ARVIS TKA vs Conventional TKA
Recruiting · NCT06663384 · Interventional (participants receive a specific treatment) · Lead sponsor: Foundation for Orthopaedic Research and Education
View the official record on ClinicalTrials.gov →Interventions studied
Evaluation of Augmented Reality technology in TKA compared to standard TKA
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
- Patients with a previous operation of the same knee, including ACL reconstruction, fracture fixation, previous arthroplasty.
- Patients that had a conversion to a different procedure intraoperatively or shortly after the TKA.
- Diagnosed with greater than Killgren Lawrence Grade II OA on the contralateral knee
- Patients that did not complete the TKA.
- Patients the Investigator deems not able to follow through with study requirements such as follow-up visits or PROM's.
Where it is running
1 location listed across 1 US state.
- Florida Orthopaedic Institute - Tampa, Florida, United States