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 @ 2:09 PM
Ignite Modification Date:
2025-12-24 @ 2:09 PM
NCT ID:
NCT06636695
Eligibility Criteria:
Inclusion Criteria:
* Participants fulfilling all of the inclusion criteria, listed below, are eligible to participate in this study:
* Patients between 40 and 80 years (inclusive) of age
* Femoro-tibial knee osteoarthritis defined
* OA grade 2-3 according to the Kellgren \& Lawrence grading scale, as defined on knee radiographs (less than 6 months old: Antero-posterior view; lateral view and skyline view)
* Symptomatic knee osteoarthritis of a unilateral knee, characterized by pain at walking VAS ≥40 on a 0 to 100mm scale
\*Bilateral knee osteoarthritis is allowed, provided the contralateral knee is characterized by a maximum pain at walkingof 30 on a 0 to 100 mm scale and doesn't require systemic analgesic treatment, with the exception of paracetamol up to the maximum dose of 4 g per day
* Outpatient capableof walking 50 meters without assistance
* Signature of the informed consent form
* Capable of understanding the study's imperatives, as well as written instructions
Exclusion Criteria:
* Grade \< 2 or \> 3 OA according to the Kellgren \& Lawrence gradingscale
* Viscosupplementation in the treatment site within the past 3 months
* Patients suffering from femoropatellar osteoarthritis
* Use of NSAIDs within the past 7 days
* Corticosteroid injection in the treatment site within the past 3 months
* Chronic use of corticosteroids (except those that are inhaled) or level III analgesics in the past 3 months and NSAID during the past month2 weeks
* PRP or PRP/HA injection in the past 12 months
* Any surgery of the knee planned within the next 12 months
* Unstable knee injury
* Systemic use of level III analgesics in the past 3 months
* History of allergy to HA
* Rheumatological disorders(exceptKOA)
* Clinical evidence of local inflammation such as redness or heat of the joint
* Current or medical history of autoimmunediseases
* Surgery or arthroscopy surgery in the affected knee within the past 3 months
* Local infection in the affected knee
* Haematologic or clotting disorders (thrombocytopenia platelet count \<150,000 platelets/µ) or blood coagulation (deficit-blood dyscrasia)
* Anaemia (Haemoglobin \<10g/dl)
* Anticoagulant treatment or Antiaggregant treatment
* Acute infection
* Immunosuppressive states
* Malignant disease
* Recent fever (within previous 2 weeks) or serious disorders (liver disease, active gastroduodenal ulcer, digestive haemorrhage, etc.)
* Pregnancy or breastfeeding or planning to become pregnant during the course of the study
* Uncontrolled diabeted
* Participation ongoing or in the past 3 months in another clinical trial
* Participation in another OA clinical study in the past year
* Refusal to sign or inability to give Informed Consent Inability to understand or comply with the requirements of the study
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT06636695
Study Brief:
Protocol Section:
NCT06636695