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Technical Brief

Tibial Contact Force and Contact Location Errors of the VERASENSE

[+] Author and Article Information
Stephanie J. Nicolet-Petersen

Biomedical Engineering Graduate Group,
University of California, Davis,
4635 2nd Avenue (Building 97),
Sacramento, CA 95817
e-mail: sjpetersen@ucdavis.edu

Stephen M. Howell

Department of Biomedical Engineering,
University of California, Davis,
4635 2nd Avenue (Building 97),
Sacramento, CA 95817
e-mail: sebhowell@mac.com

Maury L. Hull

Department of Mechanical Engineering,
University of California, Davis,
4635 2nd Avenue (Building 97),
Sacramento, CA 95817;
Department of Biomedical Engineering,
University of California, Davis,
4635 2nd Avenue (Building 97),
Sacramento, CA 95817;
Department of Orthopaedic Surgery,
University of California, Davis,
4635 2nd Avenue (Building 97),
Sacramento, CA 95817
e-mail: mlhull@ucdavis.edu

Manuscript received October 19, 2017; final manuscript received June 5, 2018; published online September 25, 2018. Assoc. Editor: Paul Rullkoetter.

J Biomech Eng 140(12), 124502 (Sep 25, 2018) (6 pages) Paper No: BIO-17-1476; doi: 10.1115/1.4040601 History: Received October 19, 2017; Revised June 05, 2018

The OrthoSensor VERASENSE knee system is a commercially available instrumented tibial insert that provides real-time intraoperative measurements of tibial contact force and contact location to guide surgeons toward improving outcomes in total knee arthroplasty (TKA). However, the device has been used contrary to the manufacturer's instructions in several studies and lacks published information on accuracy. Therefore, the primary objectives of this study were to evaluate the device's error in tibial contact force when used according to and contrary to the manufacturer's instructions, and also to evaluate the device's error in anterior-posterior (A-P) and medial-lateral (M-L) contact locations. The error in tibial contact force in one-compartment distributed loading was evaluated by applying known forces in ranges within and exceeding that instructed by the manufacturer, with rezeroing as instructed by the manufacturer, and without rezeroing. The error in tibial contact location in one-compartment concentrated loading was evaluated by applying known forces at known locations on the articular surface. Exceeding the maximum allowable load and not rezeroing did not adversely affect the bias (i.e., average error) (p > 0.05). The maximum absolute bias without rezeroing was 2.9 lbf. Rezeroing more than doubled the bias. The maximum root-mean-squared error in tibial contact location was 1.5 mm in the A-P direction. The device measures tibial contact force with comparable error well above the maximum allowable load and without rezeroing, contrary to the manufacturer's instructions.

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Copyright © 2018 by ASME
Topics: Stress , Errors
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References

Cherian, J. J. , Kapadia, B. H. , Banerjee, S. , Jauregui, J. J. , Issa, K. , and Mont, M. A. , 2014, “ Mechanical, Anatomical, and Kinematic Axis in TKA: Concepts and Practical Applications,” Curr. Rev. Musculoskeletal Med., 7(2), pp. 89–95. [CrossRef]
Meccia, B. , Komistek, R. D. , Mahfouz, M. , and Dennis, D. , 2014, “ Abnormal Axial Rotations in TKA Contribute to Reduced Weightbearing Flexion,” Clin. Orthop. Relat. Res., 472(1), pp. 248–253. [CrossRef] [PubMed]
Lutzner, J. , Kirschner, S. , Gunther, K. P. , and Harman, M. K. , 2012, “ Patients With No Functional Improvement After Total Knee Arthroplasty Show Different Kinematics,” Int. Orthop., 36(9), pp. 1841–1847. [CrossRef] [PubMed]
Gustke, K. A. , Golladay, G. J. , Roche, M. W. , Jerry, G. J. , Elson, L. C. , and Anderson, C. R. , 2014, “ Increased Satisfaction After Total Knee Replacement Using Sensor-Guided Technology,” Bone Jt. J, 96-B(10), pp. 1333–1338. [CrossRef]
Meneghini, R. M. , Ziemba-Davis, M. M. , Lovro, L. R. , Ireland, P. H. , and Damer, B. M. , 2016, “ Can Intraoperative Sensors Determine the “Target” Ligament Balance? Early Outcomes in Total Knee Arthroplasty,” J. Arthroplasty, 31(10), pp. 2181–2187. [CrossRef] [PubMed]
Warth, L. C. , Ishmael, M. K. , Deckard, E. R. , Ziemba-Davis, M. , and Meneghini, R. M. , 2017, “ Do Medial Pivot Kinematics Correlate With Patient-Reported Outcomes After Total Knee Arthroplasty?,” J. Arthroplasty, 32(8), pp. 2411–2416. [CrossRef] [PubMed]
Hamai, S. , Moro-Oka, T. A. , Dunbar, N. J. , Miura, H. , Iwamoto, Y. , and Banks, S. A. , 2012, “ In Vivo Healthy Knee Kinematics During Dynamic Full Flexion,” Biomed. Res. Int., 2013, pp. 1–4. [CrossRef]
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Figures

Grahic Jump Location
Fig. 1

The VERASENSE for Vanguard CR. The sensing areas in each compartment are bounded by the triangles shown. The sensing area occupies 22% of the area of a compartment.

Grahic Jump Location
Fig. 2

Images showing (a) one-compartment distributed loading, (b) two-compartment distributed loading, and (c) one-compartment concentrated loading. Error in tibial contact force with one-compartment distributed loading was evaluated using a three-dimensional printed medial femoral condyle load application device, and error in tibial contact force with two-compartment distributed loading was evaluated using a three-dimensional printed whole femoral component load application device (Vanguard Femoral Component, Zimmer-Biomet, Warsaw, IN). The concentrated load application device consisted of a hemispherical steel tip 3 mm in diameter. In all loading cases, a low-friction Teflon interface beneath the loading block supporting the VERASENSE enabled internal-external (I-E) rotation, and anterior-posterior (A-P) and medial-lateral (M-L) translations of the VERASENSE such that the load application device would seat in a physiologically relevant manner during loading. In the case of concentrated loading, although the low-friction interface was present, the VERASENSE did not translate and thus the location of load application was constant and repeatable under these conditions. To ensure that the load in each compartment was relatively centralized and that the loads were approximately equal during two-compartment distributed loading, a device allowing varus-valgus (V-V) rotation was added beneath the loading block. The weight of the crosshead (i.e., 5 lbf), and the addition and removal of precision weights in 5 lbf and 10 lbf increments, defined the loading steps.

Grahic Jump Location
Fig. 3

Images showing (a) the articular surface of the VERASENSE marked with points used to determine errors in tibial contact force and contact location for one-compartment concentrated loading. Regions (A) and (B) denote the outer posterior and outer anterior areas, respectively. Points 1–5 indicate loading locations within the sensing area; and (b) the coordinate system used to compute the error in contact location. An ellipse was fit to the contact location indicator shown on the display. The error in the anterior-posterior direction was the difference in x-coordinates of the center of the ellipse and the corresponding point while the error in the medial-lateral direction was the difference in the y-coordinates of the center of the ellipse and the corresponding point.

Grahic Jump Location
Fig. 4

Box and whisker plots illustrating the errors in tibial contact force for one-compartment distributed loading for each loading range with and without rezeroing. The borders of the box represent the 25th and 75th percentiles, the line between the borders represents the median, and the whiskers represent the extremes. The diamonds represent the 95% confidence interval of each mean.

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