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Procedure

Augmented Reality Technology for Osteoarthritis (ARVIS Trial)

N/A
Recruiting
Led By Brian Palumbo, MD
Research Sponsored by Foundation for Orthopaedic Research and Education
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
* Age over 18 years old
* Primary Diagnosis of Osteoarthritis (Killgren Lawrence Grade \> III) on affected side
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from enrollment until 1 year follow-up visit.

Summary

This trial is testing a new technology called ARVIS, which uses augmented reality to help with knee replacement surgery. The goal is to see if ARVIS can help improve the accuracy of bone cutting and implant

Who is the study for?
This trial is for adults over 18 with severe osteoarthritis scheduled for their first total knee arthroplasty (TKA) using kinematic alignment. Participants must be able to consent. Those not meeting these criteria, or with other conditions that might interfere, cannot join.
What is being tested?
The study compares a new augmented reality guidance system (ARVIS) in performing TKA against the standard method of TKA. It aims to assess how accurately bone cuts and implant positioning are done with ARVIS during surgery.
What are the potential side effects?
Since this trial focuses on comparing surgical techniques rather than medications, side effects may include typical surgical risks such as infection, pain at the incision site, bleeding, or issues related to knee joint replacement.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am over 18 years old.
Select...
My arthritis is severe on one side.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from enrollment until 1 year follow-up visit.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from enrollment until 1 year follow-up visit. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Radiographic Measurements bilateral knees
Secondary study objectives
Knee Injury and Osteoarthritis outcome Score (KOOS)
Knee Society Score (KSS)
Numeric Pain Rating Score (NPRS)
+1 more
Other study objectives
Virtual Reality Sickness Questionnaire (VSRQ)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: ARVIS armExperimental Treatment1 Intervention
TKA using ARVIS software
Group II: conventional TKAPlacebo Group1 Intervention
Conventional Total Knee Arthroplasty

Find a Location

Who is running the clinical trial?

DonJoy OrthopedicsUNKNOWN
1 Previous Clinical Trials
87 Total Patients Enrolled
Foundation for Orthopaedic Research and EducationLead Sponsor
14 Previous Clinical Trials
951 Total Patients Enrolled
1 Trials studying Osteoarthritis
75 Patients Enrolled for Osteoarthritis
Brian Palumbo, MDPrincipal InvestigatorFlorida Orthopaedic Institute
~33 spots leftby Nov 2026
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