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 @ 3:42 PM
Ignite Modification Date:
2025-12-24 @ 3:42 PM
NCT ID:
NCT02539992
Eligibility Criteria:
Inclusion Criteria:
1. Patient has signed an ethic commission approved study specific Informed Patient Consent Form.
2. Patient is a male or non-pregnant female age 18 years or older at time of study device implantation.
3. Patient has primary diagnosis of Non-Inflammatory Degenerative Joint Disease (NIDJD).
4. Patient is a candidate for a primary total knee replacement.
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 age ≥ 80.
3. Patient has a varus or valgus deformity greater than 10 degree or flexion contracture greater than 20 degree.
4. Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
5. Patient has received any orthopaedic surgical intervention to the lower extremities within the past year or is expected to require any orthopaedic surgical intervention to the lower extremities, other than the TKR to be enrolled in this study, within the next year.
6. Patient requires bilateral total knee replacements, or has a history of contralateral partial or total knee replacement.
7. Patient has any implanted device that would be incompatible with MRI procedures.
8. Patient has chronic heart failure (NYHA Stage ≥ 2)
9. Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
10. Patient is diagnosed with a systemic disease (e.g. Lupus Erythematosus) or a metabolic disorder (e.g. Paget"s Disease) leading to progressive bone deterioration.
11. Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
12. Patient requires revision surgery of a previously implanted total knee replacement or knee fusion to the affected joint.
13. Patient has a known sensitivity to device materials.
14. Patient is a prisoner.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT02539992
Study Brief:
Protocol Section:
NCT02539992