Skip to main content
Top
Published in: Clinical Orthopaedics and Related Research® 1/2014

01-01-2014 | Symposium: 2013 Knee Society Proceedings

Patient-specific Guides Do Not Improve Accuracy in Total Knee Arthroplasty: A Prospective Randomized Controlled Trial

Authors: Jan Victor, MD, PhD, Jan Dujardin, MD, Hilde Vandenneucker, MD, Nele Arnout, MD, Johan Bellemans, MD, PhD

Published in: Clinical Orthopaedics and Related Research® | Issue 1/2014

Login to get access

Abstract

Background

Recently, patient-specific guides (PSGs) have been introduced, claiming a significant improvement in accuracy and reproducibility of component positioning in TKA. Despite intensive marketing by the manufacturers, this claim has not yet been confirmed in a controlled prospective trial.

Questions/purposes

We (1) compared three-planar component alignment and overall coronal mechanical alignment between PSG and conventional instrumentation and (2) logged the need for applying changes in the suggested position of the PSG.

Methods

In this randomized controlled trial, we enrolled 128 patients. In the PSG cohort, surgical navigation was used as an intraoperative control. When the suggested cut deviated more than 3° from target, the use of PSG was abandoned and marked as an outlier. When cranial-caudal position or size was adapted, the PSG was marked as modified. All patients underwent long-leg standing radiography and CT scan. Deviation of more than 3° from the target in any plane was defined as an outlier.

Results

The PSG and conventional cohorts showed similar numbers of outliers in overall coronal alignment (25% versus 28%; p = 0.69), femoral coronal alignment (7% versus 14%) (p = 0.24), and femoral axial alignment (23% versus 17%; p = 0.50). There were more outliers in tibial coronal (15% versus 3%; p = 0.03) and sagittal 21% versus 3%; p = 0.002) alignment in the PSG group than in the conventional group. PSGs were abandoned in 14 patients (22%) and modified in 18 (28%).

Conclusions

PSGs do not improve accuracy in TKA and, in our experience, were somewhat impractical in that the procedure needed to be either modified or abandoned with some frequency.

Level of Evidence

Level I, therapeutic study. See instructions for authors for a complete description of levels of evidence.
Literature
1.
go back to reference Akagi M, Matsusue Y, Mata T, Asada Y, Horiguchi M, Iida H, Nakamura T. Effect of rotational alignment on patellar tracking in total knee arthroplasty. Clin Orthop Relat Res. 1999;366:155–163.PubMedCrossRef Akagi M, Matsusue Y, Mata T, Asada Y, Horiguchi M, Iida H, Nakamura T. Effect of rotational alignment on patellar tracking in total knee arthroplasty. Clin Orthop Relat Res. 1999;366:155–163.PubMedCrossRef
2.
go back to reference Anouchi YS, Whiteside LA, Kaiser AD, Milliano MT. The effects of axial rotational alignment of the femoral component on knee stability and patellar tracking in total knee arthroplasty demonstrated on autopsy specimens. Clin Orthop Relat Res. 1993;287:170–177.PubMed Anouchi YS, Whiteside LA, Kaiser AD, Milliano MT. The effects of axial rotational alignment of the femoral component on knee stability and patellar tracking in total knee arthroplasty demonstrated on autopsy specimens. Clin Orthop Relat Res. 1993;287:170–177.PubMed
3.
go back to reference Bargren JH, Blaha JD, Freeman MA. Alignment in total knee arthroplasty: correlated biomechanical and clinical observations. Clin Orthop Relat Res. 1983;173:178–183.PubMed Bargren JH, Blaha JD, Freeman MA. Alignment in total knee arthroplasty: correlated biomechanical and clinical observations. Clin Orthop Relat Res. 1983;173:178–183.PubMed
4.
go back to reference Bauwens K, Matthes G, Wich M, Gebhard F, Hanson B, Ekkernkamp A, Stengel D. Navigated total knee replacement: a meta-analysis. J Bone Joint Surg Am. 2007;89:261–269.PubMedCrossRef Bauwens K, Matthes G, Wich M, Gebhard F, Hanson B, Ekkernkamp A, Stengel D. Navigated total knee replacement: a meta-analysis. J Bone Joint Surg Am. 2007;89:261–269.PubMedCrossRef
5.
go back to reference Bellemans J, Colyn W, Vandenneucker H, Victor J. The Chitranjan Ranawat Award. Is neutral mechanical alignment normal for all patients? The concept of constitutional varus. Clin Orthop Relat Res. 2012;470:45–53.PubMedCentralPubMedCrossRef Bellemans J, Colyn W, Vandenneucker H, Victor J. The Chitranjan Ranawat Award. Is neutral mechanical alignment normal for all patients? The concept of constitutional varus. Clin Orthop Relat Res. 2012;470:45–53.PubMedCentralPubMedCrossRef
6.
go back to reference Bellemans J, Robijns F, Duerinckx J, Banks S, Vandenneucker H. The influence of tibial slope on maximal flexion after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2005;13:193–196.PubMedCrossRef Bellemans J, Robijns F, Duerinckx J, Banks S, Vandenneucker H. The influence of tibial slope on maximal flexion after total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2005;13:193–196.PubMedCrossRef
7.
go back to reference Berend ME, Ritter MA, Meding JB, Faris PM, Keating EM, Redelman R, Faris GW, Davis KE. Tibial component failure mechanisms in total knee arthroplasty. Clin Orthop Relat Res. 2004;428:26–34.PubMedCrossRef Berend ME, Ritter MA, Meding JB, Faris PM, Keating EM, Redelman R, Faris GW, Davis KE. Tibial component failure mechanisms in total knee arthroplasty. Clin Orthop Relat Res. 2004;428:26–34.PubMedCrossRef
8.
go back to reference Berger RA, Crossett LS, Jacobs JJ, Rubash HE. Malrotation causing patellofemoral complications after total knee arthroplasty. Clin Orthop Relat Res. 1998;356:144–153.PubMedCrossRef Berger RA, Crossett LS, Jacobs JJ, Rubash HE. Malrotation causing patellofemoral complications after total knee arthroplasty. Clin Orthop Relat Res. 1998;356:144–153.PubMedCrossRef
9.
go back to reference Choong PF, Dowsey MM, Stoney JD. Does accurate anatomical alignment result in better function and quality of life? Comparing conventional and computer-assisted total knee arthroplasty. J Arthroplasty. 2009;24:560–569.PubMedCrossRef Choong PF, Dowsey MM, Stoney JD. Does accurate anatomical alignment result in better function and quality of life? Comparing conventional and computer-assisted total knee arthroplasty. J Arthroplasty. 2009;24:560–569.PubMedCrossRef
10.
go back to reference Conteduca F, Iorio R, Mazza D, Caperna L, Bolle G, Argento G, Ferretti A. Evaluation of the accuracy of a patient-specific instrumentation by navigation. Knee Surg Sports Traumatol Arthrosc. 2012 June 27 [Epub ahead of print]. Conteduca F, Iorio R, Mazza D, Caperna L, Bolle G, Argento G, Ferretti A. Evaluation of the accuracy of a patient-specific instrumentation by navigation. Knee Surg Sports Traumatol Arthrosc. 2012 June 27 [Epub ahead of print].
11.
go back to reference Dennis DA. Measured resection: an outdated technique in total knee arthroplasty. Orthopedics. 2008;31:940, 943–944. Dennis DA. Measured resection: an outdated technique in total knee arthroplasty. Orthopedics. 2008;31:940, 943–944.
12.
go back to reference Dennis DA, Komistek RD, Kim RH, Sharma A. Gap balancing versus measured resection technique for total knee arthroplasty. Clin Orthop Relat Res. 2010;468:102–107.PubMedCentralPubMedCrossRef Dennis DA, Komistek RD, Kim RH, Sharma A. Gap balancing versus measured resection technique for total knee arthroplasty. Clin Orthop Relat Res. 2010;468:102–107.PubMedCentralPubMedCrossRef
13.
go back to reference Fang DM, Ritter MA, Davis KE. Coronal alignment in total knee arthroplasty: just how important is it? J Arthroplasty. 2009;24:39–43.PubMedCrossRef Fang DM, Ritter MA, Davis KE. Coronal alignment in total knee arthroplasty: just how important is it? J Arthroplasty. 2009;24:39–43.PubMedCrossRef
14.
go back to reference Haaker RG, Stockheim M, Kamp M, Proff G, Breitenfelder J, Ottersbach A. Computer-assisted navigation increases precision of component placement in total knee arthroplasty. Clin Orthop Relat Res. 2005;433:152–159.PubMedCrossRef Haaker RG, Stockheim M, Kamp M, Proff G, Breitenfelder J, Ottersbach A. Computer-assisted navigation increases precision of component placement in total knee arthroplasty. Clin Orthop Relat Res. 2005;433:152–159.PubMedCrossRef
15.
go back to reference Hanada H, Whiteside LA, Steiger J, Dyer P, Naito M. Bone landmarks are more reliable than tensioned gaps in TKA component alignment. Clin Orthop Relat Res. 2007;462:137–142.PubMedCrossRef Hanada H, Whiteside LA, Steiger J, Dyer P, Naito M. Bone landmarks are more reliable than tensioned gaps in TKA component alignment. Clin Orthop Relat Res. 2007;462:137–142.PubMedCrossRef
16.
go back to reference Harrysson OL, Hosni YA, Nayfeh JF. Custom-designed orthopedic implants evaluated using finite element analysis of patient-specific computed tomography data: femoral-component case study. BMC Musculoskelet Disord. 2007;8:91.PubMedCentralPubMedCrossRef Harrysson OL, Hosni YA, Nayfeh JF. Custom-designed orthopedic implants evaluated using finite element analysis of patient-specific computed tomography data: femoral-component case study. BMC Musculoskelet Disord. 2007;8:91.PubMedCentralPubMedCrossRef
17.
go back to reference Klatt BA, Goyal N, Austin MS, Hozack WJ. Custom-fit total knee arthroplasty (OtisKnee) results in malalignment. J Arthroplasty. 2008;23:26–29.PubMedCrossRef Klatt BA, Goyal N, Austin MS, Hozack WJ. Custom-fit total knee arthroplasty (OtisKnee) results in malalignment. J Arthroplasty. 2008;23:26–29.PubMedCrossRef
18.
go back to reference Lal K, White GS, Morea DN, Wright RF. Use of stereolithographic templates for surgical and prosthodontic implant planning and placement. Part I. The concept. J Prosthodontics. 2006;15:51–58.CrossRef Lal K, White GS, Morea DN, Wright RF. Use of stereolithographic templates for surgical and prosthodontic implant planning and placement. Part I. The concept. J Prosthodontics. 2006;15:51–58.CrossRef
19.
go back to reference Lal K, White GS, Morea DN, Wright RF. Use of stereolithographic templates for surgical and prosthodontic implant planning and placement. Part II. A clinical report. J Prosthodontics. 2006;15:117–122. Lal K, White GS, Morea DN, Wright RF. Use of stereolithographic templates for surgical and prosthodontic implant planning and placement. Part II. A clinical report. J Prosthodontics. 2006;15:117–122.
20.
go back to reference Lombardi AV Jr, Berend KR, Adams JB. Patient-specific approach in total knee arthroplasty. Orthopedics. 2008;31:927–930.PubMedCrossRef Lombardi AV Jr, Berend KR, Adams JB. Patient-specific approach in total knee arthroplasty. Orthopedics. 2008;31:927–930.PubMedCrossRef
21.
go back to reference Longstaff LM, Sloan K, Stamp N, Scaddan M, Beaver R. Good alignment after total knee arthroplasty leads to faster rehabilitation and better function. J Arthroplasty. 2009;24:570–578.PubMedCrossRef Longstaff LM, Sloan K, Stamp N, Scaddan M, Beaver R. Good alignment after total knee arthroplasty leads to faster rehabilitation and better function. J Arthroplasty. 2009;24:570–578.PubMedCrossRef
22.
go back to reference Lotke PA, Ecker ML. Influence of positioning of prosthesis in total knee replacement. J Bone Joint Surg Am. 1977;59:77–79.PubMed Lotke PA, Ecker ML. Influence of positioning of prosthesis in total knee replacement. J Bone Joint Surg Am. 1977;59:77–79.PubMed
24.
go back to reference Matsuda S, Miura H, Nagamine R, Urabe K, Hirata G, Iwamoto Y. Effect of femoral and tibial component position on patellar tracking following total knee arthroplasty: 10-year follow-up of Miller-Galante I knees. Am J Knee Surg. 2001;14:152–156.PubMed Matsuda S, Miura H, Nagamine R, Urabe K, Hirata G, Iwamoto Y. Effect of femoral and tibial component position on patellar tracking following total knee arthroplasty: 10-year follow-up of Miller-Galante I knees. Am J Knee Surg. 2001;14:152–156.PubMed
25.
go back to reference Miller MC, Berger RA, Petrella AJ, Karmas A, Rubash HE. Optimizing femoral component rotation in total knee arthroplasty. Clin Orthop Relat Res. 2001;392:38–45.PubMedCrossRef Miller MC, Berger RA, Petrella AJ, Karmas A, Rubash HE. Optimizing femoral component rotation in total knee arthroplasty. Clin Orthop Relat Res. 2001;392:38–45.PubMedCrossRef
26.
go back to reference 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;470:99–107.PubMedCentralPubMedCrossRef 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;470:99–107.PubMedCentralPubMedCrossRef
27.
go back to reference 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;470:895–902.PubMedCentralPubMedCrossRef 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;470:895–902.PubMedCentralPubMedCrossRef
28.
go back to reference Nunley RM, Ellison BS, Zhu J, Ruh EL, Williams BM, Foreman K, Ford AD, Barrack RL. Are patient-specific cutting blocks cost-effective for total knee arthroplasty? Clin Orthop Relat Res. 2012;470:889–894.PubMedCentralPubMedCrossRef Nunley RM, Ellison BS, Zhu J, Ruh EL, Williams BM, Foreman K, Ford AD, Barrack RL. Are patient-specific cutting blocks cost-effective for total knee arthroplasty? Clin Orthop Relat Res. 2012;470:889–894.PubMedCentralPubMedCrossRef
29.
go back to reference Olcott CW, Scott RD. The Ranawat Award. Femoral component rotation during total knee arthroplasty. Clin Orthop Relat Res. 1999;367:39–42.PubMed Olcott CW, Scott RD. The Ranawat Award. Femoral component rotation during total knee arthroplasty. Clin Orthop Relat Res. 1999;367:39–42.PubMed
30.
go back to reference Quack VM, Kathrein S, Rath B, Tingart M, Luring C. Computer-assisted navigation in total knee arthroplasty: a review of literature. Biomed Tech (Berl). 2012;57:269–275.PubMed Quack VM, Kathrein S, Rath B, Tingart M, Luring C. Computer-assisted navigation in total knee arthroplasty: a review of literature. Biomed Tech (Berl). 2012;57:269–275.PubMed
31.
go back to reference Rhoads DD, Noble PC, Reuben JD, Mahoney OM, Tullos HS. The effect of femoral component position on patellar tracking after total knee arthroplasty. Clin Orthop Relat Res. 1990;260:43–51.PubMed Rhoads DD, Noble PC, Reuben JD, Mahoney OM, Tullos HS. The effect of femoral component position on patellar tracking after total knee arthroplasty. Clin Orthop Relat Res. 1990;260:43–51.PubMed
32.
go back to reference Ritter MA, Faris PM, Keating EM, Meding JB. Postoperative alignment of total knee replacement: its effect on survival. Clin Orthop Relat Res. 1994;299:153–156.PubMed Ritter MA, Faris PM, Keating EM, Meding JB. Postoperative alignment of total knee replacement: its effect on survival. Clin Orthop Relat Res. 1994;299:153–156.PubMed
33.
go back to reference Shah DA, Madden LV. Nonparametric analysis of ordinal data in designed factorial experiments. Phytopathology. 2004;94:33–43.PubMedCrossRef Shah DA, Madden LV. Nonparametric analysis of ordinal data in designed factorial experiments. Phytopathology. 2004;94:33–43.PubMedCrossRef
34.
go back to reference Sharkey PF, Hozack WJ, Rothman RH, Shastri S, Jacoby SM. Insall Award paper. Why are total knee arthroplasties failing today? Clin Orthop Relat Res. 2002;404:7–13.PubMedCrossRef Sharkey PF, Hozack WJ, Rothman RH, Shastri S, Jacoby SM. Insall Award paper. Why are total knee arthroplasties failing today? Clin Orthop Relat Res. 2002;404:7–13.PubMedCrossRef
35.
go back to reference Song EK, Seon JK, Park SJ, Jung WB, Park HW, Lee GW. Simultaneous bilateral total knee arthroplasty with robotic and conventional techniques: a prospective, randomized study. Knee Surg Sports Traumatol Arthrosc. 2011;19:1069–1076.PubMedCrossRef Song EK, Seon JK, Park SJ, Jung WB, Park HW, Lee GW. Simultaneous bilateral total knee arthroplasty with robotic and conventional techniques: a prospective, randomized study. Knee Surg Sports Traumatol Arthrosc. 2011;19:1069–1076.PubMedCrossRef
36.
go back to reference Song EK, Seon JK, Yim JH, Netravali NA, Bargar WL. Robotic-assisted TKA reduces postoperative alignment outliers and improves gap balance compared to conventional TKA. Clin Orthop Relat Res. 2013;471:118–126.PubMedCrossRef Song EK, Seon JK, Yim JH, Netravali NA, Bargar WL. Robotic-assisted TKA reduces postoperative alignment outliers and improves gap balance compared to conventional TKA. Clin Orthop Relat Res. 2013;471:118–126.PubMedCrossRef
37.
go back to reference Spencer BA, Mont MA, McGrath MS, Boyd B, Mitrick MF. Initial experience with custom-fit total knee replacement: intra-operative events and long-leg coronal alignment. Int Orthop. 2009;33:1571–1575.PubMedCentralPubMedCrossRef Spencer BA, Mont MA, McGrath MS, Boyd B, Mitrick MF. Initial experience with custom-fit total knee replacement: intra-operative events and long-leg coronal alignment. Int Orthop. 2009;33:1571–1575.PubMedCentralPubMedCrossRef
38.
go back to reference Tew M, Waugh W. Tibiofemoral alignment and the results of knee replacement. J Bone Joint Surg Br. 1985;67:551–556.PubMed Tew M, Waugh W. Tibiofemoral alignment and the results of knee replacement. J Bone Joint Surg Br. 1985;67:551–556.PubMed
39.
go back to reference Victor J. Rotational alignment of the distal femur: a literature review. Orthop Traumatol Surg Res. 2009;95:365–372.PubMedCrossRef Victor J. Rotational alignment of the distal femur: a literature review. Orthop Traumatol Surg Res. 2009;95:365–372.PubMedCrossRef
40.
go back to reference Victor J, Hoste D. Image-based computer-assisted total knee arthroplasty leads to lower variability in coronal alignment. Clin Orthop Relat Res. 2004;428:131–139.PubMedCrossRef Victor J, Hoste D. Image-based computer-assisted total knee arthroplasty leads to lower variability in coronal alignment. Clin Orthop Relat Res. 2004;428:131–139.PubMedCrossRef
41.
go back to reference Victor J, Van Doninck D, Labey L, Innocenti B, Parizel PM, Bellemans J. How precise can bony landmarks be determined on a CT scan of the knee? Knee. 2009;16:358–365.PubMedCrossRef Victor J, Van Doninck D, Labey L, Innocenti B, Parizel PM, Bellemans J. How precise can bony landmarks be determined on a CT scan of the knee? Knee. 2009;16:358–365.PubMedCrossRef
42.
go back to reference Wasielewski RC, Galante JO, Leighty RM, Natarajan RN, Rosenberg AG. Wear patterns on retrieved polyethylene tibial inserts and their relationship to technical considerations during total knee arthroplasty. Clin Orthop Relat Res. 1994;299:31–43.PubMed Wasielewski RC, Galante JO, Leighty RM, Natarajan RN, Rosenberg AG. Wear patterns on retrieved polyethylene tibial inserts and their relationship to technical considerations during total knee arthroplasty. Clin Orthop Relat Res. 1994;299:31–43.PubMed
43.
go back to reference White D, Chelule KL, Seedhom BB. Accuracy of MRI vs CT imaging with particular reference to patient specific templates for total knee replacement surgery. Int J Met Robot. 2008;4:224–231. White D, Chelule KL, Seedhom BB. Accuracy of MRI vs CT imaging with particular reference to patient specific templates for total knee replacement surgery. Int J Met Robot. 2008;4:224–231.
44.
go back to reference Yoshii I, Whiteside LA, White SE, Milliano MT. Influence of prosthetic joint line position on knee kinematics and patellar position. J Arthroplasty. 1991;6:169–177.PubMedCrossRef Yoshii I, Whiteside LA, White SE, Milliano MT. Influence of prosthetic joint line position on knee kinematics and patellar position. J Arthroplasty. 1991;6:169–177.PubMedCrossRef
Metadata
Title
Patient-specific Guides Do Not Improve Accuracy in Total Knee Arthroplasty: A Prospective Randomized Controlled Trial
Authors
Jan Victor, MD, PhD
Jan Dujardin, MD
Hilde Vandenneucker, MD
Nele Arnout, MD
Johan Bellemans, MD, PhD
Publication date
01-01-2014
Publisher
Springer US
Published in
Clinical Orthopaedics and Related Research® / Issue 1/2014
Print ISSN: 0009-921X
Electronic ISSN: 1528-1132
DOI
https://doi.org/10.1007/s11999-013-2997-4

Other articles of this Issue 1/2014

Clinical Orthopaedics and Related Research® 1/2014 Go to the issue