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Computer-assisted Navigation Systems for Orthopedic Surgery

» Summary» Procedure Codes
» Description» Selected References
» Prior Approval» Policy History
» Policy
 

Medical Policy: 06.01.24 
Original Effective Date: January 2007 
Reviewed: July 2016 
Revised: July 2016 


Benefit Application
Benefit determinations are based on the applicable contract language in effect at the time the services were rendered. Exclusions, limitations or exceptions may apply. Benefits may vary based on contract, and individual member benefits must be verified. Wellmark determines medical necessity only if the benefit exists and no contract exclusions are applicable. This medical policy may not apply to FEP. Benefits are determined by the Federal Employee Program.

This Medical Policy document describes the status of medical technology at the time the document was developed. Since that time, new technology may have emerged or new medical literature may have been published. This Medical Policy will be reviewed regularly and be updated as scientific and medical literature becomes available.


Description: 

Computer-assisted navigation (CAN) systems integrate preoperative planning and intraoperative execution information by displaying three dimensional (3D) computer images in relation to patient anatomy i.e. image guided surgery systems. These systems consist of a computer workstation with image processing and surgical planning software, a localization/digitization system and a display monitor. Computer software enables the surgeon to measure distances, angles, and volumes, and rotate and zoom to determine cutting planes and implant positioning.

 

Some systems use optical tracking, which can be active or passive. Active optical tracking systems use charge-coupled device (CCD) camera arrays to track the position of light-emitting diodes mounted on instruments and/or on a reference frame. In passive optical tracking systems, the CCD camera arrays track infrared light from special reflectors placed on the instruments.

 

Other systems may use electromagnetic (EM) tracking. With this approach, the system generates an EM field, which is disrupted by the tracked instrument. The system detects disruptions in the field and then determines the instrument position. Unlike optical tracking, EM tracking does not require a clear line of sight between the tracked instrument and the camera, and the positions of both flexible and rigid instruments can be detected.

 

Computer-assisted navigation involves three steps: data acquisition, registration, and tracking.

  • Data Acquisition                                                                                                                                         Data can be acquired in three different ways including fluoroscopic, computed tomographic (CT) or magnetic resonance imaging (MRI)-guided or imageless systems.  These data are then used for registration and tracking.
  • Registration                                                                                                                                    Registration refers to the ability of relating images (i.e. radiographs, CT scan, MRI or patients’ 3D anatomy) to the anatomic 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 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 than provide real-time informationof the position and orientation of the tools’ alignment with respect to the bony anatomy of interest.

Computer-assisted navigation (CAN) in orthopedic procedures describes the use of computer-enabled tracking systems to facilitate alignment in a variety of surgical procedures, including but not limited to fixation of fractures, ligament reconstruction, osteotomy, tumor resection, preparation of the bone for joint arthroplasty, and verification of the intended implant placement. The goal of computer-assisted navigation (CAN) is to increase surgical accuracy and reduce the chance of malposition.

 

Summary

Based on the peer reviewed medical literature, the literature may support some benefit in terms of radiological alignment. However, the clinical advantages are yet to be defined. At short to mid-term follow-up, most studies have failed to show any substantial benefit in terms of functional outcome, revision rates, patient satisfaction or patient perceived quality of life, when comparing computer-assisted navigation (CAN) to conventional techniques. Further studies are needed to determine whether using CAN systems for orthopedic surgery reduces post-procedure complications and impacts functional outcomes and long-term effects, including implant longevity, need for revision, pain, and quality of life.  There is insufficient evidence to support a conclusion concerning health outcomes or benefits associated with this procedure. Therefore, computer-assisted navigation (CAN) as an adjunct to orthopedic procedure(s) is considered investigational.

 

Also, no studies have been identified that directly compared any surgical navigation systems to each other. Therefore, no clinical evidence is available to determine whether any system works better than another system.

 

Regulatory Status

Because CAN is a surgical information system in which the surgeon is only acting on the information that is provided by the navigation system, surgical navigation systems generally are subject only to 510(k) clearance from FDA. As such, 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 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 (eg, 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 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 used to place surgical instruments during surgery using anatomical landmarks and other data specifically obtained intraoperatively (eg, ligament tension, limb alignment). 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.”

FDA product code: HAW.
In 2013, the VERASENSE™ Knee System from OrthoSensor™ and the iASSIST™ Knee from Zimmer received 510(k) clearance from FDA. FDA product code ONN, OLO.


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Prior Approval: 

 

Not applicable


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Policy: 

Computer-assisted navigation as an adjunct to orthopedic procedure(s) is considered investigational.

 

Based on the peer reviewed medical literature, the literature may support some benefit in terms of radiological alignment. However, the clinical advantages are yet to be defined. At short to mid-term follow-up, most studies have failed to show any substantial benefit in terms of functional outcome, revision rates, patient satisfaction or patient perceived quality of life, when comparing computer-assisted navigation (CAN) to conventional techniques. Further studies are needed to determine whether using CAN systems for orthopedic surgery reduces post-procedure complications and impacts functional outcomes and long-term effects, including implant longevity, need for revision, pain, and quality of life. There is insufficient evidence to support a conclusion concerning health outcomes or benefits associated with this procedure. Therefore, computer-assisted navigation (CAN) as an adjunct to orthopedic procedure(s) is considered investigational.





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Procedure Codes and Billing Guidelines: 

To report provider services, use appropriate CPT* codes, Modifiers, Alpha Numeric (HCPCS level 2) codes, Revenue codes, and/or diagnosis codes.

  • 20985 Computer-assisted surgical navigational procedure for musculoskeletal procedures; image-less (List separately in addition to code for primary procedure)
  • 0054T Computer-assisted musculoskeletal surgical navigational orthopedic procedure, with image-guidance based on fluoroscopic images (List separately in addition to code for primary procedure)
  • 0055T Computer-assisted musculoskeletal surgical navigational orthopedic procedure, with image-guidance based on CT/MRI images (List separately in addition to code for primary procedure)

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Selected References: 

  • Leenders T, Vandevelde D, Mahieu G et al. Reduction in variability of acetabular cup abduction using computer assisted surgery: a prospective and randomized study. Comput Aided Surg. 2002; 7(2):99-106.
  • Sparmann M, Wolke B, Czupalla H et al. Positioning of total knee arthroplasty with and without navigation support. A prospective, randomised study. J Bone Joint Surg Br. 2003 Aug;85(6):830-5.
  • Digioia AM 3rd, Jaramaz B, Plakseychuk AY et al. Comparison of a mechanical acetabular alignment guide with computer placement of the socket. J Arthroplasty. 2002 Apr;17(3):359-64.
  • Haaker RG, Stockheim M, Kamp M et al. Computer-assisted navigation increases precision of component placement in total knee arthroplasty. Clin Orthop Relat Res. 2005 Apr; (433):152-9.
  • Keene G, Simpson D, Kalairajah Y. Limb alignment in computer-assisted minimally-invasive unicompartmental knee replacement. J Bone Joint Surg Br. 2006 Jan; 88(1):44-8.
  • Hufner T, Meller R, Kendoff D et al. The role of navigation in knee surgery and evaluation of three-dimensional knee kinematics. Oper Techniq Orthop 2005; 15(1):64-9.
  • Stulberg SD, Loan P, Sarin V. Computer-assisted navigation in total knee replacement: results of an initial experience in thirty-five patients. J Bone Joint Surg Am 2002; 84-A Suppl: 90-8.
  • Schep NW, Broeder IA, van der Werken C. Computer-assisted orthopaedic and trauma surgery. State of the art and future perspectives. Injury 2003; 34(4):299-306.
  • Decking R, Markmann Y, Fuchs J et al. Leg axis after computer navigated total knee arthroplasty: a prospective randomized trial comparing computer-navigated and manual implantation. J Arthroplasty 2005; 20(3):282-8.
  • Hamelinck HK, Haagmans M, Snoeren MM, Biert J, Van Vugt AB, Safety of computer-assisted surgery for cannulated hip screws. Clin Orthop Relat Res. 2007 Feb;455-241-5.
  • Heffner T, Kendoff D, Citak M, Geerling J, Krettek C, Precision in orthopaedic computer navigation. Orthopade.2006 Oct;35(10)1043-55.
  • Blue Cross and Blue Shield Association Technology Evaluation Center (TEC) Assessment Program. Computer-Assisted Navigation for Total Knee Arthroplasty. Vol. 22, No. 10. February 2008.
  • ECRI Institute. Computer-assisted Navigation for Total Knee Replacement. Plymouth Meeting (PA): ECRI InstituteExternal Site; 2008 August 29. 11 p. [ECRI hotline response]. .
  • ECRI Institute. Computer-assisted Navigation for Total Hip Replacement. Plymouth Meeting (PA): ECRI InstituteExternal Site; 2008 August 29. 9p. [ECRI hotline response].
  • Health technology forecast [database online]. Plymouth Meeting (PA): ECRI InstituteExternal Site; 2008 Jan 9. [updated 2010 Jun 6]. Image-guided surgery systems for joint replacement.
  • Ishida K, Matsumoto T, Tsumura N, et al. Mid-term outcomes of computer-assisted total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2011 Jul;19(7):1107-12.
  • Manzotti A, Cerveri P, De Momi E, et al. Does computer-assisted surgery benefit leg length restoration in total hip replacement? Navigation versus conventional freehand. Int Orthop. 2011 Jan;35(1):19-24.
  • ECRI. Computer-assisted Navigation for Improving Clinical Outcomes after Total Joint Arthroplasty. Plymouth Meeting (PA): ECRI InstituteExternal Site. Health Technology Assessment Information Service; 2012 August 21. [Hotline Response].
  • Burnett RS & Barrack RL. Computer-assisted total knee arthroplasty is currently of no proven clinical benefit: a systematic review. Clin Orthop Relat Res. 2012 Sep 5. [epub ahead of print]
  • Harvie P, Sloan K, and Beaver RJ. Computer navigation vs conventional total knee arthroplasty: five-year functional results of a prospective randomized trial. J Arthroplasty. 2012 May;27(5):667-72.
  • Yaffe M, Patel A, et al. Component sizing in total knee arthroplasty: patient-specific guides vs.computer -assisted navigation. Biomedical Engineering 2012 Apr:57(4):277-82.
  • Faculty of Health and Social Sciences. Unicompartmental Knee Arthroplasty: A Perspective from Computer Assisted Navigation. International Journal of Clinical Medicine. 2013 Jun(4) 20-22.
  • Blyth MG, Smith JR, et. al., Electromagnetic Navigation in Total Knee Arthroplasty – A Single Center, Randomized, Single Blind Study Comparing the Results with Conventional Techniques, J Arthroplasty 2015 February 30(2):199-205 
  • ECRI. Custom Product Briefs- Guidance. KneeAlign 2 System (OrthAlign,Inc) for Computer Assisted Alignment during Orthopedic Surgery. Published February 22, 2016. Also available at www.ecri.org
  • ECRI. Custom Product Briefs – Guidance. ORTHOsoft Systems from Zimmer CAS (Zimmer Biomet, Inc.) for Intraoperative Guidance during Orthopedic Surgery. Published August 13, 2015. Also available at www.ecri.org
  • ECRI. Overview of Selected Orthopedic Intraoperative Guidance Systems. Also available at www.ecri.org
  • StealthStation S7 (Medtronic, Inc.) for Intraoperative Guidance during Orthopedic Surgery. Published August 14, 2015. Also available at www.ecri.org
  • ECRI. Navio Surgical (Blue Belt Technologies, Inc.) for Performing Knee Arthroplasty. Published April 18, 2016. Also available at www.ecri.org
  • UpToDate. Total Hip Arthroplasty. Greg A Erens, M.D., Thomas S. Thornhill, M.D., Jeffrey N Katz, M.D., MSc. Topic last updated October 23, 2015. Also available at www.uptodate.com
  • UpToDate. Total Knee Arthroplasty. Gregory M Martins, M.D., Thomas S Thornhill, M.D., Jeffrey N Katz, M.D., MSc. Topic last updated August 4, 2015. Also available at www.uptodate.com
  • Eggerding V, Reijman M, Scholten RJ, et al. Computer-assisted surgery for knee ligament reconstruction. Cochrane Database Syst Rev. 2014;8:CD007601. PMID 25088229
  • Meuffels DE, Reijman M, Verhaar JA. Computer-assisted surgery is not more accurate or precise than conventional arthroscopic ACL reconstruction: a prospective randomized clinical trial. J Bone Joint Surg Am. Sep 5 2012;94(17):1538-1545. PMID 22832975
  • Lass R, Kubista B, Olischar B, et al. Total hip arthroplasty using imageless computer-assisted hip navigation: a prospective randomized study. J Arthroplasty. Apr 2014;29(4):786-791. PMID 24290738
  • Reininga IH, Stevens M, Wagenmakers R, et al. Comparison of gait in patients following a computer-navigated minimally invasive anterior approach and a conventional posterolateral approach for total hip arthroplasty: a randomized controlled trial. J Orthop Res. Feb 2013;31(2):288-294. PMID 22886805
  • Stiehler M, Goronzy J, Hartmann A, et al. The First SICOT Oral Presentation Award 2011: imageless computer assisted femoral component positioning in hip resurfacing: a prospective randomised trial. Int Orthop. Apr 2013;37(4):569-581. PMID 23385606
  • Xie C, Liu K, Xiao L, et al. Clinical Outcomes After Computer-assisted Versus Conventional Total Knee Arthroplasty. Orthopedics. May 1 2012;35(5):e647-653. PMID 22588405
  • Rebal BA, Babatunde OM, Lee JH, et al. Imageless computer navigation in total knee arthroplasty provides superior short term functional outcomes: a meta-analysis. J Arthroplasty. May 2014;29(5):938-944. PMID 24140274
  • Gothesen O, Espehaug B, Havelin LI, et al. Functional outcome and alignment in computer-assisted and conventionally operated total knee replacements: a multicentre parallel-group randomised controlled trial. Bone Joint J. May 2014;96-B(5):609-618. PMID 24788494
  • Lutzner J, Dexel J, Kirschner S. No difference between computer-assisted and conventional total knee arthroplasty: five-year results of a prospective randomised study. Knee Surg Sports Traumatol Arthrosc. Oct 2013;21(10):2241-2247. PMID 23851969
  • Cip J, Widemschek M, Luegmair M, et al. Conventional versus computer-assisted technique for total knee arthroplasty: a minimum of 5-year follow-up of 200 patients in a prospective randomized comparative trial. J Arthroplasty. Sep 2014;29(9):1795-1802. PMID 24906519
  • Kim YH, Park JW, Kim JS. Computer-navigated versus conventional total knee arthroplasty a prospective randomized trial. J Bone Joint Surg Am. Nov 21 2012;94(22):2017-2024. PMID 23052635
  • Hoppe S, Mainzer JD, Frauchiger L, et al. More accurate component alignment in navigated total knee arthroplasty has no clinical benefit at 5-year follow-up. Acta Orthop. Dec 2012;83(6):629-633. PMID 23140107
  • Yaffe M, Chan P, Goyal N, et al. Computer-assisted Versus Manual TKA: No Difference in Clinical or Functional Outcomes at 5-year Follow-up. Orthopedics. May 1 2013;36(5):e627-632. PMID 23672916
  • Hoffart HE, Langenstein E, Vasak N. A prospective study comparing the functional outcome of computer assisted and conventional total knee replacement. J Bone Joint Surg Br. Feb 2012;94(2):194-199. PMID 22323685
  • Huang NF, Dowsey MM, Ee E, et al. Coronal alignment correlates with outcome after total knee arthroplasty: five-year follow-up of a randomized controlled trial. J Arthroplasty. Oct 2012;27(9):1737-1741. PMID 22868073 

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Policy History: 

 

July 2016 - Annual Review, Policy Revised

August 2015 - Annual Review, Policy Renewed

September 2014 - Annual Review, Policy Renewed

October 2013 - Annual Review, Policy Renewed

December 2012 - Annual Review, Policy Renewed

December 2011 - Annual Review, Policy Renewed

December 2010 - Annual Review, Policy Renewed


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Wellmark medical policies address the complex issue of technology assessment of new and emerging treatments, devices, drugs, etc.   They are developed to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. Wellmark medical policies contain only a partial, general description of plan or program benefits and do not constitute a contract. Wellmark does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Wellmark or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. Our medical policies may be updated and therefore are subject to change without notice.

*Current Procedural Terminology © 2012 American Medical Association. All Rights Reserved.

 
Contact Information
New information or technology that would be relevant for Wellmark to consider when this policy is next reviewed may be submitted to:
  Wellmark Blue Cross and Blue Shield
  Medical Policy Analyst
  P.O. Box 9232
  Des Moines, IA 50306-9232
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