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 @ 1:19 AM
Ignite Modification Date:
2025-12-25 @ 1:19 AM
NCT ID:
NCT07188493
Eligibility Criteria:
Inclusion Criteria:
* Unicompartmental knee osteoarthritis (medial compartment), Kellgren-Lawrence grade I-III, confirmed by imaging; affecting one lower limb (with predominant symptoms in either the right or left leg)
* Age between 45 and 75 years
* Preserved passive knee extension; flexion contracture of up to 20 degrees of extension deficit is acceptable
* Signed informed consent for participation in the clinical investigation
Exclusion Criteria:
* Bicompartmental knee osteoarthritis with similar symptom severity in both compartments
* Neurological disorders
* Rheumatoid arthritis
* Coexisting dysfunctions of the hip and/or ankle joint of the affected limb
* Ligament injuries (ACL, PCL, MCL, LCL) and/or meniscus injuries (medial or lateral) causing significant joint instability (moderate instability due to ligament insufficiency, common in osteoarthritis, is not excluded)
* Bone fractures
* Sensory disturbances in the lower limbs
* Passive knee extension deficit greater than 20 degrees
* Major surgical procedures involving the knee joint within the last 6 months
* Lack of informed consent and/or inability to establish reliable verbal-logical communication with the participant
* Other medical conditions preventing independent application of the brace and/or use of the mobile application
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT07188493
Study Brief:
Protocol Section:
NCT07188493