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Congreso

Contenidos del congreso
Congreso
XXVI Congreso Nacional de la Sociedad Española de Neurocirugía
Santander, 24-26 mayo 2023
Listado de sesiones
Comunicación
3. CIRUGÍA BASICRANEAL
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P-001 - A MULTICENTRIC, RANDOMIZED CONTROLLED TRIAL TO ASSESS THE PERFORMANCE AND SAFETY OF TWO DIFFERENT BONE FLAP FIXATION SYSTEMS FOR CRANIOTOMY PROCEDURES

á. Gómez de la Riva1, M. Rico Pereira2, M. Vorsic3, V. Rokavec3, C. Asencio Cortés2 and F. Muñoz Hernandez2

1Hospital Universitario La Paz, Madrid, Spain; 2Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; 3Maribor University Medical Centre, Maribor, Slovenia.

Introduction: Titanium plates and screws (P&S) is the most widely used system to close a craniotomy after a neurosurgical procedure.

Objectives: The aim of this study was to compare the clinical safety and performance of a PEEK-based clamp-like system (Cranial LOOP, NEOS Surgery, S.L.) with the standard of care system for craniotomy closure: P&S.

Methods: International multi-center, prospective, two-arm, randomized controlled trial. Sixty patients that had a craniotomy procedure were randomized to clamp-like (CLOOP) or P&S bone flap fixation systems. Subjects were evaluated at screening (pre-operative visit), during surgery, immediately post-surgery and mid-term follow-up. Main study variables were: bone flap alignment (MR/TC assessment), easiness of use, and the presence of bulges or discomfort associated to the closure system. Potential adverse effects of both closure systems were also monitored during the trial.

Results: A total of 60 patients (54.5 ± 16.2 years, 60% women) were randomized to P&S (n = 32) or CLOOP group (n = 28). The implantation of both closure systems was rated as Easy or Very easy (96.4% CLOOP and 100% P&S), but the surgeons were more satisfied with the CLOOP system (96.4% satisfied or very satisfied) than with P&S (84.4% satisfied or very satisfied, p = 0.049). After surgery, CLOOP achieved a perfect bone flap alignment in 89.3% of cases (n = 25), while 3 cases showed a slight protrusion; P&S achieved a perfect bone flap alignment in 87.5% of cases, while 3 cases showed a slight depression and one a slight protrusion. One patient implanted with P&S reported some discomfort associated with the closure system, and another one, visible bulges. No serious adverse events or device deficiencies were associated to any of the two systems evaluated.

Conclusions: Despite the widespread use of P&S versus clamping systems, our data shows that PEEK-based clamp-like devices perform equally, or even better, than P&S for fixation of the cranial bone flap.

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Neurocirugía
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