Robotic-Assisted Knee Replacement for Knee Surgery

Recruiting 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

713 Participants Needed

Trial Summary

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 data supports the effectiveness of the treatment Omnibotics Robotic-assisted Total Knee Arthroplasty?

Research shows that robotic-assisted knee surgeries, like the Omnibotics system, can improve the accuracy of implant placement and alignment, which may lead to better outcomes and longer-lasting knee replacements. Studies have found that robotic assistance in knee surgeries can enhance component alignment and potentially increase the longevity of the knee prosthesis. ^{1 2 3 4 5}

How is the Omnibotics Robotic-assisted Total Knee Arthroplasty treatment different from other knee surgery treatments?

The Omnibotics Robotic-assisted Total Knee Arthroplasty is unique because it uses robotic technology to improve the accuracy of implant placement during knee replacement surgery, which can lead to better alignment and potentially longer-lasting results compared to traditional methods. ^{1 2 6 7 8}

What is the purpose of this trial?

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.

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

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

References

1. Germany pubmed.ncbi.nlm.nih.gov

Imageless robotic-assisted revision arthroplasty from UKA to TKA : Surgical technique and case-control study compared with primary robotic TKA. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Revision Total Knee Arthroplasty Using Robotic Arm Technology. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Robotic-Arm-Assisted vs Conventional Unicompartmental Knee Arthroplasty. The 2-Year Clinical Outcomes of a Randomized Controlled Trial. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The three-year survivorship of robotically assisted versus non-robotically assisted unicompartmental knee arthroplasty. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Robotic-Assisted versus Manual Unicompartmental Knee Arthroplasty: Contemporary Systematic Review and Meta-analysis of Early Functional Outcomes. [2021]

6. Israel pubmed.ncbi.nlm.nih.gov

[ROBOTICS- WHY NOW?] [2021]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Clinical and radiological outcomes of robotic-assisted unicompartmental knee arthroplasty: Early lessons from the first 100 consecutive knees in 85 patients. [2022]

8. England pubmed.ncbi.nlm.nih.gov

A systematic review of robotic-assisted unicompartmental knee arthroplasty: prosthesis design and type should be reported. [2019]