Effect of bone quality and quantity on the primary stability of dental implants in a simulated bicortical placement.

OBJECTIVES: Conventional dental implants inserted in the molar region of the maxilla will reach into the sinus maxillaris when alveolar ridge height is limited. When surgery is performed without prior augmentation of the sinus floor, primary stability of the implant is important for successful osseointegration. This study aimed at identifying the impact of bone quality and quantity at the implantation site on primary implant stability of a simulated bicortical placement. MATERIALS AND METHODS: In our in vitro measurements, bone mineral density, total bone thickness and overall cortical bone thickness were assessed by micro-computed tomography (µCT) of pig scapulae, which resembled well the bicortical situation found in human patients. Dental implants were inserted, and micromotion between bone and implant was measured while loading the implant with an axial torque. RESULTS: The main findings were that primary implant stability did not depend on total bone thickness but tended to increase with either increasing bone mineral density or overall cortical bone thickness. CLINICAL RELEVANCE: Limited bone height in the maxilla is a major problem when planning dental implants. To overcome this problem, several approaches, e.g. external or internal sinus floor elevation, have been established. When planning the insertion of a dental implant an important aspect is the primary stability which can be expected. With other factors, the dimensions of the cortical bone might be relevant in this context. It would, therefore, be helpful to define the minimum thickness of cortical bone required to achieve sufficient primary stability, thus avoiding additional surgical intervention.

[Tribology in hip arthroplasty : Benefits of different materials]. / Tribologie in der Hüftendoprothetik : Welches Material hat welchen Nutzen?

When it comes to total hip replacements, choosing the suitable material combination is of clinical relevance. The present review article examines the technical differences in wear and corrosion of the relevant material combinations of ceramics, metals, ceramized metals and various types of polyethylene. The material characteristics, which were often tested under standardized conditions in the laboratory, are compared with clinical results on the basis of evidence-graded clinical studies and on the basis of register studies. This article thus represents an up-to-date snapshot of the expectations and actual clinical outcomes of the present choice of material combinations. It shows that some tendencies from the field of materials research, e.g. with regard to cross-linked polyethylene, coincide with observations from practical clinical experience, while for other materials, a proven technical superiority has not yet been confirmed as an evident advantage in clinical practice.

A new sequential animal model for infection-related non-unions with segmental bone defect.

BACKGROUND: The treatment of fracture-related infections (FRI) is still a challenge for orthopedic surgeons. The prevalence of FRI is particularly high in open fractures with extensive soft-tissue damage. This study aimed to develop a new two-step animal model for non-unions with segmental bone defects, which could be used to evaluate new innovative bone substitutes to improve the therapeutic options in humans with FRI and bone defects. METHODS: After randomization to infected or non-infected groups, 30 Sprague-Dawley rats underwent a transverse osteotomy of the mid-shaft femur with a 5 mm defect. Additionally, the periosteum at the fracture zone was cauterized at both sides. After intramedullary inoculation with 103 CFU Staphylococcus aureus (infected group) or PBS (non-infected group), a fracture stabilization was done by intramedullary K-wires. After 5 weeks, the bone healing process was evaluated, and revision surgery was performed in order to obtain increased bone healing. The initial K-wires were removed, and debridement of the osteotomy-gap was done followed by a more stable re-osteosynthesis with an angle-stable plate. After further 8 weeks all rats were euthanized and the bone consolidation was tested biomechanically and the callus formation quantitatively by micro-CT analysis. RESULTS: We developed and presented a new two-stage non-union animal model through a targeted S. aureus infection. After 5 weeks, all animals showed a non-union irrespective of assignment to the infected and non-infected group. Lane and Sandhu score showed a higher callus formation in the infected group. In all infected animals, the inoculated S. aureus strain was detected in the revision surgery. The second surgery did not improve bone healing, as shown by the Lane Sandhu score and in the µ-CT analysis. Similarly, biomechanical testing showed in both groups a significantly lower maximum torque as compared to the contralateral side (p < 0.0001). CONCLUSIONS: We were able to successfully develop a new two-stage non-union animal model, which reflects a genuine clinical situation of an infection-related non-union model with segmental bone defects. This model could be used to evaluate various therapeutic anti-infectious and osteoinductive strategies in FRIs.

Bone morphogenetic proteins - 7 and - 2 in the treatment of delayed osseous union secondary to bacterial osteitis in a rat model.

BACKGROUND: Bone infections due to trauma and subsequent delayed or impaired fracture healing represent a great challenge in orthopedics and trauma surgery. The prevalence of such bacterial infection-related types of delayed non-union is high in complex fractures, particularly in open fractures with additional extensive soft-tissue damage. The aim of this study was to establish a rat model of delayed osseous union secondary to bacterial osteitis and investigate the impact of rhBMP-7 and rhBMP-2 on fracture healing in the situation of an ongoing infection. METHODS: After randomization to four groups 72 Sprague-Dawley rats underwent a transverse fracture of the midshaft tibia stabilized by intramedullary titanium K-wires. Three groups received an intramedullary inoculation with Staphylococcus aureus (103 colony-forming units) before stabilization and the group without bacteria inoculation served as healing control. After 5 weeks, a second surgery was performed with irrigation of the medullary canal and local rhBMP-7 and rhBMP-2 treatment whereas control group and infected control group received sterile saline. After further 5 weeks rats were sacrificed and underwent biomechanical testing to assess the mechanical stability of the fractured bone. Additional micro-CT analysis, histological, and histomorphometric analysis were done to evaluate bone consolidation or delayed union, respectively, and to quantify callus formation and the mineralized area of the callus. RESULTS: Biomechanical testing showed a significantly higher fracture torque in the non-infected control group and the infected rhBMP-7- and rhBMP-2 group compared with the infected control group (p < 0.001). RhBMP-7 and rhBMP-2 groups did not show statistically significant differences (p = 0.57). Histological findings supported improved bone-healing after rhBMP treatment but quantitative micro-CT and histomorphometric results still showed significantly more hypertrophic callus tissue in all three infected groups compared to the non-infected group. Results from a semiquantitative bone-healing-score revealed best bone-healing in the non-infected control group. The expected chronic infection was confirmed in all infected groups. CONCLUSIONS: In delayed bone healing secondary to infection rhBMP treatment promotes bone healing with no significant differences in the healing efficacy of rhBMP-2 and rhBMP-7 being noted. Further new therapeutic bone substitutes should be analyzed with the present rat model for delayed osseous union secondary to bacterial osteitis.

Influence of joint kinematics on polyethylene wear in anatomic shoulder joint arthroplasty.

BACKGROUND: Despite the positive results in total shoulder arthroplasties (TSAs), a higher revision rate is documented compared with total hip and knee replacements. Wear is the possible main cause of TSA failure in the long-term. This study investigated the effect of joint kinematics and the influence of the rotator cuff on the polyethylene wear performance in an anatomic TSA. METHODS: Lifting a load of 2 kg with an abduction/adduction of 0° to 90° was simulated for 2 × 106 cycles as a primary motion using a fully kinematic joint simulator. A combined rotation in anteversion-retroversion of ±5° and ±10° was also simulated. The force in the superior-inferior direction and the axial joint compression were applied under force control based on in vivo data of the shoulder. A soft tissue restraint model was used to simulate an intact and an insufficient rotator cuff. RESULTS: The highest wear rate in the intact rotator cuff group was 58.90 ± 1.20 mg/106 cycles with a combined rotation of ±10°. When an insufficient rotator cuff was simulated, the highest polyethylene wear rate determined was 79.67 ± 4.18 mg/106 cycles. CONCLUSIONS: This study confirms a high dependency of the polyethylene wear behavior and dimension on the joint kinematics in total shoulder replacement. This can be explained by an increasing cross-shear stress on the polyethylene component. The results obtained indicate that additional combined kinematics are an indispensable part of wear tests on anatomic shoulder replacements.

Mixing of Head-Stem Components in Total Hip Arthroplasty.

BACKGROUND: Implant manufacturers proclaim that the tapers of modular total hip arthroplasty are not standardized and can vary from manufacturer to manufacturer. That is why the combination of various components from different manufacturers ("Mix and Match") is not permitted. In this study, different taper combinations were investigated experimentally to assess the effect of "Mix and Match" regarding the taper connection strength. METHODS: Torque-off tests using hip stems and metal femoral heads from 6 different implant manufacturers were performed. First the components were tested as intended and afterwards the stems were combined with metal heads from other manufacturers. RESULTS: There was no significant difference in taper connection strength when stems from the manufacturers Link, Smith & Nephew, and Zimmer were combined with heads from other manufacturers. The Biomet stems showed a significantly reduced taper connection strength if femoral heads of Aesculap, DePuy, or Smith & Nephew were used. On the contrary, the DePuy stems in combination with the originally intended femoral heads showed a significantly lower taper connection strength compared to the use of heads from Link, Biomet, and Zimmer. The same was observed for the Aesculap stems in combination with Zimmer heads. CONCLUSION: The results of this study suggest that mixing components from different manufacturers may affect the taper connection strength and could reduce the stability. As safety should be a high priority in patient treatment, any potential risks should be avoided. Therefore, mixing and matching of heads and femoral stems from different manufacturers cannot be recommended.

Ion release in ceramic bearings for total hip replacement: Results from an in vitro and an in vivo study.

INTRODUCTION: Literature on the potential release of trace elements following implantation of Zirconia-platelet toughened alumina (ZPTA) ceramic components is scant. The present study therefore analysed the in vitro and in vivo potential release of ions from ZPTA bearings. MATERIAL AND METHODS: An in vitro and in vivo study was conducted. The in vitro study compared leaching in bovine serum from two groups: ZPTA ceramic heads and Co-28Cr-6Mo alloy heads, both 28-mm diameter. A third group without implant served as reference group. An in vivo clinical study compared trace elements in the whole blood of patients with 36-mm diameter ZPTA ceramic-on-ceramic articulation after three and 12 months. A cohort of subjects without any prosthesis was used as control group. The release of ions was determined by high resolution-inductively coupled plasma-mass spectrometry. RESULTS: In the in vitro experiment, significant differences (p ≤ 0.01) in trace element release for chromium, cobalt and molybdenum were found, with increased levels of ion release in the Co-28Cr-6Mo metal group. The very low detection limit for yttrium allowed detection of a small yttrium release from the ZPTA heads, which was not confirmed by the in vivo study. No significant difference between the groups was found for strontium, aluminium, and zirconium. In the in vivo study, no relevant differences in ion levels between the reference group without any implant and the study group were found at the three and 12-month follow-up. CONCLUSION: This study supports that ZPTA ceramic articulation components are safe in terms of ion release, and may be an excellent alternative to bearings based on Co-28Cr-6Mo alloys.

Influence of humeral head material on wear performance in anatomic shoulder joint arthroplasty.

BACKGROUND: The number of total shoulder arthroplasties has increased in the past years, with encouraging results. However, the survival of anatomic total shoulder arthroplasty (aTSA) is lower compared with that of knee and hip replacements. Wear-associated problems like loosening are well-known causes of long-term failure of aTSA. The main purpose of this study was to investigate the wear behavior of ceramic-polyethylene bearings compared with the standard metal-polyethylene bearings. Because there is a lack of valid experimental wear testing methods, the secondary aim was to develop a validated wear simulation. METHODS: The wear assessment was performed using a force-controlled joint simulator for 3 × 106 cycles, and polyethylene wear was assessed gravimetrically and by particle analysis. Kinetic and kinematic data were adopted from in vivo loading measurements and from several clinical studies on shoulder joint kinematics. The reaction of the rotator cuff was simulated on the basis of a virtual soft tissue model. As activity, an abduction-adduction motion of 0°-90° lifting a load of 2 kg superimposed by an anteversion-retroversion has been chosen. RESULTS: The studied aTSA resulted in a polyethylene wear rate of 62.75 ± 1.60 mg/106 cycles in combination with metallic heads. The ceramic heads significantly reduced the wear rate by 26.7% to 45.99 ± 1.31 mg/106. There were no relevant differences in terms of the particle characteristics. CONCLUSION: This is the first study that experimentally studied the wear behavior of aTSA based on patient-related and biomechanical data under load-controlled conditions. Regarding polyethylene wear, the analyzed aTSA could benefit from ceramic humeral heads.

Same Same but Different? 12/14 Stem and Head Tapers in Total Hip Arthroplasty.

BACKGROUND: Taper corrosion has been identified to be a major concern in total hip arthroplasty during the past years. So far, the mechanisms that lead to taper corrosion in modular taper junctions are not fully understood. However, it has been shown that corrosion is also influenced by the geometry and topography of the taper, and these parameters vary among the implant manufacturers. The purpose of this study was to investigate the variations of common stem and head tapers regarding design and surface characteristics. METHODS: An analysis of selected commercially available 12/14 stem and head tapers was performed. As geometric parameters, the taper angle, the opening taper diameter, and the taper length were measured using a coordinate measuring machine. Several topographic parameters were determined using a tactile roughness measurement instrument. RESULTS: Although all investigated tapers are so-called 12/14 tapers, this study showed that the stem and head tapers differ among the manufacturers. The stem tapers were clearly different in both geometry and topography, and the range in variation of the topographic parameter was greater than it was for the geometric parameter. In contrast, the head tapers were different in their geometry, although not in topography. CONCLUSION: Ultimately, this study provides an overview on the characteristics and variations of modular hip taper connections, and in addition, a new classification system regarding the surface finish is presented. These findings could be further considered in experimental corrosion or retrieval studies.

How do gait frequency and serum-replacement interval affect polyethylene wear in knee-wear simulator tests?

Polyethylene wear (PE) is known to be a limiting factor in total joint replacements. However, a standardized wear test (e.g. ISO standard) can only replicate the complex in vivo loading condition in a simplified form. In this study, two different parameters were analyzed: (a) Bovine serum, as a substitute for synovial fluid, is typically replaced every 500,000 cycles. However, a continuous regeneration takes place in vivo. How does serum-replacement interval affect the wear rate of total knee replacements? (b) Patients with an artificial joint show reduced gait frequencies compared to standardized testing. What is the influence of a reduced frequency? Three knee wear tests were run: (a) reference test (ISO), (b) testing with a shortened lubricant replacement interval, (c) testing with reduced frequency. The wear behavior was determined based on gravimetric measurements and wear particle analysis. The results showed that the reduced test frequency only had a small effect on wear behavior. Testing with 1 Hz frequency is therefore a valid method for wear testing. However, testing with a shortened replacement interval nearly doubled the wear rate. Wear particle analysis revealed only small differences in wear particle size between the different tests. Wear particles were not linearly released within one replacement interval. The ISO standard should be revised to address the marked effects of lubricant replacement interval on wear rate.

Wear in total knee arthroplasty--just a question of polyethylene?: Metal ion release in total knee arthroplasty.

PURPOSE: Biological reactions against wear particles are a common cause for revision in total knee arthroplasty. To date, wear has mainly been attributed to polyethylene. However, the implants have large metallic surfaces that also could potentially lead to metal wear products (metal ions and debris). The aim of this study was to determine the local release of cobalt, chromium, molybdenum and titanium in total knee arthroplasty during a standard knee wear test. METHODS: Four moderately conforming fixed-bearing implants were subjected to physiological loadings and motions for 5×10(6) walking cycles in a knee wear simulator. Polyethylene wear was determined gravimetrically and the release of metallic wear products was measured using high resolution-inductively coupled plasma-mass spectrometry. RESULTS: A polyethylene wear rate of 7.28 ± 0.27 mg/10(6) cycles was determined and the cumulative mass of released metals measured 1.63 ± 0.28 mg for cobalt, 0.47 ± 0.06 mg for chromium, 0.42 ± 0.06 mg for molybdenum and 1.28 ± 0.14 mg for titanium. CONCLUSION: For other metallic implants such as metal-on-metal total hip arthroplasty, the metal wear products can interact with the immune system, potentially leading to immunotoxic effects. In this study about 12 % by weight of the wear products were metallic, and these particles and ions may become clinically relevant for patients sensitive to these materials in particular. Non-metallic materials (e.g. ceramics or suitable coatings) may be considered for an alternative treatment for those patients.

The primary stability of the femoral component in cemented single and twin peg Oxford unicompartmental knee arthroplasty under adverse conditions.

AIMS: The cemented Oxford unicompartmental knee arthroplasty (OUKA) features two variants: single and twin peg OUKA. The purpose of this study was to assess the stability of both variants in a worst-case scenario of bone defects and suboptimal cementation. METHODS: Single and twin pegs were implanted randomly allocated in 12 pairs of human fresh-frozen femora. We generated 5° bone defects at the posterior condyle. Relative movement was simulated using a servohydraulic pulser, and analyzed at 70°/115° knee flexion. Relative movement was surveyed at seven points of measurement on implant and bone, using an optic system. RESULTS: At the main fixation zone, the twin peg shows less relative movement at 70°/115°. At the transition zone, relative movements are smaller for the single peg for both angles. The single peg shows higher compression at 70° flexion, whereas the twin peg design shows higher compression at 115°. X-displacement is significantly higher for the single peg at 115°. CONCLUSION: Bony defects should be avoided in OUKA. The twin peg shows high resilience against push-out force and should be preferred over the single peg. Cite this article: Bone Joint Res 2022;11(2):82-90.

Treatment of Infection-Related Non-Unions with Bioactive Glass-A Promising Approach or Just Another Method of Dead Space Management?

The treatment of infected and non-infected non-unions remains a major challenge in trauma surgery. Due to the limited availability of autologous bone grafts and the need for local anti-infective treatment, bone substitutes have been the focus of tissue engineering for years. In this context, bioactive glasses are promising, especially regarding their anti-infective potential, which could reduce the need for local and systemic treatment with conventional antibiotics. The aim of this study was to investigate the osteoinductive and osteoconductive effects, as well as the anti-infectious potential, of S53P4 using a standardized non-union model, which had not been investigated previously. Using an already established sequential animal model in infected and non-infected rat femora, we were able to investigate bioactive glass S53P4 under realistic non-union conditions regarding its osteoinductive, osteoconductive and anti-infective potential with the use of µCT scans, biomechanical testing and histological, as well as microbiological, analysis. Although S53P4 did not lead to a stable union in the non-infected or the infected setting, µCT analysis revealed an osteoinductive effect of S53P4 under non-infected conditions, which was diminished under infected conditions. The osteoconductive effect of S53P4 remained almost negligible in histological analysis, even 8 weeks after treatment. Additionally, the expected anti-infective effect could not be demonstrated. Our data suggested that S53P4 should not be used in infected non-unions, especially in those with large bone defects.

Systemic Administration of PTH Supports Vascularization in Segmental Bone Defects Filled with Ceramic-Based Bone Graft Substitute.

Non-unions continue to present a challenge to trauma surgeons, as current treatment options are limited, duration of treatment is long, and the outcome often unsatisfactory. Additionally, standard treatment with autologous bone grafts is associated with comorbidity at the donor site. Therefore, alternatives to autologous bone grafts and further therapeutic strategies to improve on the outcome and reduce cost for care providers are desirable. In this study in Sprague-Dawley rats we employed a recently established sequential defect model, which provides a platform to test new potential therapeutic strategies on non-unions while gaining mechanistic insight into their actions. The effects of a combinatorial treatment of a bone graft substitute (HACaS+G) implantation and systemic PTH administration was assessed by µ-CT, histological analysis, and bio-mechanical testing and compared to monotreatment and controls. Although neither PTH alone nor the combination of a bone graft substitute and PTH led to the formation of a stable union, our data demonstrate a clear osteoinductive and osteoconductive effect of the bone graft substitute. Additionally, PTH administration was shown to induce vascularization, both as a single adjuvant treatment and in combination with the bone graft substitute. Thus, systemic PTH administration is a potential synergistic co-treatment to bone graft substitutes.

Short-Term Heat Treatment of Ti6Al4V ELI as Implant Material.

Due to its mechanical properties and good biocompatibility, Ti6Al4V ELI (extra low interstitials) is widely used in medical technology, especially as material for implants. The specific microstructures that are approved for this purpose are listed in the standard ISO 20160:2006. Inductive short-term heat treatment is suitable for the adjustment of near-surface component properties such as residual stress conditions. A systematic evaluation of the Ti6Al4V microstructures resulting from short-term heat treatment is presently missing. In order to assess the parameter field that leads to suitable microstructures for load-bearing implants, dilatometer experiments have been conducted. For this purpose, dilatometer experiments with heating rates up to 1000 °C/s, holding times between 0.5 and 30 s and cooling rates of 100 and 1000 °C/s were systematically examined in the present study. Temperatures up to 950 °C and a holding time of 0.5 s led to microstructures, which are approved for medical applications according to the standard ISO 20160:2006. Below 950 °C, longer holding times can also be selected.

Quantitative Measurements of Backside Wear in Acetabular Hip Joint Replacement: Conventional Polyethylene Versus Cross-Linked Polyethylene.

As shown in previous studies, the modification of conventional polyethylene (CPE) to cross-linked polyethylene (XLPE) and the contribution of antioxidants result in a reduction in total wear. The aim of this study was to evaluate XLPE inserts with vitamin E and CPE regarding their resistance to the backside wear mechanism. A cementless hip cup system (Plasmafit® Plus 7, Aesculap) was dynamically loaded using CPE and XLPE inserts. The backside wear was isolated, generated and collected using the two-chamber principle. The chambers were filled with ultrapure water. After 2 × 106 cycles, the fluids were examined for wear particles according to a particle analysis. Using XLPE inserts, the backside wear was significantly reduced by 35%. While XLPE backside wear particles are significantly larger than CPE particles, they do not differ in their morphology. This study confirms the greater resistance to backside wear of XLPE compared to CPE. It can be assumed that the improved fatigue resistance of the vitamin E-stabilized XLPE inserts demonstrates XLPE's effectiveness against micro-motion and the resulting changing tensions in interface areas like surface breakdown, pitting and the release of very small particles.

Corrosion Behavior of Surface-Treated Metallic Implant Materials.

Corrosion of taper connections in total hip arthroplasty remains of concern, as particles and ions generated by corrosive processes can cause clinical problems such as periprosthetic osteolysis or adverse reaction to metallic debris. Mechanical surface treatments that introduce compressive residual stresses (RSs) in metallic materials can lead to a better performance in terms of fretting and fatigue and may lower the susceptibility to corrosion. The study investigates the impact of mechanical surface treatments on the corrosion behavior of metallic biomaterials. Compressive RSs were introduced by deep rolling and microblasting in Ti6Al4V and CoCrMo samples. Polished samples served as reference. Corrosion behavior was characterized by repeated anodic polarization. Residual stresses of up to about -900 MPa were introduced by deep rolling with a reach in depth of approximately 500 µm. Microblasting led to compressive RSs up to approximately -800 and -600 MPa for Ti6Al4V and CoCrMo, respectively, in the immediate vicinity of the surface. For Ti6Al4V, microblasting resulted in decreased corrosion resistance with lower breakdown potentials and/or increased passive current densities in comparison to the polished and deep-rolled samples. The corrosion behavior of CoCrMo on the other hand was not affected by the mechanical surface treatments.

Model-Based Roentgen Stereophotogrammetric Analysis to Monitor the Head-Taper Junction in Total Hip Arthroplasty in Vivo-And They Do Move.

Model-based Roentgen stereophotogrammetric analysis (RSA) using elementary geometrical shape (EGS) models allows migration measurement of implants without the necessity of additional attached implant markers. The aims of this study were: (i) to assess the possibility of measuring potential head-taper movement in THA in vivo using model-based RSA and (ii) to prove the validity of measured head-taper migration data in vitro and in vivo. From a previous RSA study with a 10 years follow-up, retrospectively for n = 45 patients head-taper migration was calculated as the relative migration between femoral ball head and taper of the femoral stem using model-based RSA. A head-taper migration of 0.026 mm/year can be detected with available RSA technology. In vitro validation showed a total migration of 268 ± 11 µm along the taper axis in a similar range to what has been reported using the RSA method. In vivo, a proof for interchangeable applicability of model-based RSA (EGS) and standard marker-based RSA methods was indicated by a significant deviation within the migration result after 12-month follow-up for all translation measurements, which was significantly correlated to the measured head-taper migration (r from 0.40 to 0.67; p < 0.05). The results identified that model-based RSA (EGS) could be used to detect head-taper migration in vivo and the measured movement could be validated in vitro and in vivo as well. Those findings supported the possibility of applying RSA for helping evaluate the head-taper corrosion related failure (trunnionosis).

Particle analysis of shape factors according to American Society for Testing and Materials.

Polyethylene wear is one of the major factors influencing the survivorship of joint replacements. Depending on the number, size and morphology of the polyethylene particles, biological responses of the periprosthetic soft tissue in terms of inflammatory processes can occur, leading to loosening of the implant. Various parameters are used to analyze wear particles, which are usually determined by examining scanning electron microscopy (SEM) images with a particle analysis program. In this study, three different software solutions for particle analysis (self-developed Particleanalyzer_HD, Leica QWin and ImageJ) were compared regarding particle number, size and morphology. These solutions were also compared to the American Society for Testing and Materials (ASTM) F1877-16 specifications regarding particle morphology. SEM image analysis revealed no differences for the equivalent circle diameter (p = 0.969). However, a significant difference was found for the aspect ratio between the Particleanalyzer_HD and the other two software solutions (p < 0.001) and between Leica QWin and the other two software solutions regarding the roundness (p < 0.001). Only the Particleanalyzer_HD showed an excellent agreement with the ASTM standard for both morphology parameters (intraclass correlation = 1.000). Only the Particleanalyzer_HD calculated the two morphology parameters according to the ASTM standard. A comparison of the particle morphology between different studies is barely possible, as different algorithms for particle analysis are used. It is strongly recommended that the calculation according to the ASTM standard is used to improve future comparability of findings from wear analysis studies. © 2019 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 108B:225-233, 2020.

Carbon-fibre-reinforced PEEK: An alternative material for flexion bushings of rotating hinged knee joints?

BACKGROUND: For prosthetic knee joints of the hinged type, typically polyethylene (PE) flexion bushings are used between axis and femoral component to prevent metallic wear. Nevertheless, PE-wear can lead to periprosthetic osteolysis followed by aseptic loosening of the implant. Based on high creep and wear resistance carbon-fibre-reinforced polyether ether ketones (CFR-PEEKs) could provide an alternative material to ultra-high-molecular-weight polyethylene (UHMWPE) for this bearing type. METHODS: Flexion bushings of four different materials were investigated (CFR-PEEK pitch fibres, CFR-PEEK PAN fibres, virgin PEEK without carbon fibres and UHMWPE) using a bushing tester. For determination of the polymeric and metallic wear, gravimetric measurements and particle analyses were performed. RESULTS: The polymeric wear rates of CFR-PEEK PAN (6.657 ±â€¯0.714 mg/106 cycles) and CFR-PEEK pitch (32.085 ±â€¯2.748 mg/106 cycles) were significantly higher compared to the polymeric wear rates of virgin PEEK (0.764 ±â€¯0.283 mg/106 cycles) or UHMWPE (-0.015 ±â€¯0.011 mg/106 cycles) (p < .001). In addition, the metallic wear rates were significantly higher when using bushings made of CFR-PEEK PAN (3.373 ±â€¯0.214 mg/106 cycles) and CFR-PEEK pitch (3.604 ±â€¯0.355 mg/106 cycles), than when using bushings made of virgin PEEK (0.177 ±â€¯0.049 mg/106 cycles) or UHMWPE (0.031 ±â€¯0.011 mg/106 cycles) (p < .001). The mean particle size of the two CFR-PEEK groups was significantly smaller compared to the virgin PEEK and UHMWPE group (p < .001). CONCLUSION: According to these results, the clinical use of CFR-PEEK in combination with CoCr could lead to higher wear rates and this should be avoided. Virgin PEEK may still be considered as an alternative to UHMWPE to use it for flexion bushings in a hinged knee joint.