Recruiting

ARVIS TKA vs. Conventional TKA

Sponsor:

Foundation for Orthopaedic Research and Education

Code:

NCT06663384

Conditions

Osteoarthritis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Evaluation of Augmented Reality technology in TKA compared to standard TKA

Study Details

Brief summary:

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.

Conditions

Osteoarthritis

Study ID

NCT06663384

Start date

Dec 1, 2024

Status verified date

Sep, 2026

Completion date

Nov 1, 2027

Anticipated

Primary completion date

Nov 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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:

1. Patients with a previous operation of the same knee, including ACL reconstruction, fracture fixation, previous arthroplasty.
2. Patients that had a conversion to a different procedure intraoperatively or shortly after the TKA.
3. Diagnosed with greater than Killgren Lawrence Grade II OA on the contralateral knee
4. Patients that did not complete the TKA.
5. Patients the Investigator deems not able to follow through with study requirements such as follow-up visits or PROM's.

Study Design

Enrollment

50 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: ARVIS arm

TKA using ARVIS software

placebo comparator: conventional TKA

Conventional Total Knee Arthroplasty

Interventions

Evaluation of Augmented Reality technology in TKA compared to standard TKA

Evaluation of effectiveness of AR system used to perform bone cuts when compared to traditional jigs in primary TKA

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Debbi Warren, RN

813-910-3688dwarren@foreonline.org

Peter Simon

312-509-5761psimon@foreonline.org

Locations

Florida Orthopaedic Institute

Recruiting

Tampa, Florida, United States, 33607

More Information

Sponsor

Foundation for Orthopaedic Research and Education

Last update posted

Sep 9, 2026

Last verified

Sep, 2026

Keywords

  • osteoarthritis of knee, Total Knee Replacement

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Foundation for Orthopaedic Research and Education on 2026-09-09.