Augmented Reality for Neck Surgery Preparation

Overseen By Michael R Kann, BE

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Pittsburgh

Disqualifiers: Prior surgery, Vestibular dysfunction, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how augmented reality (AR) can improve patient education and satisfaction during pre-surgery consultations for spinal procedures. Researchers aim to determine if AR use increases patient confidence in surgeons, reduces anxiety, and simplifies information comprehension. Participants will be divided into two groups: one will receive standard counseling, while the other will use AR tools to visualize their condition and procedure through Augmented Reality Enhanced Preoperative Counseling. Suitable candidates for this trial are adults planning to undergo anterior cervical discectomy and fusion (ACDF) who have not had prior surgery. As an unphased trial, this study offers a unique opportunity to explore innovative technology that could enhance the surgical experience and outcomes.

Do I need to stop my current medications for this trial?

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

What prior data suggests that augmented reality is safe for preoperative counseling?

Research has shown that using augmented reality (AR) in medical settings is generally safe and well-received. In one study, patients who used AR to prepare for surgery felt less anxious, suggesting that AR can help calm nerves. Another study found that AR helped patients understand surgical procedures better without causing any harm.

No reports of serious side effects have emerged from using AR in these situations. Since this trial uses AR to explain what will happen before surgery, it is not expected to pose any safety risks. AR is already used in healthcare to help patients understand surgeries more clearly.

Overall, AR appears to be a safe and effective tool for medical education and planning, with strong evidence supporting its use without causing problems. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the use of Augmented Reality (AR) in neck surgery preparation because it takes preoperative counseling to a whole new level. Unlike the standard approach, which relies on verbal explanations and 2D images, AR allows both the patient and surgeon to interact with a 3D holographic model of the patient's anatomy. This method helps patients better understand their specific condition and the surgical steps, making the process more engaging and informative. By providing an immersive and personalized experience, AR could potentially improve patient comprehension and satisfaction, which are essential for successful surgical outcomes.

What evidence suggests that augmented reality is effective for preoperative counseling in spinal surgery?

Research has shown that augmented reality (AR), which participants in this trial may receive as part of the Augmented Reality Enhanced Patient Pre-operative Counseling arm, can greatly improve surgical preparation. Studies have found that AR reduces patient anxiety before surgery compared to traditional methods. It also enhances patients' understanding of the procedure and satisfaction with the information provided. By using interactive 3D models, this technology explains the surgery more clearly, boosting patients' confidence in their surgical team. Overall, AR in pre-surgery settings appears promising for helping patients feel more informed and at ease. ^{1 4 6 7 8}

Who Is on the Research Team?

Edward Andrews, MD

Principal Investigator

University of Pittsburgh Medical Center

Are You a Good Fit for This Trial?

This trial is for older adults who are about to undergo spinal surgery, specifically neck surgery or Transforaminal Lumbar Interbody Fusion. Participants should be interested in how pre-operative education is delivered and willing to experience a new technology (AR) as part of their surgical preparation.

Inclusion Criteria

I am scheduled for spine surgery (ACDF or TLIF).

I am 65 years old or older.

Exclusion Criteria

I have difficulty with memory or thinking clearly.

History of vestibular dysfunction

I have not had any emergency medical procedures recently.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Preoperative Counseling

Participants receive either standard or AR-enhanced preoperative counseling to improve understanding and satisfaction

1 day

1 visit (in-person)

Surgery

Participants undergo elective spinal surgery

1 day

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction, pain levels, and confidence in the surgeon post-operatively

6 months

Multiple visits (in-person and virtual)

What Are the Treatments Tested in This Trial?

Interventions

• Augmented Reality Enhanced Preoperative Counseling

Trial Overview

The study is testing if using Augmented Reality (AR) during pre-op consultations can improve patient satisfaction, confidence in surgeons, reduce anxiety and pain levels compared to standard counseling. It will also see if AR improves understanding of the surgery and increases retention rates and referrals.

How Is the Trial Designed?

Group I: Augmented Reality Enhanced Patient Pre-operative Counseling Experimental Treatment 1 Intervention

This group of patients will undergo AR enhanced preoperative counseling. Surgeons will be provided with the same checklist of mandatory minimum information patients must receive during counseling as the control group. Both the patient and physician will wear an AR-headset. Medivis AnatomyX, a generic holographic anatomy visualization available on all AR-headset devices, will first be used to introduce the patient to normal anatomy and describe the steps of the procedure. Using Surgical AR, the patients specific imaging will then be accessed through the Medivis mobile workstation and projected into a 3D interactive model. The surgeon will use this model to highlight the patients pathology, explain how it is causing their symptoms, and review possible complications. The surgeon may refer back to the generic model in AnatomyX at any point during counseling.

Group II: Standard Patient Pre-operative Counseling Active Control 1 Intervention

These patients will undergo standard preoperative counseling. A standardized checklist will designate the mandatory information patients must receive during counseling including a description of the normal elements of the anatomy and abnormal elements of the anatomy relevant to each patient, a description of the basic steps of the surgical procedure and how it addresses each patient's individual problem, and a description of the potential risks, complications, and benefits of the procedure. Surgeons may augment the verbal descriptions of the preoperative counseling procedure with patient 2D MRI or CT imaging or generic 3D models or drawings. However, customized patient specific 3D printed models are not allowed.

Augmented Reality Enhanced Preoperative Counseling is already approved in United States, European Union for the following indications:

Approved in United States as Augmented Reality Enhanced Preoperative Counseling for:

• Preoperative education for spinal surgery

Approved in European Union as AR-enhanced preoperative counseling for:

• Patient education for surgical procedures
• Preoperative anxiety reduction

Who Is Running the Clinical Trial?

University of Pittsburgh

Lead Sponsor

Trials

1,820

Recruited

16,360,000+

Published Research Related to This Trial

Augmented reality (AR) navigation, including a virtual needle, was successfully used in 18 percutaneous spine procedures on 10 patients, demonstrating its potential to enhance accuracy in surgical planning and execution.

The study found no significant difference in target acquisition accuracy between AR-guided procedures and control data from a phantom model, suggesting that AR is a reliable tool for improving minimally invasive spine surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of augmented reality for image-guided spine procedures. Gibby, J., Cvetko, S., Javan, R., et al.[2021]

Navigated augmented reality (AR) systems can significantly enhance the accuracy of glenoid component positioning in reverse shoulder arthroplasty, especially in cases of severe deformity or limited visibility.

The use of head-mounted displays (HMD) allows surgeons to visualize real-time virtual information overlaid on the surgical field, improving the translation of preoperative plans into actual surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Glenoid Component Placement Assisted by Augmented Reality Through a Head-Mounted Display During Reverse Shoulder Arthroplasty. Rojas, JT., Lädermann, A., Ho, SWL., et al.[2022]

The new occlusal splint-based optical navigation system demonstrated high accuracy in craniomaxillofacial surgery, with average position deviations of only 0.01 mm to 0.26 mm and angle deviations of less than 1 degree, based on a study involving 10 beagle dogs.

The system's precision meets clinical requirements, suggesting it can significantly enhance surgical accuracy and outcomes in complex procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Novel Precise Optical Navigation System for Craniomaxillofacial Surgery Registered With an Occlusal Splint. Hou, Y., Chai, G., Qi, Z.[2022]

The augmented reality (AR) application demonstrated high accuracy in representing MR-derived three-dimensional models, showing no significant difference from gold standard (GS) measurements in a study involving 30 measurements on an MRI phantom.

The AR caliper tool showed a mean squared error (MSE) of 0.3%, indicating it is a precise tool for measurements, although it was slightly less accurate than traditional physical calipers, with all measurements remaining within acceptable limits for clinical use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluating the Performance of Augmented Reality in Displaying Magnetic Resonance Imaging-Derived Three-Dimensional Holographic Models. Chang, F., Laguna, B., Uribe, J., et al.[2021]

A systematic review of 15 studies involving 241 patients demonstrated that augmented reality (AR), virtual reality (VR), and mixed reality (MR) technologies used in spine surgery led to improvements in patient symptoms, indicating their efficacy in clinical practice.

The highest complication rate observed was 6.1% related to pedicle screw placement, but importantly, none of these complications resulted in lasting clinical issues, suggesting a favorable safety profile for these technologies in live surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Utility of Augmented Reality and Virtual Reality in Spine Surgery: A Systematic Review of the Literature. Sumdani, H., Aguilar-Salinas, P., Avila, MJ., et al.[2022]

In a study evaluating voice control for augmented reality in parotid surgery, 100% of voice commands were recognized in silence, but recognition dropped significantly in noisy environments, particularly when background noise exceeded 42 dB.

Male voices had a better recognition rate than female voices at a constant volume, but increasing speech volume could help improve command recognition, highlighting the importance of managing ambient noise during surgical procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented reality during parotid surgery: real-life evaluation of voice control of a head mounted display. Scherl, C., Männle, D., Rotter, N., et al.[2023]

Augmented-reality head-mounted devices (AR-HMDs) for guiding spine surgeries show similar clinical outcomes to more expensive robot-assisted surgical systems, suggesting they are a viable alternative.

The research indicates that AR-HMD technology is becoming ready for clinical use, with the potential for further validation through larger, standardized clinical trials in the future.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Augmented or Mixed Reality Enhanced Head-Mounted Display Navigation for In Vivo Spine Surgery: A Systematic Review of Clinical Outcomes. Móga, K., Hölgyesi, Á., Zrubka, Z., et al.[2023]

A novel augmented reality (AR) system was developed for head and neck surgery, allowing surgeons to visualize 3D models of anatomy with an average accuracy error of just 2.47 mm, enhancing the precision of surgical procedures.

The face validity study indicated that otolaryngologists found the AR system potentially beneficial for improving safety and efficiency during surgeries, suggesting it could be a valuable tool in the operating room.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development of augmented-reality applications in otolaryngology-head and neck surgery. Rose, AS., Kim, H., Fuchs, H., et al.[2020]

This study will assess the efficacy and safety of an augmented reality (AR) navigation system in performing surgeries for zygomaticomaxillary complex fractures, involving 22 patients divided into two groups.

The primary focus will be on the accuracy of surgical outcomes compared to preoperative plans, while secondary measures will include blood loss, operation time, and complication rates, aiming to demonstrate that AR can enhance surgical precision and reduce recovery times.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The application of augmented reality in craniofacial bone fracture reduction: study protocol for a randomized controlled trial. Lin, L., Liu, X., Gao, Y., et al.[2022]

The augmented reality system allows for accurate visualization of a 3D preoperative anatomical model during surgery using just a tablet-PC and camera, without the need for external tracking devices or artificial landmarks.

The system demonstrated real-time alignment accuracy of about 5 mm, even when anatomical reference points were not visible, making it a practical tool that integrates smoothly into surgical workflows with minimal disruption to medical staff.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

On-patient see-through augmented reality based on visual SLAM. Mahmoud, N., Grasa, ÓG., Nicolau, SA., et al.[2018]

A new augmented reality (AR) system for spine surgery was successfully implemented, using intraoperative computed tomography (iCT) to achieve high navigational accuracy with a mean registration error of only about 1 mm in 10 patients.

The use of low-dose iCT significantly reduced radiation exposure by 70%, making the procedure safer while providing intuitive 3-D visualizations of anatomical structures during surgery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of augmented reality support in spine surgery. Carl, B., Bopp, M., Saß, B., et al.[2020]

The VR/AR platform, SyncAR, was used in 49 patients for preoperative planning and intraoperative guidance, showing no complications and enhancing the understanding of patient-specific anatomy during surgery.

The use of SyncAR allowed for more precise craniotomy planning and execution, with gross total resection achieved in 34 out of 40 surgeries, indicating its effectiveness in improving surgical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Experience With Virtual and Synchronized Augmented Reality Platform for Preoperative Planning and Intraoperative Navigation: A Case Series. Louis, RG., Steinberg, GK., Duma, C., et al.[2021]

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In this randomized clinical trial, the use of AR decreased preoperative anxiety compared with traditional perioperative education and handouts.

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This study evaluates the effectiveness of AR-enhanced preoperative counseling compared to conventional methods for patients undergoing anterior cervical ...

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This randomized clinical trial assesses whether the use of an augmented reality walkthrough of the day of surgery reduces patient perioperative anxiety.

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This study provides a comprehensive review of the advancements in the application of Augmented Reality (AR) technology for perioperative visual guidance.

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Virtual and Augmented Reality in Spine Surgery

This systematic review summarizes the use of AR/VR technology in surgical education, preoperative planning, and intraoperative guidance.