Innovations in knee arthroplasty: three-dimensional modeling and analytical technology (SOMA).

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Abstract

[Indexed for MEDLINE] 18. Ann Pharm Fr. 2018 May;76(3):228-234. doi: 10.1016/j.pharma.2017.12.002. Epub 2018 Feb 2. [Review of patient-specific instrumentation for total knee prosthesis]. [Article in French] Vaillant T(1), Steelandt J(2), Cordonnier AL(2), Haghighat S(3), Anract P(4), Paubel P(5), Duhamel C(3). Author information: (1)Unité évaluation et achats des dispositifs médicaux, service évaluations pharmaceutiques et bon usage, Agence générale des équipements et produits de santé, Assistance publique-Hôpitaux de Paris, 75005 Paris, France. Electronic address: tiphaine.vaillant@aphp.fr. (2)Unité évaluation scientifique, bon usage et information, service évaluations pharmaceutiques et bon usage, Agence générale des équipements et produits de santé, Assistance publique-Hôpitaux de Paris, Paris, France. (3)Unité évaluation et achats des dispositifs médicaux, service évaluations pharmaceutiques et bon usage, Agence générale des équipements et produits de santé, Assistance publique-Hôpitaux de Paris, 75005 Paris, France. (4)Service d'orthopédie, hôpital Cochin, université Paris-V, AP-HP, 75014 Paris, France. (5)Unité évaluation et achats des dispositifs médicaux, service évaluations pharmaceutiques et bon usage, Agence générale des équipements et produits de santé, Assistance publique-Hôpitaux de Paris, 75005 Paris, France; Unité évaluation scientifique, bon usage et information, service évaluations pharmaceutiques et bon usage, Agence générale des équipements et produits de santé, Assistance publique-Hôpitaux de Paris, Paris, France; Inserm UMR S1145, institut droit et santé, faculté de pharmacie, université Paris Descartes - Sorbonne Paris Cité, 4, avenue de l'Observatoire, 75006 Paris, France. OBJECTIVES: Single use patient-specific instruments (PSI) for total knee prosthesis are introduced as a new alternative to conventional ancillaries and computer assisted surgery by improving implants positioning. An exhaustive review was carried out to identify their specific characteristics, with their advantages and disadvantages. METHODS: Medical devices suppliers were consulted in 2015 for reviewing their PSI. Their technical, clinical and economic data were compared. The results had been submitted to an orthopaedics expert commission of our university hospital for clinical and financial opinion. RESULTS: Ten companies have provided the documentation for the analysis. PSI are manufactured by suppliers using a three dimensional printing method based on CT scans or MRI images. PSI are produced according to the surgeon's preferences after a preliminary data check, which can be performed by the suppliers' engineers, the surgeon and automatic calculation. Five suppliers can produce sterile PSI with optional delivery of 3D bone models. According to the experts, the studies failed to demonstrate the superiority of a PSI or hospital economic gain. The prices listed remain high and operating room time is not always significantly reduced. CONCLUSIONS: With the development of personalized medicine, the role of PSI grows in importance. They facilitate the surgeon's work by fully respecting the anatomy. These systems offer an interesting perspective in their technical and pedagogical aspects. But it seems premature to take them into routine use given the low number of high-level studies that were currently done. Copyright © 2017 Académie Nationale de Pharmacie. Published by Elsevier Masson SAS. All rights reserved. DOI: 10.1016/j.pharma.2017.12.002