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 @ 3:57 PM
Ignite Modification Date:
2025-12-24 @ 3:57 PM
NCT ID:
NCT00493792
Eligibility Criteria:
INCLUSION CRITERIA:
1. Subjects willing to sign the informed consent.
2. Subjects able to comply with follow-up requirements including post-operative weight bearing restrictions and self-evaluations.
3. Male and non-pregnant female subjects ages 21-85 years of age at the time of surgery.
4. Subjects requiring a primary total knee replacement.
5. Subjects with a diagnosis of osteoarthritis (OA), traumatic arthritis (TA), or avascular necrosis (AVN).
6. Subjects with intact collateral ligaments as determined by the surgeon investigator.
EXCLUSION CRITERIA:
1. Subjects with inflammatory arthritis.
2. Subjects with a history of total or unicompartmental reconstruction of the affected joint.
3. Subjects that have had a high tibial osteotomy or femoral osteotomy.
4. Subjects with neuromuscular or neurosensory deficiency, which would limit the ability to assess the performance of the device.
5. Subjects with a systemic or metabolic disorder leading to progressive bone deterioration.
6. Subjects that are immunologically compromised, or receiving chronic steroids (\>30 days).
7. Subjects bone stock is compromised by disease or infection that cannot provide adequate support and/or fixation to the prosthesis.
8. Subjects with knee fusion to the affected joint.
9. Subjects with an active or suspected latent infection in or about the knee joint.
10. Subjects that are prisoners.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
85 Years
Study:
NCT00493792
Study Brief:
Protocol Section:
NCT00493792