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
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Pulsalys
- Enrollment
- 13
- Locations
- 3
- Primary Endpoint
- Detection of variation of the composition of Synovial Fluid after hyaluronic acid viscosupplementation in Osteoarthritis patients receiving SYNVISC-ONE® injection
- Status
- Completed
- Last Updated
- 4 years ago
Overview
Brief Summary
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®.
Detailed Description
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®.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or female ≥ 40 years of age with BMI ≤ 35 kg/m2
- •Femorotibial knee OA (Uni- or bilateral):
- •Responding to clinical and radiological criteria of American College of Rheumatology (ACR)
- •Symptomatic for more than 6 months in the most painful knee
- •Moderate-to-severe knee pain: knee pain score evaluated on VAS (0-100) ≥ 40 over the last month at the inclusion visit (the most painful knee is considered)
- •Eligible for knee viscosupplementation using SYNVISC-ONE®
- •Knee swelling justifying SF aspiration at baseline - Able to follow the instructions of the study
- •Having signed an informed consent
Exclusion Criteria
- •Related to the OA pathology
- •Recent macro-trauma (\< 6 months) of the knee responsible of the symptomatic knee. Micro-trauma are allowed according the Investigator's discretion
- •Concurrent articular disease interfering with the evaluation of OA and/or pain such as but not limited to articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis, chondromatosis, villonodular synovitis of the knee, seronegative spondyloarthropathy, rheumatoid arthritis, gouty arthritis, infectious arthritis, radiculalgia in the lower limbs, arteritis, chondrocalcinosis x-rays diagnosed and Calcium PyroPhosphate Dihydrate crystal deposition disease (CPPD)
- •Hemarthrosis
- •Prosthesis in the target knee
- •Related to treatment
- •Corticosteroids injection in the target knee in the last 3 months before injection (excepted for low dose injection following SF aspiration at V1 as recommended by standard treatment guidelines)
- •Hyaluronan injection in the target knee in the last 6 months before injection
- •Arthroscopy in the last 3 months before injection
- •Oral corticotherapy ≥ 5mg/day (in Prednisolone equivalent) in the last 3 months before injection
Outcomes
Primary Outcomes
Detection of variation of the composition of Synovial Fluid after hyaluronic acid viscosupplementation in Osteoarthritis patients receiving SYNVISC-ONE® injection
Time Frame: 6 months (between T0 and T6 visit)
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
Secondary Outcomes
- Detection of dried drops physicochemical index(6 months (between T0 and T6 visit))
- Detection of Synovial fluid molecular structural and chemical changes using a Raman confocal microscope(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(6 months (between T0 and T6 visit))
- Variation of Visual Analogue Scale for patient global assessment of disease activity(6 months (between T0 and T6 visit))
- Detection of Synovial fluid tribological properties through interferometry(6 months (between T0 and T6 visit))
- Variation of Knee injury and Osteoarthritis Outcome Score using a self-administered questionnaire(6 months (between T0 and T6 visit))
- Determination of Semi-quantitative Whole ORgan Magnetic Imaging Score score of the joint(At baseline visit (T0))
- Tolerance to the product(6 months (between T0 and T6 visit))
- Responder rate to treatment defined as changes in knee pain and/or knee function and/or patients disease activity according to OMERACT OARSI criteria(6 months (between T0 and T6 visit))