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 @ 2:38 AM
Ignite Modification Date:
2025-12-25 @ 2:38 AM
NCT ID:
NCT05933434
Eligibility Criteria:
Inclusion Criteria:
* Chronic knee pain (defined for at least 6 months with NRS 4 or above when pain worst)
* Patients with Grade II-III osteoarthritis according to the Kellgren Lawrence Classification and a joint width space of 1-3 mm.
* Axial hip, knee, ankle x-ray with no more than 5 degrees valgus/varus deformity
* Medial, lateral or dual compartment OA as determined above
* BMI \<35
* Danish speaker
* Patients must be legally competent and must be able to sign the written consent
Exclusion Criteria:
* Severe Osteoarthritis (Grade IV according to Kellgren Lavrence Classification)
* Intraarticular tumor, infection or fracture
* Pregnancy and breast feeding
* Cognitive impairment
* Treatment with cytostatic drugs
* Previous intraarticular knee injection in the past 3 mo.
* Unable to perform MRI scan (non-compatible implants, claustrophobia and severe obesity(\>BMI 35)
* Previous ligament reconstruction
* Meniscal operation with resection with more than 50% or multiple meniscal operations (more than one resection)
* Diabetes mellitus type 1 and 2
* Knee instability on physical examination
* History of allergy to antibiotics
* Concomitant severe infection, malignant tumor, coagulation diseases or uncontrolled or unmanaged systemic disease
* Presence of other types of inflammatory arthritis
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
75 Years
Study:
NCT05933434
Study Brief:
Protocol Section:
NCT05933434