Skip to main content


Log in

Stability and alignment do not improve by using patient-specific instrumentation in total knee arthroplasty: a randomized controlled trial

  • Knee
  • Published:
Knee Surgery, Sports Traumatology, Arthroscopy Aims and scope



The primary aim of the study was to examine stability and alignment after total knee arthroplasty (TKA) using patient-specific instrumentation (PSI) and conventional instrumentation (CI). The hypothesis was that stability and alignment would be better using PSI than CI, 12 months postoperatively. The secondary aim included the evaluation of clinical outcomes after TKA.


In this prospective randomized controlled trial, 42 patients with knee osteoarthritis received a Genesis II PS prosthesis with either PSI or CI. Patients visited the hospital preoperatively and postoperatively after 6 weeks and 3 and 12 months. To evaluate stability, varus–valgus laxity was determined in extension and flexion using stress radiographs 12 months postoperatively. Three months postoperatively, a long-leg radiograph and CT scan were obtained to measure hip–knee–ankle (HKA) alignment and component rotation. Furthermore, frontal and sagittal alignment of the components, the Knee Society Score, VAS Pain, VAS Satisfaction, Knee injury and Osteoarthritis Outcome score, Patella score (Kujala), University of California Los Angeles activity score, anterior–posterior laxity, (serious) adverse device-related events, and intraoperative complications were reported. The clinical outcomes were compared using independent t tests or non-parametric alternatives, and repeated measurements ANOVA with a significance level of p < 0.05.


No significant differences were found between the two groups regarding stability, HKA angle, and rotational alignment. In four patients, the PSI did not fit correctly on the tibia and/or femur requiring intraoperative modifications. Both groups improved significantly over time on all clinical outcomes, with no significant differences between the groups 12 months postoperatively. The PSI group showed less tibial slope than the patients in the CI group [PSI 2.6° versus CI 4.8° (p = 0.02)]. Finally, the PSI group more frequently received a thinner insert size than the CI group (p = 0.03).


Patients operated with PSI did not differ from CI in terms of stability and alignment. However, in the PSI group ligament releases were more often required intraoperatively. Furthermore, the two methods did not show different clinical results. It seems that the preoperative planning for the PSI facilitates more conservative bone cuts than CI, but whether this is clinically relevant should be investigated. Since PSI is more expensive and time consuming than CI, and does not outperform CI with regard to clinical results, we recommend to use CI.

Level of evidence


This is a preview of subscription content, log in via an institution to check access.

Access this article

Price excludes VAT (USA)
Tax calculation will be finalised during checkout.

Instant access to the full article PDF.

Fig. 1
Fig. 2
Fig. 3

Similar content being viewed by others


  1. An VVG, Sivakumar BS, Phan K, Levy YD, Bruce WJM (2017) Accuracy of MRI-based vs. CT-based patient-specific instrumentation in total knee arthroplasty: a meta-analysis. J Orthop Sci 22:116–120

    Article  PubMed  Google Scholar 

  2. Anderl W, Pauzenberger L, Kölblinger R, Kiesselbach G, Brandl G, Laky B, Kriegleder B, Heuberer P, Schwameis E (2014) Patient-specific instrumentation improved mechanical alignment, while early clinical outcome was comparable to conventional instrumentation in TKA. Knee Surg Sports Traumatol Arthrosc 24:102–111

    Article  PubMed  Google Scholar 

  3. Berger RA, Crossett LS, Jacobs JJ, Rubash HE (1998) Malrotation causing patellofemoral complications after total knee arthroplasty. Clin Orthop Relat Res 356:144–153

    Article  Google Scholar 

  4. Berger RA, Rubash HE, Seel MJ, Thompson WH, Crossett LS (1993) Determining the rotational alignment of the femoral component in total knee arthroplasty using the epicondylar axis. Clin Orthop Relat Res 286:40–47

    Google Scholar 

  5. Choong PF, Dowsey MM, Stoney JD (2009) Does accurate anatomical alignment result in better function and quality of life? Comparing conventional and computer-assisted total knee arthroplasty. J Arthroplasty 24:560–569

    Article  PubMed  Google Scholar 

  6. Goyal T, Tripathy SK (2016) Does patient-specific instrumentations improve short-term functional outcomes after total knee arthroplasty? A systematic review and meta-analysis. J Arthroplasty 31:2173–2180

    Article  PubMed  Google Scholar 

  7. Gromov K, Korchi M, Thomsen MG, Husted H, Troelsen A (2014) What is the optimal alignment of the tibial and femoral components in knee arthroplasty? Acta Orthop 85:480–487

    Article  PubMed  PubMed Central  Google Scholar 

  8. Heesterbeek PJC, Keijsers NLW, Wymenga AB (2010) Ligament releases do not lead to increased postoperative varus–valgus laxity in flexion and extension: a prospective clinical study in 49 TKR patients. Knee Surg Sports Traumatol Arthrosc 18:187–193

    Article  PubMed  CAS  Google Scholar 

  9. Heesterbeek PJC, Verdonschot N, Wymenga AB (2008) In vivo knee laxity in flexion and extension: a radiographic study in 30 older healthy subjects. Knee 15:45–49

    Article  PubMed  CAS  Google Scholar 

  10. Hossain F, Patel S, Haddad FS (2010) Midterm assessment of causes and results of revision total knee arthroplasty. Clin Orthop Relat Res 468:1221–1228

    Article  PubMed  PubMed Central  Google Scholar 

  11. Huijbregts HJTAM, Khan RJK, Fick DP, Hall MJ, Punwar SA, Sorensen E, Reid MJ, Dalle Vedove S, Haebich S (2016) Component alignment and clinical outcome following total knee arthroplasty; a randomised controlled trial comparing an intramedullary alignment system with patient-specific instrumentation. Bone Jt J 98:1043–1049

    Article  Google Scholar 

  12. Insall JN, Binazzi R, Soudry M, Mestriner LA (1985) Total knee arthroplasty. Clin Orthop Relat Res 192:13–22

    Google Scholar 

  13. Le DH, Goodman SB, Maloney WJ, Huddleston JI (2014) Current modes of failure in TKA: infection, instability, and stiffness predominate. Clin Orthop Relat Res 472:2197–2200

    Article  PubMed  PubMed Central  Google Scholar 

  14. Levy YD, An VVG, Shean CJW, Groen FR, Walker PM, Bruce WJM, Walker PM (2016) The accuracy of bony resection from patient-specific guides during total knee arthroplasty. Knee Surg Sports Traumatol Arthrosc 25:1678–1685

    Article  PubMed  Google Scholar 

  15. Luyckx T, Peeters T, Vandenneucker H, Victor J, Bellemans J (2012) Is adapted measured resection superior to gap-balancing in determining femoral component rotation in total knee replacement? J Bone Jt Surg Br 94:1271–1276

    Article  CAS  Google Scholar 

  16. Mannan A, Akinyooye D, Tr F, Hossain F (2016) A meta-analysis of functional outcomes in patient-specific instrumented knee arthroplasty. J Knee Surg 1:2–8

    Google Scholar 

  17. Mannan A, Smith TO, Sagar C, London NJ, Molitor PJA (2015) No demonstrable benefit for coronal alignment outcomes in PSI knee arthroplasty: a systematic review and meta-analysis. Orthop Traumatol Surg Res 101:461–468

    Article  PubMed  CAS  Google Scholar 

  18. Ritter MA, Davis KE, Meding JB, Pierson JL, Berend ME, Malinzak RA (2011) The effect of alignment and BMI on failure of total knee replacement. J Bone Jt Surg Am 93:1588–1596

    Article  Google Scholar 

  19. Ritter MA, Faris PM, Keating M, Meding JB (1994) Postoperative alignment of total knee replacement: its effect on survival. Clin Orthop Relat Res 299:153–156

    Google Scholar 

  20. Schimmel JJP, Defoort KC, Heesterbeek PJC, Wymenga AB, Jacobs WCH, van Hellemondt GG (2014) Bicruciate substituting design does not improve maximal flexion in total knee arthroplasty a randomized controlled trial. J Bone Jt Surg Am 96:1–8

    Article  Google Scholar 

  21. Victor J, Dujardin J, Vandenneucker H, Arnout N, Bellemans J (2014) Patient-specific guides do not improve accuracy in total knee arthroplasty: a prospective randomized controlled trial. Clin Orthop Relat Res 472:263–271

    Article  PubMed  Google Scholar 

  22. Victor J, Ghijselings S, Tajdar F, Van Damme G, Deprez P, Arnout N, Van Der Straeten C (2014) Total knee arthroplasty at 15–17 years: does implant design affect outcome? Int Orthop 38:235–241

    Article  PubMed  Google Scholar 

  23. Vide J, Pinto T, Acácio F, Henrique R (2017) Patient-specific instrumentation in total knee arthroplasty: simpler, faster and more accurate than standard instrumentation—a randomized controlled trial. Knee Surg Sports Traumatol Arthrosc 25:2616–2621

    Article  PubMed  Google Scholar 

  24. 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 28:964–970

    Article  PubMed  Google Scholar 

  25. Whiteside LA (2002) Soft tissue balancing: the knee. J Arthroplasty 17:23–27

    Article  PubMed  Google Scholar 

  26. Zalzal P, Papini M, Petruccelli D, de Beer J, Winemaker MJ (2004) An in vivo biomechanical analysis of the soft-tissue envelope of osteoarthritic knees. J Arthroplasty 19:217–223

    Article  PubMed  Google Scholar 

Download references


The authors wish to thank the research nurses Saskia Susan for her effort in patient recruitment and Jolanda Rubrech-van As for data management.

Author information

Authors and Affiliations



PH, JS, GvH, AW, and KD created the concept and design of the study. JS managed the acquisition of data. NK and PH analyzed the data and wrote the draft of the full manuscript. All the authors critically revised the manuscript and approved the final version.

Corresponding author

Correspondence to Nienke M. Kosse.

Ethics declarations

Conflict of interest

The institution received funding from Smith & Nephew to pay for staff and materials. Smith & Nephew had no role in the design or conduct of the study, the collection, management, analyses, and interpretation of the data, or the preparation and review of the manuscript.


This study was funded by Smith & Nephew.

Ethical approval

The hospital’s investigational review board and the Medical Ethical Review Board of Slotervaart and Reade (NL32953.048.11) approved the study protocol.

Informed consent

Informed consent was obtained from all individual participants included in the study.

Rights and permissions

Reprints and permissions

About this article

Check for updates. Verify currency and authenticity via CrossMark

Cite this article

Kosse, N.M., Heesterbeek, P.J.C., Schimmel, J.J.P. 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 26, 1792–1799 (2018).

Download citation

  • Received:

  • Accepted:

  • Published:

  • Issue Date:

  • DOI: