Validity and reliability of a novel 3D scanner for assessment of the shape and volume of amputees’ residual limb models

Background: Objective assessment methods to monitor residual limb volume following lower-limb amputation are required to enhance practitioner-led prosthetic fitting. Computer aided systems, including 3D scanners, present numerous advantages and the recent Artec Eva scanner, based on laser free technology, could potentially be an effective solution for monitoring residual limb volumes.Purpose: The aim of this study was to assess the validity and reliability of the Artec Eva scanner (practical measurement) against a high precision laser 3D scanner (criterion measurement) for the determination of residual limb model shape and volume.Methods: Three observers completed three repeat assessments of ten residual limb models, using both the scanners. Validity of the Artec Eva scanner was assessed (mean percentage error <2%) and Bland-Altman statistics were adopted to assess the agreement between the two scanners. Intra and inter-rater reliability (repeatability coefficient <5%) of the Artec Eva scanner was calculated for measuring indices of residual limb model volume and shape (i.e. residual limb cross sectional areas and perimeters).Results: Residual limb model volumes ranged from 885 to 4399 ml. Mean percentage error of the Artec Eva scanner (validity) was 1.4% of the criterion volumes. Correlation coefficients between the Artec Eva and the Romer determined variables were higher than 0.9. Volume intra-rater and inter-rater reliability coefficients were 0.5% and 0.7%, respectively. Shape percentage maximal error was 2% at the distal end of the residual limb, with intra-rater reliability coefficients presenting the lowest errors (0.2%), both for cross sectional areas and perimeters of the residual limb models.Conclusion: The Artec Eva scanner is a valid and reliable method for assessing residual limb model shapes and volumes. While the method needs to be tested on human residual limbs and the results compared with the current system used in clinical practice, it has the potential to quantify shape and volume fluctuations with greater resolution.