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Patient-specific instruments: industry’s innovation with a surgeon’s interest

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

Abstract

Purpose

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.

Methods

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.

Results

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.

Conclusion

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

V.

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Acknowledgments

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.

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Authors and Affiliations

  1. University Hospital Saint Luc, Av. Hippocrate 10, 1200, Brussels, Belgium

    Emmanuel Thienpont

  2. University Hospital UZ Pellenberg, KU Leuven, Leuven, Belgium

    Johan Bellemans

  3. Catholic University of Leuven, Leuven, Belgium

    Hendrik Delport

  4. AZ Maria Middelares, Gent, Belgium

    Philippe Van Overschelde

  5. Sint Augustinus, Wilrijk, Belgium

    Bart Stuyts

  6. AZ Middelheim, Antwerpen, Belgium

    Karl Brabants

  7. University Hospital UZ Ghent, Gent, Belgium

    Jan Victor

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  1. Emmanuel Thienpont
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  2. Johan Bellemans
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Correspondence to Emmanuel Thienpont.

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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

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  • DOI: https://doi.org/10.1007/s00167-013-2626-5

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