Failure analysis of a locking compression plate with asymmetric holes and polyaxial screws.

Locking compression plates (LCP) with asymmetrical holes and polyaxial screws are effective for treating mid-femoral fractures, but are prone to failure in cases of bone nonunion. To understand the failure mechanism of the LCP, this study assessed the material composition, microhardness, metallography, fractography and biomechanical performance of a retrieved LCP used for treating a bone fracture of AO type 32-A1. For the biomechanical assessment, a finite element surgical model implanted with the intact fixation-plate system was constructed to understand the stresses and structural stiffness on the construct. Also, to avoid positioning screws around the bone fracture, different working lengths of the plate (the distance between the two innermost screws) and screw inclinations (±5°, ±10° and ±15°) were investigated. The fracture site of the retrieved LCP was divided into a narrow side and broad side due to the asymmetrical distribution of holes on the plate. The results indicated that the chemical composition and microhardness of the LCP complied with ASTM standards. The fatigue failure was found to originate on the narrow side of the hole, while the broad side showed overloading characteristics of crack growth. When the screws were inserted away from the region of the bone fracture by increasing the working length, the stress of the fixation-plate system decreased. Regardless of the screw insertion angle, the maximum stress on the LCP always appeared on the narrow side, and there was little change in the structural stiffness. However, angling the screws at -10° resulted in the most even stress distribution on the fixation-plate system. In conclusion, the LCP assessed in this study failed by fatigue fracture due to bone nonunion and stress concentration. The narrow side of the LCP was vulnerable to failure and needs to be strengthened. When treating an AO type 32-A1 fracture using an LCP with asymmetrical holes and polyaxial screws, inserting the screws at -10° may reduce the risk of implant failure and positing screws around the fractured area of the bone should be avoided.

Biomechanical changes at the adjacent segments induced by a lordotic porous interbody fusion cage.

Biomechanical changes at the adjacent segments after interbody fusion are common instigators of adjacent segment degeneration (ASD). This study aims to investigate how the presence of a lordotic porous cage affects the biomechanical performance of the adjacent segments. A finite element model (FEM) of a lumbar spine implanted with a lordotic cage at L3-L4 was validated by in-vitro testing. The stress distribution on the cage and range of motion (ROM) of L3-L4 were used to assess the stability of the implant. Three angles of cage (0° = non-restoration, 7° = normal restoration and 11° = over-restoration) were modelled with different porosities (0%, 30% and 60%) and evaluated in the motions of flexion, extension, lateral bending and rotation. The ROM, intervertebral disc pressure (IDP) and facet joint force (FJF) were used to evaluate biomechanical changes at the adjacent segments in each model. The results indicated that porous cages produced more uniform stress distribution, but cage porosity did not influence the ROM, IDP and FJF at L2-L3 and L4-L5. Increasing the cage lordotic angle acted to decrease the ROM and IDP, and increase the FJF of L4-L5, but did not alter the ROM of L2-L3. In conclusion, changes in ROM, IDP and FJF at the adjacent segments were mainly influenced by the lordotic angle of the cage and not by the porosity. A larger angle of lordotic cage was shown to reduce the ROM and IDP, and increase the FJF of the lower segment (L4-L5), but had little effect on the ROM of the upper segment (L2-L3).

The Three-Dimensional Morphology of Femoral Medullary Cavity in the Developmental Dysplasia of the Hip.

OBJECTIVE: This study aimed to assess the morphology of the femoral medullary canal in subjects with developmental dysplasia of the hip (DDH) with the intent of improving the design of femoral stems in total hip arthroplasty. METHODS: Computed tomography images of 56 DDH hips, which were classified into Crowe I to Crowe IV, and 30 normal hips were collected and used to reconstruct three-dimensional morphology of the femoral medullary cavity. Images of twenty-one cross sections were taken from 20 mm above the apex of the lesser trochanter to the isthmus. The morphology of femoral cavity was evaluated on each cross section for the longest canal diameter, the femoral medullary torsion angle (FMTA), and the femoral medullary roundness index (FMRI). RESULTS: The Crowe IV group displayed the narrowest medullary canal in the region superior to the end of the lesser trochanter, but then gradually aligned with the medullary diameter of the other groups down to the isthmus. The FMTA along the femoral cavity increased with the severity of DDH, but the rate of variation of FMTA along the femoral canal was consistent in the DDH groups. The DDH hips generally showed a larger FMRI than the normal hips, indicating more elliptical shapes. CONCLUSION: A femoral stem with a cone shape in the proximal femur and a cylindrical shape for the remainder down to the isthmus may benefit the subjects with severe DDH. This design could protect bone, recover excessive femoral anteversion and facilitate the implantation in the narrow medullary canal.

Challenges of pre-clinical testing in orthopedic implant development.

The market for orthopedic implants is growing rapidly with the increasing prevalence of orthopedic diseases in an aging society. Different designs and materials have been developed over the years and have, in general, shown excellent results in pre-clinical testing. However, there have been incidences of serious complications when novel implants or materials are put into clinical use, with some well-known cases being metallosis in patients implanted with metal-on-metal hip replacements and osteolysis from polyethylene wear debris generated in hip and knee joint replacements. Unforeseen factors related to new designs, materials and surgical techniques can lead to different outcomes for pre-clinical testing and clinical use. While often an excellent indicator of a device's performance in clinical settings, pre-clinical testing does sometime fail to predict critical flaws in implant development. This article aims to explore the gaps in the current approach to testing. The ISO international standard of pre-clinical testing should be modified to more adequately capture actual clinical use of the implant and simulate daily activities. This article will also introduce modern methods for implant development, such as FEM, 3D printing and computer-aided orthopedic surgery, which can be widely applied to improve pre-clinical testing procedures and reduce the incidence of surgical malalignment by analyzing biomechanical performance, planning surgical procedure and providing surgical guide.