Safety and efficacy of three-dimensional shaping of titanium plate in subtemporal repair of skull defects: study protocol for a data analysis of 38 patients

Abstract

Background and objectives: Repair of the damaged skull is necessary after decompressive craniectomy. Previously used autologous bone, allogeneic bone, and organic material are associated with the risk of an unsatisfactory cosmetic outcome and infection. Titanium mesh is an ideal material for cranioplasty. Digital three-dimensional shaping of titanium mesh allows it to perfectly match the skull defect and can restore the anatomic appearance of the defective area. Design: Retrospective case analysis. Methods: We analyzed the surgical and follow-up data of 38 patients with skull defects who underwent subtemporal repair using three-dimensional shaping of a titanium plate at the Department of Neurosurgery, Wujiang Hospital (The First People's Hospital of Wujiang District), Nantong University, China, from January 2015 to December 2016. Outcome measures: The primary outcome measure was the incidence of complications within 12 months after surgery. The secondary outcome measures were the Glasgow outcome scale score, Karnofsky performance scale score, National Institutes of Health stroke scale score, and skull computed tomography scan results at 1, 6, 12, 18, and 24 months after repair. Partial results have been obtained for 38 patients who have been followed up for 6 to 24 months. No complications or adverse reactions occurred. Skull computed tomography scan results revealed that the titanium mesh and nail were well fixed, the skull shape was symmetrical, and no subcutaneous effusion or intracranial hemorrhage occurred. Discussion: Complications, neurological function, and imaging findings in patients with frontotemporal skull defects provide an experimental basis for three-dimensional shaping of titanium plates in subtemporal repair of frontotemporal defects. Ethics and dissemination: The study design was completed in May 2017. The protocols had been approved by the Ethics Committee of The First People's Hospital of Wujiang District in June 2017. This trial was registered in October 2017. Data of patients, who were treated from January 2015 to December 2016, were analyzed in June 2017. Data analysis will be finished in December 2017. The results of the trial will be published in a peer-reviewed journal and will be disseminated via various forms of media. Trial registration: This trial has been registered in the Chinese Clinical Trial Registry (identifier: ChiCTR-IOC-17012947). All data collection and analysis are currently ongoing.