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NCT Number: NCT07171801

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

Spinal endoscopy, particularly the unilateral biportal endoscopic (UBE) technique, is an increasingly adopted minimally invasive approach for treating lumbar spine pathologies. While it offers clinical advantages over traditional open surgery-including less tissue disruption, reduced blood loss, and faster recovery-its uptake has been limited, in part due to the technical challenges associated with two-dimensional (2D) endoscopic visualization. The lack of depth perception inherent to 2D imaging can impair spatial orientation, hand-eye coordination, and surgical precision, especially in anatomically complex regions such as the lumbar spine.

Three-dimensional (3D) endoscopic systems are designed to address this limitation by restoring binocular depth cues and providing stereoscopic visualization. Preliminary evidence from other surgical fields-such as laparoscopy and cranial neurosurgery-suggests that 3D visualization improves operative performance, task efficiency, and user confidence. However, the benefits of 3D visualization in spinal endoscopy remain poorly understood, with no rigorous controlled studies to date assessing its impact on performance metrics under standardized conditions.

This randomized, blinded, crossover pilot study is designed to objectively evaluate the effect of 3D versus 2D endoscopic visualization on technical performance during simulated UBE procedures. Participants-including surgeons at various experience levels-will complete standardized surgical tasks on high-fidelity lumbar spine models using both 2D and 3D endoscopic systems. Motion tracking technology will be employed to quantitatively analyze instrument movement, capturing key metrics such as path length, velocity, motion economy, and high-velocity excursions.

The crossover design ensures that each participant serves as their own control, and blinding minimizes observational bias during performance assessment. The simulation setting allows for reproducible conditions free from patient-related variability, ensuring that observed differences can be attributed to visualization modality rather than anatomical or clinical complexity.

Findings from this study will provide foundational data on the potential utility of 3D visualization in spinal endoscopy, with implications for surgical training, operative safety, and the future integration of stereoscopic technologies in spine surgery.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

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

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

    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.

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

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

    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

Study contacts

Contact information is provided by the study sponsor or research team.

Felix Corr, MD, MSc.

CONTACT

[email protected]

+41 71 494 1636

Sponsors and collaborators

Lead sponsor

Felix Corr

Other

Registry information

Official study title

3D vs. 2D Unilateral Biportal Endoscopic Spine Surgery: A Randomized Blinded Crossover Pilot Simulation Study

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Sep 15, 2025
Registry last updated
Sep 16, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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