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.

In Vitro Analysis of Wearing of Hip Joint Prostheses Composed of Different Contact Materials.

Cobalt-chromium-molybdenum alloy (CoCrMo) and ceramic are the two most common materials for the femoral head in hip joint prostheses, and the acetabular liner is typically made from ultra-high molecular weight polyethylene (UHMWPE), highly cross-linked polyethylene (XLPE), or highly cross-linked polyethylene blended with Vitamin E (VEXLPE). The selection of suitable materials should consider both wear performance and cost-effectiveness. This study compared the wear rate between different friction pairs using a hip joint simulator and then recommended a suitable prosthesis based on the corresponding processing technology and cost. All wear simulations were performed in accordance with ISO 14242, using the same hip joint simulator and same test conditions. This study found that when using the same material for the femoral head, the XLPE and VEXLPE liners had a lower wear rate than the UHMWPE liners, and the wear rate of the XLPE liners increased after blending with Vitamin E (VEXLPE). There was no significant difference in the wear rate of XLPE when using a CoCrMo or ceramic head. Considering the wear rate and cost-effectiveness, a CoCrMo femoral head with an accompanying XLPE liner is recommended as the more suitable combination for hip prostheses.

Wear Assessment of Tibial Inserts Made of Highly Cross-Linked Polyethylene Supplemented with Dodecyl Gallate in the Total Knee Arthroplasty.

BACKGROUND: the wear of tibial insert is still one of primary factors leading to failure of total knee arthroplasty (TKA). Dodecyl gallate (DG) has shown improvements in the oxidation stability of highly cross-linked polyethylene (HXLPE). This study aimed to assess the application of HXLPE supplemented with DG (HXLPE-DG) on the tibial insert in TKA concerning the wear resistance and the potential impact on implant fixation; Methods: tibial inserts made of HXLPE-DG were subjected to a 3 million loading-cycle wear test following ISO 14243-1:2009. The loss of mass and wear rate of the tibial inserts were calculated. The quantity, size,- and shape of wear particles were recorded; Results: the test specimens lost an average mass of 16.00 mg ± 0.94 mg, and were on an average wear rate of 3.92 mg/million cycles ± 0.19 mg/million cycles. The content of wear particles in the calf serum medium was 3.94 × 108 particles/mL ± 3.93 × 107 particles/mL, 96.66% ± 0.77% of the particles had an equivalent circular diameter less than 0.5 µm. The aspect ratio of wear particles was 1.40 (min: 1.01; max: 6.42). CONCLUSIONS: HXLPE-DG displayed advantages over the commonly used materials for tibial inserts and presented the potential of application in TKA.

Restoration of Joint Inclination in Total Knee Arthroplasty Offers Little Improvement in Joint Kinematics in Neutrally Aligned Extremities.

Kinematically aligned total knee replacements have been shown to better restore physiological kinematics than mechanical alignment and also offer good postoperative satisfaction. The purpose of this study is to evaluate the extent to which an inclined joint line in a kinematically aligned knee can alter the postoperative kinematics. A multi-body dynamic simulation was used to identify kinematic changes in the joint. To accurately compare mechanical alignment, kinematic alignment and a natural knee, a "standard" patient with neutral alignment of the lower extremities was selected for modeling from a joint database. The arthroplasty models in this study were implanted with a single conventional cruciate-retaining prosthesis. Each model was subjected to a flexion movement and the anteroposterior translation of the femoral condyles was collected for kinematic analysis. The results showed that the mechanical alignment model underwent typical paradoxical anterior translation of the femoral condyles. Incorporating an inclined joint line in the model did not prevent the paradoxical anterior translation, but a 3° varus joint line in the kinematic alignment model could reduce the peak value of this motion by about 1 mm. Moreover, the inclined joint line did not restore the motion curve back to within the range of the kinematic curve of the natural knee. The results of this study suggest that an inclined joint line, as in the kinematic alignment model, can slightly suppress paradoxical anterior translation of the femoral condyles, but cannot restore kinematic motions similar to the physiological knee. This finding implies that prostheses intended to be used for kinematic alignment should be designed to optimize knee kinematics with the intention of restoring a physiological motion curve.

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.