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706

Indications

(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): 780-5. PMID 17403800 2. Mannan A, Smith TO. Favourable rotational alignment outcomes in PSI knee arthroplasty: A Level 1 systematic review and meta-analysis. Knee. Mar 2016; 23(2): 186-90. PMID 26782300 3. 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 4. 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. PMID 32258107 5. Zhao C, Jefferies JG, Marimuthu K, et al. Patient-specific cutting guides for total knee arthroplasty. Cochrane Database Syst Rev. Jan 07 2026; 1(1): CD012589. PMID 41498625 6. Tibesku CO, Haas SB, Saunders C, et al. Comparison of clinical outcomes of VISIONAIRE patient- specific instrumentation with conventional instrumentation in total knee arthroplasty: a systematic literature review and meta-analysis. Arch Orthop Trauma Surg. Jul 2023; 143(7): 4379-4393. PMID 36449066 7. 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. PMID 30377714 8. 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 9. 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. PMID 25568414 10. 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;? 
(2) 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. PMID 24604110 12. Anderl W, Pauzenberger L, Kölblinger 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 13. Attard A, Tawy GF, Simons M, et al. Health costs and efficiencies of patient-specific and single-use instrumentation in total knee arthroplasty: a randomised controlled trial. BMJ Open Qual. 2019; 8(2): e000493. PMID 31206056 14. 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 15. 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? 
(3) 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 4 17. 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 18. 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 19. 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 20. 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 21. Broberg JS, Naudie DDR, Howard JL, et al. Contact kinematics of patient-specific instrumentation versus conventional instrumentation for total knee arthroplasty. Knee. Oct 2020; 27(5): 1501-1509. PMID 33010767 22. 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 23. 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 24. 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 25. 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 26. 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 27. 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 28. 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 29. 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 30. 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 31. 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 32. 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 33. Giannotti S, Sacchetti F, Citarelli C, et al. Single-use, patient-specific instrumentation technology in knee arthroplasty: a comparative study between standard instrumentation and PSI efficiency system. Musculoskelet Surg. Aug 2020; 104(2): 195-200. PMID 31147964 34. 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 35. Heyse TJ, Tibesku CO. Improved femoral component rotation in TKA using patient-specific instrumentation. Knee. Jan 2014; 21(1): 268-71. PMID 23140905 36. 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 37. 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 5 38. 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 39. 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 40. 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 41. 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 42. Liao G, Duoji J, Mu L, et al. Efficiency assessment of intelligent patient-specific instrumentation in total knee arthroplasty: a prospective randomized controlled trial. J Orthop Surg Res. Sep 28 2024; 19(1): 593. PMID 39342311 43. Lionberger DR, Crocker CL, Chen V. Patient specific instrumentation. J Arthroplasty. Sep 2014; 29(9): 1699-704. PMID 24810539 44. 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 45. 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 46. 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 47. 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(Suppl 5): S235-40. PMID 25732915 48. Moubarak H, Brilhault J. Contribution of patient-specific cutting guides to lower limb alignment for total knee arthroplasty. Orthop Traumatol Surg Res. Jun 2014; 100(4 Suppl): S239-42. PMID 24703790 49. Myers K, Merwin SL, Cabrera B, Lementowski P. An evaluation of the need for blood transfusion when using patient specific instrumentation for total knee arthroplasty. Int J Orthop Rehab. 2014;2:5460. https://savvysciencepublisher.com/jms/index.php/ijor/article/view/722 50. 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 51. 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 52. 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 53. 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 54. 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 55. 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? 
(4) Ollivier M, Tribot-Laspiere Q, Amzallag J, et al. Abnormal rate of intraoperative and postoperative implant positioning outliers using "MRI-based patient-specific" compared to "computer assisted" instrumentation in total knee replacement. Knee Surg Sports Traumatol Arthrosc. Nov 2016; 24(11): 3441-3447. PMID 25994474 6 57. 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 58. 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 59. 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 60. Pourgiezis N, Reddy SP, Nankivell M, et al. Alignment and component position after patient-matched instrumentation versus conventional total knee arthroplasty. J Orthop Surg (Hong Kong). Aug 2016; 24(2): 170-4. PMID 27574257 61. Predescu V, Prescura C, Olaru R, et al. Patient specific instrumentation versus conventional knee arthroplasty: comparative study. Int Orthop. Jul 2017; 41(7): 1361-1367. PMID 27995304 62. Qiu B, Liu F, Tang B, et al. Clinical Study of 3D Imaging and 3D Printing Technique for Patient- Specific Instrumentation in Total Knee Arthroplasty. J Knee Surg. Oct 2017; 30(8): 822-828. PMID 28122388 63. Randelli PS, Menon A, Pasqualotto S, et al. Patient-Specific Instrumentation Does Not Affect Rotational Alignment of the Femoral Component and Perioperative Blood Loss in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial. J Arthroplasty. Jul 2019; 34(7): 1374- 1381.e1. PMID 30979672 64. Rathod PA, Deshmukh AJ, Cushner FD. Reducing blood loss in bilateral total knee arthroplasty with patient-specific instrumentation. Orthop Clin North Am. Jul 2015; 46(3): 343-50, ix. PMID 26043048 65. 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 66. 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-? 
(5) PMID 23907610 67. Sariali E, Kajetanek C, Catonné Y. Comparison of custom cutting guides based on three-dimensional computerized CT-scan planning and a conventional ancillary system based on two-dimensional planning in total knee arthroplasty: a randomized controlled trial. Int Orthop. Nov 2019; 43(11): 2529- 2538. PMID 31227853 68. 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 69. 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 70. Stolarczyk A, Nagraba L, Mitek T, et al. Does Patient-Specific Instrumentation Improve Femoral and Tibial Component Alignment in Total Knee Arthroplasty? A Prospective Randomized Study. Adv Exp? 

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1

Medical Policy Patient-Specific Instrumentation (eg, Cutting Guides) for Joint Arthroplasty
Table of Contents • Policy: Commercial • Coding Information
• Information Pertaining to All Policies
• Policy: Medicare • Description
• References
• Authorization Information • Policy History

Policy Number: 706 BCBSA Reference Number: 7.01.144 (For Plan internal use only) NCD/LCD: NA

Related Policies
Computer-Assisted Musculoskeletal Surgical Navigational Orthopedic Procedures, #594 Policy Commercial Members: Managed Care (HMO and POS), PPO, and Indemnity
Medicare HMO BlueSM and Medicare PPO BlueSM Members

Use of patient-specific instrumentation (eg, cutting guides) for joint arthroplasty, including but not limited to use in unicompartmental or total knee arthroplasty, is considered INVESTIGATIONAL.

Prior Authorization Information
Inpatient • For services described in this policy, precertification/preauthorization IS REQUIRED for all products if the procedure is performed inpatient.
Outpatient • For services described in this policy, see below for products where prior authorization might be required if the procedure is performed outpatient.


Outpatient Commercial Managed Care (HMO and POS) This is not a covered service. Commercial PPO and Indemnity This is not a covered service. Medicare HMO BlueSM This is not a covered service. Medicare PPO BlueSM This is not a covered service.

CPT Codes / HCPCS Codes / ICD Codes
Inclusion or exclusion of a code does not constitute or imply member coverage or provider reimbursement. Please refer to the member’s contract benefits in effect at the time of service to determine coverage or non-coverage as it applies to an individual member.

2

Providers should report all services using the most up-to-date industry-standard procedure, revenue, and diagnosis codes, including modifiers where applicable. CPT Codes There is no specific CPT code for this service.

Description 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. Summary
Patient-specific instrumentation 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 patient-specific instrumentation 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 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. Policy History Date Action 5/2026 Policy updated with literature review through February 18, 2026; references added. Policy statement unchanged. 6/2025 Annual policy review. References updated. Policy statements unchanged. 6/2024 Annual policy review. References updated. Policy statements unchanged. 6/2023 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 6/2022 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 5/2021 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 6/2020 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 5/2019 Annual policy review. Description, summary, and references updated. Policy statements unchanged. 7/2018 Annual policy review.
Title changed to Patient-Specific Instrumentation (eg, Cutting Guides) for Joint Arthroplasty.7/1/2018 5/2018 Prior Authorization Information reformatted.

3

11/2017 Policy clarified to remove custom knee implants from the policy. 11/14/2017
9/2017 Annual policy review. New references added. 11/2015 Annual policy review. New references added. 2/2015 New medical policy describing investigational indications. Effective 2/1/2015. Information Pertaining to All Blue Cross Blue Shield Medical Policies Click on any of the following terms to access the relevant information: Medical Policy Terms of Use Managed Care Guidelines Indemnity/PPO Guidelines Clinical Exception Process Medical Technology Assessment Guidelines

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): 780-5. PMID 17403800
  2. Mannan A, Smith TO. Favourable rotational alignment outcomes in PSI knee arthroplasty: A Level 1 systematic review and meta-analysis. Knee. Mar 2016; 23(2): 186-90. PMID 26782300
  3. 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
  4. 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. PMID 32258107
  5. Zhao C, Jefferies JG, Marimuthu K, et al. Patient-specific cutting guides for total knee arthroplasty. Cochrane Database Syst Rev. Jan 07 2026; 1(1): CD012589. PMID 41498625
  6. Tibesku CO, Haas SB, Saunders C, et al. Comparison of clinical outcomes of VISIONAIRE patient- specific instrumentation with conventional instrumentation in total knee arthroplasty: a systematic literature review and meta-analysis. Arch Orthop Trauma Surg. Jul 2023; 143(7): 4379-4393. PMID 36449066
  7. 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. PMID 30377714
  8. 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
  9. 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. PMID 25568414
  10. 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. PMID 29576488
  11. 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. PMID 24604110
  12. Anderl W, Pauzenberger L, Kölblinger 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
  13. Attard A, Tawy GF, Simons M, et al. Health costs and efficiencies of patient-specific and single-use instrumentation in total knee arthroplasty: a randomised controlled trial. BMJ Open Qual. 2019; 8(2): e000493. PMID 31206056
  14. 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
  15. 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
  16. 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

4

  1. 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
  2. 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
  3. 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
  4. 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
  5. Broberg JS, Naudie DDR, Howard JL, et al. Contact kinematics of patient-specific instrumentation versus conventional instrumentation for total knee arthroplasty. Knee. Oct 2020; 27(5): 1501-1509. PMID 33010767
  6. 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
  7. 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
  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. PMID 23996069
  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. PMID 25937100
  10. 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
  11. 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
  12. 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
  13. 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
  14. 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
  15. 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
  16. 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
  17. Giannotti S, Sacchetti F, Citarelli C, et al. Single-use, patient-specific instrumentation technology in knee arthroplasty: a comparative study between standard instrumentation and PSI efficiency system. Musculoskelet Surg. Aug 2020; 104(2): 195-200. PMID 31147964
  18. 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
  19. Heyse TJ, Tibesku CO. Improved femoral component rotation in TKA using patient-specific instrumentation. Knee. Jan 2014; 21(1): 268-71. PMID 23140905
  20. 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
  21. 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

5

  1. 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
  2. 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
  3. 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
  4. 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
  5. Liao G, Duoji J, Mu L, et al. Efficiency assessment of intelligent patient-specific instrumentation in total knee arthroplasty: a prospective randomized controlled trial. J Orthop Surg Res. Sep 28 2024; 19(1): 593. PMID 39342311
  6. Lionberger DR, Crocker CL, Chen V. Patient specific instrumentation. J Arthroplasty. Sep 2014; 29(9): 1699-704. PMID 24810539
  7. 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
  8. 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
  9. Maus U, Marques CJ, Scheunemann D, et al. No improvement in reducing outliers in coronal axis alignment with patient-specific instrumentation. Knee Surg Sports Traumatol Arthrosc. Sep 2018; 26(9): 2788-2796. PMID 29071356
  10. 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(Suppl 5): S235-40. PMID 25732915
  11. Moubarak H, Brilhault J. Contribution of patient-specific cutting guides to lower limb alignment for total knee arthroplasty. Orthop Traumatol Surg Res. Jun 2014; 100(4 Suppl): S239-42. PMID 24703790
  12. Myers K, Merwin SL, Cabrera B, Lementowski P. An evaluation of the need for blood transfusion when using patient specific instrumentation for total knee arthroplasty. Int J Orthop Rehab. 2014;2:5460. https://savvysciencepublisher.com/jms/index.php/ijor/article/view/722
  13. 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
  14. 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
  15. 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
  16. 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
  17. 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
  18. 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
  19. Ollivier M, Tribot-Laspiere Q, Amzallag J, et al. Abnormal rate of intraoperative and postoperative implant positioning outliers using "MRI-based patient-specific" compared to "computer assisted" instrumentation in total knee replacement. Knee Surg Sports Traumatol Arthrosc. Nov 2016; 24(11): 3441-3447. PMID 25994474

6

  1. 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
  2. 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
  3. 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
  4. Pourgiezis N, Reddy SP, Nankivell M, et al. Alignment and component position after patient-matched instrumentation versus conventional total knee arthroplasty. J Orthop Surg (Hong Kong). Aug 2016; 24(2): 170-4. PMID 27574257
  5. Predescu V, Prescura C, Olaru R, et al. Patient specific instrumentation versus conventional knee arthroplasty: comparative study. Int Orthop. Jul 2017; 41(7): 1361-1367. PMID 27995304
  6. Qiu B, Liu F, Tang B, et al. Clinical Study of 3D Imaging and 3D Printing Technique for Patient- Specific Instrumentation in Total Knee Arthroplasty. J Knee Surg. Oct 2017; 30(8): 822-828. PMID 28122388
  7. Randelli PS, Menon A, Pasqualotto S, et al. Patient-Specific Instrumentation Does Not Affect Rotational Alignment of the Femoral Component and Perioperative Blood Loss in Total Knee Arthroplasty: A Prospective, Randomized, Controlled Trial. J Arthroplasty. Jul 2019; 34(7): 1374- 1381.e1. PMID 30979672
  8. Rathod PA, Deshmukh AJ, Cushner FD. Reducing blood loss in bilateral total knee arthroplasty with patient-specific instrumentation. Orthop Clin North Am. Jul 2015; 46(3): 343-50, ix. PMID 26043048
  9. 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
  10. 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-
  11. PMID 23907610
  12. Sariali E, Kajetanek C, Catonné Y. Comparison of custom cutting guides based on three-dimensional computerized CT-scan planning and a conventional ancillary system based on two-dimensional planning in total knee arthroplasty: a randomized controlled trial. Int Orthop. Nov 2019; 43(11): 2529-
  13. PMID 31227853
  14. 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
  15. 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
  16. Stolarczyk A, Nagraba L, Mitek T, et al. Does Patient-Specific Instrumentation Improve Femoral and Tibial Component Alignment in Total Knee Arthroplasty? A Prospective Randomized Study. Adv Exp Med Biol. 2018; 1096: 11-17. PMID 29623574
  17. 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
  18. Stone AH, Sibia US, MacDonald JH. Functional Outcomes and Accuracy of Patient-Specific Instruments for Total Knee Arthroplasty. Surg Innov. Oct 2018; 25(5): 470-475. PMID 30024349
  19. Sun ML, Zhang Y, Peng Y, et al. Accuracy of a Novel 3D-Printed Patient-Specific Intramedullary Guide to Control Femoral Component Rotation in Total Knee Arthroplasty. Orthop Surg. Apr 2020; 12(2): 429-441. PMID 32087620
  20. 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
  21. Teeter MG, Marsh JD, Howard JL, et al. A randomized controlled trial investigating the value of patient-specific instrumentation for total knee arthroplasty in the Canadian healthcare system. Bone Joint J. May 2019; 101-B(5): 565-572. PMID 31038991

7

  1. 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
  2. Turgeon TR, Cameron B, Burnell CD, et al. A double-blind randomized controlled trial of total knee replacement using patient-specific cutting block instrumentation versus standard instrumentation. Can J Surg. Dec 01 2019; 62(6): 460-467. PMID 31782643
  3. Van Leeuwen JAMJ, Snorrason F, Röhrl 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
  4. 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
  5. 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
  6. 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
  7. 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
  8. 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-
  9. PMID 24337791
  10. 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
  11. Zahn RK, Graef F, Conrad JL, et al. Accuracy of tibial positioning in the frontal plane: a prospective study comparing conventional and innovative techniques in total knee arthroplasty. Arch Orthop Trauma Surg. Jun 2020; 140(6): 793-800. PMID 32124032
  12. 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
  13. Zomar BO, Vasarhelyi EM, Somerville LE, et al. A Randomized Trial Investigating the Cost-Utility of Patient-Specific Instrumentation in Total Knee Arthroplasty in an Obese Population. J Arthroplasty. Sep 2021; 36(9): 3078-3088. PMID 34053752
  14. 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
  15. Braun S, Allen J, Somerville L, et al. Patient-Specific Instrumentation Versus Standard of Care in Total Knee Arthroplasty in an Obese Population: Minimum 5-year Follow-Up. J Arthroplasty. Feb 2026; 41(2): 458-464. PMID 40562084
  16. Hermodsson J, Saari T, Shareghi B, et al. Effect of patient specific instruments compared with conventional instruments in total knee arthroplasty : a randomized controlled trial. Acta Orthop. Dec 02 2025; 96: 875-884. PMID 41329855
  17. 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. Aug 2022; 37(8): 1579-1585. PMID 35077818
  18. McGrory BJ, Weber KL, Jevsevar DS, et al. Surgical Management of Osteoarthritis of the Knee: Evidence-based Guideline. J Am Acad Orthop Surg. Aug 2016; 24(8): e87-93. PMID 27355286
  19. American Academy of Orthopaedic Surgeons Surgical Management of Osteoarthritis of the Knee Evidence-Based Clinical Practice Guideline. https://www.aaos.org/quality/quality-programs/clinical- practice-guidelines/. Published December 02, 2022. Accessed February 19, 2026.
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