| Background:Ankle fracture is one of the most common fractures in the Emergency Trauma Department.The vast majority of ankle fractures are stable types which usually chose the typically conservative strategy with orthopedic cast treatment.Continuous use of non-ventilated standard cast immobilization markedly increases the rates of various complications,which severely affects patients' clinical efficacy and quality of life with lower satisfaction and compliance.With the development of the three-dimensional-printing technique,there are various 3D-printed orthoses studies have shown that they obtained the same efficacy compared to the traditional one with superior user satisfaction and compliance,and it also decreases the rates of various complications due to the long-term usage of conventional orthoses.Based on above-mentioned considerations,it is a top-priority to propose a novel 3D-printed Close-contact-cast(CCC)for the treatment of stable ankle fracture with favorite clinical efficacy and lower related complications.Objectives:The purpose of this study was to integrate both advantages of the close contact cast and 3D-printed methods,this study proposed a novel customized 3D printed orthopedic CCC with the advantages of detachable,anatomical proper-fit,light-weighted,ventilation through computer stimulation and topology optimization analysis.We hope this novel orthopedic CCC could provide stable support of the fracture area as well as lower rates of complications.Subsequently,this would propose a novel studying strategy in the rehabilitation orthoses field.Methods:Considering the design principles of Close Contact Cast technique and the detachable rehabilitation orthoses,this study proposed a novel 3D printed Close-contact-cast with computer-aided design software.After establishing the stimulation analysis platform of stable ankle fracture model and 3D-printed CCC,the finite element analysis(FEA)was used to stimulate whether this novel cast could protect the fracture area under different complicated high-level loading.In aim to reduce the weight and increase the permeability of this novel cast,topology optimization was subsequently carried out to minimize structural compliance and obtain the hollowed regions with OptiStruct module.Then the further step was to test different hollow structures with mechanical mechanics measurements to determines the optimal one.Based on all these processes,this project proposed a novel digital processes flowchart for fabricating this novel 3D-printed close contact cast of low extremity.The clinical study then conducted to compare 3D printed casts with conventional casts to evaluate clinical efficacy,safety,and patients' satisfactions.Results:The computer stimulation results showed no over-concentrated stress found at the fracture site and this validate that the novel cast could protect the fracture effectively.A 30%reduction of the volume was chosen as the optimal result in topology optimization.And the winter-sweet structure hollow was chosen as the optimal choice with mechanical mechanics test.The statistically significant differences between groups from the 3D-printed cast and the traditional one observed in C-QUEST2.0 were 11.3±1.5 points(95%CI 8.0 to 14.6;p=0.000<0.05),indicated the 3D-printed cast with superior satisfaction and compliance.Although the 3D-printed cast was not superior to the traditional cast in OMAS scores,note that the mean difference between 3D printing traditional for six weeks was 8.3±8.57 OMAS points(95%CI-10.8 to 27.5;p=0.354>0.05).There were no severe complications associated with this study,the common moderate complications in the traditional cast were observed in 3D-printed CCC,such as skin problems,joint stiffness,and muscular dystrophy.Conclusions:The 3D-printed close contact cast was successfully achieved with superior patient satisfaction,and has a favorable clinical efficacy comparable to the conventional cast.It could be as a digital option for the clinical treatment of stable ankle fractures. |
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