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 @ 7:03 PM
Ignite Modification Date:
2025-12-24 @ 7:03 PM
NCT ID:
NCT02150057
Eligibility Criteria:
Inclusion Criteria:
* Age 30-80.
* History of medial unicompartmental knee pain \> 3 months duration (medial compartment only).
* Narrowing of medial joint space \< one half of lateral compartment
* Varus deformity no greater than 80
* Mild to moderate limitation in Activities of Daily Living (ADL's) and/or recreational activities.
* Must read and understand English language and demonstrate the ability and willingness to follow the protocol and complete the questionnaires and diaries.
* Manual dexterity sufficient to perform all tasks required of study participants.
* Willingness to wear the brace a minimum of 4 hours per day.
Exclusion Criteria:
* Arthritides other than osteoarthritis.
* Previous high tibial osteotomy of the affected knee.
* Previous surgery of affected knee other than diagnostic arthroscopy with joint debridement, soft tissue reconstruction, menisectomy.
* Fixed flexion deformities / limitations \>10 degrees as compared to the contralateral limb.
* Flexion limitation \> 20 degrees.
* Significant soft tissue compromise preventing long-term brace use.
* Peripheral vascular disease or other neurovascular complaints.
* Leg-length discrepancy \> 2cm.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
30 Years
Maximum Age:
80 Years
Study:
NCT02150057
Study Brief:
Protocol Section:
NCT02150057