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 @ 10:46 PM
Ignite Modification Date:
2025-12-26 @ 10:46 PM
NCT ID:
NCT02155712
Eligibility Criteria:
Inclusion Criteria:
1. Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved; study specific Informed Patient Consent Form.
2. Patient is a male or non-pregnant female age 18-75 years at time of study device implantation.
3. Patient has a diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
4. Patient is a candidate for primary cementless total knee replacement, including a resurfaced patella.
5. Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria:
1. Patient has a Body Mass Index (BMI) \> 40.
2. Patient has a diagnosis of avascular necrosis or inflammatory arthritis.
3. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
4. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
5. Subject is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget's Disease) leading to progressive bone deterioration.
6. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
7. Patient is diagnosed with lumbar radicular pain.
8. Patient has a known sensitivity to device materials.
9. Patient is a prisoner.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT02155712
Study Brief:
Protocol Section:
NCT02155712