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The medical community demands evidence for the benefits of medical devices such as bone-anchored prostheses (BAPs). MedTech20  is a novel instrument aiming to address general benefits of medical devices.

To describe general patient-reported benefits of BAPs measured with MedTech20.

This is a cross-sectional descriptive survey.

Patients treated in Sweden who had used a BAP for >1 year were mailed the MedTech20  Questionnaire. Responses to each attribute were described, and the MedTech20   Index (0-1), in which a higher figure represents larger benefits from the product, was calculated. Index values were compared based on demographic variables (sex, unilateral or bilateral transfemoral amputation (TFA), and those having experienced any complication of implant parts or the prosthetic connection device).

The response rate was 72%. The 62 participants (41 men and 21 women; mean age 57 years) had 11 ± 6.9 mean years of BAP experience. Single attributes stated as highly relevant and with high benefit for BAPs included perceived reliability, perceived safety, sense of control of the disability, facilitation of movement outside home, no discomfort at use, and ease of use. Attributes with less relevance included aid to remember tasks, reduction of barriers to a good sleep, and reduced sense of compromised integrity. The MedTech20  Index was 0.655 ± 0.188 and was not statistically significantly different based on any of the demographic variables.

By using a general measure on attributes of medical devices, this study provides new insights strengthening the evidence regarding the benefits that BAPs provide for patients with TFA who had difficulties with socket-suspended prostheses.

By using a general measure on attributes of medical devices, this study provides new insights strengthening the evidence regarding the benefits that BAPs provide for patients with TFA who had difficulties with socket-suspended prostheses.

Individuals with a unilateral lower-limb amputation (LLA) rely heavily on their intact limb during daily physical activities. However, there is limited research on the resultant effects of this over-reliance on contractile properties of muscles in the intact limb.

To compare the muscle contractile properties of the intact limb among individuals with a unilateral LLA to those of age-matched able-bodied individuals, using tensiomyography.

This is a cross-sectional, observational study.

Nine men with a unilateral LLA and 10 able-bodied men (control) were included. Tensiomyography measures were obtained for 5 muscles gastrocnemius lateralis (GL) and medialis (GM), rectus femoris, vastus lateralis (VL), and vastus medialis. Contraction time (Tc), delay time (Td), maximal displacement (Dm), and velocity of deformation (Vd) for each muscle were compared between groups.

Tc and Td for the GL and GM muscles were lower for the LLA than the control group (GL P = .03, r = -0.51, P < .01, r = 0.67; GM P = .02, r = 0.53, P = .07, r = 0.54, respectively). Dm and Vd of the VL were significantly smaller in the LLA than the control group (P < .01, r = 0.73, P < .01, r = 0.23, respectively).

Men with a unilateral LLA seem to have slower deformation of the gastrocnemius muscles and higher stiffness of the VL than able-bodied controls. These findings may be indicative of an overuse of the intact limb as a compensation for the unilateral LLA. The confirmation of these findings in a larger sample size is required to translate these findings to practice.

Men with a unilateral LLA seem to have slower deformation of the gastrocnemius muscles and higher stiffness of the VL than able-bodied controls. These findings may be indicative of an overuse of the intact limb as a compensation for the unilateral LLA. The confirmation of these findings in a larger sample size is required to translate these findings to practice.

Ambulatory individuals with lower-limb amputation perform a variety of locomotor activities, but the step count distribution of these activities is unknown.

To describe a novel method for activity monitoring and to use it to count steps taken while walking straight ahead on level ground, turning right and left, up and down stairs, and up and down ramps.

This is an observational study.

A portable instrument to record leg motion was placed on or inside the prosthetic pylon of 10 individuals with unilateral transtibial amputations. Participants first walked a defined course in a hospital environment to train and validate a machine learning algorithm for classifying locomotor activity. Participants were then free to pursue their usual activities while data were continuously collected over 1-2 d.

Overall classification accuracy was 97.5% ± 1.5%. Orlistat When participants were free to walk about their home, work, and community environments, 82.8% of all steps were in a straight line, 9.0% were turning steps, 4.8% were steps on stairs, and 3.6% were steps on ramps.

A novel activity monitoring method accurately classified the locomotion activities of individuals with lower-limb amputation. Nearly 1 in 5 of all steps taken involved turning or walking on stairs and ramps.

A novel activity monitoring method accurately classified the locomotion activities of individuals with lower-limb amputation. Nearly 1 in 5 of all steps taken involved turning or walking on stairs and ramps.

Health economic evaluations (HEEs) in orthotics are in their infancy. Identification of evidence gaps and method design issues will inform the design of future HEEs that advance knowledge and contributes to policy and investment decisions.

The aim of this systematic review was to critically appraise the existing orthotic/prosthetic health economic evaluation literature and therefore determine evidence gaps, critical method design issues, and the extent to which the literature informs orthotic policy and investment decisions.

Systematic review.

A range of databases were searched using intervention- and HEE-related terms. The Consolidated Health Economic Checklist-Extended and the Checklist for Health Economic Evaluation Reporting Standards were used to identify issues with method design and reporting.

Nine orthotic HEEs were narrowly focused on the cost-effectiveness of low-cost orthotic devices (eg, ankle orthoses for ankle sprains). Method design (eg, cost identification and valuation) and reporting issues (eg, lack of detail about the study population) limited the extent to which this literature can inform policy and investment decisions.

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