The orthopedic device industry relies heavily on clinical evaluation to confirm the safety, performance, and clinical benefits of its implants. Limited sample size often prevents these studies from capturing the full spectrum of patient variability and real-life implant use. The device industry is accustomed to simulating benchtop tests with numerical methods and recent developments now enable virtual “in silico clinical trials” (ISCT). In this article, we describe how the advancement of computer modeling has naturally led to ISCT; outline the potential benefits of ISCT to patients, healthcare systems, manufacturers, and regulators; and identify how hurdles associated with ISCT may be overcome. In particular, we highlight a process for defining the relevant patient risks to address with ISCT, the utility of a versatile software pipeline, the necessity to ensure model credibility, and the goal of limiting regulatory uncertainty. By complementing—not replacing—traditional clinical trials with computational evidence, ISCT provides a viable technical and regulatory strategy for characterizing the full spectrum of patients, clinical conditions, and configurations that are embodied in contemporary orthopedic implant systems.
Complex intraarticular distal radius fractures (DRFs), commonly managed with volar locking plates, are challenging. Combined volar and dorsal plating is frequently applied for treatment, however, biomechanical investigations are scant. The aim of this biomechanical study was to investigate volar plating versus double plating in DRFs with different degrees of lunate facet comminution.Thirty artificial radii with simulated AO/OTA 23-C2.1 and C3.1 DRFs, including dorsal defect and lunate facet comminution, were assigned to 3 groups: Group 1 with two equally-sized lunate facet fragments; Group 2 with small dorsal and large volar fragment; Group 3 with three equally-sized fragments. The specimens underwent volar and double locked plating and non-destructive ramped loading in 0° neutral position, 40° flexion and 40° extension.In each tested position, stiffness: (1) did not significantly differ among groups with same fixation method (p ≥ 0.15); (2) increased significantly after supplemental dorsal plating in Group 2 and Group 3 (p ≤ 0.02).Interfragmentary displacements between styloid process and lunate facet in neutral position were below 0.5 mm, being not significantly different among groups and plating techniques (p ≥ 0.63).Following volar plating, angular displacement of the lunate facet to radius shaft was significantly lower in Group 1 versus both Group 2 and Group 3 (p < 0.01). It decreased significantly after supplemental dorsal plating in Group 2 and Group 3 (p < 0.01), but not in Group 1 (p ≥ 0.13), and did not differ significantly among the three groups after double plating (p ≥ 0.74).Comminution of the lunate facet within its dorsal third significantly affected the biomechanical outcomes related to complex intraarticular DRFs treated with volar and double locked plates.Double plating demonstrates superior stability versus volar plating only for lunate facet comminution within its dorsal third. In contrast, volar plating could achieve stability comparable with double plating when the dorsal third of the lunate facet is not separated by the fracture pattern. Both fixation methods indicated achievable absolute stability between the articular fragments.
Objectives: To investigate the biomechanical competence of locked plating augmented with supplemental intramedullary graft in comparison to conventional locked plate fixation in proximal humerus fractures (PHF). Methods: Complex four-part PHFs were set in 30 artificial humeri assigned to 3 study groups (n = 10 in each group). Group 1 was characterized by loss of medial support, group 2 by simulated severe cancellous bone damage due to osteoporosis, and group 3 by combination of the 2 features. After locked plating, each specimen underwent nondestructive quasi-static mechanical testing in 25 degrees lateral angulation under axial loading between 150 and 400 N in 50-N increments, accompanied by consecutive anteroposterior x-ray imaging. Subsequently, an additional 3D-printed intramedullary graft was inserted into each specimen and all tests were repeated. Results: Grafting resulted in significantly higher axial stiffness compared with no graft in groups 1 and 3 (P < 0.01) but not in group 2 (P = 0.12). Nongrafted specimens represented significantly higher stiffness in group 2 compared with groups 1 and 3 (P < 0.01), whereas no significant differences were detected among the 3 groups in the grafted state (P > 0.99). Varus deformation decreased significantly in each group after graft insertion (P ≤ 0.04). Nongrafted specimens in group 2 showed significantly lower varus deformation compared with groups 1 and 3 (P ≤ 0.04). No significant differences were registered among the 3 groups after grafting (P ≥ 0.65). Conclusions: From a biomechanical perspective, locked plating augmented with intramedullary graft has the potential to increase significantly the stability against varus collapse in unstable PHFs when compared with conventional locked plate fixation.
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