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 @ 11:36 PM
Ignite Modification Date:
2025-12-24 @ 11:36 PM
NCT ID:
NCT03153956
Eligibility Criteria:
Inclusion Criteria:
* Patients suffering from symptomatic unilateral or bilateral knee OA at the medial compartment for at least six months;
* Fulfilling the ACR clinical criteria;
* Having radiographically assessed OA of the knee with a Kellgren-Lawrence grade more than or equal to grade 2; and,
* Having VAS-Pain ≥ 3, on a scale between 0-10.
* Patients who have a shoe size between US 4 and US 12
Exclusion Criteria:
* Patients suffering from acute septic arthritis.
* Patients who received a corticosteroid injection within 3 months of the study.
* Patients who received hyaluronic acid (HA) injections within 6 months of the study
* Patients suffering from avascular necrosis of the knee.
* Patients with a history of knee buckling or recent knee injury.
* Patients who have had a joint replacement or other major surgery to the knee, hip or ankle (ipsilateral or contralateral side).
* Patients suffering from neuropathic arthropathy.
* Patients with an increased tendency to fall.
* Patients exhibiting a lack of physical or mental ability to perform or comply with the study procedure.
* Patients with a history of pathological osteoporotic fracture.
* Patients suffering from symptomatic degenerative arthritis in lower limb joints other than the knees.
* Patients with referred pain in the knees from primary back or hip joint pain.
* Patients with neurological deficits to the lower extremity (ex. foot drop)
* Patients whose shoe size is less than US 4 and greater than US 12
* Patients who have had arthroscopy within 6 months of the study
* Patients with inflammatory arthropathy
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
45 Years
Maximum Age:
75 Years
Study:
NCT03153956
Study Brief:
Protocol Section:
NCT03153956