Dyneelax represents a new, high performances medical device for ligament tears analysis of knee joint laxity.
The main aim is to develop so called LigAM, a new medical device for the computer-assisted assessment of knee laxity, with special focus on joint stability provided by the anterior cruciate ligament (ACL) status. LigAM will be able to generate diagnostic reports on the status of the ACL (complete or different types of partial tears) and associated soft tissue
structures (menisci) based upon fully automated measurement procedures and a complete analysis of static knee joint laxity, taking into account individual patient characteristics.
The device will be composed of an automated arthrometer (LigAM apparatus), and a unique data analysis software (LigAM software).
New product, new life…
LigAM will be a new product: it will stand out from all arthrometers, existing or in development, and will feature new functionalities that require re-defining arthrometer configuration and data analysis of knee laxity:
automation of knee laxity evaluations in both the sagittal and the transverse plane,
complex knee movement simulations to obtain tibial pivot shit with recorded conditions of tightening force and leg positioning recorded that ensure unique test reproducibility, unique patient benchmarking and personalized diagnostic by advanced data analysis software lying on an extensive and upgradeable database of knee laxity measurements.
The overall development of LigAM is definitely incremental, as it will follow standards of the medical devices industry starting
from new device design, prototyping, tests and validation in clinical and cadaveric studies with applications of specific norms all along product development.
LigAM will clearly stand out from current devices thanks to very unique functionalities and features:
integration of automated knee laxity evaluations in both the sagittal (anterior tibial displacement) and the transverse (internal and external tibial rotation) plane through the application of appropriate, calibrated forces/torques up to a precise, predefined level;
complex knee movement simulations to obtain tibial pivot shit with recorded conditions of tightening force and leg positioning recorded that ensure unique test reproducibility;
highly relevant outcomes (better accuracy, more appropriate treatment) for optimal patient monitoring after surgical or conservative treatment of knee soft-tissue injuries,
advanced analysis software that allows for diagnosis and unique patient benchmarking based on individual laxity profile, taking into account all laxity results, patient characteristics and pathological status;
suitable for both research and clinical follow-up of patients due to its high accuracy and reliability;
time-efficient multiplanar testing with the use of a single device.
Compared to current products, commercialized or in development, LigAM will be the sole product to allow for an integrative analysis of the knee joint laxity, a feature that is critical for the precise diagnosis and patient follow-up. LigAM will be positioned on several market segments of knee orthopaedic market:
knee surgery: complete check up of knee ligament that permits orthopedic surgeon to adapt the surgery to the lesion observed,
patient rehabilitation: high quality patient follow-up and adaptation of exercises in relation with the results obtained during the rehabilitation,
sport medicine: tool for early stage diagnosis of ligament tears allowing for a better healing through a personalized functional treatment without surgery.
How is the system made…
LigAM will be composed of an arthrometer and its associated examination couch (“LigAM apparatus”) and a software application (“LigAM software”) divided into two modules: system control and measurement, and data analysis and visualization. The new system, based on extensive technical and clinical knowledge acquired from GNRB and Rotam development by GEN and CRP, will feature significant technical improvements over existing arthrometers:
Automated knee laxity evaluations in both the sagittal (anterior tibial displacement) and the transverse (internal and external tibial rotation) plane through the application of appropriate, calibrated forces/torques;
High-precision sensors to quantify anterior tibial displacement and internal/external tibial rotation;
Standardized measuring conditions due to calibrated fixation devices for the proximal and distal lower limb segments under study;
complex knee movement simulations to obtain tibial pivot shit with recorded conditions of tightening force and leg positioning recorded that ensure unique test reproducibility ;
Electromyographic system to detect hamstrings muscles contraction ;
Advanced analysis software that allows for unique patient benchmarking, taking into account all laxity results as well as the patient’s laxity profile, other characteristics and pathological status.
The first LigAM prototype will include the hardware and measurement software module and will be further fine-tuned through preliminary in vivo tests (CRP). The prototyping process will result in “LigAM 1.0” that will then undergo:
an in vivo study on healthy participants to assess the reliability of the results generated by LigAM and to define its technical properties (CRP),
an in vivo study on ACL (anterior cruciate ligament)-injured patients to evaluate the diagnostic potential and demonstrate the clinical applicability of LigAM (CRP),
a cadaveric study in comparison to a gold standard technology, OrthopilotTM, to prove LigAM performance (CHNM).
In parallel, the data analysis and visualization module will be developed (CT). CRP has set up, in collaboration with the CHL, a systematic data recording system for the precise follow-up of patients after an injury to their ACL. Based on this prior clinical experience and newly acquired data with the LigAM 1.0, CT will develop a specific software module that integrates all laxity measurements to improve the diagnosis of knee soft tissue injuries and to predict patient trajectory. This module will rely on crucial methods and smart algorithms implemented to visualize patient data in an innovative manner and will be validated through clinical tests (CRP). All along DYNEELAX, regulatory standards will be applied to obtain CE labeling (GEN).
Several technical challenges will be taken up in DYNEELAX:
1) Facing mechanical and hardware configuration of LigAM:
coupling anterior and rotational knee laxity measurements without provoking steric hindrance (electric jack for rotation and for translation will have to work independently while integrated within the same device),
complex knee movement simulations to obtain tibial pivot by performing rotation and translation measures simultaneously with patient leg being guided by the movement of the automated examination table.
2) A particular challenge associated with the LigAM will be to define the way in which data related to anterior and rotational (internal and external rotation) laxity will be presented in an integrated way, providing both detailed and summarized analyses of the patient’s status.
3) Software implementation of modeling patient trajectory will be challenging. It will use imaginative ways of displaying the very complex and complete data in a clinically meaningful overview. The challenge is to select appropriate statistical methods (multiple regressions) and algorithms for automated processing and classification of knee translation and rotation, implement a list of suitable visualization methods and integrate aggregated information from clinical databases into the analytical software.