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 @ 11:43 PM
Ignite Modification Date:
2025-12-24 @ 11:43 PM
NCT ID:
NCT04079751
Eligibility Criteria:
Inclusion Criteria:
1. Symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty
2. Varus knee deformity of 0 to 10 degrees
3. Sufficient ligamentous function to warrant retention of the posterior cruciate ligament
4. Between the ages of 21 and 80 inclusive
5. Patients willing and able to comply with follow-up requirements and self-evaluations
6. Ability to give informed consent
Exclusion Criteria:
1. Active or prior infection
2. Medical condition precluding major surgery
3. Inflammatory arthropathy
4. Prior patellectomy
5. PCL deficiency
6. Major Coronal plane deformity
7. Valgus alignment
8. Bone defects requiring augments, cones and/or stemmed implants
9. Body Mass Index 45 or more
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
80 Years
Study:
NCT04079751
Study Brief:
Protocol Section:
NCT04079751