ARVIS TKA vs Conventional TKA

Part of paid clinical trials in Tampa, Florida.

Sponsor
Foundation for Orthopaedic Research and Education
Study ID
NCT06663384
Status
Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Evaluation of Augmented Reality technology in TKA compared to standard TKA — OTHER
    Evaluation of effectiveness of AR system used to perform bone cuts when compared to traditional jigs in primary TKA

Study Details

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 Dates

Start date
Dec 1, 2024
Status verified
Dec 2024
Primary completion
Nov 1, 2026
Completion
Nov 1, 2027

Study Design

Enrollment
50 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: ARVIS arm
    TKA using ARVIS software
  • Placebo Comparator: conventional TKA
    Conventional Total Knee Arthroplasty

Primary Outcome Measure

Radiographic Measurements bilateral knees [ Time Frame: From enrollment until 1 year follow-up visit. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Florida Orthopaedic InstituteTampaFlorida33607-

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