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The goal of computer-assisted navigation (CAN) is to increase surgical accuracy and reduce the chance of malposition of the implants. For total knee arthroplasty (TKA), malalignment is commonly defined as a variation of greater than 3 degrees from the targeted position. Proper implant alignment is believed to be an important factor for minimizing long-term wear, risk of osteolysis, and loosening of the prosthesis. In addition to reducing the risk of substantial malalignment, computer navigation may improve soft tissue balance and patellar tracking. CAN is also being investigated for operations with limited visibility such as placement of the acetabular cup in total hip arthroplasty (THA) and for minimally invasive orthopedic procedures. Other potential uses of CAN for surgical procedures of the appendicular skeleton include screw placement for fixation of femoral neck fractures and tunnel alignment during reconstruction of the anterior cruciate ligament (ACL).

CAN devices may be image-based or non-image based. Image-based devices use preoperative computed tomography CT scans and operative fluoroscopy to direct implant positioning. Newer non-image based devices use information obtained in the operating room, typically with infrared probes. For TKA, specific anatomic reference points are made by fixing signaling transducers with pins into the femur and tibia. Signal emitting cameras (e.g., infrared) detect the reflected signals and transmit the data to a dedicated computer. During the surgical procedure multiple surface points are taken from the distal femoral surfaces, tibial plateaus and medial and lateral epicondyles. The femoral head center is typically calculated by kinematic methods that involve movement of the thigh through a series of circular arcs, with the computer producing a three-dimensional (3-D) model that includes the mechanical, transepicondylar and tibial rotational axes. CAN systems direct the positioning of the cutting blocks and placement of the prosthetic implants based on the digitized surface points and model of the bones in space. The accuracy of each step of the operation (cutting block placement, saw cut accuracy, seating of the implants) can be verified, thereby allowing adjustments to be made during surgery.

Navigation involves 3 steps: data acquisition, registration, and tracking.

Data Acquisition

Data can be acquired in 3 different ways: fluoroscopic, guided by CT or magnetic resonance imaging (MRI), or imageless systems. These data are then used for registration and tracking.

Registration

Registration refers to the ability of relating images (i.e., x-rays, CT, MRI or patients’ 3-D anatomy) to the anatomical position in the surgical field. Registration techniques may require the placement of pins or “fiduciary markers” in the target bone. 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.

Tracking

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.

Since CAN is a surgical information system in which the surgeon is only acting on the information that is provided by the navigation system, surgical navigations systems generally are subject only to 510(k) clearance from the U.S. Food and Drug Administration (FDA). As such, the FDA does not require data documenting the intermediate or final health outcomes associated with CAN. (In contrast, robotic procedures, in which the actual surgery is robotically performed, are subject to the more rigorous requirement of the premarket approval application [PMA] process.) 

A variety of surgical navigation procedures have received FDA clearance through the 510(k) process with broad labeled indications. The following is an example; “The OEC FluoroTrak 9800 Plus provides the physician with fluoroscopic imaging during diagnostic, surgical and interventional procedures. The surgical navigation feature is intended as an aid to the surgeon for locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone or vertebra visible on fluoroscopic images.”

Several navigation systems (e.g., PiGalileo™ Computer-Assisted Orthopedic Surgery System, PLUS Orthopedics; OrthoPilot® Navigation System, Braun; Navitrack® Navigation System, ORTHOsoft) have received FDA clearance specifically for TKA. FDA cleared indications for the PiGalileo^TM system are representative. This system “is intended to be used in computer-assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is utilized to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g., ligament tension, limb alignment, etc.). Examples of some surgical procedures include but are not limited to:

• Total knee replacement supporting both bone referencing and ligament balancing techniques
• Minimally invasive total knee replacement"

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

12/29/2008: Code reference section updated per the 2009 CPT/HCPCS revisions

1/8/2009: Policy reviewed, no changes

6/23/2010:  Description section revised.  FEP verbiage was added to Policy Exceptions section.  Code Reference section revised to remove CPT Codes 20986 and 20987 because the codes were deleted 12/31/2008. CPT Codes 0054T and 0055T were added to the Non-Covered Codes Table.

07/29/2011: Policy reviewed; no changes.

09/25/2012: Policy reviewed; no changes.

All codes billed for this procedure are considered investigational and not eligible for coverage.

Non-Covered Codes