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Polyurethane gel liner usage in the Oxford Prosthetic Service.

The objective was to investigate which lower limb amputees are using Alpha polyurethane gel liners and the effects of these on comfort and suspension of their prosthesis. A retrospective study was carried out of case records of all patients issued with Alpha cushion and locking liners between 1997 and the end of January 1999. The type of liner used was compared with age, sex, level and cause of amputation, time since amputation, comfort and suspension. Modified Stanmore/Harold-Wood mobility grades; duration of use and number of liners issued per patient were recorded. Sixteen (16) patients were identified who had been prescribed Alpha cushion liners. Improved comfort was reported by all. Forty (40) patients were identified who had been prescribed Alpha locking liners. Twenty (20) of these reported improved comfort and 10 improved suspension. The average time since amputation was 18.5 years for those using cushion liners and 14.1 years for locking liner users. Fifty-two (52) of all 56 patients using Alpha cushion and locking liners had mobility grades of 4 or more. Trauma was the most common cause of amputation. This group is a relatively mobile group of amputees. All those using cushion liners reported improved comfort. Some of the locking liner users reported improved comfort and suspension but this was not universally the case.

Adolescent↗

Consequences of non-vascular trans-femoral amputation: a survey of quality of life, prosthetic use and problems.

Individuals with unilateral trans-femoral amputations due to non-vascular causes were studied in a mailed survey designed to investigate health-related quality of life (HRQL), prosthetic use and problems. The Swedish SF-36 Health Survey and a structured questionnaire designed for trans-femoral amputees were used. The series consisted of 97 subjects (60 men, 37 women), aged 20 to 69 years with a mean of 22 years since the amputation. Trauma was the cause of amputation in 55%, tumour in 35% and other causes in 10%. Ninety-two (92) subjects (95%) had a prosthesis and 80 (82%) used it daily. General HRQL was significantly lower than Swedish age- and gender-matched norms in all dimensions as measured by SF-36. Most frequently reported problems that had led to reduction in quality of life were heat/sweating in the prosthetic socket (72%), sores/skin irritation from the socket (62%), inability to walk in woods and fields (61%) and inability to walk quickly (59%). Close to half were troubled by stump pain (51%), phantom limb pain (48%), back pain (47%) and pain in the other leg (46%). One fourth considered themselves to have a poor or extremely poor overall situation. Transfemoral amputation, due to non-vascular causes, has an evident impact on quality of life and there are considerable problems related to the amputation and the prosthesis. Efforts to improve the physical and the psychological well-being for this group, with a long life expectancy, are needed.

Activities of Daily Living↗

Effect of trans-tibial prosthesis pylon flexibility on ground reaction forces during gait.

This study explored the effects of trans-tibial prosthesis pylon flexibility on ground reaction forces (GRFs) associated with walking and step-down. Four (4) active subjects with unilateral trans-tibial amputation and pylon lengths ranging from 4.9 cm to 25.9 cm were studied wearing an aluminium (rigid) pylon and a nylon (more flexible) pylon. Ground reaction forces were collected for the amputated limb during walking at pre-measured self-selected velocity and when stepping down from a 20 cm box. Pylon material significantly affected the magnitudes and patterns of GRFs in both tests. During walking, the most notable differences were seen in the anteroposterior (AP) direction. With the flexible pylon, the AP propulsive peak was greater (p=0.031), and the irregularities in the AP force curve were reduced. Additionally, when walking with the flexible pylon, the vertical peak associated with weight acceptance occurred earlier (p=0.010), the vertical terminal stance peak occurred later (p=0.012), and stance time was longer (p=0.010). During step-down, the vertical loading rate (p=0.010) and the peak vertical force (p=0.010) were greater with the more flexible pylon. Subjective feedback indicated that subjects could distinguish between the two pylons and felt that the nylon component was more comfortable, more flexible, and would enable them to walk more quickly. These results suggest that the pylon may be an influential component of the prosthesis with respect to gait and comfort, and that some degree of flexibility is desirable.

Adult↗

Optimising the trans-femoral prosthetic alignment for running, by lowering the knee joint.

For amputees to perform an everyday task, or to participate in physical exercise, it is crucial that they have an appropriately designed functional prosthesis. The aim of this study was to investigate the optimal trans-femoral prosthetic alignment configuration for running. A case study design was implemented as the method to collect data on four male Paralympic level trans-femoral amputee runners. In total 28 synchronised 3D kinematic, kinetic, and temporal biomechanical measures were analysed. A new prosthetic alignment, in which the prosthetic knee axis was lowered longitudinally (moved distally), was evaluated for running. The performance of the symmetry indices and running time for a total of three new modified alignments were compared to the standard prosthetic alignment. The interlimb asymmetry was found to improve when the subjects ran on the modified prosthetic alignment, and most importantly a one way ANOVA found a statistically significant increase in running velocity. This study identified that for all four subjects, who used the same prosthetic components, lowering the prosthetic knee joint centre improved their interlimb symmetry, and subsequently their running velocity by an average of 26%.

Adult↗

Ultrasound study of the motion of the residual femur within a trans-femoral socket during daily living activities other than gait.

This study analyses the residual femur motion of a single amputee within a transfemoral socket during a series of daily living activities. Two simultaneously transmitting, socket mounted transducers were connected to two ultrasound scanners. Displacement measurements of the ultrasound image of the femur were video recorded and measured on "paused" playback. Abduction/adduction and flexion/extension of the residual femur within the socket at any instant during these activities were estimated, knowing the relative positions of the two transducers and the position of the residual femur on the ultrasound image. Consistent motion patterns of the residual femur within the trans-femoral socket were noted throughout each monitored daily living activity of the single amputee studied. Convery and Murray (2000) reported that during level walking, relative to the socket, the residual femur extends 6 degrees and abducts 9 degrees by mid-stance while flexing 6 degrees and adducting 2 degrees by toe-off. Uphill/downhill, turning to the right and stepping up/down altered this reported pattern of femoral motion by approximately 1 degree. During the standing activity from a seated position the femur initially flexed 4 degrees before moving to 7 degrees extension, while simultaneously adducting 6 degrees. During the sitting activity from a standing position the femur moved from 7 degrees extension and 6 degrees adduction to 3 degrees flexion and 1 degree abduction. The activity of single prosthetic support to double support introduced only minor femoral motion whereas during the activity of prosthetic suspension the femur flexed 8 degrees while simultaneously adducting 9 degrees. Additional studies of more amputees are required to validate the motion patterns presented in this investigation.

Accidents, Occupational↗

The biomechanical effects of the inclusion of a torque absorber on trans-femoral amputee gait, a pilot study.

This paper reports on a pilot study investigating the effects on the gait of two transfemoral amputees of to the inclusion of a torque absorber (TA) and its location relative to the knee unit. Both subjects carried out gait tests with a prosthesis with no TA with, a TA proximal to the knee unit and with a TA distal to the knee unit. Three-dimensional gait analysis was carried out to establish the kinematic and kinetic gait parameters of both the prosthetic and sound side. It was found that the TA did not significantly affect the sagittal kinetic and kinematic parameters of the sound or the prosthetic side. However, for one subject the axial rotation of the socket relative to the foot was significantly greater with the TA. It was concluded that by using the methodology of this pilot study, it is possible to investigate the rotations in the transverse plane within the prosthetic limb and pelvis. Further, including a TA may reduce the relative motion between the stump and the socket and therefore may decrease skin breakdown due to diminished shear forces.

Amputation, Surgical↗

Gait analysis in prosthetics: opinions, ideas and conclusions.

A review was performed of the literature of the last eleven years (1990-2000) with the topic: "clinical use of instrumented gait analysis in patients wearing a prosthesis of the lower limb". To this end a literature search was performed in Embase, Medline and Recal. Forty-five (45) articles were identified for study from which 34 were reviewed. The reviews were divided into five subtopics: 1) adaptive strategies in gait (12 studies); 2) the influence of different parts of the prosthesis on gait (12 studies); 3) pressure measurements in the socket in gait studies (4 studies); 4) the influence of the mass of the prostheses on gait (5 studies); 5) energy considerations in gait (2 studies). A considerable part of the studies concerned the adaptive strategies of the amputee in walking and running and the evaluation of different prosthetic feet. All aspects and outcomes were reviewed concerning the clinical relevance.

Adaptation, Physiological↗

The use of snowboard boot bindings in a hip disarticulation prosthesis.

This report describes a new technique for fastening a hip disarticulation socket. It was developed at the request of the patient who needed to fasten his prosthesis using only one hand, because of a left upper limb disability. Snowboard boot bindings were secured to the socket of the prosthesis and allowed it to be securely fastened and released using his dominant hand only. The design of the bindings permitted a high closing force with minimum one-handed effort by the user.

Adult↗

Alignment of trans-tibial prostheses based on roll-over shape principles.

The authors examined the roll-over shape alignment hypothesis, which states that prosthetic feet are aligned by matching their roll-over shapes with an "ideal" shape. The "ideal" shape was considered to be the roll-over shape of the able-bodied foot-ankle system. An alignment algorithm and computational alignment system were developed to set trans-tibial alignments based on this hypothesis. Three prosthetic feet with considerably different roll-over shapes were either aligned using the alignment system or not aligned (i.e. used previous foot's alignment), and then were aligned by a team of prosthetists. No significant differences were found between roll-over shapes aligned by the computational alignment system and those based on standard clinical techniques (p = 0.944). Significant differences were found between the "no alignment" shapes and the prosthetist alignment shapes (p = 0.006), and between the "no alignment" shapes and the computational alignment system shapes (p = 0.024). The results of the experiment support the hypothesis that the goal of alignment is to match the prosthetic foot's roll-over shape, as closely as possible, with an "ideal" shape. The hypothesis is also supported by its ability to explain the results of previous studies. Using an "ideal" roll-over shape or surface as a goal for prosthetic alignment could lead to a priori alignment, eliminating the need for alignment hardware in some cases. Being able to build the alignment into a prosthesis without special hardware could be beneficial in low-income countries and in the fabrication of lightweight prostheses for the elderly.

Adult↗

Rehabilitation of the trans-femoral amputee with an osseointegrated prosthesis: the United Kingdom experience.

Osseointegration for the trans-femoral amputee has been used in the United Kingdom since 1997. To date, 11 candidates have undergone the procedure. The rehabilitation programme for the osseointegration candidate is a long and intensive programme following two surgical operations. This paper outlines the importance of a pre-osseointegration assessment to explore candidates' suitability and expectations for the procedure. The physical and prosthetic advantages of direct skeletal attachment have led to improvements in candidates' comfort, function and quality of life. However, some aspects of this promising developmental procedure for the management of the trans-femoral amputee need to be critically evaluated before it becomes a routine clinical procedure in the United Kingdom.

Amputation, Surgical↗

CIR sand casting system for trans-tibial socket.

The authors have developed a trans-tibial socket fabrication system based on the "dilatancy" principle, a process that has been commonly used in forming wheelchair Seating. The CIR Sand Casting System replaces plaster of Paris with sand for forming both a negative sand mould and a positive sand model, which can be modified for either thermoplastic socket formation or resin lamination. Initial clinical trials suggest that fabrication times are approximately 90 minutes from patient evaluation and casting to dynamic alignment. Compatibility with all existing prosthetic components is retained. It is believed the CIR socket fabrication system may be a competitive alternative for prosthetic service providers in developing countries.

Amputation, Surgical↗

Plantar foot pressure responses to changes during dynamic trans-tibial prosthetic alignment in a clinical setting.

Alignment of a lower limb prosthesis refers to the spatial orientation of the prosthetic components and socket with respect to one another. During the process of dynamic alignment, a prosthetist repeatedly modifies this spatial orientation and observes the amputee's resulting walking pattern, eventually arriving at an alignment that is judged to be optimal. Quantification of the effect of each alignment modification and correlation of the magnitude of modification with the changes in gait could improve understanding of the process and promote an evidential base for practice. This investigation quantified bilateral plantar foot pressures in six trans-tibial amputee subjects during the process of dynamic alignment at prosthetists' clinics during regularly scheduled appointments. Outcomes of changes in prosthetic alignment during the clinical dynamic alignment process were determined to be quantifiable via plantar pedobarography. Changes in the angle between the pylon and the socket in the frontal plane produced predictable shifts in foot pressure between medial and lateral foot regions under the prosthesis, and typically shifted pressure to the lateral region of the contralateral foot, regardless of the direction of the modification. Temporal parameters revealed that subjects initially adopt a conservative locomotor pattern after an alignment change but within a few steps begin to refine their gait and approach more symmetrical single limb support times. Plantar pedobarography provides the clinician with potentially useful information to augment dynamic alignment and provides a tangible record of the results of the process.

Adult↗

Clinical field testing of trans-femoral prosthetic technologies: resin-wood and ICRC-polypropylene.

The aim of this study was to evaluate the use of 2 different trans-femoral prosthetic systems, a conventional wood-resin design and an ICRC polypropylene design, in a developing country when implemented by teachers and their associates at an ISPO Caegory II recognised training establishment. The study was conducted at the Tanzanian Training Centre for Orthopaedic Technologists (TATCOT). Amputees were selected from a cohort of younger amputees, mostly with traumatic amputations, 27 were provided with the conventional design of prosthesis and 35 with the ICRC design. The outcome was evaluated clinically and technically after a median of 20 months (conventional) and 15 months (ICRC) respectively. For all prostheses provided the craftsmanship was considered acceptable in 71%, and patient satisfaction was assessed as 92%, patient compliance as 98%. Failures requiring a major intervention represented 32%. Both systems provided in this controlled environment were considered to give an acceptable clinical and technical result.

Adolescent↗

Evaluation of a contemporary CAD/CAM system.

The objective of this study is to investigate the accuracy of the TracerCAD system in measuring a model of known dimensions and volumes. A cylindrical nylon 6.6 model was prepared. Landmarks were added to indicate proximal, distal, anterior, medial, and lateral. Four additional landmarks were added at regular intervals along the length of the cylinder with a view to calculating diameters and volumes relative to these landmarks. The model was measured using a comparator with a guaranteed accuracy of 0.01 mm and was traced using the TracerCAD system (Test 1). The test was repeated with the model rotated by 90 degrees (Test 2), to determine whether there were any effects related to the orientation of the model in relation to the transmitter. The difference in average volume between measured results and TracerCAD scans was between 0.20% and -1.96%. Individual trace volumes varied between -0.0085% and -4.50%. In all volumes measured in Tests 1 and 2, all maximum volume percentage differences measured greater than 3%.

Amputation Stumps↗

A questionnaire survey of the effect of different interface types on patient satisfaction and perceived problems among trans-tibial amputees.

The objectives were to investigate the effect of three different interface types on consumer satisfaction and perceived problems among trans-tibial amputees in the Netherlands. A postal questionnaire (based on the Prosthesis Evaluation Questionnaire) was sent to 353 patients. Responders were classified in three groups of interface types: polyethylene foam (PEF) inserts, silicone liners (SIL), and polyurethane liners (PUL). Differences concerning satisfaction and problems between interface types were computed and adjusted for potential confounding by age, gender, reason for amputation and time since first prosthesis. A total of 220 patients responded (62%). Patients wearing liners reported a significantly poorer durability and higher maintenance time compared with patients using PEF inserts. Sum-scores for satisfaction or problems did not show any significant differences between groups. Analysis of individual items showed a significant difference only for satisfaction with sitting and with walking on uneven terrain in favour of PEF inserts. In contrast to most studies, interface type was included as a possible determinant of customer use, satisfaction, and perceived problems. The perceived differences between the three suspension types are to a large extent small and non-significant. The findings do not support liner prescription as a matter of course for all trans-tibial amputees. A careful analysis of patients' preferences should be made to determine the best course of action. Further studies, preferably prospective, need to be conducted to determine which systems are most comfortable and offer least complaints.

Activities of Daily Living↗

Usability of gait analysis in the alignment of trans-tibial prostheses: a clinical study.

The purpose of the study was to investigate which systematic effects of prosthetic misalignment could be observed with the use of the SYBAR system. The alignment of the prosthesis of five well-trained unilateral trans-tibial amputees was changed 15 degrees in magnitude in varus, valgus, flexion, extension, endorotation, exorotation, dorsal flexion, and plantar flexion. Subjects walked over a distance of 8 m at a self-selected walking speed with the alignment of the prosthesis as it was at the start of the experiment (reference) and with each changed alignment. Two video cameras (frontal and sagittal) and a force plate of the SYBAR system (Noldus Information Technology, The Netherlands) were used to capture gait characteristics of the subjects. Temporal and spatial characteristics, the magnitude and timing of the ground reaction force (GRF), and the external joint moments were derived from these data. Despite the substantial perturbations to prosthetic alignment, only a few effects were observed in the temporal and spatial characteristics of gait, the magnitude and timing of the GRF, and the external joint moments. Only the pattern of the ground reaction force in the mediolateral direction and the joint moment around the ankle in the frontal plane during terminal stance showed a systematic effect when the alignment was set into varus and valgus or exorotation. It was concluded that using the SYBAR system in this study revealed little effect of perturbations in prosthetic alignment, for this group of patients, and for the selected parameters. It was questioned whether this is due to the relatively low resolution of the SYBAR system or the capacity of the well-trained subjects to compensate for the disturbance in alignment. It was suggested that the usability of the SYBAR system in clinical settings should be further explored.

Adult↗