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 @ 12:50 PM
Ignite Modification Date:
2025-12-24 @ 12:50 PM
NCT ID:
NCT04139161
Eligibility Criteria:
Inclusion Criteria:
* Men and Women between the ages of 50 and 75 years old.
* Diagnosed with medial compartment tibiofemoral osteoarthritis in one of their knees.
* Be able to walk unaided for at least 25 consecutive minutes.
* Present with knee pain for at least 6 months occurring on a majority of the days in the month, or on most days (more than or equal to 4 of 7 days in a week) in one or both knees for at least 4 months.
* Osteophytes on knee x-rays.
* Grade 2 or higher out of a maximum of 4 on a modified Kellgren/Lawrence grade on the knee radiograph.
Exclusion Criteria:
* Initial Visual Analog Scale pain scores greater than 7.
* Diagnosed osteoarthritis of ankles, hips, or symptomatic osteoarthritis of the spine.
* Arthroplasty of any other lower extremity joint.
* BMI value greater than 40 kg/m2.
* Any major lower extremity injury in the past 6 months.
* Systemic Inflammatory Arthritis.
* Systemic Pain Conditions.
* Neurological Conditions that impact gait or cycling.
* Pregnant or Nursing Women.
* Major cardiovascular disease with an exercise limitation prescribed by a physician.
* Steroid injection at the knee within the previous 3 months.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
75 Years
Study:
NCT04139161
Study Brief:
Protocol Section:
NCT04139161