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Patient Outcomes With Robotic-Assisted Total Knee Arthroplasty

NCT06203756 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 713

Last updated 2025-05-20

No results posted yet for this study

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

Interventions

DEVICE

Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex UC

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

DEVICE

Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex PS

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

DEVICE

Omnibotics Robotic-assisted Total Knee Arthroplasty with Apex Revision

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

Sponsors & Collaborators

  • Corin

    lead INDUSTRY

Principal Investigators

  • Jan A Koenig, MD · NYU LANGONE-LONG ISLAND

  • Jeffrey H DeClaire, MD · DeClaire LaMacchia Orthopaedic Institute

  • Amber Randall, MD · Granite Orthopaedics

  • Corey Ponder, MD · Oklahoma Sports and Orthopedics Institute

  • John Keggi, MD · Orthopaedics New England

  • Jeffrey Lawrence, MD · Gundersen Lutheran Medical Foundation, Inc

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-09
Primary Completion
2029-01-01
Completion
2040-04-01
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06203756 on ClinicalTrials.gov