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 @ 7:14 PM
Ignite Modification Date:
2025-12-24 @ 7:14 PM
NCT ID:
NCT02873403
Eligibility Criteria:
Inclusion Criteria:
* Male or female aged between 40 and 70 years old having radiological and symptomatic medial KOA (Kellgren-Lawrence grade II, III or IV) according to the American College of Rheumatology's clinical and radiological criteria \[83\]
* Average knee pain \> 4/10 (VAS score assessed three times in two weeks before being included)
* Not currently wearing knee brace
* Varus knee alignment equal or superior to 2°
* No or light pain from the hips, ankles, feet or lumbar spine
* Moderately physically active
* Able to understand written and spoken English.
Exclusion Criteria:
* Mild KOA (Kellgren-Lawrence grade I)
* Lateral or patellar KOA
* Chronic diseases or conditions (e.g., diabetes, osteoporosis, heart disease, hypertension, neurological disorders)
* Stroke history
* Inflammatory arthritis (gout, RA, psoriatic arthritis, …)
* Musculoskeletal disorders that could influence their ability to stand and walk
* Morbid obesity (BMI \> 35)
* Intra-articular corticosteroid/hyaluronan injection in the affected knee in the past 3 months
* Unstable medication schedule and medication that causes dizziness
* Severe recent modification of diet
* Prosthetic implants in the hip, knee or ankle joint
* Poor skin condition
* Unable to walk, walk up and down stairs or any condition contraindicating the demands of the gait analysis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
70 Years
Study:
NCT02873403
Study Brief:
Protocol Section:
NCT02873403