ARVIS TKA vs Conventional TKA for Osteoarthritis

This study is looking at a new way to perform total knee replacement (TKA) surgery for people with osteoarthritis. It compares using an Augmented Reality Visualization and Information System (ARVIS) to guide bone cuts during surgery with the traditional method using standard tools (jigs). The goal is to see if the ARVIS system can more accurately restore your knee's natural alignment after surgery. You might be able to join if you are over 18, have severe osteoarthritis in one knee (Killgren Lawrence Grade > III), and are scheduled for a primary conventional TKA. The study aims to enroll 50 participants, but the current recruitment status is unclear.

Study design
This is a randomized controlled trial comparing two surgical methods for total knee replacement, with 25 participants in each group.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Your knee measurements will be taken from enrollment until 1 year after your follow-up visit.

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NCT06663384

ARVIS TKA vs Conventional TKA

Recruiting
NAAges 18+Interventional
Foundation for Orthopaedic Research and Education
~50 participants
Updated 2024-12-09 on ClinicalTrials.gov
What's tested:Evaluation of Augmented Reality technology in TKA compared to standard TKA

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Radiographic Measurements bilateral knees
Measured over From enrollment until 1 year follow-up visit.
Osteoarthritis
1 sites across 1 states
Florida1
  • Brian Palumbo, MD · PRINCIPAL_INVESTIGATOR · Florida Orthopaedic Institute

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Eligibility criteria

Inclusion

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
  • Radiographic Measurements bilateral kneesFrom enrollment until 1 year follow-up visit.

    Weight bearing anterposterior (AP), lateral and sunrise views of both knees to measure tibial slope, hip-knee alignment, medial proximal tibial angle, mechanical lateral distal femoral angle, joint line convergence angle, anatomic- mechanical angle.