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 @ 4:58 PM
Ignite Modification Date:
2025-12-24 @ 4:58 PM
NCT ID:
NCT05829850
Eligibility Criteria:
Inclusion Criteria:
* Patient between 35 and 75 years old
* Patients with knee osteoarthritis. The diagnosis is based on the following American College of Rheumatology (ACR) classification:
* Knee pain
* Positive radiography (presence of osteophytes)
* Morning stiffness \< 30 min and/or crepitus while walking
* Symptoms related to knee osteoarthritis for at least 6 months
* Treatment failure (i.e. ineffective response) with analgesics and/or NSAIDs or intolerance to NSAIDs or low-grade opioids
* Kellgren-Lawrence radiographic stage: I - III (pre-inclusion radiography)
* VAS pain index score ≥ 40 mm (VAS 0-100 mm) on the knee to be treated
* Contralateral knee pain \< 10 mm (VAS) compared to treated knee
* Patient signed inform consent form
Exclusion Criteria:
* Inability to understand the study or language used to be informed/sign the consent
* Participation in another clinical trial within 4 weeks prior to the start of the trial, and commitment to non-participation within 4 weeks following the end of the trial
* Intraarticular injection of hyaluronic acid in target knee within the 6 months prior to inclusion
* Patient who has received an intra-articular (IA) or intra-muscular (IM) steroid injection within the 3 months prior to inclusion or has taken oral corticosteroids within the month prior to inclusion
* Joint, bone, ligament, or any local or loco-regional surgery of the leg involved, arthroscopic operation on the target knee within the 3 months prior to inclusion
* Any recent trauma to the leg involved, including a sprain, dislocation within the 3 months prior to inclusion
* Rheumatoid arthritis, joint condition or any other inflammation and arthritis
* Lupus
* Dermatological disorder or any epidermal conditions that prevent an intraarticular injection
* Visible remarkable joint effusion of the target knee during physical examination evidenced by a protuberance or positive ballottement of the patella
* Evidence of a subchondral fracture, meniscal lesion, presence of bone or cartilage fragments, horizontal meniscal lesion tear (FLAP) in the target knee
* Osteonecrosis (1 or both knees)
* Daily dosage \> 101 mg of acetylsalicylic acid as part of cardiovascular preventive treatment (antithrombotic). If dose \< 101 mg, must be maintained during the study
* Known intolerance/hypersensitivity/allergy to any of the components in either product, SYNOLIS VA
* Fibromyalgia
* Patient of childbearing potential, pregnant or breast-feeding known at inclusion or in the planning phase during the study unless willing to use contraceptives through the whole duration of the study
* Excessive and repeated consumption of alcohol or illicit substances
* Any medical condition that may interfere with the proper conduct of the study (including any surgery or hospitalisation)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
75 Years
Study:
NCT05829850
Study Brief:
Protocol Section:
NCT05829850