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Bioelectric Analyses of an Osseointegrated Intelligent Implant Design System for Amputees
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Characterizing loads at transfemoral osseointegrated implants.

Wesley Niswander1, Wei Wang2, Andrew P Baumann1

  • 1U.S. Food and Drug Administration, Center for Devices and Radiological Health, Office of Science and Engineering Laboratories, Division of Applied Mechanics.

Medical Engineering & Physics
|September 26, 2020
PubMed
Summary

Limited data exist for transfemoral osseointegrated devices, hindering preclinical mechanical testing. More research on daily activities and adverse events is needed to establish comprehensive loading profiles for these implants.

Keywords:
AmputeeLoadingOsseointegrationProstheticTransfemoral

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Area of Science:

  • Biomechanics
  • Biomedical Engineering
  • Orthopedic Devices

Background:

  • Transfemoral osseointegrated (OI) devices offer an alternative to traditional socket prostheses.
  • Establishing normative and outlying mechanical loads is crucial for developing robust preclinical testing strategies.
  • Current loading data for OI devices are limited, necessitating further investigation.

Purpose of the Study:

  • To collate existing force and moment data for transfemoral osseointegrated transcutaneous implants.
  • To assess the potential of supplementary data from other devices and able-bodied subjects.
  • To characterize normative and outlying loads during activities of daily living and falling events.

Main Methods:

  • Collected and reviewed load data from transfemoral osseointegrated implants.
  • Gathered comparative data from transfemoral socket prostheses, instrumented hip/knee devices, and limb salvage endoprostheses.
  • Utilized estimated loads from able-bodied subjects for transfemoral prostheses.
  • Investigated data from daily living activities and simulated falling events.

Main Results:

  • A significant scarcity of loading data was found for transfemoral osseointegrated devices.
  • Level walking was the most frequently reported activity, providing limited insight into overall fatigue loads.
  • Supplementary data from socket prosthetics and able-bodied individuals had limited significance due to small sample sizes.
  • Data on falling events were sparse, insufficient for characterizing adverse loads on OI devices.

Conclusions:

  • Existing loading data for transfemoral osseointegrated devices are insufficient for comprehensive preclinical mechanical testing.
  • Current data primarily reflect level walking, potentially underrepresenting fatigue loads from diverse daily activities.
  • Future research must prioritize collecting extensive data on various activities of daily living and adverse events to define accurate loading profiles for OI devices.