ARVIS TKA vs Conventional TKA

Recruiting now · Not applicable

Conditions studied: Osteoarthritis

In brief

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.

Key facts

Study ID

NCT06663384

Run by

Foundation for Orthopaedic Research and Education

People needed

50

Starts

2024-12-01

Expected to finish

2027-11-01

Last updated by the study team

2024-12-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Florida Orthopaedic Institute — Tampa, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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