Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty

Enrolling by invitation · Not applicable

Conditions studied: Arthroplasties, Knee Replacement, Revision Arthroplasty

In brief

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 Arthroplasty up to 10-year follow up.

Key facts

Study ID

NCT06203756

Run by

Corin

People needed

713

Starts

2017-11-09

Expected to finish

2040-04-01

Last updated by the study team

2025-05-20

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Flagstaff Bone and Joint — Flagstaff, Arizona, United States
• Orthopaedics New England — Middlebury, Connecticut, United States
• DeClaire LaMacchia Orthopaedic Institute — Rochester, Michigan, United States
• Nyu Langone-Long Island — Garden City, New York, United States
• Oklahoma Sports and Orthopedics Institute — Oklahoma City, Oklahoma, United States
• Gundersen Health System — La Crosse, Wisconsin, United States

Full record on ClinicalTrials.gov

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