Medical Policy

 

Subject: Computer-Assisted Musculoskeletal Surgical Navigational Orthopedic Procedures of the Appendicular System
Document #: SURG.00082 Publish Date:    12/27/2017
Status: Reviewed Last Review Date:    11/02/2017

Description/Scope

This document addresses computer-assisted musculoskeletal surgical navigation for orthopedic procedures on the appendicular skeleton system.  This document does not address navigation when used for spinal or cranial procedures.

The term “computer-assisted musculoskeletal surgical navigational orthopedic procedure” describes navigation systems that provide additional information during a procedure in order to further integrate preoperative planning with intraoperative execution.

Position Statement

Investigational and Not Medically Necessary:

Computer-assisted musculoskeletal surgical navigation is considered investigational and not medically necessary as an adjunct to orthopedic procedures of the appendicular system.

Rationale

General Information

Computer-assisted surgery has been investigated in three general settings: (1) as an adjunct to surgery for trauma or fracture; (2) as an adjunct to knee or hip arthroplasty procedures; or (3) as an adjunct to anterior cruciate ligament reconstruction.  Each of these categories will be discussed separately, but in general, computer-assisted surgery attempts to either provide increased efficiency in the surgical procedure or improve the biomechanical alignment of joints.  Improvements in surgical efficiency can be measured in terms of operating time or radiation exposure.  Changes in alignment are considered an intermediate outcome.  The final health outcome involves consideration of how these changes will impact final functional outcomes, which can be assessed with knee or hip scores, or surgical revision rates.  The following review focuses on the results of randomized controlled trials.

Trauma or Fracture

Computer-assisted surgery has been most frequently mentioned as an adjunct to pelvic, acetabular or femoral fractures.  For example, fixation of these fractures typically requires percutaneous placement of screws or guidewires.  Conventional fluoroscopic guidance (C-arm fluoroscopy) provides imaging in only one plane.  Therefore, the surgeon must position the implant in one plane and then get additional images in other planes in a trial and error fashion to ensure that the device has been properly placed.  This process adds significant operating room (OR) time and radiation exposure.  It is hoped the computer-assisted surgery would allow for minimally invasive fixation and provide more versatile screw trajectories with less radiation exposure.  Therefore, computer-assisted surgery is considered an alternative to the existing image guidance using C-arm fluoroscopy.

Ideally, one would like controlled trials comparing the OR time, the radiation exposure and long-term outcomes of individuals whose surgery was conventionally guided using C-arm versus image-guided using computer-assisted surgery.  While several in vitro and review studies have been published (Digioia, 2002; Hufner, 2002; Leenders, 2002; Schep, 2003), a literature search identified only one clinical trial of computer-assisted surgery in trauma or fracture cases.  Suhm and colleagues reported on a case series of 27 individuals with femoral fractures who underwent implantation of a femoral nail (Slomczykowski, 2001).  Outcomes included precision of interlocking, exposure time and OR time.  Without a control or comparison group, it is not possible to determine the efficacy of the computer assistance.

Total Knee Arthroplasty (TKA)

Several randomized controlled trials enrolling more than 25 individuals and comparing computer-assisted with conventional TKA were identified in a literature search; two of these publications reported on long-term follow-up of the same group of individuals (Chauhan, 2004; Chin, 2005; Decking, 2005; Decking, 2007; Ensini, 2006; Kim, 2007; Lutzner, 2008; Matziolis, 2007; Spencer, 2007; Victor, 2004).  These studies compared various measures of alignment in the two groups.  While all studies reported improvements in target alignments, only four of the seven studies reported that the improvements in overall tibial/femoral alignment were statistically significant (Chauhan, Decking, Victor, Matziolis).  A key consideration is how changes in alignment relate to improvements in individual outcomes.  The study by Ensini (2007), which evaluated the outcomes of a total of 120 participants (60 individuals operated on using navigation and 60 subjects operated on using conventional technique), reported no difference in knee scores or participant satisfaction at 2-3 year follow-up.  Other studies similarly did not report a significant improvement in functional outcome.  There were no studies that evaluated a reduction in the surgical revision rate associated with computer-assisted navigation. 

Two additional randomized studies examined the role of computer-assisted navigation in individuals undergoing minimally invasive total knee arthroplasty.  Luring and colleagues (2008) randomized 60 subjects to undergo minimally invasive TKA with and without computer-assisted navigation.  While the postoperative deviation in leg axis was decreased in the navigation group, there were no differences in functional outcomes at 12 months.  Similarly, in a randomized study of 108 individuals, Dutton and colleagues (2008) reported that while navigated minimally invasive TKA was associated with an improvement in postoperative alignment, there was no difference in functional outcomes.

Blakeney and colleagues (2011) conducted a randomized controlled trial to determine the most accurate technique for aligning components in total knee arthroplasty by comparing computer-assisted surgery with two conventional techniques involving use of an intramedullary guide for the femur and either an intramedullary or an extramedullary guide for the tibia.  A total of 107 participants were randomized prior to surgery to 1 of 3 arms: (1) computer-assisted surgery for both the femur and the tibia (the computer-assisted surgery group); (2) intramedullary guides for both the femur and the tibia (the intramedullary guide group); (3) and an intramedullary guide for the femur and an extramedullary guide for the tibia (the extramedullary guide group).  Measurements of alignment using computed tomography (CT) scans and hip-to-ankle radiographs made 3 months after surgery were evaluated.  The operative times and complication rates were compared among the 3 groups.  The researchers found that the coronal tibiofemoral angle demonstrated, on average, less malalignment in the computer-assisted surgery group (1.91°) than in the extramedullary (3.22°) and intramedullary (2.59°) groups (p=0.007).  While the computer-assisted procedures resulted in better alignment, the increase in accuracy with computer-assisted surgery came at a cost of increased operative time.  The operative time for the computer-assisted surgery cohort averaged 107 minutes compared with 83 and 80 minutes, respectively, for the surgery with the extramedullary and intramedullary guides (p<0.0001).  No significant differences in any of the outcomes between the intramedullary and extramedullary guide groups were identified.  The authors concluded that based on radiography and CT measurements, implant alignment with computer-assisted total knee arthroplasty is improved compared with that associated with conventional surgery with intramedullary or extramedullary guides.  The study did not access functional outcomes beyond the 3-month postoperative period.

In 2007, Bauwens and colleagues performed a systematic review and meta-analysis comparing navigated with conventional knee arthroplasty.  A total of 33 studies (of which 11 were randomized trials) of various methodological quality were reviewed to include a total of 3423 individuals with a mean age of 67.3 ± 4.1 years.  There was no significant difference in the mechanical axes alignment between the navigated and conventional TKA procedures.  Individuals who underwent the navigated procedure had a lower risk of malalignment at critical thresholds of greater than 3° (risk ratio, 0.79; 95% confidence interval, 0.71 to 0.87) and greater than 2° (risk ratio, 0.76; 95% confidence interval, 0.71 to 0.82).  However, as the authors point out, it is unclear if this marginal benefit will result in better long-term outcomes.  Computer-assisted navigation increased the length of the mean duration of surgery by 23%.  No solid conclusions could be drawn with regards to functional outcomes or complication rates.  The authors concluded that the clinical benefits of navigated TKA are still ambiguous and that additional research involving larger studies is needed.

Seon and colleagues (2009) conducted a study comparing the clinical and radiological outcomes of TKA with and without navigation.  The study included 43 participants who underwent TKAs using a navigation system and 42 participants who underwent TKAs without a navigation system.  During the preoperative assessments, sealed envelopes were used to randomly assign the subjects into the TKA with navigation (NA-TKA) group or the TKA without navigation (CON-TKA) group.  The minimum follow-up period was 2 years.  The exclusion criteria included individuals that had undergone prior open knee surgery and those with a severe deformity (> 20° varus or > 30° flexion contracture).  All study participants had primary osteoarthritis.  All of the TKAs carried out in the CON-TKA group were performed by a single physician who was also the primary author of this study.  Both the NA-TKAs and the CON-TKAs were performed using a standard medial parapatellar approach.  The NA-TKAs were carried out using the OrthoPilot® (version 4.08, Aesculap, Tuttlingen, Germany) navigation system.  Participants in both groups underwent the same postoperative rehabilitation protocol and active range of motion exercises.  Clinical evaluations were performed preoperatively and at final follow-up.  Clinical outcomes were measured using range of motion (ROM), Hospital for Special Surgery (HSS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores.  Radiological comparisons were made using standing radiographs of the knees.  The HSS and WOMAC scores showed significant improvement at final follow-up in both groups, but showed no significant inter-group differences (p>0.05).  There was no significant difference in ROM. (p=0.962).  TKAs performed with navigation resulted in significantly better outcomes in terms of mechanical angle and prosthetic alignment outliers than TKAs performed without navigation.  However, there was no significant difference in functional outcomes between TKAs performed with or without a navigation system at 2 year follow-up.  The researchers suggested that another study be undertaken on a larger group with a longer follow-up period to determine the influence that the observed radiographic alignment improvements have on clinical results and survival rate.

In 2011, Barrett and colleagues, in a multicenter, prospectively randomized trial, compared the radiographic alignment of imageless computer-assisted surgery with conventional instrumentation in individuals undergoing TKA.  A total of 208 subjects were enrolled in the study.  The preoperative surgical plan was compared to postoperative 2-dimensional radiographic alignment measured by a blinded reviewer.  The authors found that the use of computer-assisted surgery did not offer a clinically meaningful improvement in postoperative alignment, clinical, functional, or safety outcomes compared with conventional TKA.

Hernandez-Vaquero and colleagues (2011) retrospectively reviewed 97 participants (100 TKAs) undergoing TKAs for minimal preoperative deformities.  Fifty TKAs were performed with an image-free surgical navigation system and the other 50 with a standard technique.  The researchers compared femoral angle (FA), tibial angle (TA), and femorotibial angle (FTA) and determined whether any differences altered clinical or functional scores, as measured by the Knee Society Score (KSS), or complications.  A total of 73 participants (75 TKAs) had a minimum follow-up of 8 years (mean, 8.3 years; range, 8-9.1 years).  At midterm, the authors found no difference in functional and clinical scores or implant survival between TKAs performed with and without the assistance of a navigation system.

Kuzyk and colleagues (2012) published the results of a meta-analysis which compared the sagittal alignment of tibial components using computer navigation with conventional methods.  A radiologic study was performed using 110 TKAs from 3 groups: (1) computer navigation; (2) cutting block with extramedullary guide; and (3) manual tilt of extramedullary guide.  The researchers found that the cutting block method was the most accurate, and computer navigation was the most precise.  The manual tilt group had the greatest variance.  There was no significant difference between groups with respect to the percentage of knees with posterior slope within 3° of the desired slope.  Meta-analysis of 10 studies found no reduction in outliers with computer navigation.  The authors concluded that computer navigation offers the greatest precision but does not reduce the number of outliers.

In another study, Harvie and colleagues (2012) reported on 71 subjects who were randomly allocated to undergo either computer-navigated or conventional arthroplasty.  A statistically significant improvement in alignment was seen in the computer-navigated group.  Five-year functional outcome was assessed using the Knee Society, Short Form-36, Western Ontario and McMaster Universities Osteoarthritis Index, and a patient satisfaction score.  At 5 years, 46 of the study participants were available for assessment (24 navigated and 22 conventional knees).  None of the participants had undergone revision.  No statistically significant difference was observed in any component of any measure of outcome between navigated and conventional groups.  Longitudinal data showed function to be well maintained with no difference in functional score between 2 and 5 years in either group.  The authors concluded that despite achieving better alignment, at the time of the 5-year postoperative review, the functional outcome with computer-navigated knee arthroplasty appears to be no different than those seen using a conventional jig-based technique.

Yaffee and colleagues (2013) reported the results of a study that explored whether differences in clinical, functional, or radiographic outcomes existed at 5-year follow-up between subjects who underwent computer-assisted or manual TKA.  A total of 78 consecutive TKAs were performed by a single surgeon who had experience performing computer-assisted and manual TKA.  The manual group consisted of 40 participants and computer-assisted group contained 38 participants.  All of the subjects were similar with regard to age, sex, diagnosis, body mass index, surgical technique, implants, perioperative management, Knee Society scores, and anteroposterior mechanical axis.  At the 5-year follow-up, 63 participants (34 from the manual group and 29 from the computer-assisted group) were evaluated.  No statistically significant differences were found in the Knee Society knee score (p=0.289), function score (p=0.272), range of motion (p=0.284), pain score (p=0.432), or UCLA activity score (p=0.109) between the two groups.  Postoperative radiographs revealed a significant difference in the mechanical axis (p=0.004) between the two groups; however, both groups achieved a neutral mechanical axis of ±3° (computer-assisted group mean, 2.0°; manual group mean, -0.24°).

Lutzner and colleagues reported the 5-year results of a prospective randomized study comparing computer-assisted surgery and conventional TKA.  This study reported the functional and patient-perceived outcomes.  A total of 97 individuals were available for physical and radiological examination at 5 years.  The KSS was used to assess functional outcome and the Euroquol questionnaire was used to evaluate the quality of life.  The authors concluded that there were no significant differences in functional or patient-perceived outcome after mid-term follow-up.

Rebal and colleagues (2014) conducted a meta-analysis of level I randomized trials comparing TKA using imageless computer navigation to conventional instrumentation.  Based on radiographic and functional outcomes analysis, TKA performed with computer navigation was more likely to be within 3° of ideal mechanical alignment (87.1% vs. 73.7%, p<0.01).  Navigated TKAs had a higher increase in Knee Society Score at 3 month follow-up (68.5 vs. 58.1, p=0.03) and at 12-32 month follow-up (53.1 vs. 45.8, p<0.01).  Although the authors found that computer navigation in TKA provides more accurate alignment and superior functional outcomes at short-term follow-up, the impact on functional outcomes has yet to be firmly demonstrated.

Total Hip Arthroplasty (THA)

There are fewer controlled studies examining the role of THA with computer-assisted navigation.  Two randomized studies specifically focused on placement of the acetabular component.  Parratte and Argenson (2007) reported on the results of 60 individuals undergoing THA with and without computer navigation.  The primary outcome was cup anteversion and abduction angles; there were no significant differences between the two groups.  Similarly, in a randomized trial of 25 participants, Kalteis and colleagues reported improved anteversion angles in the navigated group, and that a higher percentage of individuals were within the target region of acetabular placement.  No functional outcomes were reported in either of these trials.  In another small randomized trial of 36 subjects undergoing femoral osteotomy for dysplastic hip, Hsieh and colleagues (2006) did not report any differences in functional outcomes at 24 months between the navigated and conventional surgical group.

In an uncontrolled case series, Leenders and colleagues studied the variability in placement of the acetabular component among three groups of participants: (1) those undergoing THA using free-hand placement before computer-assisted surgery was available; (2) those undergoing THA with computer assistance; and (3) those undergoing free-hand placement after computer assistance was available (Leenders, 2002).  While there was a reduction in variability between groups one and two, there was not a significant difference between groups two and three.  No data regarding long-term outcome was reported.  Digioia and colleagues reported on a case series of 78 individuals (82 hips) who underwent THA and compared the alignment directed by a mechanical guide and computer assistance.  The authors hypothesized that the use of the mechanical guide rather than computer assistance would have resulted in an unacceptable acetabular alignment in 78% of hips (Digioia, 2002).  More recently, there appears to be growing interest in imageless navigation systems, for both arthroplasties and hip resurfacing procedures.  Numerous case series and retrospective reviews have been published that report improved alignment (Bailey, 2009; Dorr, 2007; Najarian, 2009; Olsen, 2009; Romanowski, 2008).  However, as noted above, controlled studies with functional outcomes are needed to validate that computer-assisted navigation results in improved health outcomes.

Reininga and colleagues (2013) conducted a randomized controlled trial that investigated the effectiveness of a minimally invasive computer-navigated anterior approach for THA compared to a conventional posterolateral THA technique on the restoration of physical functioning during recovery following surgery.  A total of 75 participants were included in the study; 35 underwent minimally invasive computer-navigated THA via the anterior approach, and 40 of the participants underwent conventional THA using the conventional posterolateral approach.  Gait analysis was performed preoperatively at intervals of 6 weeks, and 3 and 6 months using a body-fixed-sensor based gait analysis system.  Cadence, walking speed, step length and frontal plane angular movements of the pelvis and thorax were evaluated.  The same data were obtained from 30 healthy individuals.  No differences were noted in the recovery of spatiotemporal parameters or in angular movements of the pelvis and thorax following the computer-navigated MIS anterior approach or the conventional posterolateral approach.  The authors found that while there was an improvement in gait after surgery, small differences in several spatiotemporal parameters and angular movements of the trunk remained at 6 months postoperatively between both the participants and the healthy subjects. 

Gurgel and colleagues (2014) reported the results that focused on the acetabular component position in TKA.  A total of 20 hips were operated on using imageless navigation and 20 hips were operated on using the conventional method.  The correct position of the acetabular component was determined with CT, measuring the operative anteversion and the operative inclination and determining the cases inside Lewinnek's safe zone.  The authors found that the acetabular component position's tomography analyses were similar whether performed by conventional means or using the imageless navigation.

Anterior Cruciate Ligament Reconstruction

The positioning of the tibial and femoral tunnels is considered an important variable in anterior cruciate ligament (ACL) reconstructions.  Plaweski and colleagues (2006) reported the results of 60 subjects randomized to undergo ACL reconstruction with and without computer-assisted navigation.  The navigated group had improved measures of laxity and other alignment variables, but there was no report in improvement in functional outcomes.  Two other smaller randomized trials also reported some improvements of tunnel placement associated with computer navigation compared to conventional treatment, but with no reported improvements in functional outcomes (Hart, 2008; Mauch, 2007).

In another study, Plaweski and colleagues (2012) reported the results of a prospective multicenter observational study which compared two groups of participants requiring arthroscopic ACL reconstruction.  In this nonrandomized study, one group was managed with a computer-assisted navigation system and the control group was managed without the aid of computer-assisted navigation.  The primary evaluation criterion was based on the subjective and objective International Knee Documentation Committee (IKDC) scores.  Of the 272 participants, 214 were analyzed; 100 were in the control group and 114 in the computer-assisted navigation system group.  The researchers reported that the main outcomes at 1 year did not show any significant differences between the subjects managed with and without computer-assisted navigation.

In the meta-analyses carried out by Chen and colleagues (2012), five randomized or quasi-randomized, controlled trials comparing computer-navigated versus conventional technique in ACL reconstructions until December 1, 2009 were identified through a systematical database search.  The clinical outcomes of the trials were analyzed by Lachman test, pivot-shift test, IKDC knee score, Lysholm score, and Tegner score.  The authors found that the use of computer-assisted navigation systems led to additional operative time (8-17 min) but there were no significant differences between computer-navigated and conventional groups in terms of knee stability and functional assessment during short-term follow-up.  The authors concluded that the role of computer-assisted navigation systems on clinical performance and longevity needs further investigation in large sample, long-term randomized trials. 

Eggerding and colleagues (2014) reviewed five randomized controlled trials (RCT) with 366 participants having computer-assisted surgery (CAS) or conventional ACL surgery.  Overall the quality of the studies ranged from moderate to very low.  This was based on bias, attrition and poor reporting of trial methods/results such as adverse post-surgical events.  The authors did find moderate evidence for surgical time- CAS took longer to complete than conventional surgery (from 9 to 27 minutes longer) as well as no difference between computer-assisted surgery and conventional surgery for participant-reported knee function.  The authors concluded that the currently available evidence does not indicate that CAS in knee ligament reconstruction improves outcome.  There is a need for improved reporting in future studies of this technology.

Summary

While results of controlled trials suggest improvements in the intermediate biomechanical outcomes, there is inadequate data on final health outcomes, as assessed by improvements in functional outcomes or surgical revision rates.  Computer-assisted musculoskeletal navigation has been primarily investigated as an adjunct to surgery of the appendicular skeletal system.  Most of the research has focused on its use in the knee and hip.  There is only very preliminary literature regarding its use in the upper extremity (shoulder and elbow) and axial skeleton (spine).   

Background/Overview

Computer-assisted musculoskeletal surgical navigational systems allow surgeons to perform complex, traditionally invasive trauma surgeries, such as femoral and pelvic fracture fixation, through small incisions.  Using this navigational technology, surgeons may be able to reduce the amount of time an individual is in surgery, limit radiation exposure, blood loss and rehabilitation time while increasing surgical accuracy.  Computer-assisted musculoskeletal surgical navigation involves three steps; data acquisition, registration and tracking.

Data Acquisition

Data can be acquired in three different ways; fluoroscopic, CT/MRI guided or imageless systems.  This data is then used for registration and tracking, described below.  Image guided systems are somewhat self-explanatory.  The image-less systems rely on other information such as centers of rotation of the hip, knee or ankle, or visual information like anatomical landmarks.

Registration

Registration refers to the ability of relating images (x-rays, CT, MRI or the subjects’ 3-D anatomy) to the anatomical position in the surgical field.  Early registration techniques required the placement of pins or “fiduciary markers” in the target bone.  This required an additional surgical procedure.  More recently, 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 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.

Coding

The following codes for treatments and procedures applicable to this document are included below for informational purposes. Inclusion or exclusion of a procedure, diagnosis or device code(s) does not constitute or imply member coverage or provider reimbursement policy. Please refer to the member's contract benefits in effect at the time of service to determine coverage or non-coverage of these services as it applies to an individual member.

When services are Investigational and Not Medically Necessary:

CPT

 

20985

Computer-assisted surgical navigational procedure for musculoskeletal procedures, image-less

0054T

Computer-assisted musculoskeletal surgical navigational orthopedic procedure, with image-guidance based on fluoroscopic images  

0055T

Computer-assisted musculoskeletal surgical navigational orthopedic procedure, with image-guidance based on CT/MRI images

 

 

ICD-10 Diagnosis

 

 

All diagnoses

Note: the codes listed above are intended for navigational procedures for appendicular musculoskeletal procedures; for cranial and spinal procedures see CPT codes 61781, 61782 or 61783.

References

Peer Reviewed Publications:

  1. Bailey C, Gul R, Falworth M, et al. Component alignment in hip resurfacing using computer navigation. Clin Orthop Relat Res. 2009; 467(4):917-922.
  2. Barrett WP, Mason JB, Moskal JT, et al. Comparison of radiographic alignment of imageless computer-assisted surgery vs conventional instrumentation in primary total knee arthroplasty. J Arthroplasty. 2011; 26(8):1273-1284.e1.
  3. Blakeney WG, Khan RJ, Wall SJ. Computer-assisted techniques versus conventional guides for component alignment in total knee arthroplasty: a randomized controlled trial. J Bone Joint Surg Am. 2011; 93(15):1377-1378.
  4. Bauwens K, Matthes G, Wich M, et al. Navigated total knee replacement. A meta-analysis. J Bone Joint Surg Am. 2007; 89(2):261-269.
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  6. Cheng T, Zhang GY, Zhang XL. Does computer navigation system really improve early clinical outcomes after anterior cruciate ligament reconstruction? A meta-analysis and systematic review of randomized controlled trials. Knee. 2012; 19(2):73-77.
  7. Chin PL, Foo LS, Yang KY, et al. Randomized controlled trial comparing the radiologic outcomes of conventional and minimally invasive techniques for total knee arthroplasty. J Arthroplasty. 2007; 22(6):800-806.
  8. 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):282-288.
  9. Decking R, Markmann Y, Mattes T, et al. On the outcome of computer-assisted total knee replacement. Acta Chir Orthop Traumatol Cech. 2007; 74(3):171-174.
  10. Digioia AM, Jaramaz B, Plakseychuk AY, et al. Comparison of a mechanical acetabular alignment guide with computer placement of the socket. J Arthroplasty. 2002; 17(3):359-364.
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  12. Dutton AQ, Yeo SJ, Yang KY, et al. Computer-assisted minimally invasive total knee arthroplasty compared with standard total knee arthroplasty. A prospective, randomized study. J Bone Joint Surg Am. 2008; 90(1):2-9.
  13. Eggerding V, Reijman M, Scholten RJ, Meuffels DE. Computer-assisted surgery for knee ligament reconstruction. Cochrane Database Syst Rev. 2014;(8):CD007601.
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  17. Harvie P, Sloan K, Beaver RJ. Computer navigation vs conventional total knee arthroplasty: five-year functional results of a prospective randomized trial. J Arthroplasty. 2012; 27(5):667-672.e1
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  19. Hsieh PH, Chang YH, Shih CH. Image-guided periacetabullar osteotomy: computer assisted navigation compared with the conventional technique: a randomized study of 36 patients followed for 2 years. Acta Orthop. 2006; 77(4):591-597.
  20. Hufner T, Pohlemann T, Tarte S, et al. Computer-assisted fracture reduction of pelvic ring fractures: an in vitro study. Clin Orthop Relat Res. 2002; 399:231-239.
  21. Kim YH, Kim JS, Yoon SH. Alignment and orientation of the components in total knee replacement with and without navigation support: a prospective, randomized study. J Bone Joint Surg Br. 2007; 89(4):471-476.
  22. Kuzyk PR, Higgins GA, Tunggal JA, et al. Computer navigation vs extramedullary guide for sagittal alignment of tibial components: radiographic study and meta-analysis. J Arthroplasty. 2012; 27(4):630-637.
  23. Leenders T, Vandevelde D, Mahieu G, Nuyts R. Reduction in variability of acetabular cup abduction using computer-assisted surgery: a prospective and randomized study. Comput Aided Surg. 2002; 7(2):99-106.
  24. Luring C, Beckmann J, Haibock P, et al. Minimal invasive and computer assisted total knee replacement compared with the conventional technique: a prospective, randomised trial. Knee Surg Sports Traumatol Arthrosc. 2008; 16(10):928-934.
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  26. Lutzner J, Krummenauer F, Wolf C, et al. Computer-assisted and conventional total knee replacement: a comparative, prospective, randomised study with radiological and CT evaluation. J Bone Joint Surg Br. 2008; 90(8):1039-1044.
  27. Matziolis G, Krocker D, Weiss U, et al. A prospective, randomized study of computer-assisted and conventional total knee arthroplasty. Three-dimensional evaluation of implant alignment and rotation. J Bone Joint Surg Am. 2007; 89(2):236-243. 
  28. Mauch F, Apic G, Becker U, Bauer G. Differences in the placement of the tibial tunnel during reconstruction of the anterior cruciate ligament with and without computer-assisted navigation. Am J Sports Med. 2007; 35(11):1824-1832.
  29. Najarian BC, Kilgore JE, Markel DC. Evaluation of component positioning in primary total hip arthroplasty using an imageless navigation device compared with traditional methods. J Arthroplasty. 2009; 24(1):15-21.
  30. Olsen M, Davis ET, Waddell JP, Schemitsch EH. Imageless computer navigation for placement of the femoral component in resurfacing arthroplasty of the hip. J Bone Joint Surg Br. 2009; 91(3):310-315.
  31. Parratte S, Argenson JN. Validation and usefulness of a computer-assisted cup-positioning system in total hip arthroplasty. A prospective, randomized, controlled study. J Bone Joint Surg Am. 2007; 89(3):494-499.
  32. Plaweski S, Cazal J, Rosell P, Merloz P. Anterior cruciate ligament reconstruction using navigation: a comparative study on 60 patients. Am J Sports Med. 2006; 34(4):542-552.
  33. Plaweski S, Tchouda SD, Dumas J, et al. Evaluation of a computer-assisted navigation system for anterior cruciate ligament reconstruction: prospective non-randomized cohort study versus conventional surgery. Orthop Traumatol Surg Res. 2012; 98(6 Suppl):S91-S97.
  34. 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. 2014; 29(5):938-944.
  35. 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. 2013; 31(2):288-294.
  36. Romanowski JR, Swank ML. Imageless navigation in hip resurfacing: avoiding component malposition during the surgeon learning curve. J Bone Joint Surg Am. 2008; 90(Suppl 3):65-70.
  37. Schep NW, Broeders IA, van der Werken C. Computer-assisted orthopaedic and trauma surgery. State of the art and future perspectives. Injury. 2003; 34(4):299-306.
  38. Seon JK, Park SJ, Lee KB, et al. Functional comparison of total knee arthroplasty performed with and without a navigation system. Int Orthop. 2009; 33(4):987-990.
  39. Slomczykowski MA, Hofstetter R, Sati M, et al. Novel computer-assisted fluoroscopy system for intraoperative guidance: feasibility study for distal locking of femoral nails. J Orthop Trauma. 2001; 15(2):122-131.
  40. Spencer JM, Chauhan SK, Sloan K, et al. Computer navigation versus conventional total knee replacement: no difference in functional results at two years. J Bone Joint Surg Br. 2007; 89(4):477-480.
  41. Suhm N, Jacob AL, Nolte LP, et al. Surgical navigation based on fluoroscopy--clinical application for computer-assisted distal locking of intramedullary implants. Comput Aided Surg. 2000; 5(6):391-400.
  42. Victor J, Hoste D. Image-based computer-assisted total knee arthroplasty leads to lower variability in coronal alignment. Clin Orthop Relat Res. 2004; 428:131-139.
  43. 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. 2013; 36(5):e627-632.

Government Agency, Medical Society, and Other Authoritative Publications:

  1. Blue Cross Blue Shield Association. Computer-assisted navigation for total knee arthroplasty. TEC Assessment, 2008; 22(10).
Index

BrainLab AG Vector Vision fluoro3D
Computer-Assisted Musculoskeletal Surgical Navigational Orthopedic Procedures
DePuy CAS Knee Instrumentation
InstaTrak 3500 Plus SystemOrthoMap® 3D Module
NavioPFS™ Surgical System
Orthopilot® Next Generation
Rio Robotic Arm Interactive Orthopedic System (MAKOplasty®)
StealthStation® System
Surgetics Ortho Kneelogics Navigation System
VectorVisionA CT-free navigation system
Zimmer Ortho Guidance Systems

The use of specific product names is illustrative only.  It is not intended to be a recommendation of one product over another, and is not intended to represent a complete listing of all products available.

Document History

Status

Date

Action

Reviewed

11/02/2017

Medical Policy & Technology Assessment Committee (MPTAC) review. The document header wording updated from “Current Effective Date” to “Publish Date.” Updated References and History sections.

Reviewed

11/03/2016

Medical Policy & Technology Assessment Committee (MPTAC) review.  Updated Rationale and References sections.

Reviewed

11/05/2015

MPTAC review. Updated the Review date, Rationale, Background/Overview, References and History sections of the document. Removed ICD-9 codes from Coding section.

Reviewed

11/13/2014

MPTAC review. Updated the Review date, Rationale, References and History sections of the document.

Reviewed

11/14/2013

MPTAC review. Updated the Review date, Rationale, References, Index and History sections of the document.

Reviewed

11/08/2012

MPTAC review. Updated the Review date, Rationale, References and History sections.

Reviewed

11/17/2011

MPTAC review. Updated the Review date, Rationale and History sections. Added the RioRobotic Arm Interactive Orthopedic System (MAKOplasty®) to the Index section.

Revised

05/19/2011

MPTAC review.  Changed title to “Computer-Assisted Musculoskeletal Surgical Navigational Orthopedic Procedures of the Appendicular System. “ Revised the Position Statement and the Description/Scope section to clarify that this document does not address navigation when used for spinal or cranial procedures. Updated the Review date, References, and History sections of the document.

Reviewed

08/19/2010

MPTAC review. Updated the Review date, Coding, References, History and Index sections of the document.

Revised

08/27/2009

MPTAC review. Removed the words “of the appendicular skeleton” from the position statement. Updated the rationale, references and history sections. Removed the definitions section.

 

01/01/2009

Updated Coding section with 01/01/2009 CPT changes; removed 20986, 20987 deleted 12/31/2008.

Reviewed

08/28/2008

MPTAC review. Removed the word “pelvis” from the position statement (no change to intent of document). Updated review date, background/overview, references and history sections of document.

 

01/01/2008

Updated Coding section with 01/01/2008 CPT changes; removed CPT 0054T, 0055T, 0056T deleted 12/31/2007. The phrase “investigational/not medically necessary” was clarified to read “investigational and not medically necessary.”  This change was approved at the November 29, 2007 MPTAC meeting.

Reviewed

08/23/2007

MPTAC review. Updated review date, rationale, references, coding and history sections of document.

Reviewed

09/14/2006

MPTAC annual review. Updated references, no change to stance.

Revised

09/22/2005

MPTAC review. Revision based on Pre-merger Anthem and Pre-merger WellPoint Harmonization. 

Pre-Merger Organizations

Last Review Date

Document Number

Title

 

Anthem, Inc.

 

None

 

WellPoint Health Networks, Inc.

04/28/2005

3.07.21

Computer-Assisted Musculoskeletal Surgical Navigational Orthopedic Procedures