Loads at the implant-prosthesis interface during free and aided ambulation in osseointegrated transfemoral prostheses

Bone-anchored attachment of amputation limb prostheses is increasingly becoming a clinically accepted alternative to conventional socket suspension. The direct transfer of loads demands that the percutaneous implant system and the residual bone withstand all forces and moments transferred from the prosthesis. This study presents load measurements recorded at the bone-anchored attachment in 20 individuals with unilateral transfemoral amputation performing the everyday ambulatory activities: level ground walking, stairs ascent/descent and slope ascent/descent. Mean peak values for the sample populations across activities ranged from 498–684 N for the resultant force, 26.5–39.8 Nm for the bending moment, and 3.1–5.5 Nm for the longitudinal moment. Significant differences with respect to level walking were found for the resultant force during stairs ascent, (higher, p = 0.002), and stairs descent, (lower, p = 0.005). Using a crutch reduced the peak resultant forces and the peak bending moments with averages ranging from 5.5–12.6 % and 13.2–15.6 %, respectively. Large inter-participant variations were observed and no single activity resulted in consistently higher loading of the bone-anchored attachment across the participants. Results from this study can guide future development of percutaneous osseointegrated implant systems for limb prostheses and their rehabilitation protocols

Comparison of plantar pressure in three types of insole given to patients with diabetes at risk of developing foot ulcers – A two-year, randomized trial

Background: Special insoles and shoes designed to prevent foot ulcers caused by repetitive high pressures are recommended for patients with diabetes who have any of the following risk factors: neuropathy; peripheral vascular disease; foot deformities; previous ulcers; amputation; and skin pathologies. However, there is a need for increased knowledge regarding: a) differences in the peak pressure (PP) and pressure time integral (PTI) for different types of insoles; and b) the properties of the pressure distribution for insoles used over a period of several months. We present the results of a randomized trial to compare the plantar pressures of three commonly used insoles. Objectives: The primary objective was to compare the PP and PTI between three types of insoles. The secondary objective was to explore the long-term pattern of peak plantar pressure distribution and variations in specific regions of interest (ROI). The tertiary objective was to investigate the impacts of insole adjustments, how much the insoles were used, and the levels of patient satisfaction. Methods In a 2-year trial, 114 patients with type 1 (N\ua0=\ua031) or type 2 (N\ua0=\ua083) diabetes (62 men and 52 women; mean age, 57.7\ua0\ub1\ua015.4 years; duration of diabetes, 12.3\ua0\ub1\ua011.2 years; neuropathy, 38%), were randomized to be supplied with one of three different insoles. The ethylene vinyl acetate (EVA) insoles were used in outdoor walking shoes. The 35 EVA group (N\ua0=\ua039) received soft custom-made insoles\ua0composed of EVA of 35 shore A hardness, the 55 EVA group (N\ua0=\ua037) received custom-made\ua0insoles composed of EVA of 55 shore hardness, and the control group (N\ua0=\ua038) received prefabricated insoles composed of a hard core with a top layer of soft 12 shore hardness microfiber. Using F-Scan\uae, the in-shoe plantar pressures were measured at seven ROI (hallux, metatarsal head 1, metatarsal head 2, metatarsal head 4, metatarsal head 5, lateral aspect of the mid-foot, heel) on five occasions during the study period. The plantar-pressure variables used were PP (main outcome) and PTI. The plantar patterns of load were explored, satisfaction and usage of the insoles were rated by the participants, and insole adjustments were recorded. Results:A mixed model analysis estimated lower PP values in the heel regions for the 35 EVA and 55 EVA insoles (171\ua0\ub1\ua013 and 161\ua0\ub1\ua013\ua0kPa, respectively) than for the prefabricated insoles (234\ua0\ub1\ua010\ua0kPa) (

Foot deformities, function in the lower extremities, and plantar pressure in patients with diabetes at high risk to develop foot ulcers

Objective : Foot deformities, neuropathy, and dysfunction in the lower extremities are known risk factors that increase plantar peak pressure (PP) and, as a result, the risk of developing foot ulcers in patients with diabetes. However, knowledge about the prevalence of these factors is still limited. The aim of the present study was to describe the prevalence of risk factors observed in patients with diabetes without foot ulcers and to explore possible connections between the risk factors and high plantar pressure. Patients and methods : Patients diagnosed with type 1 ( n= 27) or type 2 ( n= 47) diabetes (mean age 60.0\ub115.0 years) were included in this cross-sectional study. Assessments included the registration of foot deformities; test of gross function at the hip, knee, and ankle joints; a stratification of the risk of developing foot ulcers according to the Swedish National Diabetes Register; a walking test; and self-reported questionnaires including the SF-36 health survey. In-shoe PP was measured in seven regions of interests on the sole of the foot using F-Scan \uae . An exploratory analysis of the association of risk factors with PP was performed. Results : Neuropathy was present in 28 (38%), and 39 (53%) had callosities in the heel region. Low forefoot arch was present in 57 (77%). Gait-related parameters, such as the ability to walk on the forefoot or heel, were normal in all patients. Eighty percent had normal function at the hip and ankle joints. Gait velocity was 1.2\ub10.2 m/s. All patients were stratified to risk group 3. Hallux valgus and hallux rigidus were associated with an increase in the PP in the medial forefoot. A higher body mass index (BMI) was found to increase the PP at metatarsal heads 4 and 5. Pes planus was associated with a decrease in PP at metatarsal head 1. Neuropathy did not have a high association with PP. Conclusions: This study identified several potential risk factors for the onset of diabetic foot ulcers (DFU). Hallux valgus and hallux rigidus appeared to increase the PP under the medial forefoot and a high BMI appeared to increase the PP under the lateral forefoot. There is a need to construct a simple, valid, and reliable assessment routine to detect potential risk factors for the onset of DFU