CAM 701144

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

Category:Surgery   Last Reviewed:June 2019
Department(s):Medical Affairs   Next Review:June 2020
Original Date:June 2015    

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 
Total knee arthroplasty (TKA; also called knee replacement) and unicompartmental knee arthroplasty (UKA) are established treatments for relief from significant, disabling pain caused by advanced arthritis. TKA is considered among the most successful medical procedures in the United States in terms of the degree of improvement in functional status and quality of life. As a result of the success of TKA, the increase in the aging population and the desire of older adults to remain physically active, the incidence of TKA is increasing rapidly. It is projected that by 2030, the demand for knee replacement will approach 3.5 million procedures annually.1 

TKA and UKA are performed by removing the damaged cartilage surface and a portion of underlying bone using a saw guided by templates and jigs. The removed cartilage and bone from the distal femur and proximal tibia are replaced with implants that recreate the surface of the joint. Patellar resurfacing may also be performed. Three-dimensional implant alignment (coronal, sagittal, axial) is considered to be critical for joint articulation and implant longevity. Generally, less than 3° deviation from the rotational or mechanical axis, as determined by a straight line through the center of the hip, knee and ankle on the coronal plane, is believed to minimize the risk of implant wear, loosening, instability and pain.

The placement of conventional cutting guides (templates and jigs) is based on anatomic landmarks or computer navigation (see evidence review 7.01.96). Use of conventional instrumentation has been shown to result in malalignment of approximately one-third of implants in the coronal plane.2 Computer-assisted navigation can significantly reduce the proportion of malaligned implants compared with conventional instrumentation, but has a number of limitations, including a lack of rotational alignment, increased surgical time and a long learning curve. In addition, no studies have demonstrated an improvement in clinical outcomes with computer-assisted navigation compared with conventional instrumentation. 

Custom implants and patient-specific instrumentation (PSI) have been developed as alternatives to off-the-shelf implants and conventional cutting guides, with the goal of improving both alignment and surgical efficiency. A number of patient-specific cutting guides and custom implants (with their associated cutting guides) are currently being marketed (see Regulatory Status section). Custom implants and patient-specific guides are constructed with the use of preoperative 3-dimensional computed tomography (CT) or magnetic resonance imaging (MRI) scans, which are taken about 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 and implants, makes adjustments and approves the surgical plan, the manufacturer fabricates the custom knee implants and/or disposable cutting guides. 

The proposed benefits of using patient-specific implants and instrumentation during TKA include improved alignment, decreased operative time, increased patient throughput, fewer instrument trays, reduced risk of fat embolism and intraoperative bleeding (no intramedullary canal reaming), shorter recovery, reduced postoperative pain, reduced revision rate and reduced costs. However, the nonsurgical costs of the procedure may be increased due to the requirement for preoperative CT or MRI, preoperative review of the template and fabrication of the PSI. In addition, the patient-specific template relies on the same anatomic landmarks as conventional TKA and does not take soft tissue balancing into account. Thus, evaluation of this technology should also address the reliability of the cutting guides and the need for intraoperative changes such as conversion to conventional instrumentation.

Regulatory Status  
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

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.

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 technology improves the net health outcome. Broadly defined, health outcomes are the length of life, quality of life (QOL), 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 technology, two domains are examined: the relevance, and quality and credibility. To be relevant, studies must represent one or more intended clinical uses 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 PICOTS were used to select literature to inform this review.

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

TKA 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 TKA 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 7.01.96). Use of conventional instrumentation has been shown to result in malalignment of approximately one-third of implants in the coronal plane.2 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.

Patient-specific instrumentation has been developed as an alternative to conventional cutting guides, with the goal of improving both alignment and surgical efficiency. A number of patient-specific cutting guides are currently being marketed (see the Regulatory Status section). Patient-specific guides are constructed with the use of preoperative 3-dimensional computed tomography or magnetic resonance imaging scans, which are taken four to six 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.

Comparators
Conventional cutting guides are currently being used for TKA (see intervention description).

Outcomes
The general outcomes of interest are symptoms, function, and QOL. Commonly-used instruments used to measure these outcomes include the Knee Society score (KSS), 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 TKA includes improved alignment, decreased operative time, increased patient throughput, fewer instrument trays, reduced risk of fat embolism and intraoperative bleeding (no intramedullary canal reaming), shorter recovery, reduced postoperative pain, reduced revision rate, and reduced costs. However, the nonsurgical costs of the procedure may be increased due to the requirement for preoperative computed tomography or magnetic resonance imaging, preoperative review of the template, and fabrication of the patient-specific instrumentation. Also, the patient-specific template relies on the same anatomic landmarks as conventional TKA and does not take soft tissue balancing into account. Thus, evaluation of this technology should also address the reliability of the cutting guides and the need for intraoperative changes such as conversion to conventional instrumentation.

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

Setting
TKA 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 U.S. population.

Systematic Reviews
There are a number of systematic reviews on patient specific instrumentation (PSI) for TKA). We focus on the five most recent, comprehensive and relevant analyses (See Tables 2 and 3). Only one of these reported functional outcomes in addition to measures of malalignment.3

Table 2. Meta-Analytic Characteristics

Study

Dates

Trials

N (Range)a

Designs

Outcomes

Gong et al (2018)4 1966-2018 23 2058 (40-180) RCTs Coronal, sagittal, axial malalignment >3°

Thienpont et al (2017)5

2011-2015

44

5822 (29-865)

RCTs and cohort

Coronal and sagittal malalignment >3°

Mannan and Smith (2016)3

2000-2014

6

444 (40-128)

RCTs

Femoral rotational malalignment >3°

Alcelik et al (2017)6

1966- 2016

12

1087

RCTs

Coronal and sagittal malalignment >3°

Mannan et al (2017)7

2000-2015

8

828 (48-232)

RCTs and cohort

Functional outcomes

RCT: randomized controlled trial.
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)4 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)5

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)3

6

444

Femoral rotational alignment

0.40

0.16 to 0.95

0.04

62

Alcelik et al (2017)6

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.7 Meta-analysis indicated that functional outcomes did not differ significantly when measured at up to two 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)7

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).4,5 Total operative time was statistically significantly shorter with PSI 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 PSI and CI groups.4

Table 5. Meta-Analytic Results for Perioperative Outcomes 

Study

Operative Time (Minutes)

Blood Loss (mL)

Hospital LOS

Gong et al (2018)4

     

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)5      

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).8-14 Six were conducted in Europe and one in Thailand. They were conducted between 2010 and 2016 and used a variety of PSI 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 PSI and CI on measures of pain, function, and quality of life for up to two 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 TKA (2016-2018) 

Study; Trial

Countries

Sites

Dates

Participants

System (Manufacturer)

Alvand et al (2017)8

UK

1

2012-2014

N= 46

Signature (Zimmer Biomet)

Kosse et al (2017)9

The Netherlands 1 2012-2013

N= 42

Visionaire (Smith & Nephew)

Maus et al (2017)10

 Germany

6

 2014-2016

N= 157

Imprint (Aesculap)

Van Leeuwen (2010)11

NCT01696552

Norway

3

 2011-2014

 N= 94

Materialise (Leuven)

Calliess et al12 Germany 2 2012-2013 N= 200 Triathlon System (Stryker)
Boonen et al (2016)13 The Netherlands 2 2010-2013 N= 180 Materialise (Leuven)
Tammachote et al (2017)14 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)8

             

N (FU)

      45 (1 year)      

PSI

      18.3 (4-31)      

Conventional

      18.2 (5-31)      

P-value

      NS      

Boonen (2016)13

             
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)12

             
N (FU) 200 (1 year)           200 (1 year)

PSI

190 (SD18)           13 (SD 16)

Conventional

178 (SD 17)           26 (SD 11)

P-Value

0.02           0.001

Kosse (2017)9

             
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)10

             
N (FU) 125 (90 days)            

PSI

144.1 (36.3)            

Conventional

155.4 (34.7)            

Mean difference (P-value)

11.3 (NS)

           

Tammachote (2017)14

             
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)11

    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 TKA who receive patient-specific cutting guides, the evidence includes a number of RCTs, comparative cohort studies, and systematic reviews of these studies. The relevant outcomes are symptoms, functional outcomes, and QOL. 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 RCTs and systematic reviews have 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 patient specific instrumentation on health outcomes.

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 review 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 KneeReplacement Performed With Single-use Efficiency Instruments With Patient Specific Technique (MyKnee®) Versus Traditional Metal Instruments With Conventional Surgical Technique

300

Apr 2020

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.

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. Blue Cross and Blue Shield Association Technology Evaluation Center. Computer-assisted navigation for total knee arthroplasty. Technology Assessment Feb 2008;Volume 22:Tab 10. PMID 18411501.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.

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 and Blue Shield Association technology assessment program (TEC) and other non-affiliated 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 2015 Forward     

06/01/2019 

Annual review, no change to policy intent. Updating description, regulatory status, rationale and references. 

06/07/2018 

Annual review, removing " custom implants" from policy statement, updating title, regulatory status and references. 

06/12/2017 

Annual review, no change to policy intent. 

06/07/2016 

Annual review, no change to policy intent. Updating background, description, regulatory status, rationale and references.

06/18/2015

NEW POLICY


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