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 @ 1:31 AM
Ignite Modification Date:
2025-12-25 @ 1:31 AM
NCT ID:
NCT00984594
Eligibility Criteria:
Inclusion Criteria:
* 18 to 55 years
* skeletally mature
* Have a symptomatic score International Cartilage Repair Society (ICRS) grade 3a, 3b, 3c, 3d, 4a, 4b articular cartilage lesion less than 2.5 cm involving the Medial Femoral Condyle or Lateral Femoral Condyle. Symptoms must include pain, pain with weight bearing and squatting, locking of joints and or swelling
* Functional meniscal tissue (defined as 5 mmor greater)
* A score of = or greater than 4 on the VAS questionnaire
Exclusion Criteria:
* Associated tibial or patellar articular cartilage defect greater than 2 ICRS
* Osteoarthritis of either knee
* Mechanical axis malalignment of greater than 5 degrees
* Patellofemoral incongruity on Merchant view
* One or more multiple defects greater than 2.5 cm
* Osteochondritis dissecans (OCD) with depth of bone loss greater than 4 mm
* Ligament treatments in the affected knee within one year prior to current study
* Previous surgical meniscus treatment in the affected knee in the last 6 months
* Less than 5 mm of meniscal tissue in ipsilateral compartment of study treatment
* use of any investigational therapy within 30 days prior to the first visit
* Corticosteroid or viscosupplementation within the past 3 months
* A score of 3 or less on the VAS questionnaire
* Active gout or pseudogout or systemic inflammatory condition
* Microfracture less than one year prior to current study
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
55 Years
Study:
NCT00984594
Study Brief:
Protocol Section:
NCT00984594