Description
Patient-specific instrumentation (PSI) has been developed as an alternative to conventional cutting guides for joint arthroplasty. Patient-specific cutting guides are constructed with the aid of preoperative 3-dimensional computed tomography or magnetic resonance imaging scans and proprietary planning software. The goals of PSI are to increase surgical efficiency and to improve implant alignment and clinical outcomes.

For individuals who are undergoing partial or total knee arthroplasty who receive patient-specific cutting guides, the evidence includes a number of randomized controlled trials, comparative cohort studies, and systematic reviews of these studies. The relevant outcomes are symptoms, functional outcomes, and quality of life. Results from the systematic reviews are mixed, finding significant improvements in some measures of implant alignment but either no improvement or worse alignment for other measures. The available systematic reviews are limited by the small size of some of the selected studies, publication bias, and differences in both planning and manufacturing of the PSI systems. Also, the designs of the devices are evolving, and some of the studies might have assessed now obsolete PSI systems. Available results from randomized controlled trial shave not shown a benefit of PSI systems in improving clinical outcome measures with follow-up currently extending out to two years. The evidence is insufficient to determine the effects of the technology on health outcomes.

Background 
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. 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.

Regulatory Status  
There are eight commercially available patient-specific instrumentation systems for total knee arthroplasty. In 2008, the Smith & Nephew Patient Matched Instrumentation (now called Visionaire™ Patient Matched Instrumentation) was the first patient-specific cutting guide to receive the Food and Drug Administration (FDA) clearance for marketing. Other systems cleared for marketing by the FDA are shown in Table 1 (FDA Product Code OOG).

Table 1.  Patient-Specific Cutting Guides for Knee Arthroplasty

Source: FDA

Related Policies
70196 Computer-Assisted Musculoskeletal Surgical Naviational Orthopedic Procedure 

Policy
Use of patient-specific instrumentation (e.g., cutting guides) for joint arthroplasty, including but not limited to use in unicompartmental or total knee arthroplasty, is investigational and/or unproven and therefore considered NOT MEDICALLY NECESSARY.

Policy Guidelines 　
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.

The preplanning for the surgery may involve magnetic resonance (MRI) or CT imaging which may help to identify these procedures.

Benefit Application
BlueCard/National Account Issues 
State or federal mandates (e.g., FEP) may dictate that all U.S. Food and Drug Administration (FDA)-approved devices, drugs or biologics may not be considered investigational, and thus these devices may be assessed only on the basis of their medical necessity.

Rationale  

Evidence reviews assess the clinical evidence to determine whether the use of a technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life, and ability to function including benefits and harms. Every clinical condition has specific outcomes that are important to patients and managing the course of that condition. Validated outcome measures are necessary to ascertain whether a condition improves or worsens; and whether the magnitude of that change is clinically significant. The net health outcome is a balance of benefits and harms.

To assess whether the evidence is sufficient to draw conclusions about the net health outcome of a technology, 2 domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent 1 or more intended clinical use of the technology in the intended population and compare an effective and appropriate alternative at a comparable intensity. For some conditions, the alternative will be supportive care or surveillance. The quality and credibility of the evidence depend on study design and conduct, minimizing bias and confounding that can generate incorrect findings. The randomized controlled trial (RCT) is preferred to assess efficacy; however, in some circumstances, nonrandomized studies may be adequate. Randomized controlled trials are rarely large enough or long enough to capture less common adverse events and long-term effects. Other types of studies can be used for these purposes and to assess generalizability to broader clinical populations and settings of clinical practice.

Clinical Context and Therapy Purpose
The purpose of patient-specific cutting guides in patients undergoing knee arthroplasty is to provide a treatment option that is an alternative to or an improvement on existing therapies.

The question addressed in this evidence review is: Does patient-specific cutting guides improve the net health outcome in patients undergoing knee arthroplasty?

The following PICO was used to select literature to inform this review.

Populations
The relevant population of interest is patients undergoing partial or total knee arthroplasty (also called knee replacement). Knee arthroplasty is an established treatment for relief from significant, disabling pain caused by advanced arthritis. This intervention is considered among the most successful medical procedures in the United States regarding the degree of improvement in functional status and quality of life. As a result of the success of knee arthroplasty, the increase in the aging population, and the desire of older adults to remain physically active, the incidence of knee arthroplasty is increasing rapidly. It is projected that by 2030, the demand for knee replacement will approach 3.5 million procedures annually.^1,

Knee arthroplasty is performed by removing the damaged cartilage surface and a portion of underlying bone using a saw guided by templates and jigs. The cartilage and bone removed 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. 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.

Interventions
The therapy being considered is patient-specific instrumentation (e.g., cutting guides). The cutting guides are used to aid the surgeon intraoperatively in making the initial distal femoral and the initial proximal tibial bone cuts during knee arthroplasty surgery. The cutting guides also establish the references for component orientations. The placement of conventional cutting guides (templates and jigs) is based on anatomic landmarks or computer navigation (see evidence review 70196). 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. Also, no studies have demonstrated an improvement in clinical outcomes with computer-assisted navigation.

Comparators
For patients undergoing knee arthroplasty, conventional cutting guides are currently being used for knee arthroplasty (see intervention description).

Outcomes
The general outcomes of interest are symptoms, functional outcomes, and quality of life. Commonly used instruments to measure these outcomes include the Knee Society Score (KSS), Oxford Knee Score, range of movement, Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and visual analog scales.

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 shown to result in improved clinical outcomes and is, therefore, not sufficient to demonstrate an improvement in clinical outcomes. Also, no long-term studies are currently available that could provide data on revision rates. It should also be noted that the design of these devices is evolving, and results from older studies may be less relevant for contemporary designs.

The proposed benefits of using patient-specific instrumentation during knee arthroplasty 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 knee arthroplasty 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.

Component alignment and perioperative outcomes are short-term outcomes. Pain, function, and quality of life should be measured in long-term studies (2 years or longer), in particular because component alignment is hypothesized to correlate to component longevity.

Study Selection Criteria
Methodologically credible studies were selected using the following principles:

• To assess efficacy outcomes, comparative controlled prospective trials were sought, with a preference for RCTs.

• In the absence of such trials, comparative observational studies were sought, with a preference for prospective studies.

• To assess long-term outcomes and adverse events, single-arm studies that capture longer periods of follow-up and/or larger populations were sought.

• Studies with duplicative or overlapping populations were excluded.

Review of Evidence
Systematic Reviews
There are a number of systematic reviews on patient specific instrumentation for total knee arthroplasty. We focus on the most recent, comprehensive, and relevant analyses (Table 2). Three of these reported functional outcomes in addition to measures of malalignment outcomes.^2,3,4

Table 2. Comparison of Trials/Studies Included in Patient-Specific Instrumentation Meta-Analyses

Table 3. Meta- Analysis Characteristics

RCT: randomized controlled trial.

Table 4. Meta- Analysis Results for Malalignment Outcomes (> 3 Degrees From Target)

CI: confidence interval; RR: relative risk.

The key question we considered is whether differences in the number of outliers greater than 3° impacted functional outcomes. A meta-analysis by Mannan et al. (2017) indicated that functional outcomes did not differ significantly when measured at up to 2 years after surgery (see Table 5).⁶ More recent meta-analyses have shown mixed outcomes with regard to benefit. Thienport et al. (2017) showed an improvement in KSS functional score with patient specific instrumentation over conventional instrumentation, but there was no significant improvement in the KSS knee score.³ In contrast, Lin et al. (2020) showed a significant improvement in the overall KSS score with patient specific instrumentation, but failed to show an improvement in the Oxford Knee Score.⁴ The follow-up period for Lin et al. was only 3 months and does not provide information on long-term outcomes.

Table 5. Meta- Analysis Results for Pain and Function Outcomes

CI: confidence interval; FU: follow-up; KSS: Knee Society Score; MD: mean difference: NR; not reported

Perioperative Outcomes
Systematic Reviews
Three of the meta-analyses included in this review reported perioperative outcomes (Table 6).^5,3,4 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. (2018) and Lin et al. (2020) 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; however, there was high heterogeneity amongst the studies.

Table 6. Meta- Analysis Results for Perioperative Outcomes

CI: confidence interval; LOS: length of stay; NR: not reported.

Randomized Controlled Trials
Several RCTs have yet to be incorporated into available meta-analyses.^63,64,65,66 Table 7 highlights some of these RCTs. Additionally, several key RCTs included in available meta-analyses examine functional outcomes that are not evaluated by the meta-analyses.^17,33 These key trials include Boonen et al. (2016) and Kosse et al. (2017) and are also included in Table 7. Results for the trials included in Table 7 were consistent with previous studies as summarized in Table 6. All but 1 trial reported no significant differences between patient specific instrumentation and conventional intervention on measures of pain, function, and quality of life for up to 2 years (Table 8). Calliess et al. (2017) reported significant outcomes with regard to KSS and WOMAC; however, follow-up did not extend beyond 1 year.⁶⁴

Both Boonen et al. (2016) and Kosse et al. (2017) also reported on the outcome of pain measured by the visual analog score. Neither study reported a difference in pain improvement between groups. Boonen et al. (2016) also reported no differences with regard to WOMAC index and EuroQoL-5D quality of life index. Kosse et al. (2017) did not report any significant differences between groups for various outcomes, including the Kujala score (also referred to as the Patella score) and the Knee Injury and Osteoarthritis Outcome Score. The RCTs used a variety of patient specific instrumentation systems.

Table 7. Characteristics of Key RCTs of Patient Specific Instrumentation for Total Knee Arthroplasty

RCT: randomized controlled trial; 

Table 8. Summary of Pain, Function, and Quality of Life Outcomes from Key RCTs

CI: confidence interval; EuroQol-5D: standardized instrument as a measure of quality of life; FU: follow-up; KOOS: Knee Injury and Osteoarthritis Outcome Score; KSS: Knee Society Score; MD: mean difference; NR: not reported; NS: not significant; OKS: Oxford Knee Score; RCT: randomized controlled trial; SD: standard deviation; PSI: patient-specific instrumentation; VAS: Visual Analog Scale; WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index.

Summary of Evidence
For individuals who are undergoing partial or total knee arthroplasty who receive patient-specific cutting guides, the evidence includes RCTs, comparative cohort studies, and systematic reviews of these studies. Relevant outcomes of interest are symptoms, functional outcomes, and quality of life. Results from the systematic reviews are mixed, finding significant improvements in some measures of implant alignment but either no improvement or worse alignment for other measures. The available systematic reviews are limited by the small size of some of the selected studies, publication bias, and differences in both planning and manufacturing of the patient specific instrumentation systems. Also, the designs of the devices are evolving, and some of the studies might have assessed now obsolete patient specific instrumentation systems. Available results from individual RCTs have not shown a benefit of patient-specific instrumentation systems in improving clinical outcome measures with follow-up currently extending out to 5 years. The evidence is insufficient to determine that the technology results in an improvement in the net health outcome.

The purpose of the following information is to provide reference material. Inclusion does not imply endorsement or alignment with the evidence review conclusions.

Practice Guidelines and Position Statements
Guidelines or position statements will be considered for inclusion in ‘Supplemental Information’ if they were issued by, or jointly by, a U.S. professional society, an international society with U.S. representation, or National Institute for Health and Care Excellence (NICE). Priority will be given to guidelines that are informed by a systematic review, include strength of evidence ratings, and include a description of management of conflict of interest.

American Academy of Orthopaedic Surgeons
In 2016, the American Academy of Orthopaedic Surgeons published a guideline on the surgical management of osteoarthritis of the knee.⁶⁷ 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.

U.S. Preventive Services Task Force Recommendations
Not applicable

Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this review are listed in Table 9.

Table 9. Summary of Key Ongoing Trials

NCT: national clinical trial.
^a Denotes industry-sponsored or cosponsored trial.

References 

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33. Kosse NM, Heesterbeek PJC, Schimmel JJP, et al. Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. Jun 2018; 26(6): 1792-1799. PMID 29181560
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35. Kotela A, Lorkowski J, Kucharzewski M, et al. Patient-Specific CT-Based Instrumentation versus Conventional Instrumentation in Total Knee Arthroplasty: A Prospective Randomized Controlled Study on Clinical Outcomes and In-Hospital Data. Biomed Res Int. 2015; 2015: 165908. PMID 26301241
36. MacDessi SJ, Jang B, Harris IA, et al. A comparison of alignment using patient specific guides, computer navigation and conventional instrumentation in total knee arthroplasty. Knee. Mar 2014; 21(2): 406-9. PMID 24378337
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38. Maus U, Marques CJ, Scheunemann D, et al. No improvement in reducing outliers in coronal axis alignment with patient-specific instrumentation. Knee Surg Sports Traumatol Arthrosc. Sep 2018; 26(9): 2788-2796. PMID 29071356
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41. Nam D, Park A, Stambough JB, et al. The Mark Coventry Award: Custom Cutting Guides Do Not Improve Total Knee Arthroplasty Clinical Outcomes at 2 Years Followup. Clin Orthop Relat Res. Jan 2016; 474(1): 40-6. PMID 25712865
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43. Ng VY, DeClaire JH, Berend KR, et al. Improved accuracy of alignment with patient-specific positioning guides compared with manual instrumentation in TKA. Clin Orthop Relat Res. Jan 2012; 470(1): 99-107. PMID 21809150
44. Noble JW, Moore CA, Liu N. The value of patient-matched instrumentation in total knee arthroplasty. J Arthroplasty. Jan 2012; 27(1): 153-5. PMID 21908169
45. Nunley RM, Ellison BS, Ruh EL, et al. Are patient-specific cutting blocks cost-effective for total knee arthroplasty?. Clin Orthop Relat Res. Mar 2012; 470(3): 889-94. PMID 22183476
46. Parratte S, Blanc G, Boussemart T, et al. Rotation in total knee arthroplasty: no difference between patient-specific and conventional instrumentation. Knee Surg Sports Traumatol Arthrosc. Oct 2013; 21(10): 2213-9. PMID 23942938
47. Pfitzner T, Abdel MP, von Roth P, et al. Small improvements in mechanical axis alignment achieved with MRI versus CT-based patient-specific instruments in TKA: a randomized clinical trial. Clin Orthop Relat Res. Oct 2014; 472(10): 2913-22. PMID 25024031
48. Pietsch M, Djahani O, Zweiger Ch, et al. Custom-fit minimally invasive total knee arthroplasty: effect on blood loss and early clinical outcomes. Knee Surg Sports Traumatol Arthrosc. Oct 2013; 21(10): 2234-40. PMID 23114870
49. Renson L, Poilvache P, Van den Wyngaert H. Improved alignment and operating room efficiency with patient-specific instrumentation for TKA. Knee. Dec 2014; 21(6): 1216-20. PMID 25450010
50. Roh YW, Kim TW, Lee S, et al. 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): 3988-95. PMID 23907610
51. Schotanus MGM, Boonen B, van der Weegen W, et al. No difference in mid-term survival and clinical outcome between patient-specific and conventional instrumented total knee arthroplasty: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. May 2019; 27(5): 1463-1468. PMID 29725747
52. Silva A, Sampaio R, Pinto E. Patient-specific instrumentation improves tibial component rotation in TKA. Knee Surg Sports Traumatol Arthrosc. Mar 2014; 22(3): 636-42. PMID 23989707
53. Stronach BM, Pelt CE, Erickson JA, et al. Patient-specific instrumentation in total knee arthroplasty provides no improvement in component alignment. J Arthroplasty. Sep 2014; 29(9): 1705-8. PMID 24890995
54. Thienpont E, Grosu I, Paternostre F, et al. The use of patient-specific instruments does not reduce blood loss during minimally invasive total knee arthroplasty?. Knee Surg Sports Traumatol Arthrosc. Jul 2015; 23(7): 2055-60. PMID 24671387
55. Van Leeuwen JAMJ, Snorrason F, Rohrl SM. No radiological and clinical advantages with patient-specific positioning guides in total knee replacement. Acta Orthop. Feb 2018; 89(1): 89-94. PMID 29161930
56. Victor J, Dujardin J, Vandenneucker H, et al. Patient-specific guides do not improve accuracy in total knee arthroplasty: a prospective randomized controlled trial. Clin Orthop Relat Res. Jan 2014; 472(1): 263-71. PMID 23616267
57. Vide J, Freitas TP, Ramos A, et al. Patient-specific instrumentation in total knee arthroplasty: simpler, faster and more accurate than standard instrumentation-a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. Aug 2017; 25(8): 2616-2621. PMID 26585908
58. Vundelinckx BJ, Bruckers L, De Mulder K, et al. Functional and radiographic short-term outcome evaluation of the Visionaire system, a patient-matched instrumentation system for total knee arthroplasty. J Arthroplasty. Jun 2013; 28(6): 964-70. PMID 23535285
59. Woolson ST, Harris AH, Wagner DW, et al. 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 05 2014; 96(5): 366-72. PMID 24599197
60. Yaffe M, Luo M, Goyal N, et al. Clinical, functional, and radiographic outcomes following total knee arthroplasty with patient-specific instrumentation, computer-assisted surgery, and manual instrumentation: a short-term follow-up study. Int J Comput Assist Radiol Surg. Sep 2014; 9(5): 837-44. PMID 24337791
61. Yan CH, Chiu KY, Ng FY, et al. Comparison between patient-specific instruments and conventional instruments and computer navigation in total knee arthroplasty: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. Dec 2015; 23(12): 3637-45. PMID 25217311
62. Zhu M, Chen JY, Chong HC, et al. Outcomes following total knee arthroplasty with CT-based patient-specific instrumentation. Knee Surg Sports Traumatol Arthrosc. Aug 2017; 25(8): 2567-2572. PMID 26410097
63. Alvand A, Khan T, Jenkins C, et al. The impact of patient-specific instrumentation on unicompartmental knee arthroplasty: a prospective randomised controlled study. Knee Surg Sports Traumatol Arthrosc. Jun 2018; 26(6): 1662-1670. PMID 28831554
64. Calliess T, Bauer K, Stukenborg-Colsman C, et al. PSI kinematic versus non-PSI mechanical alignment in total knee arthroplasty: a prospective, randomized study. Knee Surg Sports Traumatol Arthrosc. Jun 2017; 25(6): 1743-1748. PMID 27120192
65. Tammachote N, Panichkul P, Kanitnate S. Comparison of Customized Cutting Block and Conventional Cutting Instrument in Total Knee Arthroplasty: A Randomized Controlled Trial. J Arthroplasty. Mar 2018; 33(3): 746-751.e3. PMID 29108794
66. Hampton MJ, Blakey CM, Anderson AA, et al. Minimum 5-Year Outcomes of a Multicenter, Prospective, Randomized Control Trial Assessing Clinical and Radiological Outcomes of Patient-Specific Instrumentation in Total Knee Arthroplasty. J Arthroplasty. Jan 22 2022. PMID 35077818
67. McGrory BJ, Weber KL, Jevsevar DS, et al. Surgical Management of Osteoarthritis of the Knee: Evidence-based Guideline. J Am Acad Orthop Surg. Aug 2016; 24(8): e87-93. PMID 27355286

Coding Section

Procedure and diagnosis codes on Medical Policy documents are included only as a general reference tool for each policy. They may not be all-inclusive.

This medical policy was developed through consideration of peer-reviewed medical literature generally recognized by the relevant medical community, U.S. FDA approval status, nationally accepted standards of medical practice and accepted standards of medical practice in this community, Blue Cross Blue Shield Association technology assessment program (TEC) and other nonaffiliated technology evaluation centers, reference to federal regulations, other plan medical policies, and accredited national guidelines.

"Current Procedural Terminology © American Medical Association. All Rights Reserved" 

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