Patient-Specific Instrumentation for Joint Arthroplasty
Policy Number: MP-716
Latest Review Date: April 2023
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.
DESCRIPTION OF PROCEDURE OR SERVICE:
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.
The most recent literature update was performed through January 16, 2023.
Summary of Evidence
For individuals who are undergoing partial or total knee arthroplasty who receive patient-specific cutting guides, the evidence includes 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 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 trials and systematic reviews have not shown a benefit of PSI 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.
U.S. Preventive Services Task Force Recommendations
Practice Guidelines and Position Statements
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 (updated December 2, 2022). The guideline is supported by the American Society of Anesthesiologists and endorsed by several other organizations. The guideline recommends against the use of patient specific instrumentation for total knee arthroplasty, since strong evidence has not shown a difference in pain or functional outcomes when compared to conventional instrumentation. Additionally, moderate evidence has not shown a difference between patient specific and conventional instrumentation with regard to transfusions or complications.
Patient-specific instrumentation, cutting guides, total knee arthroplasty, TKA, PSI systems, MyKnee, TruMatch, Prophecy, Visionaire, Signature Planner, X-PSI Knee System, Zimmer Patient-specific instruments
APPROVED BY GOVERNING BODIES:
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 U.S. Food and Drug Administration (FDA) clearance for marketing. Other patient-specific cutting guide systems cleared for marketing include:
- Prophecy™ Pre-operative Navigation Alignment Guides (Wright Medical Technology)
- Signature™ Planner/Signature Guides (Materialise NV and Biomet)
- Visionaire Patient Matched Cutting Blocks (Smith & Nephew)
- TruMatch® Personalized Solutions (DePuy Orthopaedics)
- X-PSI Knee System (ORTHOsoft)
- Zimmer® Patient Specific Instruments and Zimmer® Patient Specific Instruments Planner (Materialise NV and Zimmer)
Coverage is subject to member’s specific benefits. Group specific policy will supersede this policy when applicable.
ITS: Home Policy provisions apply.
FEP: Special benefit consideration may apply. Refer to member’s benefit plan.
Anatomic guide 3D-printed and designed from image data set(s); first anatomic guide
Anatomic guide 3D-printed and designed from image data set(s); each additional anatomic guide (List separately in addition to code for primary procedure)
- Abane L, Anract P, Boisgard S, et al. A comparison of patient-specific and conventional instrumentation for total knee arthroplasty: a multicentre randomised controlled trial. Bone Joint J. Jan 2015; 97-B(1): 56-63.
- Abane L, Zaoui A, Anract P, et al. Can a Single-Use and Patient-Specific Instrumentation Be Reliably Used in Primary Total Knee Arthroplasty? A Multicenter Controlled Study. J Arthroplasty. Jul 2018; 33(7): 2111-2118.
- Abdel MP, Parratte S, Blanc G, et al. No benefit of patient-specific instrumentation in TKA on functional and gait outcomes: a randomized clinical trial. Clin Orthop Relat Res. Aug 2014; 472(8): 2468-76.
- 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.
- American Academy of Orthopaedic Surgeons Surgical Management of Osteoarthritis of the Knee Evidence-Based Clinical Practice Guideline. www.aaos.org/smoak2cpg Published December 02, 2022.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Boonen B, Schotanus MG, Kort NP. Preliminary experience with the patient-specific templating total knee arthroplasty. Acta Orthop. Aug 2012; 83(4): 387-93.
- 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.
- Chareancholvanich K, Narkbunnam R, Pornrattanamaneewong C. A prospective randomised controlled study of patientspecific cutting guides compared with conventional instrumentation in total knee replacement. Bone Joint J. Mar 2013; 95-B(3): 354-9.
- 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.
- 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.
- 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.
- 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.
- Daniilidis K, Tibesku CO. A comparison of conventional and patient-specific instruments in total knee arthroplasty. Int Orthop. Mar 2014; 38(3): 503-8.
- 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.
- DeHaan AM, Adams JR, DeHart ML, et al. Patient-specific versus conventional instrumentation for total knee arthroplasty: perioperative and cost differences. J Arthroplasty. Nov 2014; 29(11): 2065-9.
- 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.
- 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.
- Gong S, Xu W, Wang R, et al. Patient-specific instrumentation improved axial alignment of the femoral component, operative time and perioperative blood loss after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. Apr 2019; 27(4): 1083- 1095.
- 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.
- 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.
- Heyse TJ, Tibesku CO. Improved femoral component rotation in TKA using patient-specific instrumentation. Knee. Jan 2014; 21(1): 268-71.
- 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.
- IOM (Institute of Medicine). 2011. Clinical Practice Guidelines We Can Trust. Washington, DC: The National Academies Press.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Lin Y, Cai W, Xu B, et al. Patient-Specific or Conventional Instrumentations: A Meta-analysis of Randomized Controlled Trials. Biomed Res Int. 2020; 2020: 2164371.
- 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.
- 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.
- 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.
- 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.
- 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.
- McGrory BJ, Weber KL, Jevsevar DS, et al. Surgical Management of Osteoarthritis of the Knee: Evidence-based Guideline. J Am Acad Orthop Surg. Aug 2016; 24(8): e87-93.
- 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.
- 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
- 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.
- 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.
- 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.
- Noble JW, Moore CA, Liu N. The value of patient-matched instrumentation in total knee arthroplasty. J Arthroplasty. Jan 2012; 27(1): 153-5.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- Schotanus MGM, Boonen B, van der Weegen W, et al. No difference in mid-term survival and clinical outcome between patientspecific and conventional instrumented total knee arthroplasty: a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. May 2019; 27(5): 1463-1468.
- 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.
- 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.
- 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).
- 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.
- 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.
- 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.
- 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.
- 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
- 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.
- 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.
- Yaffe M, Luo M, Goyal N, et al. Clinical, functional, and radiographic outcomes following total knee arthroplasty with patientspecific 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.
- 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.
- 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.
Medical Policy Panel, May 2018
Medical Policy Group, July 2018 (7): New Policy.
Medical Policy Administration Committee, July 2018
Available for comment July 5 through August 18, 2018
Medical Policy Panel, April 2019
Medical Policy Group, April 2019 (7): Updates to Key Points, Approved by Governing Bodies, and References. No change to policy statement.
Medical Policy Group, June 2019: July 2019 quarterly coding update. Added new CPT codes 0561T and 0562T to Current Coding. Created Previous Coding section.
Medical Policy Panel, April 2020
Medical Policy Group, April 2020 (7): Updates to Description and Key Points. No change to Policy Statement.
Medical Policy Panel, April 2021
Medical Policy Group, April 2021 (7): Updates to Key Points and references. Policy section updated to remove "not medically necessary" statement. No change in intent.
Medical Policy Panel, April 2022
Medical Policy Group, May 2022 (7): Updates to Description, Key Points and References. No change to Policy Statement.
Medical Policy Panel, April 2023
Medical Policy Group, April 2023 (7): Updates to Key Points, Benefit Application and References. Previous Coding section. No change to Policy Statement.
This medical policy is not an authorization, certification, explanation of benefits, or a contract. Eligibility and benefits are determined on a case-by-case basis according to the terms of the member’s plan in effect as of the date services are rendered. All medical policies are based on (i) research of current medical literature and (ii) review of common medical practices in the treatment and diagnosis of disease as of the date hereof. Physicians and other providers are solely responsible for all aspects of medical care and treatment, including the type, quality, and levels of care and treatment.
This policy is intended to be used for adjudication of claims (including pre-admission certification, pre-determinations, and pre-procedure review) in Blue Cross and Blue Shield’s administration of plan contracts.
The plan does not approve or deny procedures, services, testing, or equipment for our members. Our decisions concern coverage only. The decision of whether or not to have a certain test, treatment or procedure is one made between the physician and his/her patient. The plan administers benefits based on the member’s contract and corporate medical policies. Physicians should always exercise their best medical judgment in providing the care they feel is most appropriate for their patients. Needed care should not be delayed or refused because of a coverage determination.
As a general rule, benefits are payable under health plans only in cases of medical necessity and only if services or supplies are not investigational, provided the customer group contracts have such coverage.
The following Association Technology Evaluation Criteria must be met for a service/supply to be considered for coverage:
1. The technology must have final approval from the appropriate government regulatory bodies;
2. The scientific evidence must permit conclusions concerning the effect of the technology on health outcomes;
3. The technology must improve the net health outcome;
4. The technology must be as beneficial as any established alternatives;
5. The improvement must be attainable outside the investigational setting.
Medical Necessity means that health care services (e.g., procedures, treatments, supplies, devices, equipment, facilities or drugs) that a physician, exercising prudent clinical judgment, would provide to a patient for the purpose of preventing, evaluating, diagnosing or treating an illness, injury or disease or its symptoms, and that are:
1. In accordance with generally accepted standards of medical practice; and
2. Clinically appropriate in terms of type, frequency, extent, site and duration and considered effective for the patient’s illness, injury or disease; and
3. Not primarily for the convenience of the patient, physician or other health care provider; and
4. Not more costly than an alternative service or sequence of services at least as likely to produce equivalent therapeutic or diagnostic results as to the diagnosis or treatment of that patient’s illness, injury or disease.