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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT03457051
Eligibility Criteria:
Inclusion Criteria:Inclusion criteria must and will be restricted to those patients who are generally considered candidates for UKA. Specific inclusion criteria will be restricted to patients:
* Who report that most of their pain (greater than 75%) is located in the medial part of the knee on a regular basis.
* With active range of motion from 10° of extension to 100° of flexion.
* With an intact, competent, anterior cruciate ligament.
* With overall limb alignment correctable to neutral, indicating a competent medial collateral ligament.
* With radiographs showing primarily bone-on-bone disease in the medial compartment with minimal wear in both the lateral and patellofemoral compartments of the knee.
* 50 to 80 years of age.
* With a Body Mass Index (BMI) less than 40.
For the secondary outcome of motion analysis, only patients exhibiting the following characteristics will be suitable for assessment:
* BMI of 35 or less
* No other ipsilateral or contralateral lower limb joint disorders
Exclusion Criteria:
* Those with inflammatory arthritis
* Those with no fixed address
* Those unable to commit to study requirements and follow-ups
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
50 Years
Maximum Age:
80 Years
Study:
NCT03457051
Study Brief:
Protocol Section:
NCT03457051