Long-term functional and clinical outcome of combined targeted muscle reinnervation and osseointegration for functional bionic reconstruction in transhumeral amputees: a case series.

OBJECTIVE: To describe and evaluate the combination of osseointegration and nerve transfers in 3 transhumeral amputees. DESIGN: Case series. PATIENTS: Three male patients with a unilateral traumatic transhumeral amputation. METHODS: Patients received a combination of osseointegration and targeted muscle reinnervation surgery. Rehabilitation included graded weight training, range of motion exercises, biofeedback, table-top prosthesis training, and controlling the actual device. The impairment in daily life, health-related quality of life, and pain before and after the intervention was evaluated in these patients. Their shoulder range of motion, prosthesis embodiment, and function were documented at a 2- to 5-year follow-up. RESULTS: All 3 patients attended rehabilitation and used their myoelectric prosthesis on a daily basis. Two patients had full shoulder range of motion with the prosthesis, while the other patient had 55° of abduction and 45° of anteversion. They became more independent in their daily life activities after the intervention and incorporated their prosthesis into their body scheme to a high extent. CONCLUSION: These results indicate that patients can benefit from the combined procedure. However, the patients' perspective, risks of the surgical procedures, and the relatively long rehabilitation procedure need to be incorporated in the decision-making.

Transtibial osseointegration following unilateral traumatic amputation: An observational study of patients with at least two years follow-up.

IMPORTANCE: Most patients use a traditional socket prosthesis (TSP) to ambulate independently following transtibial amputation. However, these patients generally require prosthesis repairs more than twice annually and an entirely new prosthesis every two years. Furthermore, transtibial amputation patients have four times the skin ulceration rate of transfemoral patients, prompting more frequent prosthesis refitting and diminished use. Trans-Tibial osseointegration (TTOI) is a promising technique to address the limitations of TSP, but remains understudied with only four cohorts totaling 41 total procedures reported previously. Continued concerns regarding the risk of infection and questions as to functional capacity postoperatively have slowed adoption of TTOI worldwide. OBJECTIVE: This study reports the changes in mobility, quality of life (QOL), and the safety profile of the largest described cohort of patients with unilateral TTOI following traumatic amputation. DESIGN: Retrospective observational cohort study. The cohort consisted of patients with data outcomes collected before and after osseointegration intervention. SETTING: A large, tertiary referral, major metropolitan center. PARTICIPANTS: Twenty-one skeletally mature adults who had failed socket prosthesis rehabilitation, with at least two years of post-osseointegration follow-up. MAIN OUTCOMES AND MEASURES: Mobility was evaluated by K-level, Timed Up and Go (TUG), and Six Minute Walk Test (6MWT). QOL was assessed by survey: daily prosthesis wear hours, prosthesis problem experience, general contentment with prosthesis, and Short Form 36 (SF36). Adverse events included any relevant unplanned surgery such as for infection, fracture, implant loosening, or implant failure. RESULTS: All patients demonstrated statistically significant improvement post osseointegration surgery with respect to K-level, TUG, 6MWT, prosthesis wear hours, prosthesis problem experience, general prosthesis contentment score, and SF36 Physical Component Score (p < 0.01 for all). Three patients had four unplanned surgeries: two soft tissue refashionings, and one soft tissue debridement followed eventually by implant removal. No deaths, postoperative systemic complications, more proximal amputations, or periprosthetic fractures occurred. CONCLUSIONS AND RELEVANCE: TTOI is likely to confer mobility and QOL improvements to patients dissatisfied with TSP rehabilitation following unilateral traumatic transtibial amputation. Adverse events are relatively infrequent and not further disabling. Judicious use of TTOI seems reasonable for properly selected patients. LEVEL OF EVIDENCE: 2 (Therapeutic investigation, Observational study with dramatic effect).

Posttraumatic Amputations Epidemiology and Outcomes Within the National Trauma Data Bank: Improved Survival Over Time Results in Increased Population in Need of Rehabilitation Support.

OBJECTIVE: Acute trauma care has significantly reduced mortality over the last two decades. The last study to examine the epidemiology of traumatic amputees predates these gains. The majority of those who sustain traumatic amputation are male; therefore, limited data exist on female amputees. This study aimed to (1) provide a current epidemiological analysis of traumatic amputees and (2) compare male and female amputees. DESIGN: All patients sustaining a major limb amputation in the National Trauma Data Bank from 2013 to 2017 were identified. First, descriptive analyses of patient demographics and injury characteristics were performed and compared with a previous 2000-2004 National Trauma Data Bank study. Second, female and male traumatic amputees were compared in this study. RESULTS: From 2013 to 2017, we identified 7016 patients who underwent major limb amputation. Compared with previous years, the current amputees were older and more severely injured. Mortality was 6.3% in the current years compared with 13.4% in the previous years (odds ratio, 0.44, 95% CI = 0.37-0.51, P < 0.001). After multivariable analysis, mortality remained significantly decreased, with no difference in hospital length of stay. CONCLUSIONS: Contemporary National Trauma Data Bank analysis demonstrated that patients with traumatic amputations, regardless of sex, often survive until hospital discharge, despite more severe injuries.

Functional outcomes and associated factors of individuals with unilateral traumatic lower limb amputation in Sri Lanka: An observational study.

BACKGROUND: Rehabilitation is important after an amputation surgery. This study was conducted to find the level of functional outcomes of individuals with unilateral traumatic lower limb amputation and the impact of sociodemographic, amputation, and rehabilitation characteristics on functional outcomes. METHODS: An observational cross-sectional study was conducted with 48 participants (aged 20-60 years) who visited the Center for Handicapped from across the country. Functional outcomes were measured using the Locomotor Capabilities Index, Amputee Mobility Predictor with Prosthesis, 6-minute walk distance, and spirometry test and sociodemographic, amputation, and rehabilitation characteristics using a self-constructed questionnaire. RESULTS: Amputee Mobility Predictor with Prosthesis K levels showed 65% had the ability to ambulate in the community and could master environmental barriers. Locomotor Capabilities Index scores showed 96% could independently perform basic daily activities with or without using assistive devices and 83% could perform advanced daily activities. None of the individuals had achieved their predicted 6-minute walk distance, but 52% had "good and above" level of maximum oxygen consumption; restrictive respiratory pattern was indicated among 31%. Amputee Mobility Predictor with Prosthesis and Locomotor Capabilities Index scores were significantly ( p < 0.005) affected by mobility hours/day, amputation level, prosthesis usage, and satisfaction. Six-minute walk distance was significantly ( p < 0.005) related to income, time since amputation, duration of rehabilitation, mobility hours/day, sex, job engagement, previous job, amputation level, K levels, and satisfaction with prosthesis. CONCLUSION: Rehabilitation in Sri Lanka mainly focuses on basic walking training, not on long-term survival, distance walking, and cardiorespiratory endurance, which can lead to future comorbidities. Raising awareness in the society about rehabilitation services and more effective rehabilitation programs are recommended.

The burden of post-traumatic amputations in a developing country - An epidemiological study from a level I trauma centre.

BACKGROUND: With the rapidly growing population and expanding vehicle density on the roads, there has been an upsurge in road accidents in developing countries. Knowledge about the causes and patterns of trauma-related amputations helps in the formulation of strategies for limb savage, timely management, and effective rehabilitation. OBJECTIVE: To study the epidemiology, demographic profile, and outcomes of post-trauma amputations at a level I tertiary care centre in North India. METHODS: Retrospective evaluation of the amputee data from 1st January 2018 to 31st December 2019, focusing on demographic details, injury mechanisms, surgical delays, hospital stay, and complications. RESULTS: A total of 17,445 trauma cases were seen in our trauma centre during the study period. Of these, 442 patients (2.5%) underwent major limb amputation. The hospital-based prevalence of traumatic limb amputation was 2.5%. The mean age of the amputees was 35.6years (range 1-75), and the majority were males (n = 369, 83.5%). The lower to upper limb involvement ratio was 3:1 (n = 338:105). A road traffic accident was the most common mode of injury (77.4%), followed by machine-cut injuries (16.1%). On-site traumatic amputation was seen in 23.1% (n = 102), while 43.5% had a mangled limb amputated in the hospital (mean MESS score 9.53). Overall, 27% of cases had a vascular injury after trauma, ultimately ending in limb amputation. The in-hospital mortality was 2% (n = 9/442). 43.7% of patients with a single limb amputation were discharged within 48 h. Extended hospital stay was noted in cases with associated fractures in the other limbs (28.5%), head or facial injury (9.9%), and with or without a combination of chest, abdomen, pelvic, or spine injury (7.2%). CONCLUSION: A 2.5% incidence of post-trauma amputation reflects on the severity of injury related to road and industrial accidents which predominantly affect the lower limbs at the peak of productive work life. In the absence of national amputation registries, the results underscore the need to focus on road safety protocols, patient transfer methods, and the up-gradation of local hospitals.

Microprocessor prosthetic ankles: comparative biomechanical evaluation of people with transtibial traumatic amputation during standing on level ground and slope.

BACKGROUND: The compensations occurrence due to the alteration of the posture and the gait of persons with lower limb amputation is still an issue in prosthetic fitting. Recently, prosthetic feet designed to reproduce the physiological behaviour of the ankle using a microprocessor control have been commercialized to address this issue. OBJECTIVES: Investigate the relevance of these microprocessor prosthetic ankles (MPAs) in the ability of standing on both level and inclined surfaces. METHODS: Six persons with transtibial amputation usually fitted with energy storing and returning (ESR) foot tested three MPAs: Elan® Endolite (MPA1), Meridium® Ottobock (MPA2), ProprioFoot® Ossur (MPA3). Each MPA data acquisition was preceded of a 2 weeks adaptation period at home and followed by a 3-weeks wash-out period with their ESR. Lower limb angular position and moment, Centre of Pressure (CoP) position, Ground Reaction Forces (GRF) and functional scores were collected in static, on level ground and 12% inclined slope. RESULTS: MPAs allowed a better posture and a reduction of residual knee moment on positive and/or negative slope compared to ESR. Results also reflect that the MPA2 allows the best control of the CoP in all situations. CONCLUSIONS: An increased ankle mobility is associated with a better posture and balance on slope. Gait analysis would complete these outcomes. CLINICAL RELEVANCE: This study compares three MPAs to ESR analysing static posture. Static analysis on level ground and slope represents the challenging conditions people with amputation have to cope with in their daily life, especially outdoors. Having a better understanding of the three MPAs behaviour could help to adequately fit the prosthesis to each patient. Implications for rehabilitation This is a study comparing three MPAs. The static analysis in standard and constraining conditions (slope) reflects the balance of people with amputation in their daily life, especially outdoors. Having a better understanding of the behaviour of each foot could help to adequately fit the prosthesis to each patient.

Traumatic quadruple amputee rehabilitation: from amputation to prosthetic functionality: a case report.

INTRODUCTION: Traumatic quadruple amputations limit daily living activities; however, the current literature regarding rehabilitation treatment for multi-limb amputations is scant. The patient showed adaptation to prosthetic fittings, acquiring a level of functional independence that enabled the patient to lead a nearly independent life. METHODS: The patient's therapeutic intervention was divided into a pre-prosthetic phase, which consisted of functional physical adaptation to the amputation and preparation for the prostheses, and a prosthetic phase, in which different myoelectric and microprocessor limb prostheses were integrated to be used functionally. Its functional use was favored by the training with contact electromyography feedback carried out with the Biometrics E-Link System® for the upper extremities that has made it possible to obtain many grip options in a natural way, for the lower extremities the use of the intelligent passive prostheses has overcome the functional capacity achieved in this type of patients referenced in the literature who had used prostheses of previous generations such as mechanical passive prostheses. RESULTS: With rehabilitation, the patient showed improvements in the following scales and questionnaires (initial vs. final values): Disabilities of the Arm, Shoulder, and Hand Questionnaire; Functional Independence Measure; Berg Balance Scale; Locomotor Capabilities Index in Amputees (an assessment of overall motor capacity); and Special Interest Group in Amputee Medicine scale (an assessment of the degree of mobility). CONCLUSIONS: The patient's age, psychological status, and family and personal support, in addition to technical and economic resources used for next-generation prostheses adapted to this clinical case, were crucial for his progress. IMPLICATIONS FOR REHABILITATION The use of next-generation myoelectric and microprocessor prostheses makes it possible to achieve greater end functionality in quadruple amputees. Proximal amputation levels present greater difficulty in achieving good functionality. Early and intensive rehabilitation could favour and contribute towards improving psychological states. Age, psychological status, and pain management are aspects to take into account during the rehabilitation process.

A case report: Transhumeral amputee treatment with osseointegrated prosthesis and rehabilitation.

People with proximal transhumeral amputation usually choose prosthesis as an alternative to improve occupational performance, but frequently presenting difficulties in the distal control, poor elevation to reach some object, and tolerance to use in ADL and day time, added to frustration and high perception of disability. This report described the results in the first experience with one patient who suffered a work accident in Chile in a long-term following up 7 years after discharge, who take the choice for osteointegrated prosthesis training for amputation at the proximal transhumeral level and hybrid system (electrical elbow and body-power hook), the patient has previous experience with conventional body-power prosthesis and caps. For this, a standard rehabilitation protocol was applied, modifying it in relation to the Chilean experience in classical prosthetic training. The evaluation methodology consisted of daily time measurement, functional test of 400 points (adapted), range of motion, VAS, and DASH. The patient underwent these tests with conventional mechanical support prostheses with a common cap before the osseointegration surgery and then at the end of the protocol with the new osseointegrated prostheses. The results showed an increase of 39% in the overall functionality in ADL according to the 400 pts test, according to the DASH test a decrease in perception in disability related to Work of 32 pts and increased tolerance to daily prosthetic use from 3 to 12 hrs and the function of upper extremity reach, greater support and tolerance to use, together with a better control of the prosthesis is highlighted.

Self-Contained Neuromusculoskeletal Arm Prostheses.

We report the use of a bone-anchored, self-contained robotic arm with both sensory and motor components over 3 to 7 years in four patients after transhumeral amputation. The implant allowed for bidirectional communication between a prosthetic hand and electrodes implanted in the nerves and muscles of the upper arm and was anchored to the humerus through osseointegration, the process in which bone cells attach to an artificial surface without formation of fibrous tissue. Use of the device did not require formal training and depended on the intuitive intent of the user to activate movement and sensory feedback from the prosthesis. Daily use resulted in increasing sensory acuity and effectiveness in work and other activities of daily life. (Funded by the Promobilia Foundation and others.).

Affordable passive 3D-printed prosthesis for persons with partial hand amputation.

BACKGROUND AND AIM: Partial hand amputations are common in developing countries and have a negative impact on patients and their families' quality of life. The uniqueness of each partial hand amputation, coupled with the relatively high costs of prostheses, makes it challenging to provide suitable prosthetic solutions in developing countries. Current solutions often have long lead times and require a high level of expertise to produce. The aim of this study was to design and develop an affordable patient-specific partial hand prosthesis for developing countries. TECHNIQUE: The prosthesis was designed for a patient with transmetacarpal amputation (i.e. three amputated fingers and partial palm). The final design was passive, controlled by the contralateral hand, and utilized the advanced flexibility properties of thermoplastic polyurethane in a glove-like design that costs approximately 20 USD to fabricate. Quantitative and qualitative tests were conducted to assess performance of the device after the patient used the final design. A qualitative assessment was performed to gather the patient's feedback following a series of tests of grasp taxonomy. A quantitative assessment was performed through a grasp and lift test to measure the prosthesis' maximum load capacity. DISCUSSION: This study showed that the prosthesis enhanced the patient's manual handling capabilities, mainly in the form of grasp stability. The prosthesis was light weight and could be donned and doffed by the patient independently. Limitations include the need to use the contralateral hand to achieve grasping and low grasp strength. CLINICAL RELEVANCE: Persons with partial hand amputation in developing countries lack access to affordable functional prostheses, hindering their ability to participate in the community. 3D-printed prostheses can provide a low-cost solution that is adaptable to different amputation configurations.

Functional outcome using early controlled active motion in rehabilitation of a replanted hand: A case report.

STUDY DESIGN: Case report. INTRODUCTION: This case report details the postsurgical rehabilitation and outcome of a young maintenance man who sustained a complete amputation of his dominant upper limb at the level of the distal forearm. The patient underwent replantation surgery with 2-centimeter bone shortening, followed by early controlled active motion commencing on day 6. PURPOSE OF THE STUDY: To illustrate the use of early motion after replantation. RESULTS: The patient achieved almost full active range of motion of the digits, intrinsic function, 30 seconds on Nine-Hole Peg Test and early return to work without any additional reconstructive procedures. DISCUSSION: Several fairly recently published protocols advocate initiating active range of motion at only 3 or 4 weeks after upper limb replantation. The following therapeutic interventions were considered important contributors to our favorable functional outcome; early controlled active motion, occupation-based therapy in combination with therapeutic exercises and many custom molded orthoses. CONCLUSION: Future research is required to determine if bone shortening, which is an integral part of replantation surgery, reduces tendon repair tension, allowing for early active motion and thereby contributing to a favorable outcome.

Effect of one session of mirror therapy on phantom limb pain and recognition of limb laterality in military traumatic lower limb amputees: a pilot study.

Up to 70 % of military amputees suffer phantom limb pain (PLP), which is difficult to treat. PLP has been attributed to cortical reorganisation and associated with impaired laterality. Repeated sessions of mirror therapy (MT) can benefit PLP; however, anecdotal evidence suggests one MT session could be effective. In a one-group pretest and post-test design, 16 UK military unilateral lower limb amputees (median age: 31.0, 95% CI 25.0 to 36.8 years) undertook one 10 min MT session. Visual analogue scale (VAS) pain and laterality (accuracy and reaction time) measurements were taken pre-MT and post-MT. Median VAS PLP did not differ significantly between pre-MT 15 mm (2-53 mm) and post-MT 12 mm (1-31) (p=0.875) scores. For the amputated limb, there were no significant differences between pre-MT and post-MT scores for laterality accuracy, 95.3%, 95% CI 90.5% to 97.6% and 96.7%, 95% CI 90.0% to 99.4%, respectively (p=0.778), or reaction time, 1.42 s, 95% CI 1.11 to 2.11 s and 1.42 s, 95% CI 1.08 to 2.02 s, respectively (p=0.629). Laterality was also not different between limbs for accuracy, p=0.484, or reaction time, p=0.716, and did not correlate with PLP severity. No confounding variables predicted individual responses to MT. Therefore, one 10 min MT session does not affect laterality and is not effective as standard treatment for PLP in military lower limb amputees. However, substantial PLP improvement for one individual and resolution of a stuck phantom limb for another infers that MT may benefit specific patients. No correlation found between PLP and laterality implies associated cortical reorganisation may not be the main driver for PLP. Further research, including neuroimaging, is needed to help clinicians effectively target PLP.

Outcomes, Challenges, and Pitfalls after Targeted Muscle Reinnervation in High-Level Amputees: Is It Worth the Effort?

BACKGROUND: Although the distal targets have been lost in proximal upper limb amputees, the neural signals for intuitive hand and arm function are still available and thus can be incorporated into more useful prosthetic function using targeted muscle reinnervation technique. In this article, the authors present their outcomes and range of indications in addition to experiences and pitfalls after 30 targeted muscle reinnervation cases at above-elbow and shoulder disarticulation level of amputation. METHODS: Thirty patients with above-elbow or shoulder disarticulation amputations were enrolled between 2012 and 2017. Indications for targeted muscle reinnervation surgery differed between improvement of prosthetic function (n = 19) and/or pain (n = 11). Functional outcome was evaluated with the Action Research Arm Test, the Southampton Hand Assessment Procedure, and the Clothespin-Relocation Test. Functional evaluation was performed at least at 6 months after final prosthetic fitting. RESULTS: All nerve transfers were successful and provided independent myoelectric signals. The 10 patients available for final functional evaluation showed Action Research Arm Test scores of 20.4 ± 1.9 and Southampton Hand Assessment Procedure scores of 40.5 ± 8.1. The Clothespin-Relocation Test showed a mean time of 34.3 ± 14.4 seconds. CONCLUSIONS: Targeted muscle reinnervation has improved prosthetic control and revolutionized neuroma treatment in upper limb amputees. Still, the rate of abandonment even after targeted muscle reinnervation surgery has been shown high, and several advances within the biotechnological interface will be needed to improve prosthetic function and acceptance in these patients. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, IV.

Clinical Practice Guidelines for the Rehabilitation of Lower Limb Amputation: An Update from the Department of Veterans Affairs and Department of Defense.

Between 2015 and 2017, the US Department of Veterans Affairs and the US Department of Defense developed a clinical practice guideline for rehabilitation of lower limb amputation to address key clinical questions. A multidisciplinary workgroup of US Department of Veterans Affairs and US Department of Defense amputation care subject matter experts was formed, and an extensive literature search was performed which identified 3685 citations published from January 2007 to July 2016. Articles were excluded based on established review criteria resulting in 74 studies being considered as evidence addressing one or more of the identified key issues. The identified literature was evaluated and graded using the National Academies of Science GRADE criteria. Recommendations were formulated after extensive review. Eighteen recommendations were confirmed with four having strong evidence and workgroup confidence in the recommendation. Key recommendations address patient and caregiver education, consideration for the use of rigid and semirigid dressings, consideration for the use of microprocessor knees, and managed lifetime care that includes annual transdisciplinary assessments. In conclusion, this clinical practice guideline used the best available evidence from the past 10 yrs to provide key management recommendations to enhance the quality and consistency of rehabilitation care for persons with lower limb amputation.

Successful ROTEM-guided transfusion therapy in a case of rural paediatric trauma.

Massive transfusion therapy in severe paediatric trauma is a challenge. When this occurs in a rural setting, the potential delays in accessing medical services can lead to worse coagulopathy on presentation. We report successful treatment of a child post-traumatic lower limb amputation where treatment was only initiated 3 hours postinjury due to difficulties in access/retrieval. Rotational thromboelastometry (ROTEM)-guided, goal-directed haemostatic therapy perioperatively utilising a blood product ratio of 2:2:1 units of red blood cell:free frozen plasma:platelet reverted his coagulopathy. This report aims to raise awareness of the utility of ROTEM in paediatric trauma.

Post-Operative Care And Rehabilitation After A Limb Amputation.

Jordan, 26, was involved in an unfortunate motor-bike accident and consequently had to undergo a lower limb amputation. After his operation, he faces a long ordeal to regain his mobility and self-confidence. The multi-disciplinary team assists Jordan in recovering his independence.

Physical Therapy Practice Patterns for Military Service Members with Lower Limb Loss.

INTRODUCTION: Military service members with limb loss have unrestricted access to physical therapy (PT) services. Identifying PT interventions used based on clinical rationale and patient needs/goals can provide insight towards developing best practice guidelines. The purpose of this study was to identify preferred PT practice patterns for military service members with lower limb loss. MATERIALS AND METHODS: This was a retrospective cohort study and was approved by the Naval Health Research Center (NHRC) Institutional Review Board. Data for 495 service members with lower limb loss was analyzed. Frequency of PT visits and units of treatment received were quantified in 3-month increments during the first year after injury and compared for individuals with unilateral limb loss distal to the knee (DIST), unilateral limb loss proximal to the knee (PROX), and bilateral limb loss (BILAT). RESULTS: A total of 86,145 encounters occurred during the first year after injury. Active treatments were included in 94.0% of all treatments, followed by manual therapy (15.1%), patient education (11.5%) and modalities (2.4%). The highest number of encounters, consisting of active and manual therapy, was received by the DIST group within the first 3 months, while after the first 3 months, the BILAT group had higher encounters and received more active and manual therapy. Utilization of patient education was higher in the PROX and BILAT groups compared to the DIST group throughout the first year after injury. CONCLUSIONS: Service members with limb loss utilize PT services often within the first year after injury. Trends of PT practice are most likely influenced by comorbidities and healing time variance between levels of amputation.

Postoperative Management and Rehabilitation of the Replanted or Revascularized Digit.

Postoperative care of amputated digits begins before replantation. Detailed informed consent should be obtained and completion amputation discussed if revascularization is not ultimately successful. Complications and failure of the replanted digit should also be addressed. Postoperative pharmacologic treatment should consist of aspirin, at minimum. Complications, such as venous congestion or occlusion, and arterial thrombosis, should be dealt with expediently. Digital motion rehabilitation should start after 5 to 7 days of digital viability and splinting of the affected digit. Early protective motion protocol is implemented to maintain digital motion with emphasis on tendon glide and joint motion.

Is skin pressure a relevant factor for socket assessment in patients with lower limb amputation?

BACKGROUND: Prosthetic rehabilitation improves the overall quality of life of patients, despite discomfort and medical complications. No quantitative assessment of prosthesis-patient interaction is used in routine protocols and prosthesis quality still results from the manufacturer's know-how. OBJECTIVE: Our objective is to investigate whether pressure can be a relevant factor for assessing socket adequacy. METHODS: A total of 8 transtibial amputee volunteers took part in this experimental study. The protocol included static standing and 2 minutes walking tests while the stump-to-socket interface pressures were measured. Questionnaires on comfort and pain were also conducted. RESULTS: During static standing test, maximum pressures were recorded in the proximal region of the leg, with a peak value reaching 121.1 ± 31.6 kPa. During dynamic tests, maximum pressures of 254.1 ± 61.2 kPa were recorded during the loading phase of the step. A significant correlation was found between the pain score and static maximum recorded pressure (r= 0.81). CONCLUSIONS: The protocol proposed and evaluated in this study is a repeatable, easy-to-set quantified analysis of the patient to socket interaction while standing and walking. This approach is likely to improve feedback for prosthesis manufacturers and consequently the overall design of prostheses.

Patient-Reported and Functional Outcomes After Revision Amputation and Replantation of Digit Amputations: The FRANCHISE Multicenter International Retrospective Cohort Study.

Importance: Optimal treatment for traumatic digit amputation is unknown. Objective: To compare long-term patient-reported and functional outcomes between patients treated with revision amputation or replantation for digit amputations. Design, Setting, and Participants: Retrospective cohort study at 19 centers in the United States and Asia. Participants were 338 individuals 18 years or older with traumatic digit amputations with at least 1 year of follow-up after treatment. Participants were enrolled from August 1, 2016, to April 12, 2018. Exposures: Revision amputation or replantation of traumatic digit amputations. Main Outcomes and Measures: The primary outcome was the Michigan Hand Outcomes Questionnaire (MHQ) score. Secondary outcomes were the 36-Item Short Form Health Survey (SF-36), Disabilities of the Arm, Shoulder, and Hand (DASH), and Patient-Reported Outcomes Measurement Information System (PROMIS) upper-extremity module scores and functional outcomes. Results: Among 338 patients who met all inclusion criteria, the mean (SD) age was 48.3 (16.4) years, and 85.0% were male. Adjusted aggregate comparison of patient-reported outcomes (PROs) between patients with revision amputation and replantation revealed significantly better outcomes in the replantation cohort measured by the MHQ (5.93; 95% CI, 1.03-10.82; P = .02), DASH (-4.29; 95% CI, -8.45 to -0.12; P = .04), and PROMIS (3.44; 95% CI, 0.60 to 6.28; P = .02) scores. In subgroup analyses, DASH scores were significantly lower (6 vs 9, P = .05), indicating less disability and pain, and PROMIS scores higher (78 vs 75, P = .04) after replantation. Patients with 3 or more digits amputated (including thumb) had significantly better PROs after replantation than those managed with revision amputation (22 vs 42, P = .03 for DASH and 61 vs 36, P = .01 for PROMIS). Patients who underwent replantation after 3 or more digits amputated (excluding thumb) had higher MHQ scores, which did not reach statistical significance (69 vs 65, P = .06). Revision amputation in the subgroup with single-finger amputation distal to the proximal interphalangeal joint resulted in better 2-point discrimination (6 vs 8 mm, P = .05). Compared with revision amputation, replantation resulted in better 9-hole peg test times in the subgroup with 3 or more digits amputated (including thumb) (46 vs 81 seconds, P = .001), better Semmes-Weinstein monofilament test in the subgroup with 3 or more digits amputated (excluding thumb) (3 vs 21 g, P = .008), and better 3-point pinch test in the subgroup with 2 digits amputated (excluding thumb) (6.7 vs 5.6 kg, P = .03). Conclusions and Relevance: When technically feasible, replantation is recommended in 3 or more digits amputated and in single-finger amputation (excluding thumb) distal to the proximal interphalangeal joint because it achieved better PROs, with long-term functional benefit. Thumb replantation is still recommended for its integral role in opposition.