Knee Osteoarthritis Clinical Trial
Official title:
A Proof of Concept Study in Patients Suffering of Knee Osteoarthritis (OA) and Receiving Intra-articular (IA) Injection of Synvisc-one® to Assess the Clinical Pertinence of a New Analytical Tool of Synovial Fluid
The objective of this trial is to assess the clinical pertinence of an innovative analytical tool (SYNODIAG) to analyze the Synovial Fluid (SF) composition and guide the patient treatment in a Proof of Concept (PoC) study using OA patients receiving IA injection of SYNVISC ONE®.
In a recent study on animal model (results not yet published), the use of drop deposition combined to Raman spectroscopy provided for the first time the Raman spectral signature of healthy SF. Tribological analysis of simple dried drops of SF showed the potentiality to observe physical and chemical changes due to OA process. HA concentration was correlated with the dried drop area and the increase of protein content was correlated with the height of the peripheral rim. Spectral acquisitions detailed/specified these observations as degradation of cartilage and bone tissues was measured using specific Raman band ratios. These results suggested that DDRS could be an innovative tool in OA clinical research. In this context, the Sponsor would like to assess the clinical pertinence of this innovative analytical tool in a PoC study using OA patients receiving IA injection of SYNVISC ONE®. ;
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