The aim of this study was (1) to survey the orthopaedic companies about the volume of patient-specific instruments (PSI) used in Europe and worldwide; (2) to survey a group of knee arthroplasty surgeons on their acceptance of PSI and finally; (3) to survey a medico-legal expert on PSI-related issues.
Seven orthopaedic implant manufacturers were contacted to obtain their sales figures (in volume) of PSI in Europe and worldwide for the 2011 and 2012 period. During the Open Meeting of the Belgian Knee Society, a survey by a direct voting system was submitted to a selection of knee surgeons. Finally, a number of medico-legal ‘PSI-related’ questions were submitted to an adult reconstruction surgeon/legal expert.
The total volume, for all contacted companies, of PSI in Europe for 2012 was 17,515 total knee arthroplasty (TKA) and 82,556 TKA worldwide. Biomet (Warsaw, USA) was the number one in volume, both in Europe as worldwide with their Signature system. Biomet represented 27 % of the market share in PSI worldwide. Stryker preferred not to reply to the survey because of the FDA class 1 recall on ShapeMatch cutting guides. Eighty per cent of the Belgian knee surgeons expressed a great interest in PSI and especially, for 58 % of them, if it would increase their surgical accuracy. They valued it even more in unicompartmental arthroplasty, and 55 % was ready to use single-use instruments. Surprisingly, 47 % of surgeons thought it was the company’s responsibility if something goes wrong with a PSI-assisted case. The medico-legal expert concluded that PSI is a complex process that exposes surgeons to new risks in case of failure and stated that companies should not produce surgical guides without validation of the planning by the surgeon.
Patient-specific instruments is of great interest if it can proof to increase the surgical accuracy in knee arthroplasty to the level surgeons are expecting and if in the same time it would make the surgical process more efficient.
Level of evidence
This is a preview of subscription content, access via your institution.
Buy single article
Instant access to the full article PDF.
Tax calculation will be finalised during checkout.
Subscribe to journal
Immediate online access to all issues from 2019. Subscription will auto renew annually.
Tax calculation will be finalised during checkout.
Arnout N, Victor J, Cleppe H, Soenen M, Van Damme G, Bellemans J (2009) Avoidance of patellar eversion improves range of motion after total knee replacement: a prospective randomized study. Knee Surg Sports Traumatol Arthrosc 17:1206–1210
Badlani N, Boden S, Philips F (2012) Orthopedic speciality hospitals: centers of excellence or greed machines? Orthopedics 35:e420–e425
Bali K, Walker P, Bruce W (2012) Custom-fit total knee arthroplasty: our initial experience in 32 knees. J Arthroplasty 27:1149–1154
Barrack RL, Ruh EL, Williams BM, Ford AD, Foreman K, Nunley RM (2012) Patient specific cutting blocks are currently of no proven value. J Bone Joint Surg Br 94:95–99
Boonen B, Schotanus MG, Kort NP (2012) Preliminary experience with the patient-specific templating total knee arthroplasty. Acta Orthop 83:387–393
Chareancholvanich K, Narkbunnam R, Pornrattanamaneewong C (2013) A prospective randomized controlled study of patient-specific cutting guides compared with conventional instrumentation in total knee replacement. Bone Joint J 95:354–359
Chatellard R, Sauleau V, Colmar M, Robert H, Raynaud G, Brilhault J (2013) Medial unicompartmental knee arthroplasty: does tibial component position influence clinical outcomes and arthroplasty survival? Orthop Traumatol Surg Res 99:219–225
Conteduca F, Iorio R, Mazza D, Caperna L, Bolle G, Argento G, Ferretti A (2012) Are MRI-based, patient matched cutting jigs as accurate as the tibial guides? Int Orthop 36:1589–1593
Conteduca F, Iorio R, Mazza D, Caperna L, Bolle G, Argento G, Ferretti A (2012) Evaluation of the accuracy of a patient-specific instrumentation by navigation. Knee Surg Sports Traumatol Arthrosc. doi:10.1007/s00167-012-2098-z
Daniilidis K, Tibesku CO (2013) Frontal plane alignment after total knee arthroplasty using patient-specific instruments. Int Orthop 37:45–50
Duffy GP (2011) Maximizing surgeon and hospital total knee arthroplasty volume using customized patient instrumentation and swing operating rooms. Am J Orthop (Belle Mead NJ) 40:13–16
Fitz W (2009) Unicompartmental knee arthroplasty with use of novel patient-specific resurfacing implants and personalized jigs. J Bone Joint Surg Am 91:69–76
Hansen E, Bozic KJ (2009) The impact of disruptive innovations in orthopaedics. Clin Orthop Relat Res 467:2512–2520
Hernigou P, Deschamps G (2004) Posterior slope of the tibial implant and the outcome of unicompartmental knee arthroplasty. J Bone Joint Surg Am 86:506–511
Heyse TJ, Tibesku CO (2012) Improved femoral component rotation in TKA using patient-specific instrumentation. Knee. doi:10.1016/j.knee.2012.10.009
Hofbauer M, Muller B, Murawski CD, Karlsson J, Fu FH (2013) Innovation in orthopaedic surgery as it relates to evidence-based practice. Knee Surg Sports Traumatol Arthrosc 21:511–514
Hoshino Y, Araujo P, Ahiden M, Samuelsson K, Muller B, Hofbauer M, Wolf MR, Irrgang JJ, Fu FH, Musahl V (2013) Quantitative evaluation of the pivot shift by image analysis using the iPad. Knee Surg Sports Traumatol Arthrosc 21:975–980
Howell SM, Kuznik K, Hull ML, Siston RA (2008) Results of an initial experience with custom-fit positioning total knee arthroplasty in a series of 48 patients. Orthopedics 31:857–863
Howell SM, Howell SJ, Kuznik KT, Cohen J, Hull ML (2013) Does a kinematically aligned total knee arthroplasty restore function without failure regardless of alignment category? Clin Orthop Relat Res 471:1000–1007
Johnson DR (2011) The benefits of customized patient instrumentation to lower-volume joint replacement surgeons: results from practice. Am J Orthop (Belle Mead NJ) 40:13–16
Karia M, Masjedi M, Andrews B, Jaffry Z, Cobb J (2013) Robotic assistance enables inexperienced surgeons to perform unicompartmental knee arthroplasties on dry bone models with accuracy superior to conventional methods. Adv Orthop. doi:10.1155/2013/481039
Kim SJ, Bae JH, Lim HC (2012) Factors affecting the postoperative limb alignment and clinical outcome after Oxford unicompartmental knee arthroplasty. J Arthroplasty 27:1210–1215
Koeck FX, Beckmann J, Luring C, Rath B, Grifka J, Basad E (2011) Evaluation of implant position and knee alignment after patient-specific unicompartmental knee arthroplasty. Knee 18:294–299
Krishnan SP, Dawood A, Richards R, Henckel J, Hart AJ (2012) A review of rapid prototyped surgical guides for patient-specific total knee replacement. J Bone Joint Surg Br 94:1457–1461
Lombardi AVJ, Berend KR, Adams JB (2008) Patient-specific approach in total knee arthroplasty. Orthopedics 31:927–930
Lombardi AV Jr, Frye BM (2012) Customization of cutting blocks: can this address the problem? Curr Rev Musculoskelet Med 5:309–314
Lonner JH, John TK, Conditt MA (2010) Robotic arm-assisted UKA improves tibial component alignment: a pilot study. Clin Orthop Relat Res 468:141–146
Lustig S, Scholes CJ, Oussedik SI, Kinzel V, Coolican MR, Parker DA (2013) Unsatisfactory accuracy as determined by computer navigation of Visionaire patient-specific instrumentation for total knee arthroplasty. J Arthroplasty 28:469–473
Malchau H, Bragdon CR, Muratoglu OK (2011) The stepwise introduction of innovation into orthopedic surgery: the next level of dilemmas. J Arthroplasty 26:825–831
Mont MA, McElroy MJ, Johnson AJ, Pivec R (2013) Single-use instruments, cutting blocks, and trials increase efficiency in the operating room during total knee arthroplasty. A prospective comparison of navigated and non-navigated cases. J Arthroplasty 28:1135–1140
Nam D, McArthur BA, Cross MB, Pearle AD, Mayman DJ, Haas SB (2012) Patient-specific instrumentation in total knee arthroplasty: a review. J Knee Surg 25:213–219
Nam D, Weeks KD, Reinhardt KR, Nawabi DH, Cross MB, Mayman DJ (2013) Accelerometer-based, portable navigation vs imageless, large-console computer-assisted navigation in total knee arthroplasty: a comparison of radiographic results. J Arthroplasty 28:255–261
Nam D, Maher PA, Rebolledo BJ, Nawabi DH, McLawhorn AS, Pearle AD (2013) Patient specific cutting guides versus an imageless, computer-assisted surgery system in total knee arthroplasty. Knee 20:263–267
Ng VY, DeClaire JH, Berend KR, Gulick BC, Lombardi AV Jr (2012) Improved accuracy of alignment with patient-specific positioning guides compared with manual instrumentation in TKA. Clin Orthop Relat Res 470:99–107
Nunley RM, Ellison BS, Ruh EL, Williams BM, Foreman K, Ford AD, Barrack RL (2012) Are patient-specific cutting blocks cost-effective for total knee arthroplasty? Clin Orthop Relat Res 470:889–894
Nunley RM, Ellison BS, Zhu J, Ruh EL, Howell SM, Barrack RL (2012) Do patient-specific guides improve coronal alignment in total knee arthroplasty? Clin Orthop Relat Res 470:895–902
Noble JWJ, Moore CA, Liu N (2012) The value of patient-matched instrumentation in total knee arthroplasty. J Arthroplasty 27:153–155
Pietsch M, Djahani O, Zweiger C, Plattner F, Radi R, Tschauner C, Hofmann S (2012) Custom-fit minimally invasive total knee arthroplasty: effect on blood loss and early clinical outcomes. Knee Surg Sports Traumatol Arthrosc. doi:10.1007/s00167-012-2284-z
Rosenberger RE, Fink C, Quirbach S, Attal R, Tecklenburg K, Hoser C (2008) The immediate effect of navigation on implant accuracy in primary mini-invasive unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 16:1133–1140
Ross JS, Mocanu M, Lampropulos JF, Tse T, Krumholz HM (2013) Time to publication among completed clinical trials. JAMA Intern Med 173:825–828
Slover JD, Rubash HE, Malchau H, Bosco JA (2012) Cost-effectiveness analysis of custom total knee cutting blocks. J Arthroplasty 27:180–185
Spencer BA, Mont MA, McGrath MS, Boyd B, Mitrick MF (2009) Initial experience with custom-fit total knee replacement: intra-operative events and long-leg coronal alignment. Int Orthop 33:1571–1575
Stronach BM, Pelt CE, Erickson J, Peters CL (2013) Patient-specific total knee arthroplasty required frequent surgeon-directed changes. Clin Orthop Relat Res 471:169–174
Suter LG, Paltiel AD, Rome BN, Solomon DH, Thornhill TS, Abrams SK, Katz JN, Losina E (2013) Placing a price on medical device innovation: the example of total knee arthroplasty. PLoS One 8:e62709
Thienpont E (2012) Faster recovery after minimally invasive total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. doi:10.1007/s00167-012-1978-6
Thienpont E (2012) Faster quadriceps recovery with the far medial subvastus approach in minimally invasive total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. doi:10.1007/s00167-012-2215-z
Thienpont E (2013) Letter to the Editor to Lustig et al. ‘Unsatisfactory accuracy as determined by computer navigation of Visionaire patient-specific instrumentation for total knee arthroplasty’. J Arthroplasty. doi:10.1016/j.arth.2013.05.019
Victor J, Dujardin J, Vandenneucker H, Arnout N, Bellemans J (2013) Patient-specific guides do not improve accuracy in total knee arthroplasty: a prospective randomized controlled trial. Clin Orthop Relat Res. doi:10.1007/s11999-013-2997-4
Victor J, Van Doninck D, Labey L, Van Glabbeek F, Parizel P, Bellemans J (2009) A common reference frame for describing rotation of the distal femur: a ct-based kinematic study using cadavers. J Bone Joint Surg Br 91:683–690
Vundelinckx BJ, Bruckers L, De Mulder K, De Schepper J, Van Esbroeck G (2013) Functional and radiographic short-term outcome evaluation of the Visionaire system, a patient-matched instrumentation system for total knee arthroplasty. J Arthroplasty. doi:10.1016/j.arth.2012.09.010
Watters TS, Mather RC 3rd, Browne JA, Berend KR, Lombardi AV, Bolognesi MP (2011) Analysis of procedure-related costs and proposed benefits of using patient-specific approach in total knee arthroplasty. J Surg Orthop Adv 20:112–116
Weber P, Crispin A, Schmidutz F, Utzschneider S, Pietschmann MF, Jansson V, Müller PE (2013) Improved accuracy in computer-assisted unicondylar knee arthroplasty: a meta-analysis. Knee Surg Sports Traumatol Arthrosc. doi:10.1007/s00167-013-2370-x
Zywiel MG, Johnson AJ, Mont MA (2012) Graduated introduction of orthopaedic implants: encouraging innovation and minimizing harm. J Bone Joint Surg Am 94:e158. doi:10.2106/JBJS.K.01675
The authors wish to thank Leo Beckers, Lukas Beckers, Hans Casteur, Raf Devloo, Angelique Koninckx, Peter Stuer, Luc Van Den Daele and Peter Verdonk for their contributions to the Open Meeting of the Belgian Knee Society in November 2012.
About this article
Cite this article
Thienpont, E., Bellemans, J., Delport, H. et al. Patient-specific instruments: industry’s innovation with a surgeon’s interest. Knee Surg Sports Traumatol Arthrosc 21, 2227–2233 (2013). https://doi.org/10.1007/s00167-013-2626-5
- Total knee arthroplasty
- Patient-specific instruments
- Survey study