DESCRIPTION
Computer-assisted navigation (CAN) in orthopedic procedures is proposed 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, hip and knee arthroplasty procedures, spinal fusion, and correction of spinal deformities (e.g., scoliosis).
POLICY
The use of computer assisted surgical navigation during orthopedic procedures is considered investigational.
IMPORTANT REMINDERS
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ADDITIONAL INFORMATION
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.
SOURCES
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. (5:2022). Computer-assisted navigation for orthopedic procedure (7.01.96). Retrieved January 9, 2023 from https://www.evidencepositioningsystem.com/. (40 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)
Laine, T., Lund, T., Ylikoski, M., Lohikoski, J., & Schlenzka, D. (2000). Accuracy of pedicle screw insertion with and without computer assistance: a randomised controlled clinical study in 100 consecutive patients. European Spine Journal: Official Publication of the European Spine Society, the European Spinal Deformity Society, and the European Section of the Cervical Spine Research Society, 9(3), 235–240. (Level 2 evidence)
Rhee, S.J., Kim, H., Lee, C., Kim, C., Gwak, H., & Kim, J. (2019). A comparison of long-term outcomes of computer-navigated and conventional total knee arthroplasty: A meta-analysis of randomized controlled trials. The Journal of Bone and Joint Surgery. American Volume, 101 (20), 1875-1885. Abstract retrieved May 7, 2020 from PubMed database.
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.
U. S. Food and Drug Administration. (2019, October). Stryker Navigation System With SpineMap Go Software Application, Fluoroscopy Trackers And Fluoroscopy Adapters, SpineMask Tracker. 510(k) Premarket Notification Database. K183196. Retrieved November 3, 2021 from http://www.accessdata.fda.gov.
U. S. Food and Drug Administration. (2019, October). Vital Navigation System. 510(k) Premarket Notification Database. K191722. Retrieved November 3, 2021 from http://www.accessdata.fda.gov.
Winifred S. Hayes, Inc. Medical Technology Directory. (2019, March; last update search March 2022). Comparative effectiveness review of image-based computer-aided navigation for total knee arthroplasty. Retrieved January 9, 2023 from www.Hayesinc.com/subscribers. (37 articles and/or guidelines reviewed)
ORIGINAL EFFECTIVE DATE: 12/8/2007
MOST RECENT REVIEW DATE: 2/9/2023
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