Coverage Policy Manual
Policy #: 2014019
Category: DME
Initiated: August 2017
Last Review: May 2023
  Patient-Specific Instrumentation (eg Cutting Guides) for Joint Arthroplasty
Description:
Total knee arthroplasty (TKA, also called knee replacement) is an established treatment for relief of significant, disabling pain caused by advanced arthritis. TKA is considered among the most successful medical procedures in the United States in terms of the degree of improvement in functional status and quality of life. As a result of the success of TKA, the increase in the aging population, and the desire of older adults to remain physically active, the incidence of TKA is increasing rapidly. It is projected that by 2030, the demand for knee replacement will approach 3.5 million procedures annually (Kurtz, 2007).
 
TKA is performed by removing the damaged cartilage surface and a portion of underlying bone using a saw guided by templates and jigs. The removed cartilage and bone from the distal femur and proximal tibia are replaced with implants that recreate the surface of the joint. Patellar resurfacing may also be performed. Three-dimensional implant alignment (coronal, sagittal, axial) is considered to be critical for joint articulation and implant longevity. Generally, less than 3° deviation from the rotational or mechanical axis, as determined by a straight line through the center of the hip, knee, and ankle on the coronal plane, is believed to minimize the risk of implant wear, loosening, instability, and pain.
 
The placement of conventional cutting guides (templates and jigs) is based on anatomic landmarks or computer navigation (see policy No. 2006009). Use of conventional instrumentation has been shown to result in malalignment of approximately one third of implants in the coronal plane. Computer-assisted navigation can significantly reduce the proportion of malaligned implants compared with conventional instrumentation, but has a number of limitations including a lack of rotational alignment, increased surgical time, and a long learning curve. In addition, no studies have demonstrated an improvement in clinical outcomes with computer-assisted navigation compared with conventional instrumentation.
  
Patient-specific instrumentation has been developed as an alternative to conventional cutting guides, with the goal of improving both alignment and surgical efficiency. A number of patient-specific cutting guides are currently being marketed (see the Regulatory Status section). Patient-specific guides are constructed with the use of preoperative 3-dimensional computed tomography or magnetic resonance imaging scans, which are taken 4 to 6 weeks before the surgery. The images are sent to the planner/manufacturer to create a 3-dimensional model of the knee and proposed implant. After the surgeon reviews the model of the bone, makes adjustments, and approves the surgical plan, the manufacturer fabricates the disposable cutting guides.
 
The proposed benefits of using patient-specific instrumentation during TKA include improved alignment, decreased operative time, increased patient throughput, fewer instrument trays, reduced risk of fat embolism and intraoperative bleeding (no intramedullary canal reaming), shorter recovery, reduced postoperative pain, reduced revision rate, and reduced costs. However, the nonsurgical costs of the procedure may be increased due to the requirement for preoperative computed tomography or magnetic resonance imaging, preoperative review of the template, and fabrication of the patient-specific instrumentation. Also, the patient-specific template relies on the same anatomic landmarks as conventional TKA and does not take soft tissue balancing into account. Thus, evaluation of this technology should also address the reliability of the cutting guides and the need for intraoperative changes such as conversion to conventional instrumentation.
 
Regulatory Status
A number of patient-specific cutting block systems have been cleared for marketing by the U.S. Food and Drug Administration (FDA). An example is the single-use, disposable cutting guides designed and manufactured from patient imaging data (magnetic resonance imaging, computed tomography). The cutting guides are used to aid the surgeon intraoperatively in making the initial distal femoral and the initial proximal tibial bone cuts during TKA surgery. The cutting guides also establish the references for component orientations. Planning systems (eg, from Materialise NV) for the personalized instruments have also cleared for marketing by FDA through the 510(k) process.
 
In 2008, the Smith & Nephew Patient Matched Instrumentation (now called Visionaire™ Patient Matched Instrumentation) was the first patient-specific cutting guide to receive FDA clearance for marketing. Other patient-specific cutting guide systems cleared for marketing include:
 
    • X-PSI Knee System (Orthosoft)
    • iTotal (Conformis)
    • Prophecy™ Pre-operative Navigation Alignment Guides (Wright Medical Technology)
    • TruMatch® Personalized Solutions (DePuy Orthopaedics)
    • Shapematch (Stryker)
    • Signature™ Planner/Signature Guides (Materialise)
    • Zimmer® Patient Specific Instruments and Zimmer® Patient Specific Instruments Planner (Materialise).  
    • Visionaire Patient Matched Cutting Blocks (Smith & Nephew)  
 
Coding
There are no specific codes for these implants and instrumentation. The joint arthroplasty procedure would be reported using the regular CPT codes for that surgery.
Policy/
Coverage:
Effective May 2018
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Use of patient-specific instrumentation (eg, cutting guides) for joint arthroplasty, including but not limited to use in unicompartmental or total knee arthroplasty, for any condition does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, use of patient-specific instrumentation (eg, cutting guides) for joint arthroplasty, including but not limited to use in unicompartmental or total knee arthroplasty, is investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
Effective prior to May 2018
Does Not Meet Primary Coverage Criteria Or Is Investigational For Contracts Without Primary Coverage Criteria
 
Use of custom implants or patient-specific instrumentation (eg, cutting guides) for joint arthroplasty, including but not limited to use in unicompartmental or total knee arthroplasty, for any condition does not meet member benefit certificate primary coverage criteria that there be scientific evidence of effectiveness.
 
For members with contracts without primary coverage criteria, use of custom implants or patient-specific instrumentation (eg, cutting guides) for joint arthroplasty, including but not limited to use in unicompartmental or total knee arthroplasty, is investigational. Investigational services are specific contract exclusions in most member benefit certificates of coverage.
 
 
Rationale:
Assessment of efficacy for new technology involves a determination of whether the technology improves health outcomes. The optimal study design for a therapeutic intervention is a randomized controlled trial (RCT) that includes clinically relevant measures of health outcomes. Intermediate outcome measures, also known as surrogate outcome measures, may also be adequate if there is an established link between the intermediate outcome and true health outcomes. Nonrandomized comparative studies and uncontrolled studies can sometimes provide useful information on health outcomes, but are prone to biases such as noncomparability of treatment groups, the placebo effect, and variable natural history of the condition.
 
There are a number of RCTs that compare patient-specific instrumentation (PSI) versus conventional instrumentation for total knee arthroplasty (TKA). Therefore, this evidence review will focus on systematic reviews and RCTs that address clinical outcomes. The surrogate outcome measure of a reduction in malalignment may be informative to support improvement with the new technology. However, a reduction in the percentage of malaligned implants has not been definitively shown to result in improved clinical outcomes and is therefore not sufficient to demonstrate an improvement in clinical outcomes. In addition, as this is a relatively new technology, no long-term studies are currently available that could provide data on revision rates.
 
Patient-Specific Instrumentation
Systematic Reviews
Systematic reviews published to date have not found an improvement in accuracy or clinically significant decrease in operative time with PSI.
 
Thienpont et al included 8 RCTs and 8 cohort studies (total of 1755 patients) in their 2014 meta-analysis.3 The PSI systems used in the RCTs were Signature™(Biomet),4-7 Zimmer Patient Specific Instruments® (Zimmer) (Victor, 2014; Chareancholvanich, 2013; Parratte, 2013), TruMatch® (DePuy) (Victor, 2014; Chotanaphuti, 2014; Hamilton, 2013) and Visionaire (Smith & Nephew) (Victor, 2014). This systematic review found no significant difference in the likelihood of mechanical axis malalignment with PSI versus conventional TKA across all studies, or when divided by RCTs (RR [risk ratio]=1.14, p=0.445) and cohort studies (RR=0.70, p=0.289). Alignment of the tibial component was significantly worse in the coronal and sagittal planes when using PSI. For the femoral component, alignment was significantly better in the coronal plane but not in the sagittal plane with PSI. Axial alignment of the tibial and femoral components was not significantly different between PSI and conventional instrumentation. Funnel plots showed no strong evidence of publication bias.
 
A 2014 meta-analysis by Fu et al included 10 RCTS and a total of 837 knees comparing PSI with conventional instrumentation (FU, 2014). There were no significant differences between the 2 groups for outliers from a neutral mechanical axis or femoral component placement. Malalignment of the tibial component was higher with PSI in both the coronal plane (RR=2.50, p=0.02) and the sagittal plane (RR=1.47, p=0.02). Surgical time was shorter by a modest 3.54 minutes (weighted mean difference) with PSI. A funnel plot showed minimal evidence of publication bias. The 9 comparative studies (2 RCTs) in a 2014 meta-analysis by Voletti et al used 4 different PSI systems and included 957 knee arthroplasties.13 There was no significant difference between the treatment groups in the percentage of outliers greater than 3 degrees from target alignment (p=0.7), while standard instrumentation had greater accuracy in the mechanical axis (p=0.02). Sagittal alignment, operative time, intraoperative blood loss, and cost were similar between groups (p>0.1).
 
RCTs
Two additional RCTs, published after the search dates of the systematic reviews, compared PSI and conventional instrumentation. One RCT of 112 patients found no significant improvement in alignment with use of the Signature™ Personalized Patient Care System (Kotela, 2014). Another RCT with 50 patients found no significant improvement in Knee Society Scores (KSS) at a minimum 6-month follow-up and an increase in the percentage of outliers with TruMatch® PSI (47% vs 6%, p<0.000) (Woolson, 2014). It was also reported that PSI was abandoned during surgery in 7 of 22 knees (31.8%) because of possible malalignment. In 55%, the surgeon adjusted the joint space by increasing the bone (compared with 23% of control knees) and a different size of implant than was planned was needed in 41% of PSI procedures. A third publication reported clinical outcomes from 40 patients randomized to Zimmer® PSI or conventional instrumentation; alignment data had previously been reported and was included in the systematic reviews.9,16 Similar scores were obtained for the 2 groups for gait parameters and patient-reported outcomes (KSS, Knee Injury, and Osteoarthritis Outcome Score, and Short Form-12) at 3-month follow-up.
 
Ongoing and Unpublished Clinical Trials
A search of online site ClinicalTrials.gov in August 2014 found a number of ongoing trials on patient-specific cutting guides for TKA. Many of these trials are being conducted in Europe and are independent of manufacturer funding. Larger trials include:
  • NCT02002624 - A multicenter randomized single-blind study with 140 patients that compared PSI with standard instrumentation. The outcome measures include mechanical axis and component positioning at 3 months. The study began in 2011 and was completed in July 2013.
  • NCT01876654 - An open label randomized trial with the TruMatch® patient-specific cutting guide. The primary outcome is the femorotibial mismatch angle at 2 months after surgery. The study has an estimated enrollment of 64 patients with completion targeted for June 2014.
  • NCT02096393 - A randomized double-blind trial of Zimmer Patient-Specific Instruments compared with standard instrumentation. The study began September 2013. It has a target enrollment of 100 patients with 10-year follow-up of functional outcomes completed in 2024.
  • NCT01696552 - A randomized double-blind trial of the Signature™ Patient Care system compared with conventional instrumentation. Outcomes include implant positioning at 3 months, functional outcomes at 2 years, and x-ray analysis for alignment and possible osteolytic development at 10 years. The study has an estimated enrollment of 200 patients with completion of the primary outcome measure in June 2013 and the final outcome measure in 2020.
  • NCT01072019 - A randomized open-label study of Signature™ custom guides compared with standard instrumentation. The primary outcome is patient dissatisfaction at up to 1 year. The study has an estimated enrollment of 165 patients with completion listed for March 2013. The posting was last verified in 2011.
  • NCT02128464 - A randomized double-blind trial of the Visionaire™ customized cutting guide compared with conventional instrumentation in 100 patients. The primary outcome is mechanical axis at 3 months. The estimated completion date is December 2014.
  • NCT01483066 - A randomized single-blinded comparison of ShapeMatch patient-specific cutting guides with conventional cutting guides. ShapeMatch uses a method that aligns the cutting guide with the patient’s anatomic alignment instead of the mechanical axis. Functional outcomes will be assessed at 2 years. The study has an estimated enrollment of 150 patients with completion expected December 2016.
 
Studies on custom knee implants were also identified.
  • NCT02186587- An open-label nonrandomized comparison of recovery at 6 months in patients receiving the ConforMIS custom total knee implant with the outcomes of patients who receive an off-the-shelf total knee implant. The study has an estimated enrollment of 115 patients with completion expected December 2014.
  • NCT01117571 - A manufacturer-sponsored single arm Phase IV study of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device. The primary outcome is function at 2 years. Annual revision rates through 10 years will also be examined. The study has an enrollment of 120 patients with completion expected in 2020.
 
A number of small randomized controlled trials have examined whether patient-specific cutting guides improve outcomes for total knee arthroplasty. Systematic reviews of these trials find no significant improvement in implant alignment, with some studies reporting worse alignment with patient-specific instrumentation (PSI). In addition, a substantial number of procedures are abandoned intraoperatively. If there is no improvement in alignment, it is unlikely that PSI as a category as a whole will improve clinical outcomes. However, larger RCTs examining the various PSI systems are in progress, and these systems differ in both planning and manufacturing. Therefore, future assessment of PSI should address the specific system used. Based on the evidence available at this time, use of custom made implants and patient-specific cutting guides is considered investigational.
 
Practice Guidelines and Position Statements
No guidelines or position statements that mention custom cutting guides/blocks for total knee arthroplasty were identified.
 
2015 Update
A literature search conducted through July 2015 did not reveal any new information that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2015, a RCT of 60 patients found no benefit in alignment, gait, function, or quality of life after patient-specific instrumentation for unicompartmental knee arthroplasty (Ollivier, 2015).
 
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed below:
Ongoing
  • NCT02186587- An open-label nonrandomized comparison of recovery at 6 months in patients receiving the ConforMIS custom total knee implant with the outcomes of patients who receive an off-the-shelf total knee implant. The study has an estimated enrollment of 115 patients with completion expected December 2014.
 
  • NCT01696552 - A randomized double-blind trial of the Signature™ Patient Care system compared with conventional instrumentation. Outcomes include implant positioning at 3 months, functional outcomes at 2 years, and x-ray analysis for alignment and possible osteolytic development at 10 years. The study has an estimated enrollment of 200 patients with completion of the primary outcome measure in June 2013 and the final outcome measure in 2020.  
 
  • NCT01117571 - A manufacturer-sponsored single arm Phase IV study of the ConforMIS iUni® Unicompartmental Knee Resurfacing Device. The primary outcome is function at 2 years. Annual revision rates through 10 years will also be examined. The study has an enrollment of 120 patients with completion expected in 2020.
 
  • NCT02096393 - A randomized double-blind trial of Zimmer Patient-Specific Instruments compared with standard instrumentation. The study began September 2013. It has a target enrollment of 100 patients with 10-year follow-up of functional outcomes completed in 2024.
 
  • NCT02494544 A Prospective, Randomized, Multicenter Study to Evaluate the ConforMIS iTotal® (CR) Knee Replacement System Versus Off the-Shelf Replacement (an industry sponsored or cosponsored trial): panned enrollment 800: projected completion date 2025.  
 
   
Unpublished
  • NCT01876654 - An open label randomized trial with the TruMatch® patient-specific cutting guide. The primary outcome is the femorotibial mismatch angle at 2 months after surgery. The study has an estimated enrollment of 64 patients with completion targeted for June 2014.
 
  • NCT02128464 - A randomized double-blind trial of the Visionaire™ customized cutting guide compared with conventional instrumentation in 100 patients. The primary outcome is mechanical axis at 3 months. The estimated completion date is December 2014.
 
  • NCT02002624 - A multicenter randomized single-blind study with 140 patients that compared PSI with standard instrumentation. The outcome measures include mechanical axis and component positioning at 3 months. The study began in 2011 and was completed in July 2013.
 
  • NCT01483066 - A randomized single-blinded comparison of ShapeMatch patient-specific cutting guides with conventional cutting guides. ShapeMatch uses a method that aligns the cutting guide with the patient’s anatomic alignment instead of the mechanical axis. Functional outcomes will be assessed at 2 years. The study has an estimated enrollment of 150 patients with completion expected December 2016.
 
2017 Update
 
A literature search conducted using the Medline database through August 2017. There was no information identified that would prompt a change in the coverage statement.
 
There are a number of systematic reviews on patient specific instrumentation (PSI) for total knee arthroplasty. The most recently identified reviews are discussed below.
 
Thienpont et al included 20 RCTs and 24 cohort studies (total N=5822 patients) in their 2017 systematic review (Thienpont, 2017). The PSI systems used in the RCTs were the Signature (Biomet), Zimmer Patient Specific Instruments (Zimmer), TruMatch (DePuy), Visionaire (Smith & Nephew), and MyKnee (Medacta). Meta-analysis of results for PSI vs conventional total knee arthroplasty indicated modest but statistically significant decreases in the likelihood of malalignment in the mechanical axis and femoral/coronal plane, but increases in malalignment of the tibial/sagittal and tibial/coronal planes (see Table 2). There were minor reductions in total operative time (-4.4 minutes, p=0.002) and blood loss (-37.9 mL, p=0.015) that are of uncertain clinical significance. There was some evidence of publication bias for mechanical axis alignment, but the relative risk did not change after adjusting for bias. In the 6 studies (598 knees) that reported clinical outcomes (follow-up, 6-24 months), PSI was associated with a modest improvement in function (4.3 points) assessed on the Knee Society Score.
 
Rotational alignment was evaluated in a 2016 systematic review of 6 RCTs by Mannan and Smith (Mannan, 2016).  The most commonly used PSI was Trumatch (DePuy). Meta-analysis showed a significant decrease in the risk of femoral rotational malalignment. Only 1 study was identified that evaluated tibial rotational alignment.
 
The key question we considered is whether these modest differences in the number of outliers greater than 3 degree impacts functional outcomes. This question was addressed in a 2016 meta-analysis by Mannan et al, who identified 5 RCTs and 3 prospective comparative studies that assessed functional outcomes (Mannan, 2016). Meta-analysis indicated that functional outcomes did not differ significantly when measured at up to 24 months after surgery.
 
In 2016, Boonen et al reported on a multicenter, double-blind RCT that evaluated clinical outcomes of PSI with the Signature instrumentation (Boonen, 2016). With a total of 180 patients, the trial was powered to detect a clinically significant difference on the Knee Society Score at 2 years. At follow-up, there were no statistically or clinically significant differences between the groups on any of the 5 clinical outcome measures (Knee Society Score, Oxford Knee Score, Western Ontario and McMaster Universities Osteoarthritis Index, visual analog scale score for pain, EuroQol-5D-3L index score, EuroQol-5D-3L VAS health).
 
2019 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2019. No new literature was identified that would prompt a change in the coverage statement.
 
2020 Update
A literature search was conducted through April 2020.  There was no new information identified that would prompt a change in the coverage statement.
 
2021 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2021. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
There are a number of systematic reviews on patient specific instrumentation for total knee arthroplasty. A meta-analysis by Lin et al showed a significant improvement in the overall KSS score with patient specific instrumentation but failed to show an improvement in the Oxford Knee Score (Lin, 2020). The follow-up period for was only 3 months and did not provide information on long-term outcomes.
 
Three of the meta-analyses reported perioperative outcomes (Gong, 2019; Thienpont, 2017; Lin, 2020). Total operative time was statistically significantly shorter with patient specific instrumentation in all studies but the clinical significance of these differences is not clear. There was high heterogeneity among the studies that limits the application to clinical practice. Gong et al and Lin et al reported hospital length of stay and did not find a significant difference between patient specific instrumentation and conventional instrumentation groups. All 3 meta-analyses also showed a significant reduction in blood loss with patient specific instrumentation.
 
2022 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2022. No new literature was identified that would prompt a change in the coverage statement.
 
2023 Update
Annual policy review completed with a literature search using the MEDLINE database through April 2023. No new literature was identified that would prompt a change in the coverage statement. The key identified literature is summarized below.
 
In 2016, the American Academy of Orthopaedic Surgeons published a guideline on the surgical management of osteoarthritis of the knee (updated December 2, 2022) (McGrory, 2016; AAOS, 2022). The guideline is supported by the American Society of Anesthesiologists and endorsed by several other organizations. The guideline recommends against the use of patient specific instrumentation for total knee arthroplasty since strong evidence has not shown a difference in pain or functional outcomes when compared to conventional instrumentation. Additionally, moderate evidence has not shown a difference between patient specific and conventional instrumentation with regard to transfusions or complications.
CPT/HCPCS:
0561TAnatomic guide 3D printed and designed from image data set(s); first anatomic guide
0562TAnatomic guide 3D printed and designed from image data set(s); each additional anatomic guide (List separately in addition to code for primary procedure)
References: Abdel MP, Parratte S, Blanc G, et al.(2014) No Benefit of Patient-specific Instrumentation in TKA on Functional and Gait Outcomes: A Randomized Clinical Trial. Clin Orthop Relat Res. Mar 7 2014. PMID 24604110

American Academy of Orthopaedic Surgeons (AAOS).(2022) Surgical Management of Osteoarthritis of the Knee Evidence-Based Clinical Practice Guideline. www.aaos.org/smoak2cpg Published December 02, 2022; Accessed March 10, 2023

Boonen B, Schotanus MG, Kerens B, et al(2013) Intra-operative results and radiological outcome of conventional and patient-specific surgery in total knee arthroplasty: a multicentre, randomised controlled trial. Knee Surg Sports Traumatol Arthrosc. Oct 2013;21(10):2206-2212. PMID 23928929

Boonen B, Schotanus MG, Kerens B, et al.(2016) No difference in clinical outcome between patient-matched positioning guides and conventional instrumented total knee arthroplasty two years post-operatively: a multicentre, double-blind, randomised controlled trial. Bone Joint J. Jul 2016;98-B(7):939-944. PMID 27365472

Chareancholvanich K, Narkbunnam R, Pornrattanamaneewong C.(2013) A prospective randomised controlled study of patient-specific cutting guides compared with conventional instrumentation in total knee replacement. Bone Joint J. Mar 2013;95-B(3):354-359. PMID 23450020

Chotanaphuti T, Wangwittayakul V, Khuangsirikul S, et al.(2014) The accuracy of component alignment in custom cutting blocks compared with conventional total knee arthroplasty instrumentation: prospective control trial. Knee. Jan 2014;21(1):185-188. PMID 23999209

Fu H, Wang J, Zhou S, et al.(2014) No difference in mechanical alignment and femoral component placement between patient-specific instrumentation and conventional instrumentation in TKA. Knee Surg Sports Traumatol Arthrosc. Jun 11 2014. PMID 25026931

Gong S, Xu W, Wang R, et al.(2019) Patient-specific instrumentation improved axial alignment of the femoral component, operative time and perioperative blood loss after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. Apr 2019; 27(4): 1083-1095. PMID 30377714

Hamilton WG, Parks NL, Saxena A.(2013) Patient-specific instrumentation does not shorten surgical time: a prospective, randomized trial. J Arthroplasty. Sep 2013;28(8 Suppl):96-100. PMID 23910821

Kotela A, Kotela I.(2014) Patient-specific computed tomography based instrumentation in total knee arthroplasty: a prospective randomized controlled study. Int Orthop. Jun 28 2014. PMID 24968788

Kurtz S, Ong K, Lau E, et al.(2007) Projections of primary and revision hip and knee arthroplasty in the United States from 2005 to 2030 J Bone Joint Surg Am. Apr 2007;89(4):780-785. PMID 17403800

Lin Y, Cai W, Xu B, et al.(2020) Patient-Specific or Conventional Instrumentations: A Meta-analysis of Randomized Controlled Trials. Biomed Res Int. 2020; 2020: 2164371. PMID 32258107

Mannan A, Akinyooye D, Hossain F.(2016) A Meta-analysis of Functional Outcomes in Patient-Specific Instrumented Knee Arthroplasty. J Knee Surg. Dec 01 2016. PMID 27907935

Mannan A, Smith TO.(2016) Favourable rotational alignment outcomes in PSI knee arthroplasty: A Level 1 systematic review and meta-analysis. Knee. Mar 2016;23(2):186-190. PMID 26782300

McGrory BJ, Weber KL, Jevsevar DS, et al.(2016) Surgical Management of Osteoarthritis of the Knee: Evidence-based Guideline. J Am Acad Orthop Surg. Aug 2016; 24(8): e87-93. PMID 27355286

Ollivier M, Parratte S, Lunebourg A, et al.(2015) The John Insall Award: No Functional Benefit after Unicompartmental Knee Arthroplasty Performed With Patient-specific Instrumentation: A Randomized Trial. Clin Orthop Relat Res. Mar 20 2015. PMID 25791446

Parratte S, Blanc G, Boussemart T, et al.(2013) Rotation in total knee arthroplasty: no difference between patient-specific and conventional instrumentation. Knee Surg Sports Traumatol Arthrosc. Oct 2013;21(10):2213-2219. PMID 23942938

Roh YW, Kim TW, Lee S, et al.(2013) Is TKA using patient-specific instruments comparable to conventional TKA? A randomized controlled study of one system. Clin Orthop Relat Res. Dec 2013;471(12):3988-3995. PMID 23907610

Silva A, Sampaio R, Pinto E.(2014) Patient-specific instrumentation improves tibial component rotation in TKA. Knee Surg Sports Traumatol Arthrosc. Mar 2014;22(3):636-642. PMID 23989707

Thienpont E, Schwab PE, Fennema P.(2014) A systematic review and meta-analysis of patient-specific instrumentation for improving alignment of the components in total knee replacement. Bone Joint J. Aug 2014;96-B(8):1052-1061. PMID 25086121

Thienpont E, Schwab PE, Fennema P.(2017) Efficacy of Patient-Specific Instruments in Total Knee Arthroplasty: A Systematic Review and Meta-Analysis. J Bone Joint Surg Am. Mar 15 2017;99(6):521-530. PMID 28291186

Victor J, Dujardin J, Vandenneucker H, et al.(2014) Patient-specific guides do not improve accuracy in total knee arthroplasty: a prospective randomized controlled trial. Clin Orthop Relat Res. Jan 2014;472(1):263-271. PMID 23616267

Voleti PB, Hamula MJ, Baldwin KD, et al.(2014) Current Data Do Not Support Routine Use of Patient-Specific Instrumentation in Total Knee Arthroplasty. J Arthroplasty. May 27 2014. PMID 24961893

Woolson ST, Harris AH, Wagner DW, et al.(2014) Component alignment during total knee arthroplasty with use of standard or custom instrumentation: a randomized clinical trial using computed tomography for postoperative alignment measurement. J Bone Joint Surg Am. Mar 5 2014;96(5):366-372. PMID 24599197
Group specific policy will supersede this policy when applicable. This policy does not apply to the Wal-Mart Associates Group Health Plan participants or to the Tyson Group Health Plan participants.
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