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 @ 7:32 PM
Ignite Modification Date:
2025-12-24 @ 7:32 PM
NCT ID:
NCT02521103
Eligibility Criteria:
Inclusion Criteria:
* Patient has signed an Institutional Review Board (IRB)/Ethics Committee (EC) approved, study specific Informed Patient Consent Form.
* Patient is a male or non-pregnant female, skeletally mature and age 18 years or older at time of study device implantation.
* Patient is a candidate for revision of all femoral and tibial components of a total knee replacement.
* Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation.
Exclusion Criteria:
* Patient has a Body Mass Index (BMI) \> 45.
* Patient has an active or suspected latent infection in or about the affected knee joint at time of study device implantation.
* Patient has a neuromuscular or neurosensory deficiency, which limits the ability to evaluate the safety and efficacy of the device.
* 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.
* Patient is immunologically suppressed or receiving steroids in excess of normal physiological requirements (e.g. \> 30 days).
* Patient has a failed unicondylar knee prosthesis.
* Patient has a known sensitivity to device materials.
* Patient is a prisoner.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT02521103
Study Brief:
Protocol Section:
NCT02521103