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 @ 2:52 PM
Ignite Modification Date:
2025-12-24 @ 2:52 PM
NCT ID:
NCT00415259
Eligibility Criteria:
Inclusion Criteria:
* Eligibility will be confirmed by radiographic and clinical examination
* People with medial tibiofemoral joint OA fulfilling American College of Rheumatology classification criteria and reporting average knee pain on walking \>3 on an 11-point scale
* varus knee malalignment on standing anteroposterior lower limb x-ray.
Exclusion Criteria:
* advanced radiographic knee OA (Kellgren and Lawrence stage 4
* knee surgery or intra-articular corticosteroid injection within 6 months
* current or past (within 4 weeks) oral corticosteroid use
* systemic arthritic conditions
* history of tibiofemoral/patellofemoral joint replacement or tibial osteotomy
* any other muscular, joint or neurological condition affecting lower limb function
* ankle/foot pathology or pain that precludes the use of insoles
* use of foot orthotics within past 6 months and
* use of footwear that does not accomodate an insole.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
50 Years
Study:
NCT00415259
Study Brief:
Protocol Section:
NCT00415259