The goal of computer-assisted navigation (CAN) in orthopedic procedures is to increase surgical accuracy and reduce the chance of malposition. CAN describes the use of computer-enabled tracking systems to facilitate alignment in a variety of surgical procedures, including fixation of fractures, ligament reconstruction, osteotomy, tumor resection, preparation of the bone for joint arthroplasty, and verification of the intended implant placement.
Navigation involves three steps: data acquisition, registration, and tracking:
Data acquisition can be accomplished in three different ways, fluoroscopically, guided by computed tomography (CT) or magnetic resonance imaging (MRI), or imageless systems. These data are then used for registration and tracking.
Registration refers to the ability of relating images (i.e., x-rays, CT, MRI or the individuals’ 3-D anatomy) to the anatomical position in the surgical field. A surface-matching technique can also be used in which the shapes of the bone surface model generated from preoperative images are matched to surface data points collected during surgery. The imageless systems rely on other information such as centers of rotation of the hip, knee, or ankle or visual information like anatomical landmarks.
Tracking refers to the sensors and measurement devices that can provide feedback during surgery regarding the orientation and relative position of tools to bone anatomy. For example, optical or electromagnetic trackers can be attached to regular surgical tools, which can then provide real time information of the position and orientation of the tools’ alignment with respect to the bony anatomy of interest.
The most commonly performed orthopedic computer-assisted surgeries appear to be as an adjunct to fixation of pelvic, acetabular, or femoral fractures, and as an adjunct to hip and knee arthroplasty procedures.
The use of computer assisted surgical navigational systems during orthopedic procedures to treat conditions involving the pelvis and appendicular skeleton is considered investigational.
Any specific products referenced in this policy are just examples and are intended for illustrative purposes only. It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available. These examples are contained in the parenthetical e.g. statement.
We develop Medical Policies to provide guidance to Members and Providers. This Medical Policy relates only to the services or supplies described in it. The existence of a Medical Policy is not an authorization, certification, explanation of benefits or a contract for the service (or supply) that is referenced in the Medical Policy. For a determination of the benefits that a Member is entitled to receive under his or her health plan, the Member's health plan must be reviewed. If there is a conflict between the Medical Policy and a health plan, the express terms of the health plan will govern.
Recent randomized controlled trials with short-term to mid-term follow-up have not shown improved health outcomes with CAN. Given the low short-term revision rates associated with conventional procedures and the inadequate power of available studies to detect changes in function, studies with CAN that assess health outcomes in a larger number of subjects with longer follow-up are needed.
Bae, D. K., Song, S. J., Park, C. H., Ko, Y. W., & Lee, H. (2016). A comparison of the medium-term results of total knee arthroplasty using computer-assisted and conventional techniques to treat patients with extra-articular femoral deformities. Journal of Arthroplasty, 32 (1), 71-78. Abstract retrieved September 6, 2016 from PubMed database.
BlueCross BlueShield Association. Evidence Positioning System. (5:2019). Computer-assisted navigation for orthopedic procedure (7.01.96). Retrieved July 9, 2019 from https://www.evidencepositioningsystem.com/. (29 articles and/or guidelines reviewed)
Cip, J., Obwegeser, F., Benesch, T., Bach, C., Ruckenstuhl, P., & Martin, A. (2018). Twelve-year follow-up of navigated computer-assisted versus conventional total knee arthroplasty: a prospective randomized comparative trial. Journal of Arthroplasty, 33 (5), 1404-1411. Abstract retrieved July 9, 2019 from PubMed database.
CMS.gov: Centers for Medicare & Medicaid Services. Palmetto GBA. (2019, May). Local Coverage Article: Billing and Coding: Noncovered services other than CPT category III noncovered services (A56506). Retrieved July 9, 2019 from https://www.cms.gov.
Dyrhovden, G., Fenstad, A., Furnes, O., & Gøthesen, Ø. (2016). Survivorship and relative risk of revision in computer-navigated versus conventional total knee replacement at 8-year follow-up. Acta Orthopaedica, 87 (6), 592-599. (Level 4 evidence)
Shin, Y. S., Kim, H. J., Ko, Y. R., & Yoon, J. R. (2016). Minimally invasive navigation-assisted versus conventional total knee arthroplasty: a meta-analysis. Knee Surgery, Sports Traumatology, Arthroscopy, 24 (11), 3425-3432. Abstract retrieved September 6, 2016 from PubMed database.
Song, E., Agrawal, P., Kim, S., Seo, H., & Seon, J. (2016). A randomized controlled clinical and radiological trial about outcomes of navigation-assisted TKA compared to conventional TKA: long-term follow-up. Knee Surgery, Sports Traumatology, Arthroscopy, 24 (11), 3381-3386. Abstract retrieved July 24, 2017 from PubMed database.
U. S. Food and Drug Administration. (2009, September). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K091411. Retrieved April 15, 2011 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2010, August). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K093206. Retrieved April 15, 2011 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2013, October). Center for Devices and Radiological Health. 510(k) Premarket Notification Database. K131767. Retrieved November 9, 2015 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Medical Technology Directory. (2016, September; last updated September 2018). Verasense (OrthoSensor Inc.) for use during total knee arthroplasty. Retrieved July 9, 2019 from www.Hayesinc.com/subscribers. (44articles and/or guidelines reviewed)
Winifred S. Hayes, Inc. Medical Technology Directory. (2019, March). Comparative effectiveness review of image-based computer-aided navigation for total knee arthroplasty. Retrieved July 9, 2019 from www.Hayesinc.com/subscribers. (37 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 12/8/2007
MOST RECENT REVIEW DATE: 8/8/2019
Policies included in the Medical Policy Manual are not intended to certify coverage availability. They are medical determinations about a particular technology, service, drug, etc. While a policy or technology may be medically necessary, it could be excluded in a member's benefit plan. Please check with the appropriate claims department to determine if the service in question is a covered service under a particular benefit plan. Use of the Medical Policy Manual is not intended to replace independent medical judgment for treatment of individuals. The content on this Web site is not intended to be a substitute for professional medical advice in any way. Always seek the advice of your physician or other qualified health care provider if you have questions regarding a medical condition or treatment.
This document has been classified as public information.