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 @ 3:40 PM
Ignite Modification Date:
2025-12-24 @ 3:40 PM
NCT ID:
NCT06433492
Eligibility Criteria:
Inclusion Criteria:
* Age between 38 and 70 years,
* OA diagnosed by the American College of Rheumatology (ACR) criteria,
* OA diagnosed by radiographic imaging (grade II - III according to the Kellgren-Lawrence scale),
* Pain in the knee joint for at least 3 months,
* Screening pain intensity in the target knee measured on VAS scale was required to be 4 for symptomatic knee and 2 for the contralateral knee.
Exclusion Criteria:
* Previous injections of hyaluronic acid or platelet-rich plasma within 6 months or corticosteroid injections within 3 months before the enrollment,
* Present joint infection,
* Previous knee arthroscopy up to 1 year prior to examination,
* Peripheral inflammatory and autoimmune diseases that progress with joint involvement (rheumatoid arthritis, spondyloarthropathies, systemic lupus erythematosus etc.),
* Total arthroplasty and osteotomy,
* Ankylosis of the study joint,
* Dermatitis or dermatological disease at the intended injection site,
* Known hypersensitivity to the components of the preparation,
* Coexistence of the degenerative changes in other limb joints (hip, foot),
* Cancer,
* Oral corticosteroid therapy,
* Use of medicines that affect blood clotting (heparins, oral anticoagulants, thrombolytic drugs),
* Pregnancy or breast-feeding.
* History of injury to the knee, a broken bone or dislocation of a joint, other musculoskeletal diseases that affect the study joint, neoplastic disease.
* Participation in other clinical trials.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
38 Years
Maximum Age:
70 Years
Study:
NCT06433492
Study Brief:
Protocol Section:
NCT06433492