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Computer-socket manufacturing error: how much before it is clinically apparent?

Joan E Sanders1, Michael R Severance, Kathryn J Allyn

  • 1Department of Bioengineering, University of Washington, Seattle, 98195, USA. jsanders@u.washington.edu

Journal of Rehabilitation Research and Development
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Computer-manufactured prosthetic sockets require quality standards. Metrics like mean radial error (MRE) and interquartile range (IQR) effectively identify unacceptable socket fit, guiding manufacturing improvements for transtibial prosthetics.

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Area of Science:

  • Prosthetics and Orthotics
  • Biomedical Engineering
  • Manufacturing Quality Control

Background:

  • Computer-aided design and manufacturing (CAD/CAM) are increasingly used in prosthetic socket fabrication.
  • Establishing objective quality standards for CAD/CAM prosthetic sockets is crucial for patient outcomes.
  • Clinical assessment of prosthetic socket fit is subjective and can be inconsistent.

Purpose of the Study:

  • To establish quality standards for computer-manufactured prosthetic sockets for individuals with transtibial limb loss.
  • To evaluate the efficacy of specific error metrics in assessing prosthetic socket quality.
  • To compare manufacturing errors with clinical judgments of socket fit.

Main Methods:

  • Fabricated 33 duplicate prosthetic sockets using central facilities.
  • Compared socket manufacturing errors with clinical assessments of fit.
  • Analyzed errors using mean radial error (MRE), interquartile range (IQR), and surface normal angle error (SNAE).

Main Results:

  • 23 out of 33 sockets required clinical modification.
  • Sockets with MRE > 0.25 mm were unacceptable, often needing size reduction.
  • IQR and SNAE metrics identified oversized and misshapen sockets, respectively.

Conclusions:

  • MRE, IQR, and SNAE are effective metrics for characterizing the quality of computer-manufactured prosthetic sockets.
  • These metrics can aid in developing industry-wide quality standards for prosthetic socket manufacturing.
  • Objective quality assessment can improve the fit and function of transtibial prostheses.