RecruitingNot ApplicableNCT06663384

ARVIS TKA vs Conventional TKA

A Prospective Study Using Augmented Reality Versus Conventional Jig Controls in Total Knee Arthroplasty for Osteoarthritis


Sponsor

Foundation for Orthopaedic Research and Education

Enrollment

50 participants

Start Date

Dec 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria4

  • Age over 18 years old
  • Scheduled for primary conventional TKA with kinematic alignment
  • Primary Diagnosis of Osteoarthritis (Killgren Lawrence Grade > III) on affected side
  • Able to provide informed consent

Exclusion Criteria5

  • Patients with a previous operation of the same knee, including ACL reconstruction, fracture fixation, previous arthroplasty.
  • Patients that had a conversion to a different procedure intraoperatively or shortly after the TKA.
  • Diagnosed with greater than Killgren Lawrence Grade II OA on the contralateral knee
  • Patients that did not complete the TKA.
  • Patients the Investigator deems not able to follow through with study requirements such as follow-up visits or PROM's.

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Interventions

OTHEREvaluation of Augmented Reality technology in TKA compared to standard TKA

Evaluation of effectiveness of AR system used to perform bone cuts when compared to traditional jigs in primary TKA


Locations(1)

Florida Orthopaedic Institute

Tampa, Florida, United States

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NCT06663384


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