Robotic-Assisted Knee Replacement for Knee Surgery

Enrolling by invitation at 6 trial locations

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Corin

Disqualifiers: BMI >45, Neurological disorders, Cancer, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Intraoperative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to confirm the safety and effectiveness of robotic-assisted knee replacements. It focuses on using robotic technology to assist with total knee arthroplasty (surgical repair of the knee joint) for both primary and revision surgeries. Individuals with knee issues who are considering or need total knee replacement surgery and can benefit from robotic assistance might be suitable candidates.

As an unphased trial, this study provides patients the opportunity to contribute to advancements in medical technology for knee surgery.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

What prior data suggests that this robotic-assisted knee replacement is safe?

Research has shown that robotic-assisted knee replacements, such as those using the OMNIBotics system, are generally well-received by patients. Studies indicate that this method performs surgery with high accuracy, potentially leading to better results and fewer complications. Although specific safety details are not fully outlined, this type of knee replacement is already in use and continues to be studied to ensure long-term safety and effectiveness.

For the Apex PS, UC, and Revision knee implants, research focuses on verifying their safety and effectiveness. These implants have been used previously, and current studies monitor their long-term outcomes to ensure continued safety and efficacy.

Overall, while detailed safety data is not fully provided, the ongoing use of these implants suggests confidence in their safety for knee replacement surgeries. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about robotic-assisted knee replacement because it enhances precision in knee surgeries like never before. Unlike traditional knee replacement methods, this technique uses sensor-assisted robotics to ensure optimal alignment and placement of knee components, which can potentially lead to better long-term outcomes and faster recovery times. The use of a "tibia first" workflow in both primary and revision knee arthroplasties offers a unique approach to surgery that might reduce the risk of complications and improve the overall fit and function of the knee implant.

What evidence suggests that this trial's treatments could be effective for knee surgery?

Research has shown that Omnibotics technology for robotic-assisted total knee replacement surgery yields promising results. This trial will compare various approaches using Omnibotics technology. Studies have found that this method improves the alignment of knee components, which is crucial for proper knee function. Patients often report easier movement and use of their knees shortly after surgery. The technology ensures accurate and consistent surgery, potentially leading to higher satisfaction. These findings suggest that Omnibotics robotic-assisted knee replacement could be a beneficial option for those needing knee surgery. ^{1 3 4 6 7}

Who Is on the Research Team?

Jan A Koenig, MD

Principal Investigator

NYU LANGONE-LONG ISLAND

Jeffrey H DeClaire, MD

Principal Investigator

DeClaire LaMacchia Orthopaedic Institute

Amber Randall, MD

Principal Investigator

Granite Orthopaedics

Corey Ponder, MD

Principal Investigator

Oklahoma Sports and Orthopedics Institute

John Keggi, MD

Principal Investigator

Orthopaedics New England

Jeffrey Lawrence, MD

Principal Investigator

Gundersen Lutheran Medical Foundation, Inc

Are You a Good Fit for This Trial?

This trial is for individuals planning to undergo knee replacement surgery. It's specifically looking at those who will have the procedure with robotic assistance using different types of Apex knee systems. Details on who can join are not provided, but typically participants should be in good health aside from their knee issues and meet certain age and medical criteria.

Inclusion Criteria

I am a candidate for a first-time or revision knee replacement surgery.

My joint is suitable for surgery with a robotic-assisted implant.

Patient is able and willing to sign the informed consent and follow study procedures

Exclusion Criteria

My cancer has spread to other parts of my body.

I have health conditions that could affect my healing or make surgery risky.

I do not have any infectious diseases like HIV, hepatitis, or tuberculosis.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Initial Phase

Standard robotic patients have their soft tissue balance assessed using the BalanceBot in a blinded fashion

Intraoperative

Treatment

Participants undergo robotic-assisted total knee arthroplasty with or without the BalanceBot

Intraoperative

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

What Are the Treatments Tested in This Trial?

Interventions

• Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS
• Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision
• Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC

Trial Overview The study is testing three variations of robotic-assisted total knee arthroplasty (TKA) using Omnibotics technology with different Apex systems. It aims to evaluate the precision of soft tissue balancing during surgery and track patient outcomes through surveys before and after the operation.

How Is the Trial Designed?

Group I: Revision Total Knee Arthroplasty Experimental Treatment 1 Intervention

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

Group II: Primary Total Knee Arthroplasty Experimental Treatment 2 Interventions

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

Who Is Running the Clinical Trial?

Corin

Lead Sponsor

Trials

22

Recruited

8,600+

Citations

1. clinicaltrial.be clinicaltrial.be/en/details/421471?only_active=0&only_eligible=0&only_recruiting=0&per_page=20

Patient Outcomes With Robotic-Assisted Total Knee Arthrop... 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 ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/34652515/

Robotic-assisted total knee arthroplasty with the OMNIBot ... Results: The OMNIBot is an accurate and consistent delivery tool in TKA surgery and compares favourably to instrumented, navigation-assisted ...

3. mba.eu mba.eu/wp-content/uploads/2021/10/MC-043_REV_2018_OMNIBotics_Clinical_Summary.pdf

OMNIBotics® - Clinical Summary This is a prospective study evaluating clinical outcomes, patient reported outcomes (PROMs), and patient satisfaction in robotic-assisted total knee ...

4. withpower.com withpower.com/trial/phase-arthroplasties-replacement-knee-10-2017-0220e

Robotic-Assisted Knee Replacement for Knee Surgery Trial Overview The study is testing three variations of robotic-assisted total knee arthroplasty (TKA) using Omnibotics technology with different Apex systems.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9389136/

Is it prime time for robotic-assisted TKAs? A systematic ... Although robotic-assisted total knee arthroplasty is a promising technology that provides better component alignment and superior early functional outcomes.

6. coringroup.com coringroup.com/healthcare-professionals/products/omnibotics/

OMNIBotics® | Robotic-assisted total knee arthroplasty The OMNIBot is an evolution in navigation and robotic technology for total knee arthroplasty offering highly accurate positioning of the femoral cutting guide ...

7. goldenstateortho.com goldenstateortho.com/wp-content/uploads/2022/08/Omnibotics-robotic-assisted-total-knee-replacement-overview.pdf

OMNIBotics® robotic-assisted total knee replacement OMNIBotics is a state-of-the-art procedure that combines patented technology with robotic instrumentation to help surgeons plan and execute total knee ...