Patient-reported benefits of bone-anchored transfemoral prostheses as assessed by MedTech20: A general outcome measure for medical products.

BACKGROUND

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.

OBJECTIVE

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

STUDY

DESIGN

This is a cross-sectional descriptive survey.

METHODS

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).

RESULTS

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.

CONCLUSIONS

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.