Comparing 3D and 2D Views in Biportal Spine Surgery: A Pilot Simulation Study

NCT07171801 | Not Yet Recruiting

• 1 other identifier: V1
• Study Type: interventional
• Target: 6
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to compare three-dimensional (3D) and two-dimensional (2D) visualization in biportal endoscopic spine surgery using a simulated environment. Surgeons will perform standardized tasks on a spine model while using either 3D or 2D endoscopic systems. The goal is to determine whether 3D technology can improve precision, efficiency, and movement control during surgery. The study uses a randomized, blinded, crossover design to ensure objective results and may help guide future training and technology use in spinal endoscopy.

Conditions

Spinal Diseases; Endoscopy Simulation; Lumbar Vertebrae; Randomized Controlled Trial; Three-Dimensional; Simulation Training

Outcome Measures

Primary Outcomes (2)

• Difference in Task Completion Time (seconds) and Error Rate During Spinal Endoscopic Simulation, Assessed Immediately Post-Task

  Task performance was assessed during standardized spinal endoscopic simulation tasks under both three-dimensional (3D) and two-dimensional (2D) visualization. Task completion time was measured in seconds with a digital stopwatch from the start to the successful completion of each task. Task accuracy was assessed as the number of predefined errors, including deviations from the optimal trajectory or inadvertent contact with marked "no-go" zones on the simulation model. Both measures were collected immediately during each simulation session. Lower times and fewer errors indicate better performance.

  Immediately during each simulation session (within minutes of task performance).

• Difference in Task Completion Time (seconds) and Error Rate During Spinal Endoscopic Simulation, Assessed Immediately Post-Task

  Task performance was assessed during standardized spinal endoscopic simulation tasks under both three-dimensional (3D) and two-dimensional (2D) visualization. Task completion time was measured in seconds with a digital stopwatch from the start to the successful completion of each task. Task accuracy was assessed as the number of predefined errors, including deviations from the optimal trajectory or inadvertent contact with marked "no-go" zones on the simulation model. Both measures were collected immediately during each simulation session. Lower times and fewer errors indicate better performanc

  Immediately during each simulation session (within minutes of task performance).

Study Arms (2)

Three-Dimensional Endoscopy First, Then Two-Dimensional

OTHER

Participants first perform standardized spinal endoscopic simulation tasks using a stereoscopic three-dimensional (3D) endoscopic system providing binocular depth perception via dual optical channels and polarized glasses. After completing all tasks under 3D visualization, the same participants subsequently repeat the identical tasks using conventional two-dimensional (2D) visualization on the same high-definition endoscopic platform

Device: Three-Dimensional Endoscopic Visualization; Device: Two-Dimensional Endoscopic Visualization

Two-Dimensional Endoscopy First, Then Three-Dimensional

OTHER

Participants first perform standardized spinal endoscopic simulation tasks using conventional two-dimensional (2D) visualization, with stereoscopic capability deactivated, displaying a monoscopic high-definition image. After completing all tasks under 2D visualization, the same participants subsequently repeat the identical tasks using stereoscopic three-dimensional (3D) visualization on the same endoscopic platform, viewed with polarized glasses.

Device: Three-Dimensional Endoscopic Visualization; Device: Two-Dimensional Endoscopic Visualization

Interventions

Three-Dimensional Endoscopic Visualization DEVICE

Use of a stereoscopic 3D high-definition endoscopic system with dual optical channels, projecting to a stereoscopic monitor viewed with polarized glasses, to perform standardized spinal simulation tasks.

Three-Dimensional Endoscopy First, Then Two-Dimensional; Two-Dimensional Endoscopy First, Then Three-Dimensional

Two-Dimensional Endoscopic Visualization DEVICE

Use of the same high-definition endoscopic system with stereoscopic function deactivated, providing conventional monoscopic two-dimensional visualization, to perform standardized spinal simulation tasks.

Three-Dimensional Endoscopy First, Then Two-Dimensional; Two-Dimensional Endoscopy First, Then Three-Dimensional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Enrolled in the neurosurgical residency or fellowship program at the Department of Neurosurgery, Cantonal Hospital of St. Gallen, Switzerland
• Completion of basic neurosurgical training modules, including introductory endoscopic handling
• Age ≥ 18 years
• Willingness and ability to provide informed consent

You may not qualify if:

• Prior substantial experience with three-dimensional (3D) endoscopy (defined as \> 5 independent procedures performed with 3D visualization systems)
• Ocular or neurological conditions impairing stereopsis, fine motor control, or safe endoscope handling
• Inability or unwillingness to complete the simulation protocol
• Declined participation

Sponsors & Collaborators

• Felix Corr: lead

Related Publications (3)

• Ban Y, Mcneely B, Chadha NK, Felton M. Safety and efficacy of three-dimensional versus two-dimensional endoscopy in otolaryngology surgery and training: A systematic review. Clin Otolaryngol. 2024 Sep;49(5):538-551. doi: 10.1111/coa.14171. Epub 2024 May 12.

  PMID: 38735751 BACKGROUND

• Heo DH, Kim JY, Park JY, Kim JS, Kim HS, Roh J, Park CK, Chung H. Clinical Experiences of 3-Dimensional Biportal Endoscopic Spine Surgery for Lumbar Degenerative Disease. Oper Neurosurg. 2022 Apr 1;22(4):231-238. doi: 10.1227/ONS.0000000000000090.

  PMID: 35147593 BACKGROUND

• Ma A, Xie N, Reidy J, Mobbs RJ. Three-dimensional endoscopy in lumbar spine surgery as a novel approach for degenerative pathologies: a case report. J Surg Case Rep. 2024 Aug 28;2024(8):rjae540. doi: 10.1093/jscr/rjae540. eCollection 2024 Aug.

  PMID: 39211372 BACKGROUND

MeSH Terms

Conditions

Spinal Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Stefan Motov, MD

  Kantonsspital St. Gallen, Health Ostschweiz

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Felix Corr, MD, MSc.

CONTACT

+41 71 494 1636; felix.corr@h-och.ch

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: In this single-center crossover simulation study, outcomes assessors responsible for performance evaluation and motion data analysis are blinded to the visualization modality used during each session (3D or 2D). Participants are not blinded due to the inherent perceptual differences between the two visualization systems. Investigators supervising the simulation are aware of the intervention assignments for operational purposes but are not involved in outcome assessment. All video and motion tracking data are anonymized and coded prior to analysis to maintain assessor blinding.
• Purpose: DEVICE FEASIBILITY
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Stefan Motov

Model Details: This study employs a randomized, single-center, blinded, crossover design in a high-fidelity simulated surgical environment. Each participant performs standardized unilateral biportal endoscopic spine surgery tasks using both 2D and 3D visualization systems in a randomized sequence. A washout period is incorporated between conditions to minimize carryover effects. This within-subjects crossover model allows each participant to serve as their own control, increasing statistical power and reducing inter-individual variability. Blinding is maintained for performance assessors, and objective motion tracking metrics are used to evaluate technical performance under each visualization condition.

Study Record Dates

• First Submitted: September 6, 2025
• First Posted: September 15, 2025
• Study Start: October 1, 2025
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: September 16, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share