ARVIS TKA vs Conventional TKA (ARVIS)

A Prospective Study Using Augmented Reality Versus Conventional Jig Controls in Total Knee Arthroplasty for Osteoarthritis

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.

Study Overview

• Status: Recruiting
• Conditions: Osteoarthritis
• Intervention / Treatment: Other: Evaluation of Augmented Reality technology in TKA compared to standard TKA

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Debbi Warren, RN; Phone Number: 813-910-3688; Email: dwarren@foreonline.org
• Study Contact Backup: Name: Peter Simon; Phone Number: 312-509-5761; Email: psimon@foreonline.org

Study Locations

• United States
  • Florida
    • Tampa, Florida, United States, 33607
      • Recruiting
      • Florida Orthopaedic Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARVIS arm; TKA using ARVIS software	Other: 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
Placebo Comparator: conventional TKA; Conventional Total Knee Arthroplasty	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Radiographic Measurements bilateral knees	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.	From enrollment until 1 year follow-up visit.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PROMIS-10 Survey	Patient Reported Outcome Measure Information System with 10 questions about subjects pain and function.	frome enrollment until 12 month final study visit
Knee Society Score (KSS)	A simple and objective scoring system to rate the knee and patient's functional abilities before and after total knee arthroplasty.	From enrollment until final visit at 12 months after surgery
Knee Injury and Osteoarthritis outcome Score (KOOS)	KOOS is a 42-item questionnaire that assesses the patient's opinion about the health, symptoms, and functionality of their knee.	from enrollment until completion of study at 12 months post surgery
Numeric Pain Rating Score (NPRS)	1-10 numeric scale that asks patients to rate their pain in the last 24 hours.	From enrollment until final study visit at 12 months post surgery

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Virtual Reality Sickness Questionnaire (VSRQ)	A motion sickness measurement index specialized in VR environments. 16 questions broken down into three categories (nausea, oculomotor, and disorientation) to assess the severity of each potential cybersickness symptom.	After the surgical procedure - one time only

Collaborators and Investigators

• Sponsor: Foundation for Orthopaedic Research and Education
• Collaborators: DonJoy Orthopedics
• Investigators: Principal Investigator: Brian Palumbo, MD, Florida Orthopaedic Institute

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): November 1, 2027

Study Registration Dates

• First Submitted: October 24, 2024
• First Submitted That Met QC Criteria: October 25, 2024
• First Posted (Actual): October 29, 2024

Study Record Updates

• Last Update Posted (Estimated): December 9, 2024
• Last Update Submitted That Met QC Criteria: December 4, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: osteoarthritis of knee, Total Knee Replacement
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: FORE092024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: This 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No