Subject:
Patient-Specific Instrumentation (e.g., Cutting Guides) for Joint Arthroplasty
Description:
_______________________________________________________________________________________
IMPORTANT NOTE:
The purpose of this policy is to provide general information applicable to the administration of health benefits that Horizon Blue Cross Blue Shield of New Jersey and Horizon Healthcare of New Jersey, Inc. (collectively “Horizon BCBSNJ”) insures or administers. If the member’s contract benefits differ from the medical policy, the contract prevails. Although a service, supply or procedure may be medically necessary, it may be subject to limitations and/or exclusions under a member’s benefit plan. If a service, supply or procedure is not covered and the member proceeds to obtain the service, supply or procedure, the member may be responsible for the cost. Decisions regarding treatment and treatment plans are the responsibility of the physician. This policy is not intended to direct the course of clinical care a physician provides to a member, and it does not replace a physician’s independent professional clinical judgment or duty to exercise special knowledge and skill in the treatment of Horizon BCBSNJ members. Horizon BCBSNJ is not responsible for, does not provide, and does not hold itself out as a provider of medical care. The physician remains responsible for the quality and type of health care services provided to a Horizon BCBSNJ member.
Horizon BCBSNJ medical policies do not constitute medical advice, authorization, certification, approval, explanation of benefits, offer of coverage, contract or guarantee of payment.
__________________________________________________________________________________________________________________________
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.
| Populations | Interventions | Comparators | Outcomes |
Individuals:
- Who are undergoing partial or total knee arthroplasty
| Interventions of interest are:
- Patient-specific cutting guides
| Comparators of interest are:
- Conventional cutting guides
| Relevant outcomes include:
- Symptoms
- Functional outcomes
- Quality of life
|
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 8 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 U.S. 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
| Device Name | Manufacturer | 510(K) Number | Clearance Date |
| X-Psi | Orthosoft | K131409 | 9/13/2013 |
| iTotal | Conformis | K120068 | 2/3/2012 |
| Prophecy | Wright Medical Technology | K103598 | 10/17/2011 |
| Trumatch | Depuy Orthopaedics | K110397 | 8/16/2011 |
| Shapematch | Stryker | K110533 | 5/19/2011 |
| Signature | Materialise | K102795 | 2/2/2011 |
| Zimmer | Materialise | K091263 | 11/19/2009 |
| Visionaire | Smith & Nephew | K082358 | 11/25/2008 |
Source: FDA: U.S. Food and Drug Administration.
Related Policies
- Computer-Assisted Navigation for Orthopedic Procedure (Policy #075 in the Surgery Section)
- Three-Dimensional Printed Orthopedic Implants (Policy #166 in the Surgery Section)
Policy:
(NOTE: For Medicare Advantage, please refer to the Medicare Coverage Section below for coverage guidance.)
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 considered investigational.
Medicare Coverage:
There is no National Coverage Determination (NCD) or Local Coverage Determination (LCD) for jurisdiction JL for this service. Therefore, Medicare Advantage Products will follow the Horizon BCBSNJ Medical Policy.
Policy Guidelines: (Information to guide medical necessity determination based on the criteria contained within the policy statements above.)
The preplanning for the surgery may involve magnetic resonance imaging or computed tomography, which may help to identify these procedures.
[RATIONALE: This policy was created in 2014 and has been updated regularly with searches of the PubMed database. The most recent literature update was performed through February 11, 2020.
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, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one 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. RCTs 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 following PICO was used to select literature to inform this policy.
Patients
The relevant population of interest is patients undergoing total knee arthroplasty (also called knee replacement). Total knee arthroplasty is an established treatment for relief from significant, disabling pain caused by advanced arthritis. Total knee arthroplasty 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 total knee arthroplasty, the increase in the aging population, and the desire of older adults to remain physically active, the incidence of total knee arthroplasty is increasing rapidly. It is projected that by 2030, the demand for knee replacement will approach 3.5 million procedures annually.1,
Total 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.
Intervention
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 total 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 'Computer-Assisted Navigation for Orthopedic Procedure' - Policy #075 in the Surgery Section). 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 comp.
Total knee arthroplasty is a surgical technique requiring inpatient hospitalization. Results of studies conducted outside of the United States and in the context of clinical trials may not be applicable to the general United States population.
Comparators
Conventional cutting guides are currently being used for total knee arthroplasty (see intervention description).
Outcomes
The general outcomes of interest are symptoms, function, and quality of life. Commonly-used instruments used to measure these outcomes include the Knee Society score, Oxford knee score, range of movement, Western Ontario and McMaster Universities Osteoarthritis Index, 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, because this is a relatively new technology, 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 total 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 total 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 (two years or longer), in particular because component alignment is hypothesized to correlate to component longevity.
Review of Evidence
Systematic Reviews
There are a number of systematic reviews on patient specific instrumentation for total knee arthroplasty. We focus on the 5 most recent, comprehensive and relevant analyses(See Tables 2 and 3). Only one of these reported functional outcomes in addition to measures of malalignment.2,
Table 2. Meta-Analytic Characteristics
| Study | Dates | Trials | N (Range)a | Designs | Outcomes |
| Gong et al (2018)3, | 1966-2018 | 23 | 2058 (40-180) | RCTs | Coronal, sagittal, axial malalignment >3° |
| Thienpont et al (2017)4, | 2011-2015 | 44 | 5822 (29-865) | RCTs and cohort | Coronal and sagittal malalignment >3° |
| Mannan and Smith (2016)2, | 2000-2014 | 6 | 444 (40-128) | RCTs | Femoral rotational malalignment >3° |
| Alcelik et al (2017)5, | 1966- 2016 | 12 | 1087 | RCTs | Coronal and sagittal malalignment >3° |
| Mannan et al (2017)6, | 2000-2015 | 8 | 828 (48-232) | RCTs and cohort | Functional outcomes |
RCT: randomized controlled trial.
a Patients.
Table 3. Meta-Analytic Results for Malalignment Outcomes (>3 Degrees from Target)
| Study | Trials | N (knees) | Malalignment (>3°) | RR | 95% CI | p | I2, % |
| Gong et al (2018)3, | 14 | 1273 | Hip-knee-ankle angle | 0.94 | 0.72 to 11.24 | 0.68 | 41 |
 | 12 | 1137 | Femoral/coronal plane | 0.86 | 0.57 to 1.30 | 0.47 | 37 |
| 12 | 1137 | Tibial/coronal plane | 1.36 | 0.75 to 2.49 | 0.31 | 46 |
| 9 | 941 | Femoral sagittal alignment | 1.07 | 0.84 to 1.35 | 0.59 | 46 |
| 10 | 989 | Tibial/sagittal plane | 1.31 | 0.92 to 1.86 | 0.13 | 57 |
| Thienpont et al (2017)4, | 29 | 3479 | Coronal mechanical axis | 0.79 | 0.65 to 0.95 | 0.013 | 51 |
| 13 | 1527 | Tibial/sagittal plane | 1.32 | 1.12 to 1.56 | 0.001 | 0 |
| 15 | 1943 | Femoral/coronal plane | 0.74 | 0.55 to 0.99 | 0.043 | 32 |
| 17 | 1983 | Tibial/coronal plane | 1.30 | 0.92 to 1.83 | 0.13 | 21.5 |
| Mannan and Smith (2016)2, | 6 | 444 | Femoral rotational alignment | 0.40 | 0.16 to 0.95 | 0.04 | 62 |
| Alcelik et al (2017)5, | 12 | 1087 | Mechanical axis | 0.96 | 0.78 to 1.17 | 0.65 | 42 |
| | | Coronal plane femoral | 0.75 | 0.56 to 1.01 | 0.06 | 37 |
| | | Coronal plane tibial | 1.35 | 0.94 to 1.95 | 0.11 | 43 |
| | | Sagittal plane femoral | 0.91 | 0.68 to 1.22 | 0.04 | 55 |
| | | Sagittal plane tibial | 1.41 | 1.09 to 1.84 | 0.01 | 44 |
| | | Femoral rotation | 0.55 | 0.08 to 1.08 | 0.08 | 63 |
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. This question was addressed in a meta-analysis by Mannan et al (2017), who identified 5 RCTs and 3 prospective comparative studies that assessed functional outcomes.6, Meta-analysis indicated that functional outcomes did not differ significantly when measured at up to 2 years after surgery (see Table 4).
Table 4. Meta-Analytic Results for Pain and Function Outcomes
| Study | Trials | N (knees) | Functional Outcome Measures | FU, mo | MD | 95% CI | p | I2, % |
| Mannan et al (2017)6, | 3 | 195 | KSS functional score | 24 | -0.21 | -9.31 to 8.88 | 0.96 | 82 |
| 3 | 195 | KSS knee score | 24 | 0.90 | -6.15 to 7.95 | 0.80 | 85 |
| 5 | 244 | Range of motion (deg) | 3-24 | 3.72 | -0.46 to 7.91 | 0.08 | 70 |
| 3 | 118 | Oxford Knee Score | 3-12 | -0.48 | -1.83 to 0.86 | 0.48 | 0 |
CI: confidence interval; FU: follow-up; KSS: Knee Society Score; MD: mean difference.
Perioperative Outcomes
Two meta-analyses reported perioperative outcomes (Table 5).3,4, Total operative time was statistically significantly shorter with patient specific instrumentation but the clinical significance of these differences is not clear. Gong et al (2018) reported hospital length of stay and did not find a significant difference between patient specific instrumentation and confidence interval groups.3,
Table 5. Meta-Analytic Results for Perioperative Outcomes
| Study | Operative Time (Minutes) | Blood Loss (mL) | Hospital LOS |
| Gong et al (2018)3, | | | |
| Total N | 871 | 450 | 685 |
| Mean difference (95% CI) | -7.35 (-10.95 to -3.75) p < 0.0001 | -83.42 (-146.65 to -20.18) p = 0.010 | -0.16 (-0.40 to 0.07) P = 0.17 |
| I2 | 78% | 74% | 19% |
| Thienpoint et al (2017)4, | | | |
| Total N | 3480 | 1251 | |
| Mean difference (95% CI) | -4.4 (-7.2 to -1.7)p=0.002 | -37.9 (-68.4 to -7.4) | |
| I2 | 94% | 91% | |
CI: confidence interval; LOS: length of stay.
Randomized Controlled Trials
Seven RCTs (Total n=827; range 42 to 200) were published after the Mannan et al (2017) systematic review (Table 6).7,8,9,10,11,12,13, Six RCTs were conducted in Europe and one in Thailand. They were conducted between 2010 and 2016 and used a variety of patient specific instrumentation systems. Results were consistent with previous studies as summarized in the Mannan et al (2017) systematic review. All but one trial reported no significant differences between patient specific instrumentation and CI on measures of pain, function, and quality of life for up to 2 years (Table 7).
Two RCTs reported perioperative outcomes and had results consistent with previous studies and meta-analyses.
Table 6. Characteristics of Key RCTs of Patient Specific Instrumentation for Total Knee Arthroplasty (2016-2018)
| Study; Trial | Countries | Sites | Dates | Participants | System (Manufacturer) |
| Alvand et al (2017)7, | United Kingdom | 1 | 2012-2014 | N= 46 | Signature (Zimmer Biomet) |
| Kosse et al (2017)8, | The Netherlands | 1 | 2012-2013 | N= 42 | Visionaire (Smith & Nephew) |
| Maus et al (2017)9, | Germany | 6 | 2014-2016 | N= 157 | Imprint (Aesculap) |
| Van Leeuwen (2010)10,NCT01696552 | Norway | 3 | 2011-2014 | N= 94 | Materialise (Leuven) |
| Calliess et al 11, | Germany | 2 | 2012-2013 | N= 200 | Triathlon System (Stryker) |
| Boonen et al (2016)12, | The Netherlands | 2 | 2010-2013 | N= 180 | Materialise (Leuven) |
| Tammachote et al (2017)13, | Thailand | 1 | 2012-2014 | N= 108 | Visionaire (Smith & Nephew) |
RCT: randomized controlled trial; TKA: total knee arthroplasty.
Table 7. Summary of Pain, Function, and Quality of Life Outcomes from Key RCTs (2016-2018)
| Study | KSS | Kujala | VAS Pain | OKS | EURO QOL-5D | KOOS | WOMAC |
| Alvand (2017)7, | | | | | | | |
| N (FU) | | | | 45 (1 year) | | | |
| PSI | | | | 18.3 (4-31) | | | |
| Conventional | | | | 18.2 (5-31) | | | |
| P-value | | | | NS | | | |
| Boonen (2016)12, | | | | | | | |
| N (FU) | 163 (2 years) | | 163 (2 years) | 163 (2 years) | 163 (2 Years) | | 163 (2 years) |
| PSI | 81.9 (78.1 to 85.8) | | 20.4 (14.4 to 26.5) | 15.2 (13.1 to 17.2) | 72.5 (68.2 to 76.7) | | 80.7 (76.3 to 85.0) |
| Conventional | 82.2 78.6 to 85.8) | | 17.4 (12.2 to 22.6) | 15.1 (13.1 to 17.1) | 76.2 (71.9 to 80.5) | | 86.6 (83.4 to 89.8) |
| P-value | 0.807 | | 0.227 | 0.304 | 0.968 | | 0.753 |
| Calliess (2017)11, | | | | | | | |
| N (FU) | 200 (1 year) | | | | | | 200 (1 year) |
| PSI | 190 (SD 18) | | | | | | 13 (SD 16) |
| Conventional | 178 (SD 17) | | | | | | 26 (SD 11) |
| P-Value | 0.02 | | | | | | 0.001 |
| Kosse (2017)8, | | | | | | | |
| N (FU) | 42 (1 year) | 42 (1 year) | 42 (1 year) | | | 42 (1 year) | |
| PSI | 180 (135-200) | 70 (44-100) | 5 (0-40) | | | 94 (50-100) | |
| Conventional | 175 (115-200) | 62 (33-95) | 11 (0-81) | | | 81 (33-100) | |
| P-value | NS | NS | NS | | | NS | |
| Maus (2017)9, | | | | | | | |
| N (FU) | 125 (90 days) | | | | | | |
| PSI | 144.1 (36.3) | | | | | | |
| Conventional | 155.4 (34.7) | | | | | | |
| Mean difference (P-value) | 11.3 (NS) | | | | | | |
| Tammachote (2017)13, | | | | | | | |
| N (FU) | | | | | | | 102 (2 years) |
| PSI | | | | | | | 5 (SD 6) |
| Conventional | | | | | | | 4 (SD 6) |
| Mean difference | | | | | | | 1 (-1.8 to 3), P=0.62 |
| Van Leeuwen (2017)10, | | | 94 (2 years) | | 94 (2 years) | 94 (2 years) | |
| PSI | | | 1.2 (1.9) | | 77 | 7582 (16) | |
| Conventional | | | 2.3 (2.3) | | 75 | 78 (15) | |
| p-value | | | 0.2 | | 0.7 | 0.6 | |
RCT: randomized controlled trial; OKS: Oxford Knee Score; FU: follow-up; NS: not significant; SD: standard deviation; VAS: Visual Analog Scale; PSI: patient-specific instrumentation; KSS: Knee Society Score; KOOS: Knee Injury and Osteoarthritis Outcome Score; WOMAC: Western Ontario and McMaster Universities Osteoarthritis Index; EuroQol-5D: standardized instrument as a measure of quality of life.
Summary of Evidence
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. 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 RCTs have not shown a benefit of patient-specific instrumentation systems in improving clinical outcome measures with follow-up currently extending out to 2 years. The evidence is insufficient to determine the effects of the technology on health outcomes.
SUPPLEMENTAL INFORMATION
Practice Guidelines and Position Statements
No guidelines or statements were identified.
U.S. Preventive Services Task Force Recommendations
Not applicable.
Ongoing and Unpublished Clinical Trials
Some currently unpublished trials that might influence this policy are listed in Table 8.
Table 8. Summary of Key Ongoing Trials
| NCT No. | Trial Name | Planned Enrollment | Completion Date |
| NCT02845206 | Randomised Controlled Trial of Patient Specific Instrumentation vs Standard Instrumentation in Total Knee Arthroplasty | 172 | Feb 2020 |
| NCT03148379a | A Multi-center, Prospective, Randomized Study Comparing Surgical and Economic Parameters of Total Knee Replacement Performed With Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique | 300 | Apr 2021 |
| NCT01696552 | Patient-specific Positioning Guides (PSPG) Technique Versus Conventional Technique in Total Knee Arthroplasty - a Prospective Randomized Study | 109 | Jan 2024 |
| NCT02177227a | Attune With TruMatch TM Personalized Solutions Instruments: A Prospective Randomized Controlled Trial Comparing Clinical and Economic Outcomes in Patients With a BMI Between 30 and 50 | 184 | Aug 2024 |
| NCT02096393 | A Prospective, Randomised Control Trial Assessing Clinical and Radiological Outcomes of Patient Specific Instrumentation in Total Knee Arthroplasty | 100 | Dec 2024 |
NCT: national clinical trial.
a Denotes industry-sponsored or cosponsored trial.]
________________________________________________________________________________________
Horizon BCBSNJ Medical Policy Development Process:
This Horizon BCBSNJ Medical Policy (the “Medical Policy”) has been developed by Horizon BCBSNJ’s Medical Policy Committee (the “Committee”) consistent with generally accepted standards of medical practice, and reflects Horizon BCBSNJ’s view of the subject health care services, supplies or procedures, and in what circumstances they are deemed to be medically necessary or experimental/ investigational in nature. This Medical Policy also considers whether and to what degree the subject health care services, supplies or procedures are clinically appropriate, in terms of type, frequency, extent, site and duration and if they are considered effective for the illnesses, injuries or diseases discussed. Where relevant, this Medical Policy considers whether the subject health care services, supplies or procedures are being requested primarily for the convenience of the covered person or the health care provider. It may also consider whether the services, supplies or procedures are more costly than an alternative service or sequence of services, supplies or procedures that are at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of the relevant illness, injury or disease. In reaching its conclusion regarding what it considers to be the generally accepted standards of medical practice, the Committee reviews and considers the following: all credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, physician and health care provider specialty society recommendations, the views of physicians and health care providers practicing in relevant clinical areas (including, but not limited to, the prevailing opinion within the appropriate specialty) and any other relevant factor as determined by applicable State and Federal laws and regulations.
___________________________________________________________________________________________________________________________
Index:
Patient-Specific Instrumentation (e.g., Cutting Guides) for Joint Arthroplasty
Patient-Specific Cutting Guides and Custom Knee Implants
Visionaire™ Patient Matched Instrumentation
MyKnee® Patient Matched Cutting Blocks (Medacta)
Signature™ Planner/Signature Guides (Materialise N.V. and Biomet)
ShapeMatch® Cutting Guide (Stryker)
TruMatch® Personalized Solutions (Depuy Orthopaedics)
Prophecy™ Pre-operative Navigation Alignment Guides (Wright Medical Technology)
Zimmer® Patient Specific Instruments and Zimmer® Patient Specific Instruments Planner (Materialise N.V. and Zimmer)
Visionaire Patient Matched Cutting Blocks (Smith & Nephew)
X-PSI Knee System (ORTHOsoft)
References:
1. Kurtz S, Ong K, Lau E, et al. 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
2. Mannan A, Smith TO. 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
3. Gong, SS, Xu, WW, Wang, RR, Wang, ZZ, Wang, BB, Han, LL, Chen, GG. 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, 2018 Nov 1. PMID 30377714
4. Thienpont E, Schwab PE, Fennema P. 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
5. Alcelik I, Blomfield M, Ozturk C, et al. A comparison of short term radiological alignment outcomes of the patient specific and standard instrumentation for primary total knee arthroplasty: A systematic review and meta-analysis. Acta Orthop Traumatol Turc. May 2017;51(3):215-222. PMID 28502570
6. Mannan A, Akinyooye D, Hossain F. A meta-analysis of functional outcomes in patient-specific instrumented knee arthroplasty. J Knee Surg. Sep 2017;30(7):668-674. PMID 27907935
7. 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. Aug 22 2017. PMID 28831554
8. 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. Nov 28 2017. PMID 29181560
9. 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. Oct 25 2017. PMID 29071356
10. Van Leeuwen J, 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
11. 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
12. Boonen B, Schotanus MG, Kerens B, et al. 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
13. Tammachote, NN, Panichkul, PP, Kanitnate, SS. Comparison of Customized Cutting Block and Conventional Cutting Instrument in Total Knee Arthroplasty: A Randomized Controlled Trial.. J Arthroplasty, 2017 Nov 8;33(3). PMID 29108794
Codes:
(The list of codes is not intended to be all-inclusive and is included below for informational purposes only. Inclusion or exclusion of a procedure, diagnosis, drug or device code(s) does not constitute or imply authorization, certification, approval, offer of coverage or guarantee of payment.)
CPT*
There are no specific codes for this instrumentation.
HCPCS
* CPT only copyright 2020 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association.
_________________________________________________________________________________________
Medical policies can be highly technical and are designed for use by the Horizon BCBSNJ professional staff in making coverage determinations. Members referring to this policy should discuss it with their treating physician, and should refer to their specific benefit plan for the terms, conditions, limitations and exclusions of their coverage.
The Horizon BCBSNJ Medical Policy Manual is proprietary. It is to be used only as authorized by Horizon BCBSNJ and its affiliates. The contents of this Medical Policy are not to be copied, reproduced or circulated to other parties without the express written consent of Horizon BCBSNJ. The contents of this Medical Policy may be updated or changed without notice, unless otherwise required by law and/or regulation. However, benefit determinations are made in the context of medical policies existing at the time of the decision and are not subject to later revision as the result of a change in medical policy
____________________________________________________________________________________________________________________________ |