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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07171801
Enrollment
6
Registered
2025-09-15
Start date
2025-10-01
Completion date
2025-12-01
Last updated
2025-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Detailed description

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.

Interventions

DEVICEThree-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.

DEVICETwo-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.

Sponsors

Felix Corr
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
DEVICE_FEASIBILITY
Masking
SINGLE (Outcomes Assessor)

Masking description

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.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

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

Contacts

Primary ContactFelix Corr, MD, MSc.
felix.corr@h-och.ch+41 71 494 1636

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026