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 — OTHEREvaluation 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 armTKA using ARVIS software
- Placebo Comparator: conventional TKAConventional Total Knee Arthroplasty
Primary Outcome Measure
Radiographic Measurements bilateral knees [ Time Frame: From enrollment until 1 year follow-up visit. ]
Central Contacts
- Debbi Warren, RN813-910-3688
- Peter Simon312-509-5761
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Florida Orthopaedic Institute | Tampa | Florida | 33607 | - |
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