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Bone flap fixation with a polymeric clamp-like device in pediatric patients: a safe and effective method that allows

Daniel Demarchi1, Carlos Asencio-Cortés2

  • 1Neurosurgical Department at Sor María, Ludovica Children's Hospital, La Plata, Buenos Aires, Argentina. drdemarchi@gmail.com.

Child'S Nervous System : Chns : Official Journal of the International Society for Pediatric Neurosurgery
|February 2, 2026
PubMed

Insights

The Cranial LOOP device safely and effectively secures bone flaps after pediatric craniotomy, promoting bone growth and fusion. It is also safe for children under three years old, showing excellent results.

Area of Science:

  • Neurosurgery
  • Pediatric Surgery
  • Biomaterials

Background:

  • Craniotomy requires secure bone flap fixation for optimal healing.
  • Pediatric patients present unique challenges for bone flap fixation due to ongoing growth.

Purpose of the Study:

  • To evaluate the safety and efficacy of the Cranial LOOP device for pediatric craniotomy bone flap fixation.
  • To assess the off-label use of Cranial LOOP in children under three years old.

Main Methods:

  • Retrospective analysis of 60 pediatric patients using Cranial LOOP.
  • Assessment of bone stability, growth, alignment, fusion, esthetics, and complications via follow-up visits and CT scans.

Main Results:

  • All patients achieved adequate bone stability, growth, and alignment with satisfactory esthetic outcomes.
  • 90.5% of patients demonstrated bone fusion by one year post-surgery.
  • No postoperative complications related to the Cranial LOOP device were observed; off-label use yielded comparable results.

Conclusions:

  • Cranial LOOP is a safe and effective method for pediatric craniotomy fixation, supporting bone growth and fusion.
  • The device is suitable for use in children under three years old, with positive outcomes.
Abstract

Keywords:
Bone developmentCranial LOOPCraniotomyNeurosurgical procedures

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