BlueCross BlueShield of Tennessee Medical Policy Manual

Computer Assisted Surgical Navigation for Orthopedic Procedures

DESCRIPTION

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:

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.

POLICY

IMPORTANT REMINDERS

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 extraarticular femoral deformities. Journal of Arthroplasty, 32 (1), 71-78. Abstract retrieved September 6, 2016 from PubMed database.

BlueCross BlueShield Association. Medical Policy Reference Manual. (1:2017). Computer-assisted navigation for orthopedic procedure (7.01.96). Retrieved July 24, 2017 from BlueWeb. (32 articles and/or guidelines reviewed)

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)

Meuffels, D. E., Reijman, M. & Verhaar J. A. (2012). Computer-assisted surgery is not more accurate or precise than conventional arthroscopic ACL reconstruction:  A prospective randomized clinical trial. Journal of Bone and Joint Surgery, 94 (17), 1538-1545. (Level 2 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/cdrh_docs/pdf9/K091411.pdf.

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/cdrh_docs/pdf9/K093206.pdf.

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/cdrh_docs/pdf9/K093206.pdf.

Winifred S. Hayes, Inc. Medical Technology Directory. (2012, December; last update search October 2016). Computer-aided total hip arthroplasty. Retrieved July 24, 2017 from www.Hayesinc.com/subscribers. (76 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2012, December; last update search November 2016). Image-based computer-aided navigation for total knee arthroplasty. Retrieved July 24, 2017 from www.Hayesinc.com/subscribers. (55 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Medical Technology Directory. (2012, December; last update search November 2016). Imageless computer-aided navigation for total knee arthroplasty. Retrieved July 24, 2017 from www.Hayesinc.com/subscribers. (87 articles and/or guidelines reviewed)

Winifred S. Hayes, Inc. Technology Brief. (2016). Verasense (OrthoSensor inc.) for use during total knee arthroplasty. Retrieved July 24, 2017 from www.Hayesinc.com/subscribers. (44 articles and/or guidelines reviewed)

ORIGINAL EFFECTIVE DATE:  12/8/2007

MOST RECENT REVIEW DATE:  9/14/2017

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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.

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