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 @ 2:50 AM
Ignite Modification Date:
2025-12-25 @ 2:50 AM
NCT ID:
NCT01225133
Eligibility Criteria:
Inclusion Criteria:
* Male and female patients,
* Age 40-70 years,
* Prediagnosed, confirmed and documented diagnosis of OA of the knee. Diagnosis performed by a medical specialist (orthopedic surgeon, surgeon, radiologist) according to the American College of Rheumatology criteria,
* Documented radiologic changes of the knee-joint Kellgren-Lawrence criteria \> or = grade 2 in conventional X-ray or MRI-scan,
* Mean average pain intensity of 40 or more on two 100 mm visual analogue scales in the 7 days before baseline assessment,
* Written informed consent.
Exclusion Criteria:
* Pain in the knee caused by oCongenital dysplasia of the affected knee oRheumatoid arthritis oAutoimmune diseases oMalignancies oStatus post Knee surgery oStatus post Arthroscopy
* Administration of chondroprotective drugs in the preceding 3 months,
* Intra-articular injection into the affected knee-joint during the preceding 3 months,
* Beginning of a systemic medication with corticosteroids within the preceding three months,
* Beginning of any new treatment for OA during the previous 4 weeks (with the exception of analgesic treatment with Paracetamol or NSAIDs),
* Pregnancy or breastfeeding,
* Acute mental disorders,
* Serious acute organic diseases,
* Serious chronic co-morbidity,
* Obesity WHO-grade II/III
* Blood coagulation disorders,
* Coagulation-inhibiting medication other than Aspirin and Clopidogrel,
* Invasive measures performed at the affected joint during the previous 12 weeks or planned within the following 12 month,
* In the process of applying for pension or disability benefits,
* Simultaneous participation in any other clinical trial,
* Participation in a clinical trial during the 6 month before inclusion into this trial,
* Missing of the written informed consent form.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT01225133
Study Brief:
Protocol Section:
NCT01225133