Clinical evaluation, the “mantra” of our medical age …
Since the origins of arthroplasty, clinical evaluation in orthopedic surgery has undergone many changes, particularly with regard to the development of hip and knee prostheses. Scientific documentation has greatly benefited over the past decades from all advances in computerized methods for the collection and statistical processing of clinical elements and the “digital” processing of images via increasingly high-performance computers, formerly traditional “PC”, now easily tablets or smartphones.
The OrthoWave ™ software suite
The OrthoWave ™ software suite, created by surgeons for surgeons by the company ARIA sas (62150 HOUDAIN – France – RCS: 332210095 SIRET: 33221009500011), is a software suite dedicated to the evaluation and clinical studies in orthopedics, in particular for hip and knee prostheses. The OrthoWave servers, for 15 years, are currently in charge of more than 520,000 clinical evaluation files for hip and knee prostheses, for more than 2,000 surgeons registered in the OrthoWave databases in France and abroad. . … OrthoWave is also the software used for several years for the Italian RIPO registry in northern Italy; it is also directly connected (procedures by XML transfers) to the National Joint Registry of England and Wales (NJR). It is also the official SOFCOT-SFHG register of hip resurfacing prostheses in France for 5 years.
ISO 14155 compliance
At each stage of its development since its creation in 1996, and until today, the principles of “good clinical practice for the design, evaluation methods, registration and report of investigations have always been taken into account during clinical trials conducted on human subjects with a view to evaluating the safety or performance of medical devices” in accordance with the standards in force ISO 14155 … In terms of regulations, OrthoWave hosting is secure on servers dedicated non-shared, in accordance with the recommendations of the CNIL under following reference: declaration n ° 1207969 (2007) renewed under number 1874942vO (2015) – CNIL MR001 / MR003 / MR004 approvals The manager of this database is declared to the regulatory authorities as a health professional, orthopedic surgeon, involved in several scientific institutions at the national level (Société Française d’Orthopédie – SoFCOT, Société Française de Hip and Knee – SFHG) and internationally (European Hip Society – EHS).
Data entry on smartphones and automatic monitoring in “remote access”
The current solution offered by version v7 of the OrthoWave ™ software suite is a proven solution, in cloud computing and AJAX language on secure servers and providing complete encryption of all upload and download data transfers… It benefits with this version 7 from all the advantages of data entry on all media (including smartphones and tablets) with a “connected patient” system allowing patients to directly enter their PROMS-type evaluations using the AMS (Automatic Monitoring System) protocol, which avoids reconvocations of face-to-face patients, all the more appreciable in these times of the Covid pandemic …
A software dedicated to clinical studies perfectly compatible with MDR regulations
This means that this “SaMD – Software as a Service” has been directly thought out and designed for the fastest and most user-friendly online collection of clinical record forms (CRF – Clinical Record Form) in orthopedic surgery, or for any other area of clinical follow-up. It is in no way a software suite for office automation, or practice management, or even short-term monitoring of patient performance after fast-track or outpatient surgery … Its ambition is to offer a high-performance, supported tool upon the latest technological developments, for clinical studies, their analyzes, for the purpose of long-term scientific publications, or the preparation of regulatory dossiers for official authorities. In this regard, the implementation of the new MDR procedures at the European level gives particular interest to the OrthoWave ™ software suite, whether it concerns both observational and purely epidemiological studies or registers complying with ODEP recommendations. C’est dire que ce “SaMD – Software as a Service” a été directement pensé et conçu pour la collection en ligne la plus rapide et la plus conviviale des fiches de recherche clinique (CRF – Clinical Record Form) en chirurgie orthopédique, ou pour tout autre domaine de suivi clinique. Il ne s’agit en aucun cas d’une suite logicielle de bureautique, ou de gestion de cabinet, voire de suivi à court terme des performances de patients après chirurgie en fast track ou ambulatoire… Son ambition est de proposer un outil performant, supporté par les dernières évolutions technologiques, pour les études cliniques, leurs analyses, à fins de publications scientifiques au long cours, ou de réalisation de dossiers réglementaires en France pour les instances HAS, telles la CNEDiMTS, ou le SED. A cet égard, la mise en place des nouvelles procédures MDR au niveau Européen confère un intérêt tout particulier à la suite logicielles OrthoWave™, qu’il s’agisse des études tant observationnelles que purement épidémiologiques, ou des registres de conformité sous recommandations ODEP.
A new generation of PROMS with the OWOS10 questionnaire
A new “Patient Reported Outcomes Measures – PROM within the OrthoWave platforms has also been set up, in the form of a functional questionnaire on 100 points, supplemented by a “prosthetic status” making it possible to follow in the long term the evolution not only of the patient but also the status of the prosthesis and occurrence of any complications … This is the OWOS10 questionnaire, currently being validated, however already recommended for use in OrthoWave, in particular regarding the procedures for our remote “automatic monitoring system (AMS) ”.Une nouvelle évaluation au sein des plates-formes OrthoWave a en outre été mise en place, sous forme d’un questionnaire fonctionnel sur 100 points, complété par un « statut prothétique » permettant de suivre dans le long terme l’évolution non seulement du patient, mais également de l’état de la prothèse et d’éventuelles complications… Il s’agit du questionnaire OWOS10, actuellement en cours de validation, mais déjà recommandé pour une utilisation dans OrthoWave, notamment à propos des procédures de « suivi automatisé du statut des prothèses (AMS) » .
OrthoWave v7: the answer to the challenges of “modern” clinical evaluation in Orthopedics
This version 7 of OrthoWave can therefore meet the major challenge of clinical evaluation in medical practices, with in particular the creation of a brand-new data entry and management tool, moving from the standard PC to a “light” form on smartphone. For any development of additional modules or creation of new platforms in orthopedic surgery or any other medical field, their deployments and activations can be fast thanks to the totally scalable structure of this “big” SQL system. These developments can be fully effective within very short deadlines after validation of the specifications, thanks to the involvement of all existing IT infrastructures and routines. Do not hesitate to contact us via the “contact” section of this site for any request or additional information.
“Longitudinal” clinical surveillance methods outside of RIPH qualification (Jardé’s law)
As part of a “longitudinal” clinical follow-up allowing from the files recorded at the OrthoWave servers to practice for the analyses a simple extraction of data during any MDR type request, we remain with OrthoWave in a qualification. “no-RIPH” according to the French Jardé law (or equivalent at European level). This is prospective-retrospective research that fits perfectly into the framework of usual procedures, analyzing current medical practice, and also considered as a legal, ethical, and quality obligation. No prior agreement from a CPP (Committee for the protection of persons) is therefore required in this so-called “continuous flow” clinical monitoring option, unlike specific regulatory research (CE marking, registrations or renewal of trademarks), falling within the scope of RIPH 1, 2 or 3 of the Jardé law.
This MDR regulation and the clinical follow-up which must intervene in the long term by simple extraction from OrthoWave servers, therefore, makes it possible to qualify this global database, which currently has more than 250,000 forms for 25 years, as a real treatment registry dedicated to hip and knee prostheses. Approved according to the CNIL in the MR004 agreement, this register can thus be qualified as the equivalent of a “health data warehouse (DHS)” in terms of efficiency and protection of patient data.