DESCRIPTION
The term computer-assisted musculoskeletal surgical navigational orthopedic procedure describes navigation systems that provide additional information during a procedure that attempt to further integrate preoperative planning with intraoperative execution.
Navigation involves three steps: data acquisition, registration, and tracking:
Data acquisition can be accomplished in three different ways, fluoroscopic, guided by computed tomography (CT) or magnetic resonance imaging (MRI), or imageless systems. This data is 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. Surface-matching technique can 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.
POLICY
The use of computer assisted surgical navigational systems during orthopedic procedures to treat conditions involving the pelvis and appendicular skeleton is considered investigational.
Any device utilized for this procedure must have FDA approval specific to the indication, otherwise it will be considered investigational. (See Additional Information below.)
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ADDITIONAL INFORMATION
Surgical navigations systems require clearance from the U.S. Food and Drug Administration (FDA), but generally are subject only to 510(k) clearance, since computer-assisted surgery is considered analogous to a surgical information system in which the surgeon is only acting on the information that is provided by the navigation system. As such, the FDA does not require data documenting the intermediate or final health outcomes associated with computer-assisted surgery. (In contrast, robotic procedures, in which the actual surgery is robotically performed, are subject to the more rigorous requirement of the premarket approval application process.) A variety of surgical navigation procedures have received FDA clearance through the 510(k), and, in general, the labeled indications are very broad.
No controlled studies were found in the published literature that validates using computer assisted navigational systems to reduce post-procedure complications or increases longevity.
SOURCES
BlueCross BlueShield Association. Medical Policy Reference Manual. (2:2010). Computer assisted musculoskeletal surgical navigational orthopedic procedure (7.01.96). Retrieved April 15, 2011 from BlueWeb. (18 articles and/or guidelines reviewed)
Costa, D. J., & Sindwani, R. (2009). Advances in surgical navigation. Otolaryngologic Clinics of North America, 42 (5), 799-811.
Hayes. Medical Technology Directory. (2009, February). Imageless computer-assisted surgery for total knee replacement. Retrieved April 15, 2011 from www.Hayesinc.com/subscribers. (57 articles and/or guidelines reviewed)
Kendoff, D., Citak, M., Voos, J., & Pearle, A. D. (2009). Surgical navigation in knee ligament reconstruction. Clinics in Sports Medicine, 28 (1), 41-50.
Knoyves, A., Willis-Owen, C. A., & Spriggins, A. J. (2010). The long-term benefit of computer-assisted surgical navigation in unicompartmental knee arthroplasty. Journal of Orthopaedic Surgery and Research, 5, 94.
Molli, R. G., Anderson, K. C., Buehler, K. C., & Markel, D. (2011). Computer-assisted navigation software advancements improve the accuracy of total knee arthroplasty. The Journal of Arthroplasty, 26 (3), 432-438. (Level 3 Evidence - Independent study)
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. (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.
Ybinger, T. & Kumpan, W. (2007). Enhanced acetabular component positioning through computer assisted navigations. International Orthopedics, (Suppl. 1), 35-38.
ORIGINAL EFFECTIVE DATE: 12/8/2007
MOST RECENT REVIEW DATE: 5/12/2011
ID_BT
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