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ARVIS TKA vs Conventional TKA

RECRUITINGN/ASponsored by Foundation for Orthopaedic Research and Education
Actively Recruiting
PhaseN/A
SponsorFoundation for Orthopaedic Research and Education
Started2024-12-01
Est. completion2026-11-01
Eligibility
Age18 Years+
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT06663384

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

Age: 18 Years+Healthy volunteers accepted
Inclusion Criteria:

* 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 Criteria:

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

Conditions2

ArthritisOsteoarthritis

Locations1 site

Florida Orthopaedic Institute
Tampa, Florida, 33607

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Trial data from ClinicalTrials.gov. Trial status and eligibility can change — verify directly with the study contact or on ClinicalTrials.gov.

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