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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Устройство Three-Dimensional Endoscopic Visualization
  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.
• Устройство Two-Dimensional Endoscopic Visualization
  Use of the same high-definition endoscopic system with stereoscopic function deactivated, providing conventional monoscopic two-dimensional visualization, to perform standardized spinal simulation tasks.

Первичные конечные точки

• Difference in Task Completion Time (seconds) and Error Rate During Spinal Endoscopic Simulation, Assessed Immediately Post-Task [Срок оценки: 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 [Срок оценки: Immediately during each simulation session (within minutes of task performance).]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Оценка устройства

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Публикации

• 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
• 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
• 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

Идентификаторы

NCT: NCT07171801 · V1

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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