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

50 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this clinical trial is to analyze the effect of augmented reality (AR) on patient education and overall satisfaction when used during preoperative counseling in adults undergoing spinal surgery. The main aims of this study are: Aim 1: To determine if the use of AR in preoperative consultations is associated with higher levels of patient satisfaction, higher levels of confidence in surgeons, lower levels of preoperative anxiety, and lower patient reported pain scores. Aim 2: To determine if the use of AR in preoperative consultation will enhance patient education and understanding during the surgical consent process and lead to higher patient retention rates and new patient referrals. This study will compare AR enhanced preoperative patient counseling with conventional preoperative counseling practices.

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 data supports the idea that Augmented Reality for Neck Surgery Preparation is an effective treatment?

The available research shows that augmented reality (AR) is being used effectively in various surgical procedures, including spine and shoulder surgeries. For example, AR helps surgeons visualize complex anatomical structures and improve the accuracy of surgical procedures. In shoulder surgery, AR assists in the precise placement of components, which is crucial for avoiding complications. Although the research does not directly address neck surgery, the successful application of AR in similar surgeries suggests it could be beneficial for neck surgery preparation as well. ^{1 2 3 4 5}

What safety data exists for augmented reality in neck surgery preparation?

The available research primarily focuses on the use of augmented reality (AR) in spine and craniofacial surgeries, rather than specifically for neck surgery preparation. Studies have explored AR's role in navigation and planning, indicating potential benefits in safety and efficiency. However, direct safety data for AR in neck surgery preparation is limited, and more specific studies would be needed to draw definitive conclusions. ^{6 7 8 9 10}

Is Augmented Reality Enhanced Preoperative Counseling a promising treatment for neck surgery preparation?

Yes, Augmented Reality Enhanced Preoperative Counseling is promising because it can improve surgical planning and performance by providing a clear, interactive view of the surgery area. This helps doctors prepare better and potentially perform surgeries more accurately and efficiently. ^{4 7 8 11 12}

Research Team

Edward Andrews, MD

Principal Investigator

University of Pittsburgh Medical Center

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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]

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 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]

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]

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 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]

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]

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]

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 (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]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Glenoid Component Placement Assisted by Augmented Reality Through a Head-Mounted Display During Reverse Shoulder Arthroplasty. [2022]

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

Evaluating the Performance of Augmented Reality in Displaying Magnetic Resonance Imaging-Derived Three-Dimensional Holographic Models. [2021]

3. Germany pubmed.ncbi.nlm.nih.gov

On-patient see-through augmented reality based on visual SLAM. [2018]

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

Development of augmented-reality applications in otolaryngology-head and neck surgery. [2020]

5. Germany pubmed.ncbi.nlm.nih.gov

Implementation of augmented reality support in spine surgery. [2020]

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

Early Experience With Virtual and Synchronized Augmented Reality Platform for Preoperative Planning and Intraoperative Navigation: A Case Series. [2021]

7. Switzerland 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. [2023]

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

Utility of Augmented Reality and Virtual Reality in Spine Surgery: A Systematic Review of the Literature. [2022]

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

A Novel Precise Optical Navigation System for Craniomaxillofacial Surgery Registered With an Occlusal Splint. [2022]

10. England pubmed.ncbi.nlm.nih.gov

The application of augmented reality in craniofacial bone fracture reduction: study protocol for a randomized controlled trial. [2022]

11. Germany pubmed.ncbi.nlm.nih.gov

Augmented reality during parotid surgery: real-life evaluation of voice control of a head mounted display. [2023]

12. Germany pubmed.ncbi.nlm.nih.gov

Use of augmented reality for image-guided spine procedures. [2021]