Clinical trial: Innovative Tool to Analyse Synovial Fluid of Patients With Knee Ostearthritis After IA Injection of Synvisc-one® (NCT04321668)

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:

          1. 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

          2. 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

               -  Change in the dosage regimen of symptomatic slow-acting drugs for osteoarthritis
                  (SYSADOA) or dietary supplement, i.e., curcuma extract, chondroitin, glucosamine,
                  diacerein or avocado-soya unsaponifiables in the last 3 months before injection

               -  An anticipated need for any forbidden OA treatments during the trial

               -  Contraindications to SYNVISC-ONE®: hypersensitivity or allergy to the product
                  components and infections or skin diseases in the area of the injection site

               -  Anticoagulant anti-vitamin K (such as coumarinic) before injection

          3. Related to associated diseases

               -  Severe and uncontrolled diseases (type I diabetes, liver failure, renal failure,
                  lung/heart disease, progressive malignant neoplasia or in remission for less than
                  5 years, HIV)

               -  Malignancy or history of malignancy, or other major disease (e.g., systemic
                  fungal infection) or other severe uncontrolled conditions (e.g., drug or alcohol
                  abuse), that are significant and/or that may pose a health risk to the subject in
                  the study or may have an impact on the study assessments

               -  High risk of hemorrhage and risk of infection at the site of injection

               -  Anticipated need for any surgical or other invasive procedure during the trial
                  including prosthesis in the target knee

          4. Related to patients

               -  Close collaborators to the Sponsor, the study coordinator or the Investigator

               -  Participation in a clinical trial in the last 3 months before injection

               -  Patient under guardianship or judicial protection

               -  Pregnancy, breastfeeding, planned conception, or premenopausal women without
                  effective contraception (pill, patch, ring, diaphragm, implant and intrauterine
                  device), tubal ligation or hysterectomy

          5. Related to MRI counter-indication

               -  Risk groups for MRI scanning due to magnetic field: metal in body:
                  pacemaker/AICD/ICD (coronary defibrillator), nervus vagus stimulator, artificial
                  heart valve (depending on type), metal clips on cerebral arteries or veins, metal
                  particles in eye, port-a-cath, metal stents, hydrocephalic pump/insuline pump,
                  metal implants; f/e screws, prostheses, piercings

               -  Claustrophobia or serious mobility problem (uncontrolled Parkinson, tremors)
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 40 Years old.
Subject must be at most 80 Years

Patient description (medical language): A 47-year-old woman comes to the office complaining of pain in the calf and knee when she bends down. The pain limits her activity. Her medical history is significant for osteoarthritis, for which she uses nonsteroidal anti-inflammatory drugs (NSAIDs) for the past two years. She is living with her husband and has 3 children. She doesn't smoke but drinks alcohol occasionally. Her vital signs are normal. On physical examination, there is a small effusion in the right knee. The effusion grew a little larger and she developed a tender swelling in the popliteal fossa and calf. Both the pain and swelling worsened as she bent and straightened her knee.

Patient description (patient's own words): I'm a 47-year-old woman, married with 3 kids. I don't smoke and I drink occasionally. I went to the doctor because of pain in my calf and knee when I was bending down. This has been limiting my daily activities. I have been diagnosed with osteoarthritis for which I have taken anti-inflammatory drugs for the past 2 years. The doctor saw a small fluid buildup in my right knee. This buildup became a bit bigger and I have a swollen calf. The pain is worse when I bend and straighten my knee.

Does the patient match the trial criteria? 1