ARVIS TKA vs Conventional TKA

NCT ID: NCT06663384

Last Updated: 2024-12-09

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-12-01
• Study Completion Date: 2027-11-01

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.

Detailed Description

This study is a Randomized Controlled Trial evaluating the effectiveness of an AR system utilized to perform bone cuts when compared to traditional jigs in primary TKA for treatment of primary osteoarthritis. Our primary objective is to determine if the ARVIS augmented reality platform is a reliable tool to restore native lower extremity alignment during TKA. An estimated 50 patients will be enrolled in the study, with 25 in the AR-group and 25 in the non-AR conventional kinematic alignment group. A 20% attrition rate (10 patients) is expected throughout the study, leaving 20 patients in each study group. The Investigator intend to evaluate only patients who've met the clinical and radiographic indications for TKA for one knee (Killgren Lawrence Grade > III) and have less than Killgren Lawrence Grade II OA of the contralateral knee. The Investigators intend to use the uninvolved knee as a radiographic comparison to determine ARVIS's post-operative restorative accuracy to the patient's native alignment. Pre- and post-operative radiographs will include standing knee AP, PA, lateral, sunrise, and hip-to-ankle radiographs.

The investigators have chosen to reproduce the patient's native alignment during TKA rather than mechanical alignment given the predominance of recent literature demonstrating superior function and outcome of kinematic based techniques. Intraoperatively, the investigators will use ARVIS to prospectively record bone resection thickness, distal femoral resection angle, femoral component sagittal orientation, femoral component rotation, tibial resection thickness, coronal tibial resection angle, and tibial slope.

The ARVIS is an augmented reality headset with a heads-up display capable of presenting pre-resection hip center and lower extremity alignment. The heads-up display provides real time, intra-operative feedback during bone resections to optimize the component position and lower extremity alignment as compared to the uninvolved contralateral limb. Unlike other methods used to prepare bone cuts during TKA, such as traditional jigs or robotic systems, ARVIS is a self-contained, wearable surgical guidance device controlled by the surgeon, designed to ensure surgeon can focus on their patient while they perform bone cuts on tibia and femur - not a screen across the room.

The procedure of TKA is the same for traditional approach utilizing jigs and ARVIS approach.

ARVIS has received 510(k) clearance from the FDA as of July 2021.

Conditions

Osteoarthritis

Keywords

osteoarthritis of knee, Total Knee Replacement

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

ARVIS arm

TKA using ARVIS software

Group Type: EXPERIMENTAL

Evaluation of Augmented Reality technology in TKA compared to standard TKA

Intervention Type: OTHER

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

conventional TKA

Conventional Total Knee Arthroplasty

Group Type: PLACEBO_COMPARATOR

Evaluation of Augmented Reality technology in TKA compared to standard TKA

Intervention Type: OTHER

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

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

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DonJoy Orthopedics

UNKNOWN

Sponsor Role: collaborator

Foundation for Orthopaedic Research and Education

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Brian Palumbo, MD

Role: PRINCIPAL_INVESTIGATOR

Florida Orthopaedic Institute

Locations

Florida Orthopaedic Institute

Tampa, Florida, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Debbi Warren, RN

Role: CONTACT

Phone: 813-910-3688

Email: dwarren@foreonline.org

Peter Simon

Role: CONTACT

Phone: 312-509-5761

Email: psimon@foreonline.org

Other Identifiers

FORE092024

Identifier Type: -

Identifier Source: org_study_id