Long-Term Safety and Performance of a Polymeric Clamplike Cranial Fixation System

Abstract

After a craniotomy procedure to access the brain, neurosurgeons have several options to fix the bone flap to the skull. The aim of this study was to assess if a polymeric clamplike fixation system (Cranial LOOP) is a safe and reliable system that maintains over time an appropriate alignment of the bone flap. This is an observational, retrospective, case series study of 60 patients who underwent a craniotomy and were subject to cranial bone flap fixation with the Cranial LOOP fixation system. Baseline clinical parameters, surgical variables, medical records, and all postoperative medical images available were reviewed to assess the bone flap alignment and potential adverse events. A total of 182 Cranial LOOPs were implanted in the 60 patients (56.01 ± 20.21 years, 55% women) included in the study. The cranial fixation system maintained a good bone flap alignment in 95% of the patients studied immediately after surgery and in up to 96.7% of them at the end of follow-up. No intraoperative complications were reported. An ulcer potentially related to a device was detected, which was solved without the need for device removal. No artifacts were observed in any of the 219 medical images analyzed. Cranial LOOP is a safe and reliable postoperative long-term cranial bone flap fixation system. This device can fix the bone flap after a wide range of craniotomy procedures, performed in multiple locations, and provides good bone flap alignment. Cranial LOOP does not interfere in patient follow-up through medical imaging.