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:
2025-12-25 @ 2:24 AM
Ignite Modification Date:
2025-12-25 @ 2:24 AM
NCT ID:
NCT06927934
Eligibility Criteria:
Inclusion Criteria:
* Age ≥ 21 years.
* Body Mass Index (BMI) ≥ 18.5 kg/m².
* Body Mass Index (BMI) \< 35 kg/m².
* Presence of trauma or degenerative diseases (e.g., osteoarthritis) confirmed by radiographic imaging (Kellgren-Lawrence score 2-4).
* The subject is prescribed an injection of stabilized hyaluronic acid (DIART ONE 20 mg/mL - 2 mL or 30 mg/mL - 3 mL) for temporary replacement of synovial fluid in the knee joint.
* Signed written informed consent to participate in the study.
Exclusion Criteria:
* Age \< 21 years.
* Body Mass Index (BMI) \< 18.5 kg/m².
* Body Mass Index (BMI) ≥ 35 kg/m².
* Pregnancy or lactation.
* No radiographic confirmation of osteoarthritis (Kellgren-Lawrence score 0-1).
* Known hypersensitivity to hyaluronic acid, its metabolites, or excipients in the injectable implant.
* Increased bleeding tendency.
* Injury or infection at the injection site.
* Confirmed infectious joint disease.
* Systemic connective tissue diseases (e.g., active rheumatoid arthritis, ankylosing spondylitis).
* Non-osteoarthritis arthritis.
* Planned total knee joint replacement.
* Gait disorders of neurological origin.
* Intra-articular hyaluronic acid injection in the study knee within 3 months prior to enrollment.
* Surgery or orthopedic intervention on the study knee in the last 3 months.
* Cancer
* Decompensated diabetes mellitus.
* Hematological diseases.
* Inability or unwillingness to comply with study procedures.
* Language barriers that prevent understanding of the informed consent form.
* Any other condition deemed by the investigator to preclude participation.
* Participation in another clinical study.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Study:
NCT06927934
Study Brief:
Protocol Section:
NCT06927934