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 @ 11:54 PM
Ignite Modification Date:
2025-12-24 @ 11:54 PM
NCT ID:
NCT04757051
Eligibility Criteria:
Inclusion Criteria:
* male or female aged between 18 and 99 years
* diagnosis of symptomatic knee OA: Kellgren \& Lawrence grade II/III
* physician's recommendation to use BENART TM prior to recruitment
* signed informed consent
Exclusion Criteria:
* known allergy or hypersensitivity to any of the BENART TM components
* infection or skin disease at or around the injection site
* severe Inflammation, synovitis, or arthritis of the knee joint and/or any other signs of inflammation (e.g. pain causing nocturnal awakenings, knee heat,...)
* history of autoimmune and crystal diseases (e.g. gout, pseudogout, hereditary hemochromatosis, ...)
* evidence of lymphatic or venous stasis or serious blood disorders
* known pregnancy or breast feeding
* significant joint effusion (confirmed by objective clinical signs and/or ultrasound and/or puncture)
* individuals who are unable to fully understand all aspects of the study that are relevant to the decision to participate, or who could be manipulated or unduly influenced as a result of a compromised position, expectation of benefits or fear of retaliatory response (including persons needing legally designated representatives, illiterate persons or persons with insufficient knowledge of local language)
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04757051
Study Brief:
Protocol Section:
NCT04757051