Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty

NCT06203756 | Enrolling By Invitation FDA Device

• 1 other identifier: CSP-2017-01
• Study Type: interventional
• Target: 713
• Locations: 1 country
• Sites: 6

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.

Conditions

Arthroplasties, Knee Replacement; Revision Arthroplasty

Keywords

Robotic-Assisted Total Knee Arthroplasty; Knee Replacement; Knee outcomes

Outcome Measures

Primary Outcomes (1)

• Survivorship

  Frequency of device and implant related adverse events and revision surgery to be recorded.

  10 Years

Secondary Outcomes (3)

• Change in KOOS from baseline to 10 years after surgery

  from enrolment to 10 years

• Change in UCLA from baseline to 10 years after surgery

  from enrolment to 10 years

• Change in Promis-10 from baseline to 10 years after surgery

  from enrolment to 10 years

Study Arms (2)

Revision Total Knee Arthroplasty

OTHER

Sensor-assisted robotic surgery cohort with a tibia first workflow. Revision Total Knee Arthroplasty components.

Device: Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision

Primary Total Knee Arthroplasty

OTHER

Sensor-assisted robotic surgery cohort with a tibia first workflow. Primary Total Knee Arthroplasty

Device: Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC; Device: Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS

Interventions

Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC DEVICE

Robotic-assisted total knee arthroplasty in femur and tibial first workflows using the BalanceBot to characterize soft tissue balance, and the Apex UltraCongruent (UC) knee implant type

Also known as: BalanceBot, Apex Knee System, Active Spacer

Primary Total Knee Arthroplasty

Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS DEVICE

Robotic-assisted total knee arthroplasty with a tibial first workflow using the BalanceBot to characterize soft tissue balance, and the Apex PosteriorStabilized (PS) knee implant type

Primary Total Knee Arthroplasty

Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision DEVICE

Robotic-assisted total knee arthroplasty with a tibial first workflow using the BalanceBot to characterize soft tissue balance, and the Apex Revision knee implant type

Revision Total Knee Arthroplasty

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Corin: lead

Study Sites (6)

Flagstaff Bone and Joint

Flagstaff, Arizona, 86001, United States

Location

Orthopaedics New England

Middlebury, Connecticut, 06762, United States

Location

DeClaire LaMacchia Orthopaedic Institute

Rochester, Michigan, 48307, United States

Location

Nyu Langone-Long Island

Garden City, New York, 11530, United States

Location

Oklahoma Sports and Orthopedics Institute

Oklahoma City, Oklahoma, 73114, United States

Location

Gundersen Health System

La Crosse, Wisconsin, 54601, United States

Location

Study Officials

• Jan A Koenig, MD

  NYU LANGONE-LONG ISLAND

  PRINCIPAL INVESTIGATOR

• Jeffrey H DeClaire, MD

  DeClaire LaMacchia Orthopaedic Institute

  PRINCIPAL INVESTIGATOR

• Amber Randall, MD

  Granite Orthopaedics

  PRINCIPAL INVESTIGATOR

• Corey Ponder, MD

  Oklahoma Sports and Orthopedics Institute

  PRINCIPAL INVESTIGATOR

• John Keggi, MD

  Orthopaedics New England

  PRINCIPAL INVESTIGATOR

• Jeffrey Lawrence, MD

  Gundersen Lutheran Medical Foundation, Inc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: January 12, 2024
• Study Start: November 9, 2017
• Primary Completion (Estimated): January 1, 2029
• Study Completion (Estimated): April 1, 2040
• Last Updated: May 20, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (6)