Status:
ENROLLING_BY_INVITATION
Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty
Lead Sponsor:
Corin
Conditions:
Arthroplasties, Knee Replacement
Revision Arthroplasty
Eligibility:
All Genders
Phase:
NA
Brief Summary
This is a post-market multicentre study that has been implemented to confirm safety and performance of cemented CR/UC and PS Apex Knee implants in primary or revision Robotic Assisted Total Knee Arthr...
Detailed Description
This study has been implemented to confirm safety and performance of cemented CR/UC and PS Apex Knee implants in primary or revision RA-TKA up to 10-year follow up. Prospective data will be collected...
Eligibility Criteria
Inclusion
- Patient must be a candidate for a primary or revision total knee arthroplasty
- Patient is able and willing to sign the informed consent and follow study procedures
- Patient's joint must be anatomically and functionally suited to receive the selected implant and accommodate use of the robotic assistance
Exclusion
- Patient has a BMI \>45.
- 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).
- The presence of highly communicable disease or diseases that may limit follow-up (e.g. immuno-compromised conditions, hepatitis, active tuberculosis, HIV, etc.).
- Presence of known active metastatic or neoplastic disease.
- Cancer patients unless they have received curative treatment and have no evidence of recurrence for 5 years.
- 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).
- Patient has an active infection or joint sepsis.
- Patient has muscular, neurological or vascular deficiencies which compromise the affected extremity (i.e., Parkinson's Disease, Multiple Sclerosis, and Charcot joints).
- 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.).
- Patients who are currently on medical leave from their employment due to Worker's Compensation.
- 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).
- 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.
- Patients who are currently involved in another clinical study with an investigational device.
- Patients with current litigation pending related to medical treatment of any sort.
- Patients, who, in the opinion of the investigator, will not be able to complete the study per the protocol.
Key Trial Info
Start Date :
November 9 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2040
Estimated Enrollment :
713 Patients enrolled
Trial Details
Trial ID
NCT06203756
Start Date
November 9 2017
End Date
April 1 2040
Last Update
May 20 2025
Active Locations (6)
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1
Flagstaff Bone and Joint
Flagstaff, Arizona, United States, 86001
2
Orthopaedics New England
Middlebury, Connecticut, United States, 06762
3
DeClaire LaMacchia Orthopaedic Institute
Rochester, Michigan, United States, 48307
4
Nyu Langone-Long Island
Garden City, New York, United States, 11530