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:
2025-12-26 @ 11:11 AM
Ignite Modification Date:
2025-12-26 @ 11:11 AM
NCT ID:
NCT04022928
Eligibility Criteria:
Inclusion Criteria:
* Age of at least twenty years
* Ankle pain lasted for at least 6 months, despite conservative treatment or inability to tolerate the side effects of medications
* Ankle radiographs taken within 6 months (reviewed by the senior author) were equivalent to grade 1-4 osteoarthritis by the Kellgren Lawrence grading system
* Average ankle pain of \> 3cm on a 10-cm visual analog scale (VAS)
* Radiological evidence of bilateral ankle osteoarthritis was accepted if VAS pain in the contralateral ankle was \< 3 cm
* Normal activity level, not bedridden or confined to a wheelchair, able to walk 30 meters without the aid of a walker, crutches or cane
* No use of physical therapy or changes in shoes or orthotic devices during the study
Exclusion Criteria:
* Pregnancy or lactation in women
* Lower leg trauma in a location other than within the ankle
* Previous surgery involving the spine, hip or knee
* The presence of an active infection of the ankle
* Surgery involving the affected ankle within the previous 12 months
* Intraarticular steroid or hyaluronate injection in the ankle within the previous 6 months
* Treatment with anticoagulants or immunosuppressives
* History of rheumatoid arthritis, gout, or other inflammatory arthropathy
* The presence of visual or vestibular impairments
* Poor health status (such as a neoplasm, diabetes mellitus, or paresis) that would interfere with the assessments
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
20 Years
Maximum Age:
70 Years
Study:
NCT04022928
Study Brief:
Protocol Section:
NCT04022928