A Multi-Criteria Assessment Strategy for 3D Printed Porous Polyetheretherketone (PEEK) Patient-Specific Implants for Orbital Wall Reconstruction.

Pure orbital blowout fractures occur within the confines of the internal orbital wall. Restoration of orbital form and volume is paramount to prevent functional and esthetic impairment. The anatomical peculiarity of the orbit has encouraged surgeons to develop implants with customized features to restore its architecture. This has resulted in worldwide clinical demand for patient-specific implants (PSIs) designed to fit precisely in the patient's unique anatomy. Material extrusion or Fused filament fabrication (FFF) three-dimensional (3D) printing technology has enabled the fabrication of implant-grade polymers such as Polyetheretherketone (PEEK), paving the way for a more sophisticated generation of biomaterials. This study evaluates the FFF 3D printed PEEK orbital mesh customized implants with a metric considering the relevant design, biomechanical, and morphological parameters. The performance of the implants is studied as a function of varying thicknesses and porous design constructs through a finite element (FE) based computational model and a decision matrix based statistical approach. The maximum stress values achieved in our results predict the high durability of the implants, and the maximum deformation values were under one-tenth of a millimeter (mm) domain in all the implant profile configurations. The circular patterned implant (0.9 mm) had the best performance score. The study demonstrates that compounding multi-design computational analysis with 3D printing can be beneficial for the optimal restoration of the orbital floor.

Quantitative Assessment of Point-of-Care 3D-Printed Patient-Specific Polyetheretherketone (PEEK) Cranial Implants.

Recent advancements in medical imaging, virtual surgical planning (VSP), and three-dimensional (3D) printing have potentially changed how today's craniomaxillofacial surgeons use patient information for customized treatments. Over the years, polyetheretherketone (PEEK) has emerged as the biomaterial of choice to reconstruct craniofacial defects. With advancements in additive manufacturing (AM) systems, prospects for the point-of-care (POC) 3D printing of PEEK patient-specific implants (PSIs) have emerged. Consequently, investigating the clinical reliability of POC-manufactured PEEK implants has become a necessary endeavor. Therefore, this paper aims to provide a quantitative assessment of POC-manufactured, 3D-printed PEEK PSIs for cranial reconstruction through characterization of the geometrical, morphological, and biomechanical aspects of the in-hospital 3D-printed PEEK cranial implants. The study results revealed that the printed customized cranial implants had high dimensional accuracy and repeatability, displaying clinically acceptable morphologic similarity concerning fit and contours continuity. From a biomechanical standpoint, it was noticed that the tested implants had variable peak load values with discrete fracture patterns and failed at a mean (SD) peak load of 798.38 ± 211.45 N. In conclusion, the results of this preclinical study are in line with cranial implant expectations; however, specific attributes have scope for further improvements.

Treatment effects in randomised trials using routinely collected data for outcome assessment versus traditional trials: meta-research study.

OBJECTIVE: To compare effect estimates of randomised clinical trials that use routinely collected data (RCD-RCT) for outcome ascertainment with traditional trials not using routinely collected data. DESIGN: Meta-research study. DATA SOURCE: Studies included in the same meta-analysis in a Cochrane review. ELIGIBILITY CRITERIA FOR STUDY SELECTION: Randomised clinical trials using any type of routinely collected data for outcome ascertainment, including from registries, electronic health records, and administrative databases, that were included in a meta-analysis of a Cochrane review on any clinical question and any health outcome together with traditional trials not using routinely collected data for outcome measurement. REVIEW METHODS: Effect estimates from trials using or not using routinely collected data were summarised in random effects meta-analyses. Agreement of (summary) treatment effect estimates from trials using routinely collected data and those not using such data was expressed as the ratio of odds ratios. Subgroup analyses explored effects in trials based on different types of routinely collected data. Two investigators independently assessed the quality of each data source. RESULTS: 84 RCD-RCTs and 463 traditional trials on 22 clinical questions were included. Trials using routinely collected data for outcome ascertainment showed 20% less favourable treatment effect estimates than traditional trials (ratio of odds ratios 0.80, 95% confidence interval 0.70 to 0.91, I2=14%). Results were similar across various types of outcomes (mortality outcomes: 0.92, 0.74 to 1.15, I2=12%; non-mortality outcomes: 0.71, 0.60 to 0.84, I2=8%), data sources (electronic health records: 0.81, 0.59 to 1.11, I2=28%; registries: 0.86, 0.75 to 0.99, I2=20%; administrative data: 0.84, 0.72 to 0.99, I2=0%), and data quality (high data quality: 0.82, 0.72 to 0.93, I2=0%). CONCLUSIONS: Randomised clinical trials using routinely collected data for outcome ascertainment show smaller treatment benefits than traditional trials not using routinely collected data. These differences could have implications for healthcare decision making and the application of real world evidence.

Accuracy Assessment of Molded, Patient-Specific Polymethylmethacrylate Craniofacial Implants Compared to Their 3D Printed Originals.

The use of patient-specific implants (PSIs) in craniofacial surgery is often limited due to a lack of expertise and/or production costs. Therefore, a simple and cost-efficient template-based fabrication workflow has been developed to overcome these disadvantages. The aim of this study is to assess the accuracy of PSIs made from their original templates. For a representative cranial defect (CRD) and a temporo-orbital defect (TOD), ten PSIs were made from polymethylmethacrylate (PMMA) using computer-aided design (CAD) and three-dimensional (3D) printing technology. These customized implants were measured and compared with their original 3D printed templates. The implants for the CRD revealed a root mean square (RMS) value ranging from 1.128 to 0.469 mm with a median RMS (Q1 to Q3) of 0.574 (0.528 to 0.701) mm. Those for the TOD revealed an RMS value ranging from 1.079 to 0.630 mm with a median RMS (Q1 to Q3) of 0.843 (0.635 to 0.943) mm. This study demonstrates that a highly precise duplication of PSIs can be achieved using this template-molding workflow. Thus, virtually planned implants can be accurately transferred into haptic PSIs. This workflow appears to offer a sophisticated solution for craniofacial reconstruction and continues to prove itself in daily clinical practice.