Description du projet
Un dispositif innovant pour la mesure automatisée de la laximétrie dynamique
Le ligament croisé antérieur (LCA) est un élément essentiel du genou. La méthode de référence actuelle pour diagnostiquer les lésions du LCA est le test de Lachman, qui mesure la «laxité» (relâchement) des ligaments du genou. Ce processus est fiable lorsqu’il est effectué par un spécialiste. Cependant, les médecins généralistes et les non-spécialistes ont besoin d’une radiographie ou d’un examen IRM pour confirmer le diagnostic. Le projet Dyneelax, financé par l’UE, propose le premier dispositif médical permettant une mesure automatisée de la laximétrie dynamique indépendamment des examens tels que les radiographies et les IRM. Le dispositif réalise des tests de Lachman et des examens de rotation objectifs et reproductibles pour évaluer la laximétrie du LCA ainsi que le diagnostic et le pronostic de l’état de récupération.
Objectif
The knee is the largest, and one of the most complex and fragile joints in the human body, and the anterior cruciate ligament (ACL) is one of its core components. The ACL is vital to healthy knee function, stabilising the joint throughout its range of motion.
In order to diagnose ACL injuries, the current gold standard is the Lachman’s test, which measures the ‘laxity’ (looseness) of the ligaments in the knee. Often done by hand, this is a reliable process when carried out by a specialist such as an orthopaedist. In contrast, general practitioners (GPs) and other non-specialists require x-ray or magnetic resonance imaging (MRI) exams to confirm their diagnosis. However, waiting periods for mechanised tests in the EU are long, sometimes entirely unpredictable, due to limited equipment availability and the need to prioritise emergency cases.
To overcome this, Genourob has developed Dyneelax, which is the first medical device for automated dynamic laximetry measurement. Dyneelax carries out objective and reproducible Lachman’s tests and rotational exams to assess the laximetry of the ACL. Automation and standardisation of this non-invasive, quantitative testing allows the diagnosis and prognosis of ACL injury and recovery status. It is independent of examinations such as x-ray and MRI scans and it can be used also by non-specialists such as GPs. This means quicker, more effective treatment for better recovery of patients.
At Genourob our mission is to transform the clinical protocol for diagnosing and prognosis of ACL injuries. In this way, GPs would be patients’ main point of contact with the healthcare system, replacing the need to wait for an MRI scan or x-ray for ACL injuries’ treatment. The SME Instrument grant is ideal for completing our product roadmap as it will enable our post-market surveillance to be carried out, to allow us to make the clinical claim that Dyneelax is an effective substitute for MRI scans in diagnosing and evaluating injuries to the ACL
Champ scientifique
- medical and health sciencesclinical medicinerheumatology
- medical and health sciencesclinical medicinesurgery
- natural sciencescomputer and information sciencessoftwaresoftware development
- social sciencessociologygovernancecrisis management
- engineering and technologymedical engineeringdiagnostic imagingmagnetic resonance imaging
Programme(s)
Régime de financement
SME-1 - SME instrument phase 1Coordinateur
53000 LAVAL
France
L’entreprise s’est définie comme une PME (petite et moyenne entreprise) au moment de la signature de la convention de subvention.