Cranio-spinal Neurosurgical Approaches
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorFondazione Policlinico Universitario Agostino Gemelli IRCCS
About this trial
The goal of this observational study is to learn how different cranio-spinal surgical approaches work and how much anatomical exposure each technique provides in donated human cadaver specimens. The study also aims to understand anatomical variations and to evaluate new surgical techniques and tools that may improve neurosurgical training and practice.
The main questions it aims to answer are:
* How much surgical exposure area and volume of work does each cranio-spinal approach allow? * How do anatomical variations influence the effectiveness and feasibility of different approaches? Researchers will also compare results obtained using different surgical visualization methods (such as the surgical microscope approach or macroscopic evaluation) to see if any method improves visibility or operative efficiency.
Cadaveric specimens will undergo:
* Step-by-step cranio-spinal surgical approaches performed by trained neurosurgeons. * Quantitative measurements of exposed anatomical areas using imaging software (BrainChop). * Assessment of operative time, perceived difficulty by surgeons, and visibility of target anatomical structures. * Testing of new surgical instruments or techniques when applicable, without involving any drugs or medical devices.
This study follows Italian regulations on post-mortem body donation for scientific research (Law No. 10/2020) and is conducted at a single research center recognized as an IRCCS (Istituto di Ricovero e Cura a Carattere Scientifico-Scientific Institute for Hospitalization and Care).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cadaveric specimens from individuals who provided informed consent for post-mortem donation of their body or tissues for scientific research.
Specimens that meet all legal requirements for anatomical donation under Italian Law No. 10/2020 and Presidential Decree (DPR) No. 47/2023.
Specimens that are available for the full duration of the study and suitable for performing multiple cranio-spinal surgical approaches.
Disqualifiers
Specimens that do not meet the legal or ethical requirements for anatomical donation as defined by Italian regulations.
Cadavers with major anatomical deformities, advanced tissue degradation, or pathological conditions that would interfere with surgical dissection or measurement accuracy.
Specimens lacking adequate documentation or verified donor consent for post-mortem donation.
Trial population
The study population consists of human cadaveric specimens voluntarily donated for scientific and educational purposes under Italian post-mortem donation regulations. Specimens are obtained through the anatomical donation program of the participating institution and represent a natural range of adult anatomical variability. These cadavers serve as preclinical anatomical models for evaluating cranio-spinal neurosurgical approaches in a controlled laboratory setting. The population provides diverse anatomical characteristics that allow systematic assessment of surgical exposure, feasibility, and technical performance across different surgical corridors.
Trial design
Design model
Case-only
Time perspective
Retrospective
Treatments tested in this trial
Standardized cranio-spinal neurosurgical approaches performed on donated cadaveric specimens to assess surgical exposure, feasibility, anatomical variation, and selected new techniques.
Procedure/SurgeryThis intervention consists of performing standardized cranio-spinal neurosurgical approaches on donated human cadaveric specimens to evaluate surgical exposure, operative feasibility, and anatomical variation in a preclinical setting. The procedures use both macroscopic and microscopic visualization systems. uantitative measurements of exposure area and operative workspace are obtained through dedicated imaging and navigation-based software. The intervention also allows controlled testing of new surgical tools or techniques, with surgeon-reported assessments of difficulty, visibility, and usability. In addition, hands-on dissection sessions are incorporated to support structured surgical training and technical skill development.
Treatment groups
35 Participants
are divided into 1 treatment groupGroup A: Cranio-Spinal Neurosurgical Approaches Using Cadaveric Specimens1 intervention
Trial outcomes
Primary outcomes
1
Quantification of Work Volume and Exposed Area in Cranio-Spinal Surgical Approaches
Work volume represents the three-dimensional operative space created by each cranio-spinal surgical approach. Quantification will be performed using BrainChop imaging software on standardized CT scans. Segmentation will follow predefined protocols to ensure reproducibility. Higher values indicate a larger and more accessible operative corridor. Unit of Measure: cubic millimeters (mm³).
Time frame
Measurements will be obtained twice for each approach on every specimen: before the dissection using baseline CT imaging and after completing the approach using repeat CT imaging on the same day.2
Exposed Anatomical Surface Area Obtained by Each Surgical Approach
Exposed Anatomical Surface Area Obtained by Each Surgical Approach Description: Exposed area corresponds to the two-dimensional anatomical surface revealed by each surgical approach. Measurements will be obtained from CT-based reconstructions using the same standardized segmentation workflow. Higher surface values reflect wider surgical exposure. Unit of Measure: square millimeter
Time frame
Measurements will be obtained twice for each approach on every specimen: before the dissection using baseline CT imaging and after completing the approach using repeat CT imaging on the same day.Locations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: