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 @ 11:34 PM
Ignite Modification Date:
2025-12-24 @ 11:34 PM
NCT ID:
NCT06203756
Eligibility Criteria:
Inclusion Criteria:
1. Patient must be a candidate for a primary or revision total knee arthroplasty
2. Patient is able and willing to sign the informed consent and follow study procedures
3. Patient's joint must be anatomically and functionally suited to receive the selected implant and accommodate use of the robotic assistance
Exclusion Criteria:
1. Patient has a BMI \>45.
2. Significant neurological or musculoskeletal disorders or disease that may interfere with total knee arthroplasty survival, adversely affect gait or weight bearing, (i.e. Paget's disease, Charcot's disease, muscular dystrophy, multiple sclerosis).
3. The presence of highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, HIV, etc.).
4. Presence of known active metastatic or neoplastic disease.
5. Cancer patients unless they have received curative treatment and have no evidence of recurrence for 5 years.
6. Patient has a mental condition that may interfere with the subject's ability to give an informed consent or willingness to fulfill the study requirements (i.e., severe mental retardation such that the Subject cannot understand the informed consent process, global dementia, prior strokes that interfere with the Subject's cognitive abilities, senile dementia, and Alzheimer's Disease).
7. Patient has an active infection or joint sepsis.
8. Patient has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Multiple Sclerosis, and Charcot joints).
9. Patients with allergies or suspected sensitivity to any patient-contacting component of the implant to be used in the study Has known sensitivity to implants or the materials in the device including but not limited to: Ti, Al, V, Co, Cr, Mo, Ni and Si3N4.).
10. Patients who are currently on medical leave from their employment due to Worker's Compensation.
11. Patients who are at high risk for poor healing or confounding outcomes or at excessive risk for surgery (e.g., clinically significant/being actively treated for renal, hepatic, cardiac, hematologic, or neurologic disease or poorly controlled diabetes (HbA1c \> 8 mg/dL) or previous history of joint infection).
12. Patients who are known drug or alcohol abusers or with psychological disorders as defined by DSM V that could affect follow-up care or treatment outcomes.
13. Patients who are currently involved in another clinical study with an investigational device.
14. Patients with current litigation pending related to medical treatment of any sort.
15. Patients, who, in the opinion of the investigator, will not be able to complete the study per the protocol.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT06203756
Study Brief:
Protocol Section:
NCT06203756