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 @ 5:47 PM
Ignite Modification Date:
2025-12-24 @ 5:47 PM
NCT ID:
NCT03883568
Eligibility Criteria:
Inclusion Criteria:
1. Informed consent obtained.
2. Ambulatory (able to walk unassisted)
3. At least 18 years of age
4. Capable of understanding the study
5. Capable of writing and reading in local language
6. Predominantly tibiofemoral knee osteoarthritis and satisfy the clinical classification criteria of the American College of Rheumatology (ACR): Knee pain and three of the following criteria: over 50 years age, less than 30 minutes of morning stiffness, crepitus on active motion, bony tenderness, bony enlargement, or no palpable warmth.
7. Highest probability to progress based on the algorithm based on the following parameters:
* Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire
* BMI (in recording height and weight)
* Pain NRS of the index knee at the moment of the screening visit
* Pain NRS of the index knee during the last week before the screening visit
* Age
* Gender
* KIDA parameters of the index knee, based on standardized weight-bearing (KIDA) radiograph, measured \< 3 months (patients with a Joint Space Width (JSW) \< 2 mm of the index knee will not be included)
Exclusion Criteria:
8. Not being able to comply to the protocol
9. Participating in a trial with local therapeutic intervention for index knee OA (pharmaceutical or surgical) or systemic Disease Modifying OsteoArthritic Drugs (DMOADs) or potential DMOADs treatments for OA at the same time or within the past 6 months or anticipated in the forthcoming; participation in non-interventional registries or epidemiological studies is allowed.
10. Surgery of the index knee in the past 6 months (to avoid interferences with imaging)
11. Scheduled or expected surgery of the index knee in the next 2 years (to avoid interferences with imaging)
12. Pregnancy (child bearing woman) because of imaging (radiation and MRI, risks)
13. Predominantly patellar femoral knee OA (clinical judgment)
14. The following secondary osteoarthritis of the knee: clinically significant deformities of the lower limbs (varus \>10°, valgus \>10°), septic arthritis, inflammatory joint disease, gout, major chondrocalcinosis (pseudogout), Paget's disease of the bone, ochronosis, acromegaly, haemochromatosis, Wilson's disease, rheumatic symptoms due to malignancies, primary osteochondromatosis, osteonecrosis, osteochondritis dissecans, haemophilia
15. Generalized pain syndrome, for example fibromyalgia
16. Patients with contra indication to MRI or CT
17. Hip replacement or expected hip replacement within 6 months
18. Osteosynthesis material near the knee joint
19. Self-reported severe Intervertebral disc (IVD) degeneration or facet OA
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03883568
Study Brief:
Protocol Section:
NCT03883568