Clinical trial NCT06203756: Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty
Official title: Improved Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Arthroplasties, Knee Replacement
Revision Arthroplasty
Keywords: Robotic-Assisted Total Knee Arthroplasty
Knee Replacement
Knee outcomes
Lead sponsor: Corin
Sponsor class: INDUSTRY
First posted: 2024-01-12
Enrollment: 713
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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 Arthroplasty up to 10-year follow up.

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 for this Post Market Clinical Follow up (PMCF) study and the data will be fed into the Post-Market Surveillance (PMS) and Clinical Evaluation processes of the devices under assessment on annual basis and support presentations at orthopaedic congresses and/or peer-reviewed publication(s).

Participants will be selected for recruitment into the study from the general population of participants requiring a primary or revision knee-arthroplasty and considered suitable to receive the Apex Knee System.

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.

Primary outcomes:
measure: Survivorship
timeFrame: 10 Years
Secondary outcomes:
measure: Change in KOOS from baseline to 10 years after surgery
timeFrame: from enrolment to 10 years
measure: Change in UCLA from baseline to 10 years after surgery
timeFrame: from enrolment to 10 years
measure: Change in Promis-10 from baseline to 10 years after surgery
timeFrame: from enrolment to 10 years
Other outcomes:
Locations:
city: Flagstaff
country: United States
facility: Flagstaff Bone and Joint
state: Arizona
city: Middlebury
country: United States
facility: Orthopaedics New England
state: Connecticut
city: Rochester,
country: United States
facility: DeClaire LaMacchia Orthopaedic Institute
state: Michigan
city: Garden City
country: United States
facility: Nyu Langone-Long Island
state: New York
city: Oklahoma City
country: United States
facility: Oklahoma Sports and Orthopedics Institute
state: Oklahoma
city: La Crosse
country: United States
facility: Gundersen Health System
state: Wisconsin
Study officials:
affiliation: NYU LANGONE-LONG ISLAND
name: Jan A Koenig, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: DeClaire LaMacchia Orthopaedic Institute
name: Jeffrey H DeClaire, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Granite Orthopaedics
name: Amber Randall, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Oklahoma Sports and Orthopedics Institute
name: Corey Ponder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Orthopaedics New England
name: John Keggi, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gundersen Lutheran Medical Foundation, Inc
name: Jeffrey Lawrence, MD
role: PRINCIPAL_INVESTIGATOR
References: