Augmented Reality Technology for Osteoarthritis

(ARVIS Trial)

Overseen By Debbi Warren, RN

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Foundation for Orthopaedic Research and Education

Disqualifiers: Previous knee surgery, Others

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: 1 day

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new augmented reality system, ARVIS TKA (Augmented Reality Visualization and Information System), to improve the accuracy of knee replacement surgery for people with osteoarthritis, a condition causing joint pain and stiffness. The study compares this technology with traditional knee replacement methods to determine if it better aligns bones and implants during surgery. Suitable participants have osteoarthritis, plan to undergo knee replacement, and can attend follow-up visits. As an unphased trial, this study offers the chance to contribute to innovative research that could enhance surgical outcomes for future patients.

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 prior data suggests that this augmented reality technology is safe for osteoarthritis treatment?

Research shows that the ARVIS system, used in total knee replacement surgery, provides real-time, hands-free guidance to enhance surgical accuracy. Previous studies have examined its effectiveness in achieving precise bone cuts and correct implant placement.

Although these studies do not provide specific safety data, the ARVIS system is designed to assist surgeons without interfering with the surgery itself. This design suggests it is likely safe, as it functions as a tool rather than a treatment. As this is an early-stage study, the focus is on the technology's functionality and immediate effects.

Overall, while specific information on side effects is lacking, the technology's design and purpose suggest it should not pose major safety risks. However, as with any new technology, unexpected issues may arise, and participants should be aware of this possibility. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about ARVIS TKA because it uses augmented reality (AR) to enhance precision during total knee arthroplasty (TKA) for osteoarthritis. Unlike conventional TKA, which relies heavily on the surgeon's experience and traditional imaging, ARVIS TKA integrates real-time data and visual overlays, helping surgeons align and position implants with greater accuracy. This innovative approach could lead to improved outcomes and quicker recovery times for patients by minimizing potential errors and optimizing surgical technique.

What evidence suggests that ARVIS is effective for osteoarthritis?

Research shows that the ARVIS system, available to participants in this trial, helps surgeons make precise cuts during knee replacement surgery. Studies have found that augmented reality (AR) in surgery improves the placement of knee implants. Accurate placement is crucial for better functioning and longer-lasting knee replacements. Early results suggest that ARVIS may offer more precision than traditional methods, potentially leading to better outcomes for individuals with severe knee arthritis. Participants in this trial will be assigned to either the ARVIS arm or the conventional TKA arm to compare these approaches. ^{2 6 7 8 9}

Who Is on the Research Team?

Brian Palumbo, MD

Principal Investigator

Florida Orthopaedic Institute

Are You a Good Fit for This Trial?

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.

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

My arthritis is severe on one side.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• ARVIS TKA

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.

How Is the Trial Designed?

Group I: ARVIS arm Experimental Treatment 1 Intervention

TKA using ARVIS software

Group II: conventional TKA Placebo Group 1 Intervention

Conventional Total Knee Arthroplasty

ARVIS TKA is already approved in United States for the following indications:

Approved in United States as ARVIS for:

• Total Hip Arthroplasty
• Total Knee Arthroplasty
• Unicompartmental 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+

Published Research Related to This Trial

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]

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]

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]

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]

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 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]

Citations

1. trialx.com trialx.com/clinical-trials/listings/305673/arvis-tka-vs-conventional-tka/

ARVIS TKA vs Conventional TKA | Clinical Research Trial ... This study is a Randomized Controlled Trial evaluating the effectiveness of an AR system utilized to perform bone cuts when compared to ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11094513/

An Image-Based Augmented Reality System for Achieving ... This study aimed to determine whether accurate bone resection can be achieved in TKA surgery using image-based AR.

3. enovis.com enovis.com/investors/press-releases/enovis-launches-arvis-only-augmented-reality-surgical-guidance-system

Enovis Launches ARVIS®, Only Augmented Reality ... ARVIS is the first system with proprietary hardware designed to assist surgeons in precisely placing hip and knee joint replacements.

4. mdpi.com mdpi.com/2075-1729/13/2/451

Research Advances in the Application of AI for ... Total knee arthroplasty (TKA) is the most conclusive treatment for severe knee osteoarthritis, and its efficacy relies on the reconstruction of ...

5. researchgate.net researchgate.net/publication/379844066_An_Image-Based_Augmented_Reality_System_for_Achieving_Accurate_Bone_Resection_in_Total_Knee_Arthroplasty

(PDF) An Image-Based Augmented Reality System for ... Conclusions: On light of our preliminary results, the Knee + system is accurate and effective to perform TKA. The translation from pilot ...

6. enovis.com enovis.com/arvis

Arvis® - Augmented Reality Surgical Guidance This wearable, self-contained system delivers real-time, hands-free surgical guidance directly to you at the point of care.

7. trials.arthritis.org trials.arthritis.org/trials/NCT06663384

ARVIS TKA vs Conventional TKA - Clinical Trial Finder This study is a pilot analysis of a novel augmented reality guidance platform, the augmented reality visualization and information system (ARVIS, Insight ...

8. accessdata.fda.gov accessdata.fda.gov/cdrh_docs/pdf24/K243980.pdf

March 21, 2025 Kico Knee Innovation Company Pty Limited ... The ARVIS head mounted display is for displaying augmented reality visualization and information to the user intraoperatively. The augmented/ ...

9. arvissurgery.com arvissurgery.com/

Reimagine Orthopedic Surgery with ARVIS | AR for Knee and ... ARVIS is a revolutionary new surgical guidance technology for joint replacement that uses augmented reality (AR) to provide your surgeon real-time information.