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

Qualifiers

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 design

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.

Treatment groups

35 Participants
are divided into 1 treatment group

Locations

This trial has no locations