A new device for bone cranial flap fixation: Technical note and surgical remarks. A multicentric experience

Area of Science:

• Neurosurgery
• Biomaterials
• Medical Devices

Background:

• Craniotomy bone flap fixation is a standard neurosurgical procedure.
• Current fixation methods aim for safety, reliability, ease of use, and minimal imaging artifacts.
• The development of improved fixation devices is crucial for patient outcomes.

Purpose of the Study:

• To evaluate the safety, reliability, and efficacy of the novel NT cranial small fixation system.
• To compare the NT cranial system with traditional titanium miniplates and screws.
• To assess bone flap position, fusion, and cosmetic results post-craniotomy.

Main Methods:

• An observational, multicentric case series study involving 56 patients.
• Fixation of cranial bone flaps using the NT cranial small fixation system.
• A case-control group utilized titanium miniplates and screws.
• Postoperative CT scans with 3D reconstruction at day 1 and day 90 evaluated bone flap fusion and position.

Main Results:

• 140 NT cranial small fixation devices were implanted in 56 patients.
• The NT system demonstrated stronger fixation qualities compared to controls.
• Optimal bone flap fusion and favorable cosmetic results were observed.
• No surgical or significant postsurgical complications were associated with the NT device.

Conclusions:

• The NT cranial small fixation system provides a safe and reliable method for postoperative cranial bone flap fixation.
• The system is easily applied and shows promising results in early-stage clinical use.
• Further investigation in larger patient cohorts is warranted to confirm these findings.