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Biomechanical Variability and Usability of a Novel Customizable Fracture Fixation Technique.

ABSTRACT: A novel in situ customizable osteosynthesis technique, Bonevolent™ AdhFix, demonstrates promising biomechanical properties under the expertise of a single trained operator. This study assesses inter- and intra-surgeon biomechanical variability and usability of the AdhFix osteosynthesis platform. Six surgeons conducted ten osteosyntheses on a synthetic bone fracture model after reviewing an instruction manual and completing one supervised osteosynthesis. Samples underwent 4-point bending tests at a quasi-static loading rate, and the maximum bending moment (BM), bending stiffness (BS), and AdhFix cross-sectional area (CSA: mm²) were evaluated. All constructs exhibited a consistent appearance and were suitable for biomechanical testing. The mean BM was 2.64 ± 0.57 Nm, and the mean BS was 4.35 ± 0.44 Nm/mm. Statistically significant differences were observed among the six surgeons in BM (p < 0.001) and BS (p = 0.004). Throughout ten trials, only one surgeon demonstrated a significant improvement in BM (p < 0.025), and another showed a significant improvement in BS (p < 0.01). A larger CSA corresponded to a statistically significantly higher value for BM (p < 0.001) but not for BS (p = 0.594). In conclusion, this study found consistent biomechanical stability both across and within the surgeons included, suggesting that the AdhFix osteosynthesis platform can be learned and applied with minimal training and, therefore, might be a clinically viable fracture fixation technique. The variability in BM and BS observed is not expected to have a clinical impact, but future clinical studies are warranted.

SUBMITTER: Colding-Rasmussen T

PROVIDER: S-EPMC10604275 | biostudies-literature | 2023 Sep

REPOSITORIES: biostudies-literature

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Biomechanical Variability and Usability of a Novel Customizable Fracture Fixation Technique.

Colding-Rasmussen Thomas T Schwarzenberg Peter P Horstmann Peter Frederik PF Ottesen Casper Bent Smedegaard CBS Garcia Jorge San Jacinto JSJ Hutchinson Daniel John DJ Malkoch Michael M Petersen Michael Mørk MM Varga Peter P Tierp-Wong Christian Nai En CNE

Bioengineering (Basel, Switzerland) 20230929 10

A novel in situ customizable osteosynthesis technique, Bonevolent™ AdhFix, demonstrates promising biomechanical properties under the expertise of a single trained operator. This study assesses inter- and intra-surgeon biomechanical variability and usability of the AdhFix osteosynthesis platform. Six surgeons conducted ten osteosyntheses on a synthetic bone fracture model after reviewing an instruction manual and completing one supervised osteosynthesis. Samples underwent 4-point bending tests at ...[more]

PMID: 37892877

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Project description:PurposeThe purpose of this study was to investigate finite element biomechanical properties of the novel transpedicular transdiscal (TPTD) screw fixation with interbody arthrodesis technique in lumbar spine.MethodsAn L4-L5 finite element model was established and validated. Then, two fixation models, TPTD screw system and bilateral pedicle screw system (BPSS), were established on the validated L4-L5 finite element model. The inferior surface of the L5 vertebra was set immobilised, and moment of 7.5 Nm was applied on the L4 vertebra to test the range of motion (ROM) and stress at flexion, extension, lateral bending and axial rotation.ResultsThe intact model was validated for prediction accuracy by comparing two previously published studies. Both of TPTD and BPSS fixation models displayed decreased motion at L4-L5. The ROMs of six moments of flexion, extension, left lateral bending, right lateral bending, left axial rotation and right axial rotation in TPTD model were 1.92, 2.12, 1.10, 1.11, 0.90 and 0.87°, respectively; in BPSS model, they were 1.48, 0.42, 0.35, 0.38, 0.74 and 0.75°, respectively. The screws' peak stress of above six moments in TPTD model was 182.58, 272.75, 133.01, 137.36, 155.48 and 150.50 MPa, respectively; and in BPSS model, it was 103.16, 129.74, 120.28, 134.62, 180.84 and 169.76 MPa, respectively.ConclusionBoth BPSS and TPTD can provide stable biomechanical properties for lumbar spine. The decreased ROM of flexion, extension and lateral bending was slightly more in BPSS model than in TPTD model, but TPTD model had similar ROM of axial rotation with BPSS model. The screws' peak stress of TPTD screw focused on the L4-L5 intervertebral space region, and more caution should be put at this site for the fatigue breakage.The translational potential of this articleOur finite element study provides the biomechanical properties of novel TPTD screw fixation, and promotes this novel transpedicular transdiscal screw fixation with interbody arthrodesis technique be used clinically.

Project description:Titanium fixation devices are the gold standard for the treatment of mandibular fractures; however, they present serious limitations, such as non-degradability and generation of imaging artifacts. As an alternative, biodegradable magnesium alloys have lately drawn attention due to their biodegradability and biocompatibility. In addition, magnesium alloys offer a relatively high modulus of elasticity in comparison to biodegradable polymers, being a potential option to substitute titanium in highly loaded anatomical areas, such as the mandible. This study aimed to evaluate the biomechanical competence of magnesium alloy WE43 plates for mandibular fracture fixation in comparison to the clinical standard or even softer polymer solutions. A 3D finite element model of the human mandible was developed, and four different fracture scenarios were simulated, together with physiological post-operative loading and boundary conditions. In a systematic comparison, the material properties of titanium alloy Ti-6Al-4V, magnesium alloy WE43, and polylactic acid (PLA) were assigned to the fixation devices, and two different plate thicknesses were tested. No failure was predicted in the fixation devices for any of the tested materials. Moreover, the magnesium and titanium fixation devices induced a similar amount of strain within the healing regions. On the other hand, the PLA devices led to higher mechanical strains within the healing region. Plate thickness only slightly influenced the primary fixation stability. Therefore, magnesium alloy WE43 fixation devices seem to provide a suitable biomechanical environment to support mandibular fracture healing in the early stages of bone healing. Magnesium WE43 showed a biomechanical performance similar to clinically used titanium devices with the added advantages of biodegradability and radiopacity, and at the same time it showed a remarkably higher primary stability compared to PLA fixation devices, which appear to be too unstable, especially in the posterior and more loaded mandibular fracture cases.

Dataset Information

Biomechanical Variability and Usability of a Novel Customizable Fracture Fixation Technique.

Publications

Biomechanical Variability and Usability of a Novel Customizable Fracture Fixation Technique.

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