Patient-Specific Instrumentation (eg, Cutting Guides) for Joint Arthroplasty - CAM 701144HB

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

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

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

Study2 Lin et al. (2020)4 Gong et al. (2018)5 Thienpoint et al. (2017)3 Mannan et al. (2017)6
Abane et al. (2015)7
Abane et al. (2017)8      
Abdel et al. (2014)9    
Anderl et al. (2016)10    
Bali et al. (2012)11      
Barke et al. (2013)12      
Barrack et al. (2012)13      
Barrett et al. (2014)14      
Boonen et al. (2012)15      
Boonen et al. (2013)16  
Boonen et al. (2016)17    
Chareancholvanich et al. (2013)18  
Chen et al. (2014)19      
Chen et al. (2015)20    
Chotanaphuti et al. (2014)21    
Cucchi et al. (2018)22      
Daniilidis et al. (2014)23      
De Vloo et al. (2017)24    
DeHann et al. (2014)25      
Ferrara et al. (2015)26      
Gan et al. (2015)27      
Hamilton et al. (2013)28  
Heyse et al. (2014)29      
Huijbregts et al. (2016)30    
Kassab et al. (2014)31      
Khuangsirikul et al. (2014)32      
Kosse et al. (2018)33    
Kotela et al. (2014)34  
Kotela et al. (2015)35
MacDessi et al. (2014)36      
Marimuthu et al. (2014)37      
Maus et al. (2017)38    
Molicnik et al. (2015)39    
Nabavi et al. (2015)40      
Nam et al. (2016)41      
Nankivell et al. (2015)42      
Ng et al. (2012)43      
Noble et al. (2012)44    
Nunley et al. (2012)45      
Parratte et al. (2013)46  
Pfitzner et al. (2014)47    
Pietsch et al. (2013)48  
Renson et al. (2014)49      
Roh et al. (2013)50  
Schotanus et al. (2018) 51      
Silva et al. (2014)52  
Stronach et al. (2014)53      
Thienpoint et al. (2015)54      
Van Leeuwen et al. (2018)55    
Victor et al. (2014)56    
Vide et al. (2017)57  
Vundelinckx et al. (2013)58  
Woolson et al. (2014)59
Yaffe et al. (2014)60    
Yan et al. (2015)61
Zhu et al. (2015)62      

Table 3. Meta- Analysis Characteristics

Study Dates Trials N (Range)a Designs Outcomes

Lin et al. (2020)4

2012 – 2018

29

2487 (24 – 180)

RCTs

Mechanical axis malalignment, functional outcomes

Gong et al. (2018)5

1966 – 2018

23

2058 (40 – 180)

RCTs

Coronal, sagittal, axial malalignment > 3°

Thienpont et al. (2017)3

2011 – 2015

44

5822 (29 – 865)

RCTs and cohort

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.

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

Study

Trials

N (knees)

Malalignment (> 3°)

RR

95% CI

p

I2, %

Lin et al. (2020)4

17

1577

Hip-knee-ankle angle

0.88

0.74 to 1.04

0.13

38

Gong et al. (2018)5

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)3

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

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

Study Trials N (knees) Functional Outcome Measures FU, months MD 95% CI p I2, %
Lin et al. (2020)4 3 337 KSS 3 -0.17 -0.33 to -0.02 0.02 0
  5 651 Oxford Knee Score NR 0.07 -0.09 to 0.22 0.4 32
Thienport et al. (2017)3 6 300 KSS functional score 16.7 4.3 1.5 to 7.2 0.003 NR
  6 300 KSS knee score 16.7 1.5 -0.3 to 3.3 0.093 NR
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: 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

Study Operative Time (Minutes) Blood Loss (mL) Hospital LOS
Lin et al. (2020)4      
Total N 1404 300 543
Mean difference (95% CI); p-value -0.36 (-0.67 to -0.04); p = 0.03 -0.49 (-0.92 to -0.05); p = 0.03 -0.10 (-0.27 to 0.07); p = 0.24
I2 88% 71% 33
Gong et al. (2018)5      
Total N 871 450 685
Mean difference (95% CI); p-value -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)3     NR
Total N 3480 1251  
Mean difference (95% CI); p-value -4.4 (-7.2 to -1.7); p = 0.002 -37.9 (-68.4 to -7.4); p = 0.015  
I2 94% 91%  

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

Study; Trial

Countries

Sites

Dates

Participants

System (Manufacturer)

Hampton et al. (2022)6

United Kingdom

2

2013 – 2015

88

NexGen Knee (Zimmer)

Alvand et al. (2017)63

United Kingdom

1

2012 – 2014

46

Signature (Zimmer Biomet)

Kosse et al. (2017)33

The Netherlands

1

2012 – 2013

22

Visionaire (Smith & Nephew)

Calliess et al. (2017)64

Germany

2

2012 – 2013

200

Triathlon System (Stryker)

Boonen et al. (2016)17

The Netherlands

2

2010 – 2013

180

Materialise (Leuven)

Tammachote et al. (2017)65

Thailand

1

2012 – 2014

108

Visionaire (Smith & Nephew)

RCT: randomized controlled trial; 

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

Study

KSS

Kujala

VAS Pain

OKS

EuroQoL-5D

KOOS

WOMAC

Hampton et al. (2022)66

 

NR

NR

 

 

NR

NR

N (FU)

77 knees (5 years)

 

 

77 knees (5 years)

77 knees (5 years)

 

 

PSI increase from baseline, mean (SD)

92.5 (6.8)

 

 

40.8 (6.9)

 

 

 

Conventional increase from baseline, mean (SD)

92.4 (7.1)

 

 

42.5 (7.4)

 

 

 

p-value

.86

 

 

.24

.78

 

 

Alvand (2017)63

NR

NR

NR

 

NR

NR

NR

N (FU)

 

 

 

45 (1 year)

 

 

 

PSI, mean (range)

 

 

 

18.3 (4 – 31)

 

 

 

Conventional, mean (range)

 

 

 

18.2 (5 – 31)

 

 

 

P-value

 

 

 

NS

 

 

 

Boonen (2016)17

 

 

 

 

 

 

 

N (FU)

163 (2 years)

 

163 (2 years)

163 (2 years)

163 (2 Years)

 

163 (2 years)

PSI, mean (95% CI)

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, mean (95% CI)

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

.807

 

.227

.304

.968

 

.753

Calliess (2017)64

 

NR

NR

NR

NR

NR

 

N (FU)

200 (1 year)

 

 

 

 

 

200 (1 year)

PSI, mean (SD)

190 (18)

 

 

 

 

 

13 (16)

Conventional, mean (SD)

178 (17)

 

 

 

 

 

26 (11)

P-Value

0.02

 

 

 

 

 

0.001

Kosse (2017)33

 

 

 

NR

NR

 

NR

N (FU)

42 (1 year)

42 (1 year)

42 (1 year)

 

 

42 (1 year)

 

PSI, median (range)

180 (135 – 200)

70 (44 – 100)

5 (0 – 40)

 

 

94 (50 – 100)

 

Conventional, median (range)

175 (115 – 200)

62 (33 – 95)

11 (0 – 81)

 

 

81 (33 – 100)

 

P-value

NS

NS

NS

 

 

NS

 

Tammachote (2017)65

 

 

 

 

 

 

 

N (FU)

 

 

 

 

 

 

102 (2 years)

PSI, mean (SD)

 

 

 

 

 

 

5 (6)

Conventional, mean (SD)

 

 

 

 

 

 

4 (6)

Mean difference (CI); p-value

 

 

 

 

 

 

1 (-1.8 to 3), p = 0.62

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 No. Trial Name Planned Enrollment Completion Date
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 2023
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 50 194 Aug 2024
NCT02096393 A Prospective, Randomised Control Trial Assessing Clinical and Radiological Outcomes of Patient Specific Instrumentation in Total Knee Arthroplasty 100 Dec 2024
Unpublished      
NCT02845206 Randomised Controlled Trial of Patient Specific Instrumentation vs Standard Instrumentation in Total Knee Arthroplasty 172 Feb 2020

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

References 

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  10. Anderl W, Pauzenberger L, Kolblinger R, et al. Patient-specific instrumentation improved mechanical alignment, while early clinical outcome was comparable to conventional instrumentation in TKA. Knee Surg Sports Traumatol Arthrosc. Jan 2016; 24(1): 102-11. PMID 25326759
  11. Bali K, Walker P, Bruce W. Custom-fit total knee arthroplasty: our initial experience in 32 knees. J Arthroplasty. Jun 2012; 27(6): 1149-54. PMID 22285230
  12. Barke S, Musanhu E, Busch C, et al. Patient-matched total knee arthroplasty: does it offer any clinical advantages?. Acta Orthop Belg. Jun 2013; 79(3): 307-11. PMID 23926734
  13. Barrack RL, Ruh EL, Williams BM, et al. Patient specific cutting blocks are currently of no proven value. J Bone Joint Surg Br. Nov 2012; 94(11 Suppl A): 95-9. PMID 23118393
  14. Barrett W, Hoeffel D, Dalury D, et al. In-vivo alignment comparing patient specific instrumentation with both conventional and computer assisted surgery (CAS) instrumentation in total knee arthroplasty. J Arthroplasty. Feb 2014; 29(2): 343-7. PMID 23993343
  15. Boonen B, Schotanus MG, Kort NP. Preliminary experience with the patient-specific templating total knee arthroplasty. Acta Orthop. Aug 2012; 83(4): 387-93. PMID 22880715
  16. Boonen B, Schotanus MG, Kerens B, et al. 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): 2206-12. PMID 23928929
  17. 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): 939-44. PMID 27365472
  18. Chareancholvanich K, Narkbunnam R, Pornrattanamaneewong C. 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): 354-9. PMID 23450020
  19. Chen JY, Yeo SJ, Yew AK, et al. The radiological outcomes of patient-specific instrumentation versus conventional total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. Mar 2014; 22(3): 630-5. PMID 23996069
  20. Chen JY, Chin PL, Tay DK, et al. Functional Outcome and Quality of Life after Patient-Specific Instrumentation in Total Knee Arthroplasty. J Arthroplasty. Oct 2015; 30(10): 1724-8. PMID 25937100
  21. Chotanaphuti T, Wangwittayakul V, Khuangsirikul S, et al. The accuracy of component alignment in custom cutting blocks compared with conventional total knee arthroplasty instrumentation: prospective control trial. Knee. Jan 2014; 21(1): 185-8. PMID 23999209
  22. Cucchi D, Menon A, Zanini B, et al. Patient-Specific Instrumentation Affects Perioperative Blood Loss in Total Knee Arthroplasty. J Knee Surg. Jun 2019; 32(6): 483-489. PMID 29791925
  23. Daniilidis K, Tibesku CO. A comparison of conventional and patient-specific instruments in total knee arthroplasty. Int Orthop. Mar 2014; 38(3): 503-8. PMID 23900384
  24. De Vloo R, Pellikaan P, Dhollander A, et al. Three-dimensional analysis of accuracy of component positioning in total knee arthroplasty with patient specific and conventional instruments: A randomized controlled trial. Knee. Dec 2017; 24(6): 1469-1477. PMID 28943039
  25. DeHaan AM, Adams JR, DeHart ML, et al. Patient-specific versus conventional instrumentation for total knee arthroplasty: peri-operative and cost differences. J Arthroplasty. Nov 2014; 29(11): 2065-9. PMID 25065735
  26. Ferrara F, Cipriani A, Magarelli N, et al. Implant positioning in TKA: comparison between conventional and patient-specific instrumentation. Orthopedics. Apr 2015; 38(4): e271-80. PMID 25901619
  27. Gan Y, Ding J, Xu Y, et al. Accuracy and efficacy of osteotomy in total knee arthroplasty with patient-specific navigational template. Int J Clin Exp Med. 2015; 8(8): 12192-201. PMID 26550129
  28. Hamilton WG, Parks NL, Saxena A. Patient-specific instrumentation does not shorten surgical time: a prospective, randomized trial. J Arthroplasty. Sep 2013; 28(8 Suppl): 96-100. PMID 23910821
  29. Heyse TJ, Tibesku CO. Improved femoral component rotation in TKA using patient-specific instrumentation. Knee. Jan 2014; 21(1): 268-71. PMID 23140905
  30. Huijbregts HJ, Khan RJ, Fick DP, et al. Component alignment and clinical outcome following total knee arthroplasty: a randomised controlled trial comparing an intramedullary alignment system with patient-specific instrumentation. Bone Joint J. Aug 2016; 98-B(8): 1043-9. PMID 27482015
  31. Kassab S, Pietrzak WS. Patient-specific positioning guides versus manual instrumentation for total knee arthroplasty: an intraoperative comparison. J Surg Orthop Adv. 2014; 23(3): 140-6. PMID 25153812
  32. Khuangsirikul S, Lertcharoenchoke T, Chotanaphuti T. Rotational alignment of femoral component between custom cutting block and conventional technique in total knee arthroplasty. J Med Assoc Thai. Feb 2014; 97 Suppl 2: S47-51. PMID 25518175
  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
  34. Kotela A, Kotela I. Patient-specific computed tomography based instrumentation in total knee arthroplasty: a prospective randomized controlled study. Int Orthop. Oct 2014; 38(10): 2099-107. PMID 24968788
  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
  37. Marimuthu K, Chen DB, Harris IA, et al. A multi-planar CT-based comparative analysis of patient-specific cutting guides with conventional instrumentation in total knee arthroplasty. J Arthroplasty. Jun 2014; 29(6): 1138-42. PMID 24524776
  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
  39. Molicnik A, Naranda J, Dolinar D. Patient-matched instruments versus standard instrumentation in total knee arthroplasty: a prospective randomized study. Wien Klin Wochenschr. Dec 2015; 127 Suppl 5: S235-40. PMID 25732915
  40. Nabavi A, Olwill CM. Early outcome after total knee replacement using computed tomography-based patient-specific cutting blocks versus standard instrumentation. J Orthop Surg (Hong Kong). Aug 2015; 23(2): 182-4. PMID 26321546
  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
  42. Nankivell M, West G, Pourgiezis N. Operative efficiency and accuracy of patient-specific cutting guides in total knee replacement. ANZ J Surg. Jun 2015; 85(6): 452-5. PMID 25387721
  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
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Coding Section

Codes Number Description
CPT   No specific code – see Policy Guidelines
ICD-9 Procedure    
ICD-9 Diagnosis   Investigational for all diagnoses
HCPCS    
ICD-10-CM (efffective 10/01/15)   Investigational for all diagnoses
  M17.0-M17.9

Osteoarthritis of the knee code range

ICD-10-PCS (effective 10/01/15)   ICD-10-PCS codes are only used for inpatient services. There is no specific ICD-10-PCS code for this procedure.
Type of Service    
Place of Service    

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" 

History From 2024 Forward     

01012024  NEW POLICY

06/21/2024 Annual review, no change to policy intent 

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