Micro-porous PLGA/ß-TCP/TPU scaffolds prepared by solvent-based 3D printing for bone tissue engineering purposes.

The 3D printing process of fused deposition modelling is an attractive fabrication approach to create tissue-engineered bone substitutes to regenerate large mandibular bone defects, but often lacks desired surface porosity for enhanced protein adsorption and cell adhesion. Solvent-based printing leads to the spontaneous formation of micropores on the scaffold's surface upon solvent removal, without the need for further post processing. Our aim is to create and characterize porous scaffolds using a new formulation composed of mechanically stable poly(lactic-co-glycol acid) and osteoconductive ß-tricalcium phosphate with and without the addition of elastic thermoplastic polyurethane prepared by solvent-based 3D-printing technique. Large-scale regenerative scaffolds can be 3D-printed with adequate fidelity and show porosity at multiple levels analysed via micro-computer tomography, scanning electron microscopy and N2 sorption. Superior mechanical properties compared to a commercially available calcium phosphate ink are demonstrated in compression and screw pull out tests. Biological assessments including cell activity assay and live-dead staining prove the scaffold's cytocompatibility. Osteoconductive properties are demonstrated by performing an osteogenic differentiation assay with primary human bone marrow mesenchymal stromal cells. We propose a versatile fabrication process to create porous 3D-printed scaffolds with adequate mechanical stability and osteoconductivity, both important characteristics for segmental mandibular bone reconstruction.

Advances in fixation strength of reorienting rectangular triple pelvic innominate osteotomies - A biomechanical investigation of two screw fixation techniques.

BACKGROUND: Reorientating pelvic osteotomies are performed to prevent femoral-acetabular impingement or degenerative arthritis. A Toennis-Kalchschmidt triple pelvis innominate osteotomy is used in symptomatic patients. This study aimed to investigate the biomechanical behaviour of two different acetabular screw configurations for triple pelvis innominate osteotomy osteosynthesis. METHODS: Two screw-orientation techniques in rectangular os ilium osteotomy were compared by osteotomising 12 artificial hemipelvises with triple pelvis innominate osteotomy protocol (fragment reorientation: 10.5° inclination and 10.0° anteversion) and randomising them in 2 groups (n = 6) for implantation with three 4.5 mm screws. Bidirectional group had a bidirectional screw orientation and Monoaxial group had a monoaxial direction of all three screws through iliac crest. All specimens were tested under progressively increasing cyclic loading until failure. Group-wise comparisons of acetabular cup medialisation, anteversion and inclination were evaluated via motion tracking at cycles 250, 500, 750, 1000, 1250, 1500, 1750, 2000, 2250, and 2500. Failure was defined as reaching 5° inclination or 5° anteversion. FINDINGS: Acetabular cup medialisation (p ≤ 0.026), anteversion (p ≤ 0.021) and inclination (p ≤ 0.039) all increased significantly during testing in both groups. There were no significant differences for the group-wise comparisons at the cycle points defined in the methods (p ≥ 0.182). No significant differences were detected between groups for cycles to failure and failure load (p = 0.873). INTERPRETATION: Bidirectional screw alignment does not lead to significant advantages compared to pure monoaxial if all three axial screws are evenly distributed over the osteotomy geometry. The triple pelvis innominate osteotomy is susceptible to changes in anteversion, inclination and medialisation under partial weight-bearing. Cautious rehabilitation protocols are recommended.

First Tarsometatarsal Joint Fusion in Foot-A Biomechanical Human Anatomical Specimen Analysis with Use of Low-Profile Nitinol Staples Acting as Continuous Compression Implants.

Background and Objectives: The aim of this study was to investigate under dynamic loading the potential biomechanical benefit of simulated first tarsometatarsal (TMT-1) fusion with low-profile superelastic nitinol staples used as continuous compression implants (CCIs) in two different configurations in comparison to crossed screws and locked plating in a human anatomical model. Materials and Methods: Thirty-two paired human anatomical lower legs were randomized to four groups for TMT-1 treatment via: (1) crossed-screws fixation with two 4.0 mm fully threaded lag screws; (2) plate-and-screw fixation with a 4.0 mm standard fully threaded cortex screw, inserted axially in lag fashion, and a 6-hole TMT-1 Variable-Angle (VA) Fusion Plate 2.4/2.7; (3) CCI fixation with two two-leg staples placed orthogonally to each other; (4) CCI fixation with one two-leg staple and one four-leg staple placed orthogonally to each other. Each specimen was biomechanically tested simulating forefoot weightbearing on the toes and metatarsals. The testing was performed at 35-37 °C under progressively increasing cyclic axial loading until construct failure, accompanied by motion tracking capturing movements in the joints. Results: Combined adduction and dorsiflexion movement of the TMT-1 joint in unloaded foot condition was associated with no significant differences among all pairs of groups (p ≥ 0.128). In contrast, the amplitude of this movement between unloaded and loaded foot conditions within each cycle was significantly bigger for the two CCI fixation techniques compared to both crossed-screws and plate-and-screw techniques (p ≤ 0.041). No significant differences were detected between the two CCI fixation techniques, as well as between the crossed-screws and plate-and-screw techniques (p ≥ 0.493) for this parameter of interest. Furthermore, displacements at the dorsal and plantar aspects of the TMT-1 joint in unloaded foot condition, together with their amplitudes, did not differ significantly among all pairs of groups (p ≥ 0.224). Conclusions: The low-profile superelastic nitinol staples demonstrate comparable biomechanical performance to established crossed-screws and plate-and-screw techniques applied for fusion of the first tarsometatarsal joint.

Volar versus combined dorsal and volar plate fixation of complex intraarticular distal radius fractures with small dorsoulnar fragment - a biomechanical study.

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.

In Silico Clinical Trials in the Orthopedic Device Industry: From Fantasy to Reality?

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.

Overdrilling increases the risk of screw perforation in locked plating of complex proximal humeral fractures - A biomechanical cadaveric study.

Locked plating of proximal humerus fractures (PHF) is associated with high failure rates (15-37%). Secondary screw perforation is a prominent mode of failure for PHF and typically requires reoperation. The anatomical fracture reduction is an essential factor to prevent fixation failure. However, recent studies indicate that the risk of secondary screw perforation may increase if the articular surface is perforated during predrilling of the screw boreholes (overdrilling). This study aimed to determine whether overdrilling increases the risk of secondary screw perforation in unstable PHF. Nine pairs of human cadaveric proximal humeri were osteotomized to simulate a malreduced and highly unstable 3-part fracture (AO/OTA 11 B1.1), followed by their assignment to two study groups for overdrilling or accurate predrilling in paired design, and fixation with a locking plate. Overdrilling was defined by drilling the calcar screw's boreholes through the articular surface. All humeri were cyclically loaded to screw perforation failure. Number of cycles to initial screw loosening and final perforation failure were analysed. The accurately predrilled group revealed a significantly higher number of cycles to both initial screw loosening (p < 0.01) and final screw perforation failure (p = 0.02), compared to the overdrilled one. This is the first study reporting that drilling to the correct depth significantly increases endurance until screw perforation failure during cyclic loading after locked plating in a highly unstable PHF model. Prevention of overdrilling the boreholes could help reduce failure rates of locked plating. Future work should investigate the prevalence and consequences of overdrilling in clinics.

Secondary Perforation Risk in Plate Osteosynthesis of Unstable Proximal Humerus Fractures: A Biomechanical Investigation of the Effect of Screw Length.

Secondary perforation of screws into the joint surface is a commonly reported mechanical fixation failure mode in locked plating of proximal humerus fractures (PHF). This study investigated the influence that screws tip to joint distance (TJD) has on the biomechanical risk of secondary screw perforation and the stability of PHF. Ten pairs of cadaveric proximal humeri with a wide range of bone mineral density were used. Each specimen was osteotomized and instrumented with the PHILOS plate, simulating a highly unstable 3-part fracture. Bones were randomized into a long screw group (LSG) with 4 mm TJD, or a short screw group (SSG) with 8 mm TJD. A custom biomechanical setup was used to test the samples to failure cyclically with a constant valley load and an increasing ramp. The number of cycles to the initial screw loosening event was significantly higher for the LSG (mean ± standard deviation: 17,532 ± 6,458) compared with the SSG (11,102 ± 5,440) (p < 0.01). The mode of failure during testing was lateral-inferior displacement combined with varus collapse, with calcar screws perforating first. The number of cycles to failure event for LSG (27,849 ± 5,648) was not significantly different compared with SSG (28,782 ± 7,307) (p = 0.50). Screws that purchase closer to the joint had better initial stability and resistance against loosening. Placing longer screws, within limits dictated by the surgical guide, is expected to decrease the risk of secondary perforation failures in unstable PHF. These findings require clinical corroboration. © 2019 Orthopaedic Research Society. Published by Wiley Periodicals, Inc. J Orthop Res 37:2625-2633, 2019.

Does Supplemental Intramedullary Grafting Increase Stability of Plated Proximal Humerus Fractures?

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.