Total knee arthroplasty with a rotating hinge knee with carbon-fibre-reinforced (CFR)-PEEK as an alternative bushing material with enhanced creep, wear and fatigue behaviour has been clinically established [1-4]. The objective of our study was to compare results from in vitro biotribological characterisation to ex vivo findings on a retrievals. A modified in vitro wear simulation based on ISO 14243-1 was performed for 5 million cycles on rotating hinge knee (RHK) designs (EnduRo®) out of cobalt-chromium and ZrN-multilayer ceramic coating. The rotational & flexion axles-bushings and the flanges are made of CFR-PEEK with 30% polyacrylonitrile fibre content. Analysis of 12 retrieved EnduRo® RHK systems in cobalt-chromium and ZrN-multilayer in regard to loosening torques, microscopic surface analysis, distinction between different wear modes and classification with a modified HOOD-score has been performed. For the RHK design with the polyethylene gliding surface and bushings and flanges made out of CFR-PEEK, a cumulative volumetric wear was measured to be 12.9±3.95 mm3 in articulation to cobalt-chromium and 1.3±0.21 mm3 to ZrN-multilayer coating - a significant 9.9-fold decrease (p=0.0072). For the CFR-PEEK flexion bushing and flanges the volumetric wear rates were 2.3±0.48 mm3/million cycles (cobalt-chromium) and 0.21±0.02 mm3/million cycles (ZrN-multilayer) (p=0.0016). The 5 million cycles of in vitro wear testing reflect a mean in vivo service life of 2.9 years, which is in accordance to the time in vivo of 12–60 months of the retrieved RHK components [5]. The main wear modes were comparable between retrievals and in vitro specimens, whereby the size of affected area on the retrieved components showed a higher variation. For the EnduRo® RHK design the findings on retrieved implants demonstrate the high suitability of CFR-PEEK as a biomaterial for highly loaded bearings, such as RHK bushings and flanges in articulation to cobalt-chromium and to a ZrN-multilayer coating.
The use of rotating hinge (RH) prostheses for severe primary as well as revision arthroplasty is widely established. Aim of this study was to investigate long term results of a new RH prosthesis (EnduRo®, B Braun, Germany), which uses carbon-fiber reinforced poly-ether-ether-ketone (CFR PEEK) as a new bearing material, first time used in knee arthroplasty. Fifty-six consecutive patients, who received the EnduRo® RH prosthesis were included in this prospective study: 21 patients (37.5%) received the prosthesis as a primary total knee arthroplasty (TKA) and 35 patients (62.5%) underwent revision total knee arthroplasties (rTKA). Clinical and radiographic examinations were performed preoperatively as well as postoperatively after 3 and 12 months and annually thereafter. Min. Follow up was 7 and mean follow up 9,3 years. Clinical examination included Knee Society Score (KSS), Western Ontario and McMaster Osteoarthritis Index (WOMAC), Oxford Knee Score (OKS), and range of motion (ROM). Competing risk analysis was assessed for survival with respect to indication and failure mode. KSS, WOMAC, OKS, and ROM significantly improved from the preoperative to the follow up investigations (p < 0.0001). There was no difference in clinical outcome between the primary and the revision group. The overall cumulative incidence for revision for any reason was 23.6% and the cumulative incidence for complications associated with failure of the prothesis was 5.6% at 7 years, respectively. Complications occurred more frequently in the revision group (p = 0.002). The evaluated RH prosthesis provided reliable and durable results with a minimum follow-up of 7 years. Prosthesis survival was successful considering the complexity of cases. The use of this RH system in primary patients showed high survival rates. Long-term functional and clinical results proved to be satisfying in both revision and primary cases. No adverse events were associated with the new bearing material CFR-PEEK.
Ten to twenty percent of patients are dissatisfied with the clinical result after total knee arthroplasty (TKA). Aim of this study was to investigate the impact of personality traits on patient satisfaction and subjective outcome of TKA. We investigated 80 patients with 86 computer navigated TKAs (Emotion 84% of our patients were satisfied, while 16% were not satisfied with clinical outcome. The FPI-R showed statistically significant influence of four personality traits on patient satisfaction: life satisfaction ( The results of our study show that personality traits may influence patient satisfaction and clinical outcome after TKA. Thus, patients personality traits may be a useful predictive factor for postoperative satisfaction after TKA.
Although established serum inflammatory biomarkers, such as serum C-reactive protein (CRP) and serum white blood cell count (WBC), showed low accuracies in the literature, they are still commonly used in diagnosing periprosthetic joint infections (PJI). For a sufficient preoperative diagnosis novel more accurate serum parameters are needed. The aim of our study was to evaluate the performances of the established and novel routinely available serum parameters in diagnosing periprosthetic joint infections when using the proposed European Bone and Joint Infection Society (pEBJIS) criteria. In this retrospective study, 177 patients with an indicated revision surgery after a total joint replacement were included from 2015 to 2019. The easily accessible and routinely available serum parameters CRP, WBC, the percentage of neutrophils (%N), the neutrophils to lymphocytes ratio (NLR), fibrinogen and the platelet count to mean platelet volume ratio (PC/mPV) were evaluated preoperatively. The performances were examined via receiver operating characteristic (ROC) curve analysis (AUC). The curves were compared using the z-test. Seventy-five cases (42%) showed a PJI based on the pEBJIS-criteria.Aim
Method
Cementless total knee arthroplasty (TKA) implants use an interference fit to achieve fixation, which depends on the difference between the inner dimensions of the implant and outer dimensions of the bone. However, the most optimal interference fit is still unclear. A higher interference fit could lead to a superior fixation, but it could also cause bone abrasion and permanent deformation during implantation. Therefore, this study aims to investigate the effect of increasing the interference fit from 350 µm to 700 µm on the primary stability of cementless tibial implants by measuring micromotions and gaps at the bone-implant interface when subjected to two loading conditions. Two cementless e.motion® tibial components (Total Knee System, B. Braun) with different interference fit and surface coating were implanted in six pairs of relatively young human cadaver tibias (47–60 years). The Orthoload peak loads of gait (1960N) and squat (1935N) were applied to the specimens with a custom made load applicator (Figure 1A). The micromotions (shear displacement) and opening/closing gaps (normal displacement) were measured with Digital Image Correlation (DIC) in 6 different regions of interest (ROIs - Figure 1B). Two General Linear Mixed Models (GLMMs) were created with micromotions and interfacial gaps as dependent variables, bone quality, loading conditions, ROIs, and interference fit implants as independent variables, and the cadaver specimens as subject variables.Introduction
Methods
Knee arthroplasty with a rotating hinge knee (RHK) prosthesis has become an important clinical treatment option for knee revisions and primary patients with severe varus or valgus deformities and instable ligaments. The rotational axle constraints the anterior-posterior shear and varus-valgus moments, but currently used polyethylene bushings may fail in the mid-term due to insufficient creep and wear resistance of the material. Due to that carbon-fibre-reinforced (CFR) PEEK as an alternativ bushing material with enhanced creep, wear and fatigue behaviour has been introduced in a RHK design [Grupp 2011, Giurea 2014]. The objective of our study was to compare results from the pre-clinical biotribological characterisation to ex vivo findings on a series of retrieved implants. In vitro wear simulation according to ISO 14243-1 was performed on rotating hinge knee devices (EnduRo® Aesculap, Germany) made out of cobalt-chromium and of a ZrN multi-layer ceramic coating for 5 million cycles. The mobile gliding surfaces were made out of polyethylene (GUR 1020, β-irradiated 30 ± 2 kGy). For the bushings of the rotational and flexion axles and the flanges a new bearing material based on CFR-PEEK with 30% PAN fiber content was used. Analysis of 12 retrieved EnduRo® RHK systems in cobalt-chromium and ZrN multi-layer in regard to
loosening torques in comparison with initial fastening torques Optical, DSLR camera and stereo light microscope analysis distinction between different wear modes and classification with a modified HOOD-score SEM & EDX of representative samples surface roughness and depth profilometry with a focus on the four CFR-PEEK components integrated in the EnduRo® RHK design. For the rotating hinge knee design with flexion bushing and flanges out of CFR-PEEK the volumetric wear rates were 2.3 ± 0.48 mm3/million cycles (cobalt-chromium) and 0.21 ± 0.02 mm3/million cycles (ZrN multi-layer), a 10.9-fold reduction (p = 0.0016). The UHMWPE and CFR-PEEK particles were comparable in size and morphology and predominantly in submicron size [5]. The biological response to representative sub-micron sized CFR-PEEK particles has been demonstrated in vivo based on the leucoyte-endothelian-cell interactions in the synovia of a murine intra-articular knee model by Utzschneider 2010. Schwiesau 2013 extracted the frequency of daily activities in hip and knee replacement patients from literature and estimated an average of 1.76 million gait cycles per year. Thus, the 5 million cycles of in vitro wear testing reflect a mean in vivo service life of 2.9 years, which fits to the time in vivo of 12–60 months of the retrieved RHK devices. The in vitro surface articulation pattern of the wear simulation tests are comparable to findings on retrieved CFR-PEEK components for both types of articulations – cobalt-chromium and ZrN multi-layer coating. For the rotating hinge knee design the findings on retrieved implants demonstrate the high suitability of CFR-PEEK as a biomaterial for highly loaded bearings, such as RHK bushings and flanges in articulation to cobalt-chromium and to a ZrN multi-layer coating.
The complex process of inflammation and osteolysis due to wear particles still is not understood in detail. So far, Ultra-high-molecular-weight-polyethylene (UHMWPE) is the bearing material of choice in knee arthroplasty and revision knee arthroplasty, but there is a growing demand for alternative bearing materials with improved wear properties. Lately, increasing interest developed in the use of natural and carbon-fiber-reinforced-poly-ether-ether-ketones (CFR-PEEK). While there is a lack of data concerning the effects of CFR-PEEK particles on human tissue, the effects of such wear debris The aim of this study was to analyze human tissue containing CFR-PEEK as well as UHMWPE wear debris. The authors hypothesized no difference between the used biomaterials because of similar size parameters of the wear particles in a prior knee simulator study of this implant. Synovial tissue samples of 10 patients while knee revision surgery of a rotating hinge knee implant design (Enduro®, Aesculap, Germany) were achieved. The tibial inserts of this design were made from UHMWPE (GUR 1020), whereas the bushings and flanges are made of CFR-PEEK containing 30% polyacrylonitrile (PAN) based carbon fibers (PEEK-Optima LT1, Invibio Ltd. Thornton-Cleveleys, UK). In a prior The tissue was fixed with 4% paraformaldehyde, embedded in paraffin, sliced into 2 µm thick sections stained with hematoxylin and eosin in a standard process. A modified panoptical staining (preincubation in propylenglycol; >3h; 35°C) was also done which stained the UHMWPE particles turquoise. The study was approved by the ethics committee of the local university.Introduction
Methods and Materials
In a prospective randomized study of two groups of 65 patients each, we compared the acetabular component position when usingthe imageless navigation system compared to the freehand conventional technique for cementless total hip arthroplasty. The position of the component was determined postoperatively on computed tomographic scans of the pelvis. There was no significant difference for postoperative mean inclination (p=0.29), but a significant difference for mean postoperativ acetabular component anteversion (p=0.007), for mean deviation of the postoperative anteversion from the target position of 15°(p=0.02) and for the outliers regarding inclination (p=0.02) and anteversion (p<0.05) between the computer-assisted and the freehand-placement group.Material and Methods
Results
In a recent study we evaluated the clinical and radiographic long-term results as well as the serum metal concentrations of 105 cementless primary total hip prosthesis, performed between November 1992 and May 1994 with a 28-mm high-carbide-concentration metal-on-metal articulating surfaces. Forty-one patients who had had a total of forty-four arthroplasties were available for follow-up evaluation at a minimum of seventeen years postoperatively. The median serum cobalt concentration of the patients with their hip replacement as the only source of cobalt was 0.7 µg/L (range 0.4–5.1µg/L), showing no significant difference to the previous study after a minimum of 10 years follow-up. We were investigating the systemic dissemination, which in turn, did not show more severe effects, such as carcinogenicity or renal failure. There are many complex issues associated with the analysis of metal ions, including collecting technique, analysis and reporting of the results. At the AAOS in March 2013, the Hip Society mentioned, that systemic ion levels are just one factor in the evaluation and should not be relied upon solely to determine the need for revision surgery. Furthermore, the correlation between cobalt or chromium serum, urin or synovial fluid levels and adverse local tissue reactions is incompletely understood. In our present study we evaluated the serum, urin as well as the joint aspirate metal concentrations, of cementless total hip arthroplasties with a high-carbon, metal-on-metal bearing (Metasul®) at a mean of eighteen-years follow-up. We performed a correlation analysis to evaluate the relationship between these values and to determine whether elevated serum metal concentrations are associated with elevated and local metal concentrations and with early failure of metal-on-metal articulations.Introduction
Patients and Methods
Accuracy of implantation is an accepted prognostic factor for the long term survival of total knee replacement (TKR). The use of navigation demonstrated a significant higher accuracy of implant orientation in comparison to conventional methods. However, these systems are often thought to be technically demanding, to increase operating time and to involve a long learning curve. We performed a prospective, multicenter study to compare the accuracy of implantation of a TKR measured on post-operative X-rays in experienced and less experienced centers. All centers used the same navigation system (Ortho-Pilot ®, Asculap, Tuttlingen, FRG): 4 had already a significant experience with it (group A – 182 cases), 9 centers were considered as beginners with less than 10 cases performed prior to the study (group B – 221 cases). Accuracy of implantation was measured on post-operative antero-posterior and lateral long leg X-rays with five items: mechanical femoro-tibial angle, coronal orientation of the femoral component, sagittal orientation of the femoral component, coronal orientation of the tibial component, sagittal orientation of the tibial component. When the measured angle was in the expected range, one point was given. The accuracy note was defined as the sum of all points given for each patient, with a maximum of 5 points (all items fulfilled) and a minimum of 0 point (no item fulfilled). The mean accuracy note was compared in the two groups by a Student t-test at a 0.05 level of significance. Power of the study was 0.80. There were no significant differences in pre-operative parameters between the two groups, except for the clinical KSS. The mean operative time was significantly longer in group B than in group A (110 minutes vs 90 minutes, p=0.01). However this difference occurred mainly during the first twenty cases in the beginner centres where we observed a clear tendency to achieve the same operative time as the experienced centres at the end of the study. The mean accuracy note was 4.3 ± 0.8 (range, 1 to 5) in the control group and 4.3 ± 0.9 (range, 1 to 5) in the study group (p >
0.05). The power of the study to detect a 0.25 point difference in the post-operative accuracy note was retrospectively calculated to be 0.80. There were no significant differences between the two groups for all individual radiographic items. This study is, to our knowledge, the first one which investigates the learning curve of navigated TKR The used navigation system allowed a very accurate implantation of a TKR in both experienced and less experienced centers. There was no detectable learning curve with respect to accuracy of TKR implantation, clinical outcome and complication rate. The duration of the learning curve when considering the operating time was 30 cases.