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 @ 3:02 AM
Ignite Modification Date:
2025-12-25 @ 3:02 AM
NCT ID:
NCT00312533
Eligibility Criteria:
Inclusion Criteria:
* Men or women aged 18 to 80 years
* with a diagnosis of osteoarthritis of the knee. Diagnosis will be based on radiographic examination (Kellgren-Lawrence 2 or 3) or by previous arthroscopic diagnosis.
Surgical treatment for osteoarthritis will be limited to arthroscopic surgeries that include removal of loose bodies, resection of unstable meniscus tears and loose or unstable chondral flaps, removal of osteophytes if they limit extension, and lysis of adhesions. These types of treatments may provide symptomatic relief by increasing joint volume in knees with osteoarthritis and relieving joint contact pressures.
Exclusion Criteria:
* Patients with grade 4 Kellgren-Lawrence on radiographic examination will be excluded.
* Patients with a prior synovectomy on knee to be injected will be excluded.
* Patients will be excluded if they have rheumatoid disease or any other serious systemic disease, acute synovitis or excessive effusion, allergy to avian products/hyaluronan-based injection components/corticosteroid injection, pregnant, previous arthroscopic surgery within the last 6 months or had a joint infection within the previous 3 months.
* Patients who have undergone a prior synovectomy will not be included.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT00312533
Study Brief:
Protocol Section:
NCT00312533