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 @ 1:37 PM
Ignite Modification Date:
2025-12-24 @ 1:37 PM
NCT ID:
NCT02580695
Eligibility Criteria:
Inclusion Criteria:
* Symptomatic Knee OA, Kellgren and Lawrence grade I, II, III on plain Rx films.
* Chondromalacia patella grade I-III on knee MRI. With or without meniscal tear.
* Stable knee and normal clinical exam of involved extremity
* Written informed consent for patients.
Exclusion Criteria:
* Bilateral symptomatic knee OA
* Local or systemic infection.
* Active neoplasia or immunosuppressive state
* Pregnancy or Breastfeeding
* Body Mass Index ≥ 30
* Presence of Pacemaker or Lower extremity metal implant
* Anticoagulant treatment other than aspirin.
* Recent use of oral (previous month) or intra-articular (previous 3 months) corticosteroids
* Concomitant inflammatory joint disease (cristal, connective tissue disease)
* Valgus (\>10o) or Varus (\>5o) deformity of involved extremity
* Condilar or Tibial plateau Generalized Bone Marrow edema on MRI
* Significant symptomatic hip or spine disease
* Significant abnormality in baseline lab tests
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT02580695
Study Brief:
Protocol Section:
NCT02580695