ABSTRACT
Introduction Cranioplasty is performed by placing an artificial plate in place of a patient's native skull bones to repair post-craniectomy defects after trauma. Implanted materials can range from titanium to synthetic polyether derivatives and are produced by multiple manufacturers. There are few studies characterizing complications associated with these cranioplasty plates to date. We aimed to quantify and categorize complications of these devices using a national federal database. Methods The Manufacturer and User Facility Device Experience (MAUDE) database was queried for all entries reported under the category "plate, cranioplasty, preformed, non-alterable" with the additional product code GXN between the time range from September 1, 2010, to September 1, 2020. After data extraction, each of the entries was screened for duplicates and tabulated into different categories of complications. Additionally, product information such as the plate manufacturer was extracted from each entry. Results The search yielded 329 unique event reports. The most frequent complications were infection (39%), followed by incorrectly fitting implants (30%) and implant breaks (6%). Other major complications included cerebrospinal fluid leakage and cerebral edema (5%), wound dehiscence (5%), and migration of hardware (3%). The brands associated with the most entries in the database were the Synthes (DePuy Synthes Companies, Massachusetts, United States) polyetheretherketone (PEEK) patient-specific implants (PSI) (57%), the Biomet (Zimmer Biome, Indiana, United States) hard tissue replacement-polyetherketoneketone (HTR-PEKK) patient-matched implant (PMI) (23%), and the AccuShape PEEK PSI (MedCAD, Dallas, USA) (5%). Conclusions Infection and improperly fitting implants appear to be the two most frequent complications of cranioplasty plates. The goals of future research should include the prevention of plate infections as well as improving techniques to custom-fit implantable devices.
ABSTRACT
STUDY DESIGN: This was a systematic review and meta-analysis. OBJECTIVE: The objective was (1) to measure rates of successful resolution of dysphagia in patients after undergoing surgical intervention for diffuse idiopathic skeletal hyperostosis (DISH); and (2) to determine if older age, longer duration of preoperative symptoms, or increased severity of disease was correlated with unsuccessful surgical intervention. SUMMARY OF BACKGROUND DATA: DISH, also known as Forestier disease, is an enthesopathy affecting up to 35% of the elderly population. Many patients develop osteophytes of the anterior cervical spine, which contribute to chronic symptoms of dysphagia causing debilitating weight loss and possibly resulting in the placement of a permanent gastrostomy feeding tube. For patients that fail conservative medical management, an increase in surgical interventions have been reported in the literature in the last 2 decades. MATERIALS AND METHODS: A systematic search was performed on PubMed, Medline, Cochrane Library, and Embase. Studies measuring outcomes after surgical intervention for patients with dysphagia from DISH were selected for inclusion. Two independent reviewers screened and assessed all literature in accordance with Cochrane systematic reviewing standards. RESULTS: In total, 22 studies reporting 119 patients were selected for inclusion. Successful relief of dysphagia was obtained in 89% of patients after surgical intervention. Failure to relieve dysphagia was associated with increased length of symptoms preoperatively (P<0.01) using logistic regression. Patients with more severe preoperative symptoms also seem to have an increased risk for treatment failure (risk ratio, 2.86; 95% confidence interval, 1.19-6.85; P=0.02). Treatment failure was not associated with patient age, use of intraoperative tracheostomy, implementation of additional fusion procedures, level of involved segments, or number of involved segments. CONCLUSIONS: Patients undergoing surgical intervention have a higher likelihood of failing surgery with increasing preoperative symptom length and increased preoperative symptom severity. LEVEL OF EVIDENCE: Level III.
