Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 12:38 PM
Ignite Modification Date:
2025-12-24 @ 12:38 PM
NCT ID:
NCT04293861
Eligibility Criteria:
Inclusion Criteria:
* Male or female between the age of 40 and 80 with BMI ≤ 40
* Monolateral (unless contralateral knee is grade I and asymptomatic) femorotibial knee OA associated or not with femoropatellar knee OA
* Responding to clinical and radiological criteria of the American College of Rheumatology (ACR) (Appendix 1)
* Symptomatic for more than 6 months in the most painful knee
* Radiological Kellgren \& Lawrence (K\&L) II or III in radiographs from less than 12 months (Appendix 2)
* Mean knee pain score at rest over the last 24 hours evaluated on VAS (0-100) ≥ 40 (Appendix 3) with a washout period for Paracetamol and oral NSAIDs depending on the half-life of the drug (Appendix 4). The most painful knee is considered.
* Able to follow the instructions of the study
* Having signed an ICF
Exclusion Criteria:
Related to the OA pathology
* Bilateral (except asymptomatic and grade I) OA of the knee
* Radiological K\&L grade I or IV (Appendix 2)
* Chondromatosis or villonodular synovitis of the knee
* Recent trauma (\< 1 month) of the knee responsible of the symptomatic knee
* Acute inflammatory OA (KOFUS (Knee Osteoarthritis Flare Up Scale) score ≥ 7, Appendix 5)
* Articular disease resulting from articular dysplasia, aseptic osteonecrosis, acromegaly, Paget's disease, hemophilia, hemochromatosis….
* Inflammatory disease i.e. rheumatoid arthritis, gout, infectious arthritis, acute calcium pyrophosphate arthritis
* Pathologies interfering with the evaluation of OA (radiculalgia in the lower limbs, arteritis…..)
* Presence of another joint (other than the target knee) affected by OA (confirmed in radiographs and symptomatic)
Related to treatments
* Corticosteroids injection in the target knee in the last month before first injection
* Hyaluronan injection in the target knee in the last 6 months before first injection
* Arthroscopy and surgery in the target knee in the last 6 months before first injection
* Oral corticotherapy ≥ 5mg/day (in Prednisone equivalent) in the last 3 months before first injection
* OA treatments based on curcuma extract (e.g. FLEXOFYTOL) in the last 3 months before first injection
* Change in the dosage of SYSAD i.e. chondroitin, glucosamine, diacerein or avocado-soy unsaponifiables in the last 3 months before first injection
* Paracetamol and oral NSAIDs before inclusion and follow-up visits (washout period depending on the half-life of the drug, Appendix 4).
* Osteoporosis-related treatments based on strontium ranelate, selective estrogen-receptor modulator (SERM) and parathormone (PTH) in the last 12 months before first injection
* An anticipated need for any forbidden OA treatments during the trial
* Contraindications to HYMOVIS®: hypersensitivity to the product components and infections or skin diseases in the area of the injection site.
* Non-pharmacologic therapy (including physical therapy) for the lower extremities initiated in the month before first injection
* Anticoagulant (coumarinic compound) and heparin
Related to associated diseases
* Severe diseases (liver or renal failure, lung/heart disease, tumor, HIV….)
* Allergy or contra-indication to hyaluronan
* Severe alteration of mobility enabling functional evaluation
* 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
Related to patients
* Participation to a therapeutic clinical trial in the last 3 months before first injection
* Under guardianship or judicial protection
* Pregnancy, breastfeeding, planned conception, premenopausal women without contraception, tubal ligation or hysterectomy
Related to MRI counter-indication
* Patient with a pacemaker, an implantable defibrillator, neurosurgical clips, a neurostimulator, cochlear implant, a stent from less than 3 weeks, an insulin pump
* Patient with a ferromagnetic splinter in the body, or having wire sutures
* Serious mobility problem (Parkinson, tremors),
* Claustrophobia
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT04293861
Study Brief:
Protocol Section:
NCT04293861