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®.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
13
SYNVISC-ONE® (Hylan G-F 20), 10 mL single-injection viscosupplement Status : CE marked (CE 0086) class III Medical Device The IP is used according to its usual dosage, administration and indication
Centre Medical Chant d'Oiseau
Woluwe-Saint-Pierre - Sint-Pieters-Woluwe, Brussels Capital, Belgium
Hopital Delta, CHIREC
Auderghem, Belgium
Cliniques Universitaires Saint Luc - UCL
Woluwe-Saint-Pierre - Sint-Pieters-Woluwe, Belgium
Detection of variation of the composition of Synovial Fluid after hyaluronic acid viscosupplementation in Osteoarthritis patients receiving SYNVISC-ONE® injection
Tribological properties (i.e. the dried drop surface and the peripheral height profile) of the synovial fluid will be analyzed through optical microscopy (2D morphological examinations) in OA patients receiving SYNVISC-ONE® injection
Time frame: 6 months (between T0 and T6 visit)
Detection of Synovial fluid tribological properties through interferometry
Topography measurement (3D tribological examination) will be performed using white light interferometry (smartWLI-microscope, GBS mbH, Germany) on the periphery of the drops.
Time frame: 6 months (between T0 and T6 visit)
Detection of Synovial fluid molecular structural and chemical changes using a Raman confocal microscope
Based on Raman spectroscopy
Time frame: 6 months (between T0 and T6 visit)
Detection of dried drops physicochemical index
Based on surface of dried drops and Raman ratios
Time frame: 6 months (between T0 and T6 visit)
Variation of Visual Analogue Scale for the mean knee pain at rest and while walking over the last month
The pain Visual Analogue scale (VAS) is a continuous scale comprised of a horizontal line, usually 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme.
Time frame: 6 months (between T0 and T6 visit)
Variation of Knee injury and Osteoarthritis Outcome Score using a self-administered questionnaire
The KOOS outcome score is a 42-item self-administrated questionnaire comprising 5 subscales: Pain, Symptoms, Activities of Daily Living, Sports and Recreation function, and Quality Of Life. A separate score ranging from 0 to 100, where 100 represents the best result, will be calculated for each subscale. A global score will be calculated by summing the score of each subscale.
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Time frame: 6 months (between T0 and T6 visit)
Variation of Visual Analogue Scale for patient global assessment of disease activity
The Visual Analogue Scale (VAS) is a continuous scale comprised of a horizontal line, usually 10 centimeters in length, anchored by one verbal descriptors for Global Assessment of disease activity.
Time frame: 6 months (between T0 and T6 visit)
Determination of Semi-quantitative Whole ORgan Magnetic Imaging Score score of the joint
MRI Imaging will be analyzed for WORMS by central reading in order to find correlation between the Imaging and the synovial fluid composition.
Time frame: At baseline visit (T0)
Responder rate to treatment defined as changes in knee pain and/or knee function and/or patients disease activity according to OMERACT OARSI criteria
Responder criteria for osteoarthritis clinical trials will be based on the questionnaires describe above.
Time frame: 6 months (between T0 and T6 visit)
Tolerance to the product
Number of Adverse events (AE or Adverse Device Effect or Device Deficiency; will be coded in terms of SOC and LLT using the last version of MedDRA) and drop offs
Time frame: 6 months (between T0 and T6 visit)