Patient-specific instrumentation in total knee arthroplasty. Should we adopt it?☆

Rodrigues, Ana Sofia Teles; Gutierres, Manuel António Pereira

doi:10.1016/j.rboe.2016.06.008

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Revista Brasileira de Ortopedia

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REVIEW ARTICLE • Rev. bras. ortop. 52 (03) • May-Jun 2017 • https://doi.org/10.1016/j.rboe.2016.06.008 copy

Patient-specific instrumentation in total knee arthroplasty. Should we adopt it?^☆ ☆ Work performed in the Universidade do Porto, Faculdade de Medicina, Porto, Portugal.

Authorship SCIMAGO INSTITUTIONS RANKINGS

ABSTRACT

Total knee arthroplasty (TKA) is a surgical procedure of paramount relevance that restores a substantial degree of function in arthritic knees. Increased consideration has been given to the influence of limb alignment on longevity after TKA, as errors in component placement can be associated with inferior function and compromised long-term performance. Consequently, numerous studies comparing patient-specific instrumentation (PSI) to standard instruments (SI) have been published. Patient-specific approaches use preoperative imaging to create specific materials for each patient's anatomy and were designed to achieve a higher rate of success in TKA, causing the entire procedure to be more efficient and cost-effective. However, it is not clear to what degree these studies support the potential advantages of PSI. Thus, the present study aimed to review the current evidence comparing PSI to SI, concerning alignment, cost-effectiveness, and postoperative functional evaluation.

Keywords:
Arthroplasty; Replacement; Knee/instrumentation; Patient-specific modeling; Knee prosthesis; Prosthesis design

Study	Study type	PSI system	Number of TKAs	Results	Outcomes
Abdel et al. ⁴4 Abdel MP, Parratte S, Blanc G, Ollivier M, Pomero V, Viehweger E, et al. No benefit of patient-specific instrumentation in TKA on functional and gait outcomes: a randomized clinical trial. Clin Orthop Relat Res. 2014;472(8):2468-76.	RCT		20 PSI	No difference in early functional, quality-of-life or gait outcomes.	Functional evaluation
			20 SI
Barke et al. ²²22 Barke S, Musanhu E, Busch C, Stafford G, Field R. Patient- matched total knee arthroplasty: does it offer any clinical advantages? Acta Orthop Belg. 2013;79(3):307-11.	Retrospective	Visionaire^® (Smith & Nephew)	39 PSI	SI achieved a MA closer to neutral. OT was equivalent.	MA, OT
			50 SI
Barrack et al. ¹⁷17 Barrack RL, Ruh EL, Williams BM, Ford AD, Foreman K, Nunley RM. Patient specific cutting blocks are currently of no proven value. J Bone Joint Surg Br. 2012;94 11 (Suppl. A):95-9.	Retrospective	Signature^® (Biomet)	100 PSI	Equivalent MA accuracy, decreased OT and reduced number of instrument trays with PSI.	MA, OT, number of instrument trays
			100 SI
Barret et al. ²³23 Barrett W, Hoeffel D, Dalury D, Mason JBB, Murphy J, Himden S. In- vivo alignment comparing patient specific instrumentation with both conventional and computer assisted surgery (CAS) instrumentation in total knee arthroplasty. J Arthroplasty. 2014;29(2):343-7.	Prospective non-RCT	TruMatch^® (DePuy)	66 PSI	Comparable MA and OT between groups.	MA, OT
			86 SI
Boonen et al. ¹⁴14 Boonen B, Schotanus MG, Kerens B, van der Weegen W, van Drumpt RA, Kort NP. Intra- operative results and radiological outcome of conventional and patient-specific surgery in total knee arthroplasty: a multicentre, randomized controlled trial. Knee Surg Sports Traumatol Arthrosc. 2013;21(10):2206-12.	RCT	Signature^® (Biomet)	90 PSI	Equivalent MA, sagittal and coronal alignment of femur and tibia. PSI decreased OT by 5 min.	MA, CFC, CTC, SFC, STC, OT
			90 SI
Chareancholvanich et al. ¹¹11 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. 2013;95-B(3):354-9.	RCT	Patient-Specific Instruments^® (Zimmer)	40 PSI	No difference in MA. Improved accuracy in CTC (89.8 ± 1.2 vs 90.5 ± 1.9, p = 0.030) and fewer outliers in SFC with PSI (p = 0.012). PSI decreased OT by 5 min.	MA, CFC, CTC, SFC, OT
			40 SI
Daniilidis et al. ⁶6 Daniilidis K, Tibesku CO. A comparison of conventional and patient-specific instruments in total knee arthroplasty. Int Orthop. 2014;38(3):503-8.	Retrospective	Visionaire^® (Smith & Nephew)	150 PSI	MA equivalent, with fewer outliers with PSI (9.3% vs. 21.2%).	MA
			156 SI
Hamilton et al. ¹⁵15 Hamilton WG, Parks NL. Patient-specific instrumentation does not shorten surgical time: a prospective, randomized trial. J Arthroplasty. 2014;29(7):1508-9.	RCT	TruMatch^® (DePuy)	26 PSI	No difference in MA, CFC, CTC and SFC with PSI. Increased posterior slope in SI (p < 0.001). PSI required fewer instrument trays but it was 4 min longer.	MA, CFC, CTC, SFC, STC, OT, number of instrument trays
			26 SI
Heyse et al. ⁷7 Heyse TJ, Tibesku CO. Improved femoral component rotation in TKA using patient-specific instrumentation. Knee. 2014;21(1):268-71.	Retrospective	Visionaire^® (Smith & Nephew)	46 PSI	Reduced rate of FCR outliers in PSI group compared to SI (2.2% vs 22.9%, p = 0.003).	FCR
			48 SI
Ivie et al. ¹⁹19 Ivie CB, Probst PJ, Bal AK, Stannard JT, Crist BD, Sonny Bal B. Improved radiographic outcomes with patient-specific total knee arthroplasty. J Arthroplasty. 2014;29(11):2100-3.	Retrospective	iTotal^® G2 (ConforMIS)	100 PSI	MA and CFC more accurate with PSI, with fewer outliers (p = 0.0016 and p = 0.032, respectively). No difference in CTC and in sagittal alignment between the two groups. No changes were required.	MA, CFC, CTC, SFC, STC, need for applying changes
			100 SI
Kotela et al. ²⁴24 Kotela A, Kotela I. Patient-specific computed tomography based instrumentation in total knee arthroplasty: a prospective randomized controlled study. Int Orthop. 2014;38(10):2099-107.	RCT	Signature^® (Biomet)	49 PSI	CTC showed more outliers in PSI group (38.78% vs 19.57%, p = 0.0458).	MA, CFC CTC, SFC, STC
			46 SI
Marimuth et al. ¹⁰10 Marimuthu K, Chen DB, Harris IA, Wheatley E, Bryant CJ, MacDessi SJ. A multi-planar CT-based comparative analysis of patient-specific cutting guides with conventional instrumentation in total knee arthroplasty. J Arthroplasty. 2014;29(6):1138-42.	Retrospective	Visionaire^® (Smith & Nephew)	115 PSI	No differences in the evaluated parameters. Similar number of outliers.	MA, CFC, CTC, SFC, STC, FCR
			185 SI
Ng et al. ²2 Ng VY, DeClaire JH, Berend KR, Gulick BC, Lombardi AV Jr. Improved accuracy of alignment with patient-specific positioning guides compared with manual instrumentation in TKA. Clin Orthop Relat Res. 2012;470(1):99-107.	Retrospective	Signature^® (Biomet)	105 PSI	Overall MA similar, but fewer outliers with PSI (9% vs 22%, p = 0.018); CFC (90.7 vs 91.3, p < 0.001) and CTC (89.9 vs 90.4, p = 0.005) closer to neutral in PSI group compared to SI.	MA, CFC, CTC
			55 SI
Noble et al. ¹²12 Noble JW Jr, Moore CA, Liu N. The value of patient-matched instrumentation in total knee arthroplasty. J Arthroplasty. 2012;27(1):153-5.	RCT	Visionaire^® (Smith & Nephew)	15 PSI	MA closer to neutral with PSI (1.7 vs 2.8, p = 0.03). PSI showed reduction in OT (7 min) and number of instrument trays needed.	MA, CFC, CTC, OT, number of instrument trays
			14 SI
Nunley et al. ¹⁶16 Nunley RM, Ellison BS, Ruh EL, Williams BM, Foreman K, Ford AD, et al. Are patient-specific cutting blocks cost- effective for total knee arthroplasty? Clin Orthop Relat Res. 2012;470(3):889-94.	Retrospective	Signature^® (Biomet)	57 PSI	Equivalent numbers of outliers with respect to MA. Decreased OT by 12 min after PSI.	MA, OT
			57 SI
Nunley et al. ²¹21 Nunley RM, Ellison BS, Zhu J, Ruh EL, Howell SM, Barrack RL. Do patient-specific guides improve coronal alignment in total knee arthroplasty? Clin Orthop Relat Res. 2012;470(3):895-902.	Retrospective	Signature^® (Biomet)	50 PSI	Equivalent numbers of outliers with respect to MA.	MA
			50 SI
Renson et al. ²⁰20 Renson L, Poilvache P, Van den Wyngaert H. Improved alignment and operating room efficiency with patient-specific instrumentation for TKA. Knee. 2014;21(6):1216-20.	Prospective case series	Signature^® (Biomet)	71 PSI	Fewer outliers in MA with PSI compared to SI (13% vs 29%, p = 0.043). Decreased OT time by 9 min and the number of instrument trays by six trays with PSI.	MA, CFC, CTC, SFC, STC, OT, number of instrument trays
			60 SI
Roh et al. ⁹9 Roh YW, Kim TW, Lee S, Seong SC, Lee MC. Is TKA using patient-specific instruments comparable to conventional TKA? A randomized controlled study of one system. Clin Orthop Relat Res. 2013;471(12):3988-95.	RCT	Signature^® (Biomet)	42 PSI	No difference groups with respect to all evaluated parameters. Equivalent number of outliers. OT was 13 min longer with PSI and PSI had to be aborted in 16% of knees.	MA, CFC, CTC, SFC, STC, FCR, OT, need for applying changes
			48 SI
Silva et al. ¹⁸18 Silva A, Sampaio R, Pinto E. Patient-specific instrumentation improves tibial component rotation in TKA. Knee Surg Sports Traumatol Arthrosc. 2014;22(3):636-42.	Prospective randomized	Signature^® (Biomet)	23 PSI	No significant difference in FCR and TCR between groups, but less dispersion and amplitude of TCR around the neutral position with PSI.	FCR, TCR
			22 SI
Stronach et al. ²⁵25 Stronach BM, Pelt CE, Erickson JA, Peters CL. Patient-specific instrumentation in total knee arthroplasty provides no improvement in component alignment. J Arthroplasty. 2014;29(9):1705-8.	Retrospective	Signature^® (Biomet)	58 PSI	No improvement in alignment with PSI. Worsening of accuracy of the tibial slope with PSI (38% vs 61%, p = 0.01). Equivalent OT.	MA, CFC, CTC, SFC, STC, OT
			62 SI
Stronach et al. ²⁶26 Stronach BM, Pelt CE, Erickson J, Peters CL. Patient-specific total knee arthroplasty required frequent surgeon- directed changes knee. Clin Orthop Relat Res. 2013;471(1):169-74.	Retrospective	Signature^® (Biomet)	66 PSI	Equivalent OT but multiple changes required intraoperatively with PSI (2.4 changes/knee).	OT, need for applying changes
			62 SI
Tibesku et al. ¹³13 Tibesku CO, Hofer P, Portegies W, Ruys CJ, Fennema P. Benefits of using customized instrumentation in total knee arthroplasty: results from an activity-based costing model. Arch Orthop Trauma Surg. 2013;133(3):405-11.	Activity-based costing model	Visionaire^® (Smith & Nephew)		Increased efficacy in OT and utilization of instrument trays with PSI. PSI is economically effective.	OT, number of instrument trays
Victor et al. ¹1 Victor J, Dujardin J, Vandenneucker H, Arnout N, Bellemans J. Patient-specific guides do not improve accuracy in total knee arthroplasty: a prospective randomized controlled trial. Clin Orthop Relat Res. 2014;472(1):263-71.	RCT	Signature^® (Biomet)	61 P SI	No significant differences between PSI and SI with respect to component alignment. PSI had more outliers than SI in CTC (14.6% vs 3.1%, p = 0.03) and STC (21.3% vs 3.1%, p = 0.002). Visionaire^® subgroup had more overall coronal alignment outliers (p = 0.04) but fewer SFC outliers (p = 0.001). PSI was abandoned in 22% of patients and modified in 28% of patients.	MA, CFC, CTC, SFC, STC, FCR, need for applying changes
		TruMatch^® (DePuy)	64 SI
		Visionaire^® (Smith & Nephew)
		Patient-Specific Instruments^® (Zimmer)
Vundelinckx et al. ³3 Vundelinckx BJ, Bruckers L, De Mulder K, De Schepper J, Van Esbroeck G. Functional and radiographic short-term outcome evaluation of the Visionaire system, a patient-matched instrumentation system for total knee arthroplasty. J Arthroplasty. 2013;28(6):964-70.	RCT	Visionaire^® (Smith & Nephew)	31 PSI	Equivalent MA. Improved STC with PSI (2.9 ± 2.39 vs 5.0 ± 2.14, p = 0.0008). No difference in pain, patient satisfaction, or functional outcomes (KOOS, Lysholm score).	MA, STC, functional evaluation
			31 SI
Woolson et al. ⁸8 Woolson ST, Harris AH, Wagner DW, Giori NJ. 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. 2014;96(5):366-72.	RCT	TruMatch^® (DePuy)	22 PSI	Increased number of outliers in PSI group with respect to tibial slope (32% vs 8%, p = 0.032). No significant difference with regard to OT or Knee Society rating or function score.	MA, CFC, CTC, STC, FCR, OT, functional evaluation
			26 SI
Yaffe et al. ⁵5 Yaffe M, Luo M, Goyal N, Chan P, Patel A, Cayo M, 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. 2014;9(5):837-44.	Retrospective	Patient-Specific Instruments^® (Zimmer)	44 PSI	No difference in MA, SFC or STC. No difference in pain, motion, Knee Society knee scores; PSI had higher Knee Society function scores pre- and postoperatively	MA, SFC, STC, functional evaluation
			40 SI

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[1] * Corresponding author. E-mail: a.sofiateles@gmail.com (A.S. Rodrigues).

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Patient-specific instrumentation in total knee arthroplasty. Should we adopt it?☆ ☆ Work performed in the Universidade do Porto, Faculdade de Medicina, Porto, Portugal.

ABSTRACT

Patient-specific instrumentation in total knee arthroplasty. Should we adopt it?^☆ ☆ Work performed in the Universidade do Porto, Faculdade de Medicina, Porto, Portugal.