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 @ 12:14 AM
Ignite Modification Date:
2025-12-25 @ 12:14 AM
NCT ID:
NCT07224958
Eligibility Criteria:
Inclusion Criteria:
* Inclusion Criteria:
* Age 40-85 years.
* BMI ≤ 35.
* Physician-diagnosed medial compartment knee osteoarthritis.
* Visual Analog Scale (VAS) walking pain ≥ 4.
* Willing to wear assigned brace ≥ 4 hours/day.
* Able to walk independently for 20 minutes unaided.
* Stable pain medication regimen ≥ 4 weeks.
* ≥3 months since last hyaluronic acid (HA), platelet-rich plasma (PRP), or steroid injection.
Exclusion Criteria:
* Lateral or patellofemoral osteoarthritis.
* Prior knee replacement.
* Significant ligament injury or acute lower limb injury.
* Neurological condition affecting gait.
* Severe psychiatric or neurological disorder affecting pain perception.
* Skin condition or allergy preventing brace use.
* Current use of another brace or assistive device.
* Recent opioid or corticosteroid use (\<4 weeks).
* Pregnant.
Exclusion Criteria:
\-
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
85 Years
Study:
NCT07224958
Study Brief:
Protocol Section:
NCT07224958