Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT06663384

ARVIS TKA vs Conventional TKA

Led by Foundation for Orthopaedic Research and Education · Updated on 2024-12-09

50

Participants Needed

1

Research Sites

152 weeks

Total Duration

On this page

Sponsors

F

Foundation for Orthopaedic Research and Education

Lead Sponsor

D

DonJoy Orthopedics

Collaborating Sponsor

AI-Summary

What this Trial Is About

This study is a pilot analysis of a novel augmented reality guidance platform, the augmented reality visualization and information system (ARVIS, Insight Medical), with aims to demonstrate accuracy of bone resection and implant alignment during kinematic alignment total knee arthroplasty.

CONDITIONS

Official Title

ARVIS TKA vs Conventional TKA

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age over 18 years old
  • Scheduled for primary conventional total knee arthroplasty with kinematic alignment
  • Primary diagnosis of osteoarthritis with Killgren Lawrence Grade greater than III on the affected knee
  • Able to provide informed consent
Not Eligible

You will not qualify if you...

  • Previous surgery on the same knee, including ACL reconstruction, fracture fixation, or prior arthroplasty
  • Conversion to a different procedure during or shortly after the planned total knee arthroplasty
  • Osteoarthritis greater than Killgren Lawrence Grade II on the opposite knee
  • Did not complete the total knee arthroplasty procedure
  • Investigator determines inability to comply with study follow-up visits or patient-reported outcome measures

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Florida Orthopaedic Institute

Tampa, Florida, United States, 33607

Actively Recruiting

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Research Team

D

Debbi Warren, RN

CONTACT

P

Peter Simon

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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ARVIS TKA vs Conventional TKA | DecenTrialz