Augmented Reality Technology for Osteoarthritis

(ARVIS Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Brian Palumbo, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Foundation for Orthopaedic Research and Education

Disqualifiers: Previous knee surgery, Others

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

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.

Do I need to stop taking my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment ARVIS TKA, ARVIS, Augmented Reality Visualization and Information System for osteoarthritis?

Research shows that augmented reality (AR) systems in total knee arthroplasty (TKA) help surgeons improve the accuracy of bone resections and alignment during surgery, which can lead to better outcomes. These systems provide real-time information and feedback, enhancing the precision of surgical procedures. ^{1 2 3 4 5}

Is augmented reality technology generally safe for use in surgeries?

The research does not provide specific safety data for augmented reality technology in surgeries, but it highlights the importance of accurate registration and alignment during procedures, which can help minimize errors. ^{1 2 4 6 7}

How is the ARVIS TKA treatment different from other osteoarthritis treatments?

ARVIS TKA uses augmented reality (AR) technology to enhance surgical precision in knee replacement by overlaying digital information on the surgical field, allowing surgeons to see real-time data and improve accuracy during the procedure. ^{1 2 3 4 8}

Research Team

Brian Palumbo, MD

Principal Investigator

Florida Orthopaedic Institute

Eligibility Criteria

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.

Inclusion Criteria

I am over 18 years old.

My arthritis is severe on one side.

I can understand and agree to the study's procedures and risks.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo total knee arthroplasty using either ARVIS or conventional jigs

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment, including radiographic measurements and patient-reported outcomes

12 months

Multiple visits (in-person)

Treatment Details

Interventions

• ARVIS TKA (Procedure)

Trial Overview 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.

Participant Groups

Group I: ARVIS arm Experimental Treatment 1 Intervention

TKA using ARVIS software

Group II: conventional TKA Placebo Group 1 Intervention

Conventional Total Knee Arthroplasty

Who Is Running the Clinical Trial?

Foundation for Orthopaedic Research and Education

Lead Sponsor

Trials

16

Recruited

1,000+

DonJoy Orthopedics

Collaborator

Trials

2

Recruited

140+

Findings from Research

The augmented reality (AR) navigation system demonstrated high accuracy in measuring femoral resection angles, with differences of only 0.8° in the coronal plane and 0.6° in the sagittal plane during experimental tests on 10 femoral specimens.

In a clinical study involving 72 patients, the AR system significantly reduced the error in coronal alignment during total knee arthroplasty compared to traditional intramedullary guides, indicating that AR technology can enhance surgical precision.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented Reality-Assisted Femoral Bone Resection in Total Knee Arthroplasty. Tsukada, S., Ogawa, H., Nishino, M., et al.[2022]

The Knee+ augmented reality system demonstrated high accuracy in total knee arthroplasty, with cutting errors of less than 1° for coronal alignment and less than 2° for flexion/extension, based on a pilot study involving 5 patients with an average age of 76.4 years.

Despite limited existing literature on augmented reality in knee arthroplasty, the pilot study suggests that this technology could enhance surgical precision, warranting further high-level studies to evaluate its effectiveness and cost compared to traditional methods.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The use of augmented reality for limb and component alignment in total knee arthroplasty: systematic review of the literature and clinical pilot study. Iacono, V., Farinelli, L., Natali, S., et al.[2023]

Augmented reality (AR) technology can significantly enhance surgical procedures like total knee and hip arthroplasty by overlaying digital information onto the physical surgical field, improving the surgeon's perception and interaction with the anatomy.

AR has the potential to revolutionize education and professional development in arthroplasty by providing immersive training experiences that combine real-world practice with digital guidance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented Reality in Orthopedic Practice and Education. Keating, TC., Jacobs, JJ.[2020]

The AR-KNEE system, an augmented reality navigation tool, demonstrated high accuracy in guiding tibial bone resection during total knee arthroplasty, with minimal differences in alignment measurements (e.g., varus/valgus angle accuracy of 0.5°).

This pilot study, which involved resecting 10 tibial sawbones, suggests that the AR-KNEE system could enhance surgical precision in knee surgeries, potentially improving patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented reality-based navigation system applied to tibial bone resection in total knee arthroplasty. Tsukada, S., Ogawa, H., Nishino, M., et al.[2020]

In a study comparing two navigation systems for total knee arthroplasty (TKA), the augmented reality (AR)-assisted navigation system demonstrated a success rate of 95.4% for proper femoral prosthesis alignment, which is comparable to the 93.2% success rate of the accelerometer-based navigation system.

The AR-assisted navigation system was found to be noninferior to the accelerometer-based system, meaning it is just as effective in achieving the desired coronal alignment of the femoral prosthesis, based on a cohort of 227 total knee surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Femoral prosthesis alignment of augmented reality-assisted versus accelerometer-based navigation in total knee arthroplasty: A noninferiority analysis. Tsukada, S., Kizaki, K., Saito, M., et al.[2023]

In a 10-week study involving 164 patients undergoing elective orthopedic procedures, independent clinical reviewers identified significantly more adverse events (99) compared to surgeons (14), highlighting a gap in surgeons' reporting practices.

While surgeons effectively captured major adverse events, they missed many minor events that were documented by reviewers, suggesting that using standardized assessment tools like SAVES V2 and OrthoSAVES could enhance overall adverse-event reporting in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES? Chen, BP., Garland, K., Roffey, DM., et al.[2018]

A review of 23 studies on augmented-reality head-mounted devices (HMDs) used in surgery found that the mean registration errors varied by method, with pattern markers showing an average error of 2.6 mm, which is considered a minimum acceptable standard for surgical applications.

The majority of studies utilized in-house software and focused on hard tissue specialties, indicating that while AR technology shows promise in enhancing surgical precision, the variability in registration methods and errors needs to be standardized for optimal efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Systematic review of techniques used to validate the registration of augmented-reality images using a head-mounted device to navigate surgery. Chegini, S., Edwards, E., McGurk, M., et al.[2023]

Augmented reality (AR) is becoming increasingly important in medicine, particularly for training and surgical procedures, as it enhances real-world environments with additional information.

Current AR systems are being utilized for preoperative planning and intraoperative guidance, indicating a significant potential for improving surgical outcomes and efficiency in orthopaedic applications.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented reality and its future in orthopaedics. Blackwell, M., Morgan, F., DiGioia, AM.[2019]

References

1. United States pubmed.ncbi.nlm.nih.gov

Augmented Reality-Assisted Femoral Bone Resection in Total Knee Arthroplasty. [2022]

2. Germany pubmed.ncbi.nlm.nih.gov

The use of augmented reality for limb and component alignment in total knee arthroplasty: systematic review of the literature and clinical pilot study. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Augmented Reality in Orthopedic Practice and Education. [2020]

4. Germany pubmed.ncbi.nlm.nih.gov

Augmented reality-based navigation system applied to tibial bone resection in total knee arthroplasty. [2020]

5. Japan pubmed.ncbi.nlm.nih.gov

Femoral prosthesis alignment of augmented reality-assisted versus accelerometer-based navigation in total knee arthroplasty: A noninferiority analysis. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Can Surgeons Adequately Capture Adverse Events Using the Spinal Adverse Events Severity System (SAVES) and OrthoSAVES? [2018]

7. Scotland pubmed.ncbi.nlm.nih.gov

Systematic review of techniques used to validate the registration of augmented-reality images using a head-mounted device to navigate surgery. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Augmented reality and its future in orthopaedics. [2019]