereby aiding in the formulation of appropriate mobility goals, as well as facilitating the prescription of a prosthetic device that is most appropriate for anticipated functional goals., (Copyright © 2023. Published by Elsevier Inc.)

Background: The choice of incident amputation level can have a profound effect on clinical outcomes. Amputations at the transmetatarsal (TM) or transtibial (TT) levels result in greater preservation of function and mobility, whereas transfemoral (TF) amputations typically result in a greater adverse impact. Prior investigations have explored racial/ethnic and regional variation in incident amputation level. This study overcomes some of the methodological limitations seen in prior research through the use of a large national, multiyear veteran sample and by including only those who have undergone an incident amputation., Objectives: (1) Determine if there are national/regional differences in the frequency of incident TF amputation compared with TM and TT amputation, (2) Determine if race/ethnicity and geographic region are associated with incident TF amputation level, and (3) Determine if racial/ethnic disparities of incident TF amputation differ by the presence of diabetes or prior revascularization., Design: Retrospective cohort study of veterans undergoing an incident dysvascular lower extremity amputation., Setting: One hundred ten Veterans Affairs (VA) Medical Centers., Participants: Seven thousand two hundred ninety-six Veterans undergoing incident unilateral dysvascular lower extremity amputation identified in the Veterans Affairs Surgical Quality Improvement Program (VASQIP) database (2005-2014)., Interventions: Not applicable., Main Outcome Measure: Incident amputation level., Results: The White, Black, and Hispanic risk for an incident TF amputation was 31% (n = 1356), 35% (n = 810), and 46% (n = 293), respectively. In the Continental region, Blacks who had not had a prior revascularization were more likely to undergo a TF amputation compared to Whites both with and without diabetes (odds ratio [OR] = 1.4; 95% confidence interval [CI], 1.1, 1.9 and OR = 1.5; 95% CI, 1.1, 2.1, respectively). In the Southeast region, Hispanics compared with Whites were at increased odds of undergoing a TF amputation, irrespective of a diabetes or a prior revascularization (ORs ≥ 2.9)., Conclusions: Racial and ethnic disparities exist in choice of proximal compared with distal amputation in specific VA geographic regions., (© 2021 American Academy of Physical Medicine and Rehabilitation.)

Introduction: The most suitable elevated vacuum (EV) pressure may differ for each individual prosthesis user depending on suspension needs, socket fit, prosthetic components, and health. Mechanical and physiological effects of EV were evaluated in an effort to determine the optimal vacuum pressure for three individuals., Methods: Instrumented EV sockets were created based on the participants' regular EV sockets. Inductive distance sensors were embedded into the wall of the socket at select locations to measure limb movement relative to the socket. Each participant conducted an activity protocol while limb movement, limb fluid volume, and user-reported comfort were measured at various socket vacuum pressure settings., Results: Increased socket vacuum pressure resulted in reduced limb-socket displacement for each participant; however, 81-93% of limb movement was eliminated by a vacuum pressure setting of 12 (approximately -9 inHg). Relative limb-socket displacement by sensor location varied for each participant, suggesting distinct differences related to socket fit or residual limb tissue content. The rate of limb fluid volume change and the change in socket comfort did not consistently differ with socket vacuum pressure, suggesting a more complex relationship unique to each individual., Conclusions: Practitioners may use individual responses to optimize socket vacuum pressure settings, balancing mechanical and physiological effects of EV for improved clinical outcomes., Competing Interests: Conflict of Interest: Authors state no conflicts of interest.

Background: Women Veterans with amputation are a group with unique needs whose numbers have grown over the last 5 years, accounting for nearly 3% of all Veterans with amputation in 2019. Although identified as a national priority by the Veterans Health Administration, the needs of this population have remained largely underrepresented in amputation research., Objective: To describe the experiences of women Veterans with lower extremity amputation (LEA) related to prosthetic care provision and devices., Design: National qualitative study using semi-structured individual interviews., Participants: Thirty women Veterans with LEA who had been prescribed a prosthesis at least 12 months prior., Approach: Inductive content analysis., Key Results: Four key themes emerged: (1) a sense of "feeling invisible" and lacking a connection with other women Veterans with amputation; (2) the desire for prosthetic devices that meet their biological and social needs; (3) the need for individualized assessment and a prosthetic limb prescription process that is tailored to women Veterans; the current process was often perceived as biased and either dismissive of women's concerns or failing to adequately solicit them; and (4) the desire for prosthetists who listen to and understand women's needs., Conclusions: Women Veterans with LEA articulated themes reminiscent of those previously reported by male Veterans with LEA, such as the importance of prostheses and the central role of the provider-patient relationship. However, they also articulated unique needs that could translate into specific strategies to improve prosthetic care, such as integrating formal opportunities for social support and peer interaction for women Veterans with LEA, advocating for administrative changes and research efforts to expand available prosthetic component options, and ensuring that clinical interactions are gender-sensitive and free of bias., (© 2022. The Author(s).)

Objective: The aim of this study was to determine the cumulative incidence of, and the risk factors associated with, contralateral amputation in patients with chronic limb threatening ischaemia (CLTI)., Methods: This was a retrospective cohort study of patients with incident unilateral transmetatarsal (TM), transtibial (TT), or transfemoral (TF) amputation secondary to CLTI, identified from the National Veterans Affairs Surgical Quality Improvement Program database (2004 - 2014). Thirteen potential pre-operative risk factors for contralateral amputation were considered. A competing risk analysis to estimate the cumulative incidence of contralateral amputation was performed using a Fine-Gray subdistribution hazard model. The effect of risk factors on contralateral amputation was estimated by computing subdistribution hazard ratios (sub-HR) with 95% confidence intervals (CI)., Results: From the database, 7 360 patients met the inclusion criteria. The contralateral amputation risk was 7.7% and was greatest in those who underwent a TF amputation (9.7%), followed by TT (7.4%) and TM amputation (6.6%) (p < .001). Among the 588 contralateral amputations, 50% were at the TF level, 34% at the TT level, and 16% at the TM level. The adjusted risk of contralateral amputation was greater in those who underwent an incident TF amputation or were Black or Hispanic. The factor that contributed to risk of contralateral amputation to the greatest extent was dialysis (sub-HR, 2.3; 95% CI 1.7 - 3.0; p < .001) while those who were obese (compared with underweight) were at lowest risk (0.67; 95% CI 0.46 - 0.97; p = .030)., Conclusion: The one year risk of contralateral amputation in patients with CLTI is related to incident amputation level, medical comorbidities, correlates with race/ethnicity, and body mass index at the time of the incident amputation. The identified risk factors are largely not modifiable; however, they can be used to help identify populations at elevated risk., (Copyright © 2022 European Society for Vascular Surgery. All rights reserved.)

Objective: Amputation level decision making in patients with chronic limb threatening ischaemia is challenging. Currently, evidence relies on published average population risks rather than individual patient risks. The result is significant variation in the distribution of amputation levels across health systems, geographical regions, and time. Clinical decision support has been shown to enhance decision making, especially complex decision making. The goal of this study was to translate the previously validated AMPREDICT prediction models by developing and testing the usability of the AMPREDICT Decision Support Tool (DST), a novel, web based, clinical DST that calculates individual one year post-operative risk of death, re-amputation, and probability of achieving independent mobility by amputation level., Methods: A mixed methods approach was used. Previously validated prediction models were translated into a web based DST with additional content and format developed by an expert panel. Tool usability was assessed using the Post-Study System Usability Questionnaire (PSSUQ; a 16 item scale with scores ranging from 1 to 7, where lower scores indicate greater usability) by 10 clinician end users from diverse specialties, sex, geography, and clinical experience. Think aloud, semi-structured, qualitative interviews evaluated the AMPREDICT DST's look and feel, user friendliness, readability, functionality, and potential implementation challenges., Results: The PSSUQ overall and subscale scores were favourable, with a mean overall total score of 1.57 (standard deviation [SD] 0.69) and a range from 1.00 to 3.21. The potential clinical utility of the DST included (1) assistance in counselling patients on amputation level decisions, (2) setting outcome expectations, and (3) use as a tool in the academic environment to facilitate understanding of factors that contribute to various outcome risks., Conclusion: After extensive iterative development and testing, the AMPREDICT DST was found to demonstrate strong usability characteristics and clinical relevance. Further evaluation will benefit from integration into an electronic health record with assessment of its impact on physician and patient shared amputation level decision making., (Copyright © 2021 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Objective: To (1) evaluate the effects of a group-based self-management treatment intervention (VETPALS) on physical and psychosocial functioning (primary outcomes) and quality of life (secondary outcome) in individuals with amputation and (2) examine the feasibility and acceptability of the intervention in a large national health care system., Design: Randomized controlled trial with masked outcome assessment., Setting: Five Veterans Affairs medical centers geographically dispersed across the United States., Participants: 147 individuals with amputation during the past 2 years due to chronic limb threatening ischemia (N=147)., Interventions: Participants were randomized into VETPALS (N =71) or education control (N=76). VETPALS consisted of a 4-hour workshop and 4 additional 2-hour sessions addressing self-management skills, health and activity, managing emotions, communication and social support, and maintaining goals and gains. Education control consisted of the provision of amputation-related educational materials and provider follow-up if requested., Main Outcome Measures: Primary outcomes were physical functioning (Short Musculoskeletal Functional Assessment) and psychosocial functioning (Patient Health Questionnaire-9). Secondary outcomes were quality of life (global) and quality of life (satisfaction with health) from the World Health Organization Quality of Life Scale (brief). Assessment was conducted at baseline, 6 weeks (treatment completion), and 6 months (follow-up)., Results: Participants randomized to VETPALS reported significantly improved psychosocial functioning and quality of life (satisfaction with health) relative to controls at 6 months (B=1.84; 95% confidence interval, 0.37,3.31 and B=-0.61; 95% confidence interval, -1.11,-0.12, respectively). There were no differences in physical functioning over time between VETPALS and education control at either time point. Follow-up multiple imputation sensitivity analyses produced an identical pattern of results. Among VETPALS participants, treatment initiation was low (56%), but treatment retention (93% attended 4 of 5 classes) and overall satisfaction (100% reported very helpful or better and would recommend to a friend) were high., Conclusions: Group-based self-management improves psychosocial functioning for individuals with amputation due to chronic limb threatening ischemia. In-person participation is challenging for this population, but individuals who successfully initiate treatment typically persist and are highly satisfied., (Published by Elsevier Inc.)

Objective: The decision to undertake a major lower limb amputation can be complex. This review evaluates the performance of risk prediction tools in estimating mortality, morbidity, and other outcomes following amputation., Methods: A systematic review was performed following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. The MEDLINE, Embase, and Cochrane databases were searched to identify studies reporting on risk prediction tools that predict outcomes following amputation. Outcome measures included the accuracy of the risk tool in predicting a range of post-operative complications, including mortality (both short and long term), peri-operative morbidity, need for re-amputation, and ambulation success. A narrative synthesis was performed in accordance with the Guidance on the Conduct of Narrative Synthesis In Systematic Reviews., Results: The search identified 518 database records. Twelve observational studies, evaluating 13 risk prediction tools in a total cohort of 61 099 amputations, were included. One study performed external validation of an existing risk prediction tool, while all other studies developed novel tools or modified pre-existing generic calculators. Two studies conducted external validation of the novel/modified tools. Nine tools provided risk estimations for mortality, two tools provided predictions for post-operative morbidity, two for likelihood of ambulation, and one for re-amputation to the same or higher level. Most mortality prediction tools demonstrated acceptable discrimination performance with C statistic values ranging from 0.65 to 0.81. Tools estimating the risk of post-operative complications (0.65 - 0.74) and necessity for re-amputation (0.72) also performed acceptably. The Blatchford Allman Russell tool demonstrated outstanding discrimination for predicting functional mobility outcomes post-amputation (0.94). Overall, most studies were at high risk of bias with poor external validity., Conclusion: This review identified several risk prediction tools that demonstrate acceptable to outstanding discrimination for objectively predicting an array of important post-operative outcomes. However, the methodological quality of some studies was poor, external validation studies are generally lacking, and there are no tools predicting other important outcomes, especially quality of life., Competing Interests: Conflicts of interest Daniel Norvell and Joseph Czerniecki were involved in the development of the AMPREDICT tools,(18)(,)(22)(,)(26) and Christopher Twine and Emma Thomas-Jones developed UKAmpRisk.(23) Ryan A. Preece, Nafi Dilaver, Cherry-Ann Waldron, Philip Pallmann, Emma Thomas-Jones, Brenig L. Gwilym, Christopher P. Twine, and David C. Bosanquet are currently part of the team running PERCEIVE.(33), (Copyright © 2021 European Society for Vascular Surgery. All rights reserved.)

Knee osteoarthritis is a leading cause of ambulatory disability in adults. The most prescribed mobility aid, the walking cane, is often underloaded and therefore fails to reduce knee joint loading and provide symptomatic relief. For this study, a novel walking cane with haptic biofeedback was designed to improve cane loading and reduce the knee adduction moment (KAM). To determine; 1) the short-term efficacy of a novel walking cane using haptic biofeedback to encourage proper cane loading and 2) the effects of the novel cane on KAM. Cane loading and KAM, peak knee adduction moment (PKAM), and knee adduction angular impulse (KAAI)) while walking were calculated under five conditions: 1) naïve, 2A) after scale training (apply 20%BW to cane while standing, using a beam scale), 2B) scale recall (attempt to load the cane to 20%BW), 3A) after haptic training (vibrotactile biofeedback delivered when target cane load achieved), and 3B) haptic recall (attempt to load the cane to 20%BW with vibrotactile biofeedback delivered). Compared to the naïve condition all interventions significantly increased cane loading and reduced PKAM and KAAI. No differences between haptic recall and scale recall condition were observed. The haptic biofeedback cane was shown to be an effective and simple way to increase cane loading and reduced knee loading. Haptic biofeedback and scale training were equally effective at producing immediate short-term improvements in cane loading and knee loading. Future studies should examine the long-term effects of scale training and canes with haptic biofeedback on knee joint health, pain, and osteoarthritis disease progression., (Copyright © 2020 Elsevier Ltd. All rights reserved.)

Background: Prosthetic feet are available in a range of stiffness categories, however, there is limited evidence to guide optimal selection during prosthetic foot prescription. The aim of this study was to determine the effect of commercial prosthetic foot stiffness category on foot-ankle biomechanics, gait symmetry, community ambulation, and relative foot stiffness perception., Methods: Participants were fit in randomized order with three consecutive stiffness categories of a commonly-prescribed prosthetic foot. Prosthetic foot roll-over shape and ankle push-off power and work were determined via data collected during walking in a motion analysis laboratory. Step activity was recorded during community use of each foot. Self-reported perception of relative foot stiffness was assessed with an ad hoc survey., Findings: Seventeen males with transtibial amputation completed the study. Prosthetic foot roll-over radius increased with increased prosthetic foot stiffness categories (p < 0.001). Both prosthetic ankle push-off peak power and work decreased with increased foot stiffness categories (p = 0.002). There was no association between prosthetic foot stiffness category and step length symmetry or steps per day. When assessed post-accommodation, there was no association between relative foot stiffness perception and the stiffness category across prosthetic foot conditions., Interpretation: Prosthetic foot stiffness category was significantly associated with changes in prosthetic foot-ankle biomechanical variables, however, was not associated with changes in gait symmetry or community ambulation. Relative prosthetic foot stiffness perception after accommodation was generally inconsistent with the order of prosthetic foot stiffness categories., Clinical Relevance: While there were quantifiable differences in prosthetic foot-ankle biomechanics across stiffness categories, no significant differences were detected in gait symmetry or mean daily step count in the community. Furthermore, after community use, participants perceptions of relative stiffness across feet were generally inconsistent with the order of prosthetic foot stiffness categories. These findings raise questions as to whether changes in commercial prosthetic foot stiffness category (within a clinically relevant range) affect subjective and objective measures relevant to successful outcomes from prosthetic foot prescription., (Published by Elsevier Ltd.)

Elevated vacuum (EV) is suggested to improve suspension and limb volume management for lower limb prosthesis users. However, few guidelines have been established to facilitate configuration of EV sockets to ensure their safe and proper function. A benchtop model of an EV socket was created to study how prosthetic liner tensile elasticity, socket fit, and socket vacuum pressure affect liner displacement and subsequent pressure on the residual limb. A domed carbon fiber layup was used to represent an EV socket. Inserts were used to simulate various air gaps between the socket and liner. Various prosthetic liner samples were placed under the carbon fiber layup. Liner displacement and the corresponding pressure change underneath the liner were measured as vacuum was applied between the liner sample and socket wall. Tissue vacuum pressure increased linearly with socket vacuum pressure until the liner contacted the socket wall. Predicted tissue vacuum pressure matched well with experimental results. Findings suggest that the effect of vacuum pressure on the residual limb is primarily determined by air gap distance. The developed model may be used to assess effects of EV on residual limb tissues based on an individual's socket fit, liner characteristics, and applied vacuum. Understanding the physiological effects of EV on the residual limb could help practitioners avoid blister formation and improve EV implementation., Competing Interests: Declaration of Competing Interest The authors declare no conflict of interest., (Copyright © 2020 IPEM. Published by Elsevier Ltd. All rights reserved.)

Objective: To identify timing, incidence, and risk factors for ipsilateral re-amputation within 12 months of first dysvascular amputation and to determine specific subgroups of patients at each amputation level that are at increased risk., Methods: A retrospective cohort study evaluating 7187 patients with first unilateral transmetatarsal (TM), transtibial (TT), or transfemoral (TF) amputation secondary to diabetes and/or peripheral artery disease (PAD) were identified in the VA Surgical Quality Improvement Program database between 2004 and 2014. Re-amputation was defined as any subsequent ipsilateral soft tissue/bony revision or amputation to a higher level. Twenty-three potential pre-operative risk factors (and nine potential interactions) were identified. A backward stepwise Cox regression was used to identify risk factors. Incidence rates and hazard ratios (HR) with 95% confidence intervals (CI) were computed., Results: The median time to highest level of re-amputation in the first year was 33 (interquartile range, 13-73) days. Risk of requiring at least one re-amputation was 41% (TM), 25% (TT), and 9% (TF). Risk factors associated with requiring re-amputation included chronic obstructive pulmonary disease, elevated white blood cell count, abnormal ankle brachial index (ABI), history of revascularisation, and alcohol misuse. TM patients who had diabetes only (HR 1.9; 95% CI 1.4-2.5), diabetes with an abnormal ankle brachial index (ABI) score (HR 2.4; 95% CI 1.8-3.2), and kidney failure (HR 1.7; 95% CI 1.3-2.1) were at the greatest risk of re-amputation. TT amputees who were smokers were also at an increased risk (HR 1.4; 95% CI 1.2-1.6)., Conclusion: This research identified important risk factors for failure of primary healing and need for re-amputation at the TM and TT level. If considering a TM amputation, caution should be exercised in patients with diabetes, in particular those with an abnormal ABI and/or renal failure. At the TT level, caution should be exercised in those who smoke., (Copyright © 2020 European Society for Vascular Surgery. Published by Elsevier B.V. All rights reserved.)

Background: Previous studies investigating limb volume change with elevated vacuum have shown inconsistent results and have been limited by out-of-socket volume measurements and short, single-activity protocols., Objectives: To evaluate the effectiveness of elevated vacuum for managing limb fluid volume compared to suction suspension with an in-socket measurement modality during many hours of activity., Study Design: Fixed-order crossover design with a standardized out-of-laboratory activity protocol., Methods: Transtibial electronic elevated vacuum users participated in two sessions. Elevated vacuum was used during the first session, and suction suspension in the second. Participants completed a 5.5-h protocol consisting of multiple intervals of activity. In-socket residual limb fluid volume was continuously measured using a custom portable bioimpedance analyzer., Results: A total of 12 individuals participated. Overall rate of fluid volume change was not significantly different, though the rate of posterior fluid volume change during Cycle 3 was significantly lower with elevated vacuum. Although individual results varied, 11 participants experienced lower overall rates of fluid volume loss in at least one limb region using elevated vacuum., Conclusion: Elevated vacuum may be more effective as a volume management strategy after accumulation of activity. Individual variation suggests the potential to optimize the limb fluid volume benefits of elevated vacuum by reducing socket vacuum pressure for some users., Clinical Relevance: A better understanding of how elevated vacuum (EV) affects residual limb fluid volume will allow prosthetists to make more informed clinical decisions regarding accommodation strategies designed to improve daily socket fit.

Objective: To assess whether the risk of subsequent lower-limb amputations and death following an initial toe amputation among individuals with diabetes has changed over time and varies by demographic characteristics and geographic region., Research Design and Methods: Using Veterans Health Administration (VHA) electronic medical records from 1 October 2004 to 30 September 2016, we determined risk of subsequent ipsilateral minor and major amputation within 1 year after an initial toe/ray amputation among veterans with diabetes. To assess changes in the annual rate of subsequent amputation over time, we estimated age-adjusted incidence of minor and major subsequent ipsilateral amputation for each year, separately for African Americans (AAs) and whites. Geographic variation was assessed across VHA markets ( n = 89) using log-linear Poisson regression models adjusting for age and ethnoracial category., Results: Among 17,786 individuals who had an initial toe amputation, 34% had another amputation on the same limb within 1 year, including 10% who had a major ipsilateral amputation. Median time to subsequent ipsilateral amputation (minor or major) was 36 days. One-year risk of subsequent major amputation decreased over time, but risk of subsequent minor amputation did not. Risk of subsequent major ipsilateral amputation was higher in AAs than whites. After adjusting for age and ethnoracial category, 1-year risk of major subsequent amputation varied fivefold across VHA markets., Conclusions: Nearly one-third of individuals require reamputation following an initial toe amputation, although risks of subsequent major ipsilateral amputation have decreased over time. Nevertheless, risks remain particularly high for AAs and vary substantially geographically., (© 2020 by the American Diabetes Association.)

Objectives: Characterize the course of depressive symptoms during the first year after dysvascular amputation and identify factors that predict symptom trajectories., Design: Prospective cohort study of individuals undergoing lower extremity amputation (LEA), surveyed at 4 time points (perioperative period, 6 weeks, 4 months, and 12 months postamputation). Multilevel modeling was used to describe and predict trajectories., Setting: Four Veterans Affairs medical centers, a university hospital, and a level I trauma center., Participants: Participants (N=141; 74% retention) were a consecutive sample, eligible if they were undergoing their first unilateral LEA secondary to dysvascular disease., Interventions: Not applicable., Main Outcome Measure: Patient Health Questionnaire-9., Results: Approximately 40% of participants endorsed at least moderate depressive symptoms at perioperative baseline. Individuals with greater depressive symptoms in the perioperative period concurrently reported greater pain, poorer self-rated health, and prior mental health treatment. In the first 6 weeks after amputation there was a substantial improvement in depressive symptoms, especially among individuals with greater symptoms at baseline. Depressive symptoms were generally stable after 6 weeks. None of the covariates assessed significantly predicted trajectories of depressive symptom improvement., Conclusions: Watchful waiting may be the most appropriate course of action for many patients in the first 6 weeks after amputation. After 6 weeks, however, symptom levels tend to stabilize, suggesting that active intervention is called for if patients remain depressed at this point. Some patients may benefit from more proactive intervention, such as those with prior mental health treatment histories., (Published by Elsevier Inc.)

Background: Patients undergoing amputation of the lower extremity for the complications of peripheral artery disease and/or diabetes are at risk of treatment failure and the need for reamputation at a higher level. The aim of this study was to develop a patient-specific reamputation risk prediction model., Methods: Patients with incident unilateral transmetatarsal, transtibial or transfemoral amputation between 2004 and 2014 secondary to diabetes and/or peripheral artery disease, and who survived 12 months after amputation, were identified using Veterans Health Administration databases. Procedure codes and natural language processing were used to define subsequent ipsilateral reamputation at the same or higher level. Stepdown logistic regression was used to develop the prediction model. It was then evaluated for calibration and discrimination by evaluating the goodness of fit, area under the receiver operating characteristic curve (AUC) and discrimination slope., Results: Some 5260 patients were identified, of whom 1283 (24·4 per cent) underwent ipsilateral reamputation in the 12 months after initial amputation. Crude reamputation risks were 40·3, 25·9 and 9·7 per cent in the transmetatarsal, transtibial and transfemoral groups respectively. The final prediction model included 11 predictors (amputation level, sex, smoking, alcohol, rest pain, use of outpatient anticoagulants, diabetes, chronic obstructive pulmonary disease, white blood cell count, kidney failure and previous revascularization), along with four interaction terms. Evaluation of the prediction characteristics indicated good model calibration with goodness-of-fit testing, good discrimination (AUC 0·72) and a discrimination slope of 11·2 per cent., Conclusion: A prediction model was developed to calculate individual risk of primary healing failure and the need for reamputation surgery at each amputation level. This model may assist clinical decision-making regarding amputation-level selection., (© 2019 BJS Society Ltd Published by John Wiley & Sons Ltd.)

Background: Patients who undergo lower extremity amputation secondary to the complications of diabetes or peripheral artery disease have poor long-term survival. Providing patients and surgeons with individual-patient, rather than population, survival estimates provides them with important information to make individualized treatment decisions., Methods: Patients with peripheral artery disease and/or diabetes undergoing their first unilateral transmetatarsal, transtibial or transfemoral amputation were identified in the Veterans Affairs Surgical Quality Improvement Program (VASQIP) database. Stepdown logistic regression was used to develop a 1-year mortality risk prediction model from a list of 33 candidate predictors using data from three of five Department of Veterans Affairs national geographical regions. External geographical validation was performed using data from the remaining two regions. Calibration and discrimination were assessed in the development and validation samples., Results: The development sample included 5028 patients and the validation sample 2140. The final mortality prediction model (AMPREDICT-Mortality) included amputation level, age, BMI, race, functional status, congestive heart failure, dialysis, blood urea nitrogen level, and white blood cell and platelet counts. The model fit in the validation sample was good. The area under the receiver operating characteristic (ROC) curve for the validation sample was 0·76 and Cox calibration regression indicated excellent calibration (slope 0·96, 95 per cent c.i. 0·85 to 1·06; intercept 0·02, 95 per cent c.i. -0·12 to 0·17). Given the external validation characteristics, the development and validation samples were combined, giving a total sample of 7168., Conclusion: The AMPREDICT-Mortality prediction model is a validated parsimonious model that can be used to inform the 1-year mortality risk following non-traumatic lower extremity amputation of patients with peripheral artery disease or diabetes., (Published 2019. This article is a U.S. Government work and is in the public domain in the USA.)