IL-6-induced response of human osteoblasts from patients with rheumatoid arthritis after inhibition of the signaling pathway.

Interleukin (IL-) 6 is a critical factor in inflammatory processes of rheumatoid arthritis (RA). This is of high interest as the progression of RA may lead to the implantation of joint endoprostheses, which is associated with a pro-inflammatory increase in IL-6 in the periprosthetic tissue. Biological agents such as sarilumab have been developed to inhibit IL-6-mediated signaling. However, IL-6 signaling blockade should consider the inhibition of inflammatory processes and the regenerative functions of IL-6. This in vitro study investigated whether inhibiting IL-6 receptors can affect the differentiation of osteoblasts isolated from patients with RA. Since wear particles can be generated at the articular surfaces of endoprostheses leading to osteolysis and implant loosening, the potential of sarilumab to inhibit wear particle-induced pro-inflammatory processes should be investigated. Both in monocultures and indirect co-cultures with osteoclast-like cells (OLCs), human osteoblasts were stimulated with 50 ng/mL each of IL-6 + sIL-6R and in combination with sarilumab (250 nM) to characterize cell viability and osteogenic differentiation capacity. Furthermore, the influence of IL-6 + sIL-6R or sarilumab on viability, differentiation, and inflammation was evaluated in osteoblasts exposed to particles. Stimulation with IL-6 + sIL-6R and sarilumab did not affect cell viability. Except for the significant induction of RUNX2 mRNA by IL-6 + sIL-6R and a significant reduction with sarilumab, no effects on cell differentiation and mineralization could be detected. Furthermore, the different stimulations did not affect the osteogenic and osteoclastic differentiation of co-cultured cells. Compared to the osteoblastic monocultures, a decreased release of IL-8 was triggered in the co-culture. Among these, treatment with sarilumab alone resulted in the greatest reduction of IL-8. The co-culture also showed clearly increased OPN concentrations than the respective monocultures, with OPN secretion apparently triggered by the OLCs. Particle exposure demonstrated decreased osteogenic differentiation using different treatment strategies. However, sarilumab administration caused a trend toward a decrease in IL-8 production after stimulation with IL-6 + sIL-6R. The blockade of IL-6 and its pathway have no significant effect on the osteogenic and osteoclastic differentiation of bone cells derived from patients with RA. Nonetheless, observed effects on the reduced IL-8 secretion need further investigation.

The effect of a digital-assisted group rehabilitation on clinical and functional outcomes after total hip and knee arthroplasty-a prospective randomized controlled pilot study.

BACKGROUND: The rising number of total hip and knee arthroplasties and the decreasing availability of physiotherapists require clinically and economically effective rehabilitation approaches. Therefore, the present pilot study investigated the effect of a novel digital-assisted individualized group rehabilitation program on clinical and functional outcomes after total hip and knee arthroplasty. METHODS: In this randomized controlled pilot study, 26 patients undergoing total knee or hip replacement were randomly assigned to either the intervention group (IG, novel digital-assisted group therapy) or the control group (CG, standard postoperative physiotherapy currently carried out in Germany). The IG received the novel digital-assisted group therapy twice per week for a six-months period, while the CG received individual outpatient therapy depending on the prescription of the supervising physician. The number of therapy sessions was recorded. Moreover, subjective outcomes (EuroQol-5Dimensions (EQ-5D) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)), functional outcome (30 s sit to stand test and timed up and go test (TUG)), as well as gait parameters were quantified preoperatively as well as at three and six months after surgery. Data were analyzed using an analysis of covariance with baseline-adjustment. RESULTS: No patient-reported falls, pain, and hospital readmissions were recorded. On average, the IG received more therapy sessions. The clinical and functional outcomes were mainly not significantly different between groups at three- and six-months follow-up, but medium to large effect sizes for the differences in quality of life (EQ-5D) as well as pain, stiffness, and physical function (WOMAC), and TUG performance were observed in favor of the IG. However, the IG showed a higher variability of gait velocity after total joint replacement. CONCLUSION: The digital-assisted rehabilitation had positive effects on quality of life, pain, stiffness, physical function, and TUG performance. Nevertheless, the therapy concept may be improved by adding exercises focusing on gait performance to reduce gait variability. The results indicate that the digital-assisted therapy concept is effective and safe. Therefore, a consecutive full-scaled randomized controlled clinical trial is recommended. TRIAL REGISTRATION: This study was retrospectively registered on 14/02/2022 in the German Clinical Trial Register (DRKS00027960).

Patellar Tracking in Total Knee Arthroplasty-Influence on Clinical and Functional Outcome.

Anterior knee pain is a common problem after primary total knee arthroplasty (TKA). The aim of this study was to find parameters in patellar positioning which influence the clinical and functional outcome after TKA. Included were 59 patients who underwent TKA, of which three patients were treated bilaterally (n = 62 included knees). In a periodical follow-up of up to 5 years, each patient had to answer three questionnaires (HSS, WOMAC, SF-36) and underwent three radiographies of the knee (including merchant view) and a clinical examination, including Range Of Motion (ROM). All radiographs were evaluated by a single observer blinded to clinical data, who collected multiple parameters of sagittal and axial patellar alignment including newly developed methods for measuring patellar shift and tilt. Depending on the measurement results, three groups were built for each parameter and the influence on the outcome was determined. A lateral patellar tilt of more than 4° resulted in lower scores for both the HSS and WOMAC. The rarely investigated patellar facet angle showed a significantly inferior clinical and functional outcome in late follow-up of >24 months if lower than 142°, possibly due to progressive osteosclerotic changes of the patella caused by increased contact stress with corresponding patellar morphology. No significant difference was found for all other parameters. The newly developed method for measuring patellar shift has proven to be a valuable and easy instrument in the postoperative setting.

Low-Load Unilateral and Bilateral Resistance Training to Restore Lower Limb Function in the Early Rehabilitation After Total Knee Arthroplasty: A Randomized Active-Controlled Clinical Trial.

Background: Continuous passive motion (CPM) is frequently used during rehabilitation following total knee arthroplasty (TKA). Low-load resistance training (LLRT) using continuous active motion (CAM) devices is a promising alternative. We investigated the effectiveness of CPM compared to LLRT using the affected leg (CAMuni) and both legs (CAMbi) in the early post-operative rehabilitation. HYPOTHESES: (I) LLRT (CAMuni and CAMbi) is superior to CPM, (II) additional training of the unaffected leg (CAMbi) is more effective than unilateral training (CAMuni). Materials and Methods: Eighty-five TKA patients were randomly assigned to three groups, respectively: (i) unilateral CPM of the operated leg; (ii) unilateral CAM of the operated leg (CAMuni); (iii) bilateral alternating CAM (CAMbi). Patients were assessed 1 day before TKA (pre-test), 1 day before discharge (post-test), and 3 months post-operatively (follow-up). PRIMARY OUTCOME: active knee flexion range of motion (ROMFlex). SECONDARY OUTCOMES: active knee extension ROM (ROMExt), swelling, pain, C-reactive protein, quality of life (Qol), physical activity, timed-up-and-go performance, stair-climbing performance, quadriceps muscle strength. Analyses of covariances were performed (modified intention-to-treat and per-protocol). Results: Hypothesis I: Primary outcome: CAMbi resulted in a higher ROMFlex of 9.0° (95%CI -18.03-0.04°, d = 0.76) and 6.3° (95%CI -14.31-0.99°, d = 0.61) compared to CPM at post-test and follow-up, respectively. SECONDARY OUTCOMES: At post-test, C-reactive protein was lower in both CAM groups compared with CPM. Knee pain was lower in CAMuni compared to CPM. Improved ROMExt, reduced swelling, better stair-climbing and timed-up-and-go performance were observed for CAMbi compared to CPM. At follow-up, both CAM groups reported higher Qol and CAMbi showed a better timed-up-and-go performance. Hypothesis II: Primary outcome: CAMbi resulted in a higher knee ROMFlex of 6.5° (95%CI -2.16-15.21°, d = 0.56) compared to CAMuni at post-test. SECONDARY OUTCOMES: At post-test, improved ROMExt, reduced swelling, and better timed-up-and-go performance were observed in CAMbi compared to CAMuni. Conclusions: Additional LLRT of the unaffected leg (CAMbi) seems to be more effective for recovery of function than training of the affected leg only (CAMuni), which may be mediated by positive transfer effects from the unaffected to the affected limb (cross education) and/or preserved neuromuscular function of the trained, unaffected leg. Trial Registration: ClinicalTrials.gov Identifier: NCT02062138.

Retrospective Comparative Study of the Influence on Quality of Primary Total Hip Arthroplasty by the EndoCert-Certification System in a Communal Hospital. / Retrospektive vergleichende Untersuchung zum Einfluss auf die Qualität bei primärer Hüftendoprothetik durch EndoCert-Zertifizierung an einem kommunalen Krankenhaus.

The EndoCert®-Initiative system sets specific requirements for the structural, process and result quality in certified Arthroplasty Centers in Germany. However, it remains unclear to what extent the certification process can increase the quality in total hip and knee arthroplasty. Aim of the comparative retrospective study is to analyse the change in quality of total hip arthroplasty in a communal hospital before and after the certification process. All primary total hip arthroplasties (n = 366) between 2013 and 2016 were included in the study retrospectively and grouped by treatment period. Treatment was performed in group 1 without clinical pathways, in group 2 pathway-controlled without a valid certificate and in group 3 pathway-controlled after final completion of the certification process. Outcome quality was analysed using quality indicators defined by the EndoCert-Initiative and further predefined indicators. Results show quality improvement under certified pathway-controlled treatment, e.g. time of surgery, cup and stem positioning, blood transfusion rate, periprosthetic fractures. However, improvements were not significantly in all cases and limitations must be recognized. Positive effects of the certification process legitimate capital investment and efforts. Further quality indicators may be implemented in the certification process to improve quality of treatment in arthroplasty.

Kramer and Chevron Osteotomy for Hallux Valgus Deformity - Retrospective Comparison of Functional and Radiological Results. / Kramer- und Chevron-Osteotomie bei Hallux valgus ­ retrospektive vergleichende Untersuchung des funktionellen und radiologischen Ergebnisses.

BACKGROUND: Hallux valgus is the most common forefoot deformity, with a prevalence of up to 23%. Surgical treatment is necessary in symptomatic patients. Prospective studies comparing different procedures are rare. Chevron osteotomy is the preferred procedure for distal osteotomy. The relevance of Kramer osteotomy is not clearly defined. The objective of this study was to compare the two procedures in terms of functional and radiological outcome. MATERIAL AND METHODS: 174 patients (42 male, 132 female, 44.0 ± 16.8 years), treated with Chevron (n = 71) or Kramer osteotomy (n = 103) between 2008 and 2015, were enrolled in this retrospective study. Time for surgery was analysed. Pre- and postoperative X-rays were evaluated to detect hallux valgus angle, intermetatarsal angle and position of sesamoids (mean ± SD). Function and quality of life were assessed using the Foot and Ankle Outcome Score (FAOS) and EuroQol5D questionnaire. Pain was rated by using the numeric rating scale (NRS). Statistical analyses were performed with mixed model ANOVA and the t test for independent samples. RESULTS: Both procedures reduce the hallux valgus angle (Kramer: 30° to 9°; Chevron 26° to 16°; p < 0.001). A significant difference was found between the two procedures (10° ± 2°; 95% CI: - 12.93; - 6.49; p < 0.001). A minimally reduced intermetatarsal angle was found in both groups (14° ± 3° to 12° ± 3°; p < 0.001). However, there was no significant difference between the two procedures (p = 0.116). The position of sesamoids was more improved by Kramer osteotomy (2/2 to 0/1; p < 0.001) according to Appel than with the Chevron osteotomy (2/2 to 2/1; p = 0.052). Time for surgery was significantly shorter when Kramer osteotomy was performed (31 ± 14 min vs. 44 ± 12 min; p < 0.001). No relevant differences in pain and function were observed (NRS postoperative Chevron: 1.3; Kramer: 1.7; p = 0.413; FAOS: no significant differences in all categories). CONCLUSION: The results of the two procedures were equal in functional outcome. Time of surgery and radiological results were significantly better in the group with Kramer osteotomy. Therefore, Kramer osteotomy is an alternative option to Chevron osteotomy. Further prospective studies are necessary to confirm these results.

Periprosthetic Tibial Fracture with Nonunion and Ascending Prosthetic Joint Infection: A Case Report of an Individual Treatment Strategy.

INTRODUCTION: Periprosthetic fractures are severe injuries that demand the surgeon's full expertise and special diagnostic and therapeutic strategies. A major complication is the occurrence of an infectious nonunion, including an ascending infection from the fracture site to the arthroplasty. CASE REPORT: This case report presents on a patient with a well-functioning revision total knee arthroplasty (TKA) who suffered a periprosthetic tibia fracture. Initial treatment with plating failed and the fracture had to be revised due to an infectious non-union with a multidrug-resistant Staphylococcus epidermidis, and its eradication was complicated by septic loosening of the patient's knee arthroplasty. After multiple revisions of the nonunion, a two-stage exchange arthroplasty with a partial replacement of the distal femur due to a bone defect was necessary to obtain an acceptable result. CONCLUSION: The objective of this case report is to present an individual surgical strategy in a complex case of periprosthetic fracture and TKA with major complications. It is shown that the infection of the bone and implants is a challenging situation for surgical treatment. There is still no optimal management strategy due to missing standards as well as controversies in treatment.

Prospective comparative clinical study of ceramic and metallic femoral components for total knee arthroplasty over a five-year follow-up period.

BACKGROUND: The aim of this prospective comparative study was to evaluate the clinical and radiological outcomes of a TKA system, comparing a ceramic (BIOLOX® delta) and metallic (Co28Cr6Mo) femoral component over a five-year follow-up period. METHODS: Forty-three TKA patients (17 metallic and 26 ceramic femoral components) were enrolled in the study. Clinical and radiological evaluations were performed preoperatively and at three, 12, 24 and 60months postoperatively, using the HSS-, WOMAC- and SF36-Scores, in addition to standardized X-rays. RESULTS: The HSS-Score improved significantly from 58.7±12.7 points preoperatively to 88.5±12.3 points at five-years postoperative in the ceramic group, and 60.8±7.7 to 86.2±9.4 points in the metallic group. WOMAC- and SF-36-Scores showed significant improvement over time in both groups. There were no significant differences between groups for HSS-, WOMAC- and SF-36-Scores, nor for range of motion (p≤0.897) at any follow-up evaluation. Furthermore, radiological evaluation showed no implant loosening or migration in either group. CONCLUSIONS: Mid-term outcomes for the ceramic femoral components demonstrated good clinical and radiological results, as well as comparable survivorship to the metallic femoral component of the same total knee system, and to other commonly used metallic total knee systems. Therefore, ceramic knee implants may be a promising solution for the population of patients with osteoarthritis and metal sensitivity. Long-term studies are required in order to confirm the positive mid-term clinical results, and to follow the implant survival rate in regard to the enhanced wear resistance of ceramic implants.

Press-fit versus threaded acetabular cups in total hip arthroplasty: Functional and radiological results after five years.

Prospectively the outcome after total hip replacement with a new threaded acetabular cup design was compared to an established press-fit cup. After 1, 2 and 5 years, the 36-item Short Form Health Survey, Western Ontario and McMaster University Osteoarthritis Index and Harris Hip Score revealed no significant differences between the two groups (each group: n=42 patients), except for a higher Harris Hip Score in the threaded cup group after five years (p=0.02). After five years, one threaded cup had a mild radiolucent line without further signs of loosening. All other cups of both groups (98.6%) showed a full osseous integration. The cup inclination angle ranged from 41-58° (threaded cups) to 39-77° (press-fit cups). The new threaded cup provides equivalent clinical outcomes and osseous integration but more precise implant positioning compared to the press-fit design. No complications typically ascribed to threaded cups (acetabular fractures, bone resorption, nerve impairment) occurred.

Adhesive strength of total knee endoprostheses to bone cement - analysis of metallic and ceramic femoral components under worst-case conditions.

Evaluation of the adhesive strength of femoral components to the bone cement is a relevant parameter for predicting implant safety. In the present experimental study, three types of cemented femoral components (metallic, ceramic and silica/silane-layered ceramic) of the bicondylar Multigen Plus knee system, implanted on composite femora were analysed. A pull-off test with the femoral components was performed after different load and several cementing conditions (four groups and n=3 components of each metallic, ceramic and silica/silane-layered ceramic in each group). Pull-off forces were comparable for the metallic and the silica/silane-layered ceramic femoral components (mean 4769 N and 4298 N) under standard test condition, whereas uncoated ceramic femoral components showed reduced pull-off forces (mean 2322 N). Loading under worst-case conditions led to decreased adhesive strength by loosening of the interface implant and bone cement using uncoated metallic and ceramic femoral components, respectively. Silica/silane-coated ceramic components were stably fixed even under worst-case conditions. Loading under high flexion angles can induce interfacial tensile stress, which could promote early implant loosening. In conclusion, a silica/silane-coating layer on the femoral component increased their adhesive strength to bone cement. Thicker cement mantles (>2 mm) reduce adhesive strength of the femoral component and can increase the risk of cement break-off.

Coexistent lumbar spine disorders have a crucial impact on the clinical outcome after total hip replacement.

BACKGROUND: Degenerative hip and spine disease are known to frequently coexist. Lumbar spine disorders (LSDs), as opposed to other patient-related factors, are disregarded in the assessment of the clinical outcome after total hip replacement (THR). This prospective study investigates the influence of LSDs on the pre- and postoperative health-related quality of life and functional outcome of patients undergoing THR. METHODS: According to clearly defined criteria, 42 patients scheduled for cementless THR were assigned either to the LSD (13 patients with LSDs) or non-LSD group (29 patients without LSDs). A clinical assessment was performed preoperatively as well as 12, 24 and 60 months postoperatively using the Harris hip score (HHS), the Western Ontario and McMaster University osteoarthritis index (WOMAC) and the 36-item short form health survey (SF-36). RESULTS: The statistical analysis comparing the pre- and postoperative status within both groups showed an ongoing improvement of mean HHS and WOMAC after THR. The non-LSD group had a significantly higher postoperative HHS and WOMAC after 12, 24 and 60 months as well as SF-36 after 24 and 60 months. The LSD group improved significantly in the HHS at 24 and 60 months and the WOMAC at 12, 24 and 60 months postoperatively, whereas the SF-36 improvement was not significant. Comparison of preoperative data in both groups revealed a significantly higher SF-36 in the non-LSD group but no difference between the HHS and WOMAC. At each postoperative assessment, the HHS, WOMAC and SF-36, including its physical and mental health sum scores, were significantly higher in the non-LSD group, except for the WOMAC after 60 months. CONCLUSION: Owing to their crucial impact on hip function scores and health-related quality of life, it is recommended to consider LSDs preoperatively in studies dealing with the clinical outcome after THR.

Prospective multi-centre study on a composite ceramic femoral component in total knee arthroplasty: Five-year clinical and radiological outcomes.

BACKGROUND: Enhanced wear resistance of ceramics in general and improved mechanical characteristics of composite ceramics in terms of strength and resistance meet the demands for application in TKA. The aim of this prospective international multi-centre study was to evaluate the 5-year clinical and radiological outcomes of an unconstrained TKA with a composite ceramic femoral component. METHODS: A total of 107 patients (109 knees) underwent TKA with the MULTIGEN-PLUS Ceramic Knee at seven centres in three European countries. Clinical and radiological assessments were performed preoperatively and postoperatively at 3, 12, 24 and 60 months, using HSS, WOMAC, SF-36 and standardised radiographs. RESULTS: Mean HSS and WOMAC increased significantly from 55.1±11.5 (21-83) and 48.1±16.6 (3-90) preoperatively to 85.6±9.6 (49-98) and 73.3±20.4 (17-100) at 60 months. Mean SF-36 showed significant improvements in patients' quality of life (49.1±17.6 (12-96) preoperatively versus 67.7±23.1 (12-100) at 60 months). Non-progressive radiolucent lines (<1 mm) were observed around the femoral component in four cases. Neither implant migration nor loosening were registered. Kaplan-Meier survivorship was 96.0% at 60 months (92.1-100%, CI 95%). CONCLUSIONS: Five-year implant survival rate of the ceramic knee is comparable to other metallic and ceramic unconstrained TKA systems. Although the assessment of long-term implant survivorship is still pending, the ceramic implants represent a promising solution for patients with allergies against metallic components and furthermore for the general osteoarthritis population due to enhanced wear resistance.

Biomechanical stability of novel mechanically adapted open-porous titanium scaffolds in metatarsal bone defects of sheep.

Open-porous titanium scaffolds for large segmental bone defects offer advantages like early weight-bearing and limited risk of implant failure. The objective of this experimental study was to determine the biomechanical behavior of novel open-porous titanium scaffolds with mechanical-adapted properties in vivo. Two types of the custom-made, open-porous scaffolds made of Ti6Al4V (Young's modulus: 6-8 GPa and different pore sizes) were implanted into a 20 mm segmental defect in the mid-diaphysis of the metatarsus of sheep, and were stabilized with an osteosynthesis plate. After 12 and 24 weeks postoperatively, torsional testing was performed on the implanted bone and compared to the contralateral non-treated side. Maximum torque, maximum angle, torsional stiffness, fracture energy, shear modulus and shear stress were investigated. Furthermore, bone mineral density (BMD) of the newly formed bone was determined. Mechanical loading capabilities for both scaffolds were similar and about 50% after 12 weeks (e.g., max. torque of approximately 20 Nm). A further increase after 24 weeks was found for most of the investigated parameters. Results for torsional stiffness and shear modulus as well as bone formation depended on the type of scaffold. Increased BMD after 24 weeks was found for one scaffold type but remained constant for the other one. The present data showed the capability of mechanically adapted open-porous titanium scaffolds to function as bone scaffolds for large segmental defects and the influence of the scaffold's stiffness. A further increase in the biomechanical stability can be assumed for longer observation periods of greater than six months.

Total knee replacement system with a ceramic femoral component versus two traditional metallic designs: a prospective short-term study.

PURPOSE: To compare the short-term outcome of the Multigen Plus system using a symmetric ceramic femoral component with that of 2 metallic total knee replacement (TKR) systems. METHODS: 60 patients (62 knees) with osteoarthritis or rheumatoid arthritis underwent primary TKR using the Genia system (n=20), the Multigen Plus system (n=17), and the Multigen Plus system with a ceramic femoral component (n=25). Outcome was evaluated pre- and post-operatively (at 3, 12, and 24 months) using the Hospital for Special Surgery (HSS) score, the Western Ontario and McMaster Universities (WOMAC) score, and the Short-Form 36 (SF-36) score. RESULTS: The 3 groups did not differ significantly at all 4 time points in terms of the HSS score, WOMAC score, and SF-36 score. The range of motion was significantly less in patients treated with the Genia system. Postoperatively, the HSS and WOMAC scores improved significantly in all 3 groups, whereas the SF-36 score improved significantly (at 12 and 24 months) only in patients treated with the Multigen Plus system with a ceramic femoral component. The implant position in most patients was optimal. All radiolucent lines were within 1 mm and did not progress. CONCLUSION: The short-term outcome of the 3 TKR systems was comparable. Ceramic femoral components performed comparably to traditional metallic designs.

Third-body abrasive wear of tibial polyethylene inserts combined with metallic and ceramic femoral components in a knee simulator study.

AIM: Total knee arthroplasties have reached a high grade of quality and safety, but most often fail because of aseptic implant loosening caused by polyethylene wear debris. Wear is generated at the articulating surfaces, e.g. caused by third-body particles. The objective of this experimental study was to determine the wear of tibial polyethylene inserts combined with metallic and ceramic femoral components under third-body wear conditions initiated by bone cement particles.
 METHODS AND MATERIALS: Wear testing using a cemented unconstrained bicondylar knee endoprosthesis (Multigen Plus CR knee system) was performed in a knee wear simulator. Tibial polyethylene inserts were combined with the identical femoral component design, but made of two different materials (cobalt-chromium and ceramic). Bone cement debris including zirconium oxide particles was added every 500,000 cycles between the articulating surfaces. After 5 million load cycles, the amount of wear was determined gravimetrically and compared with results from standard wear test conditions. The surfaces of tibial inserts were also analyzed.
 RESULTS: The average gravimetrical wear of the tibial polyethylene inserts in combination with cobalt-chromium and ceramic femoral components under third-body wear conditions amounted to 31.88 ± 4.53 mg and 13.06 ± 1.88 mg after 5 million cycles, respectively, and was higher than under standard wear test conditions in both cases.
 CONCLUSIONS: The wear simulator test demonstrates that wear of polyethylene inserts under third-body wear conditions, in combination with ceramic femoral components, was significantly lower than with metallic femoral components.

Ceramic femoral components in total knee arthroplasty - two year follow-up results of an international prospective multi-centre study.

BACKGROUND: Total knee arthroplasty can be considered as a reliable surgical procedure with a good long-term clinical result. However, implant failure due to particle induced aseptic loosening as well as the aspect of hypersensitivity to metal ions still remains an emerging issue. METHODS: The purpose of this prospective international multi-centre study was to evaluate the clinical and radiological outcomes and the reliability of the unconstrained Multigen Plus Total Knee System with a new BIOLOX® delta ceramic femoral component. Cemented total knee arthroplasty was performed on 108 patients (110 knees) at seven hospitals in three countries. Clinical and radiological evaluations were performed preoperatively, and after 3, 12 and 24 months postoperatively using the HSS-, WOMAC-, SF-36-score and standardised X-rays. RESULTS: The mean preoperative HSS-Score amounted to 55.5 ± 11.5 points and improved significantly in all postoperative evaluations (85.7 ± 11.7 points at 24 months). Furthermore, improvements in WOMAC- and SF-36-score were evaluated as significant at all points of evaluation. Radiolucent lines around the femoral ceramic component at 24 months were found in four cases. Progression of radiolucent lines was not seen and no implant loosening was observed. During the 24 month follow-up eight patients underwent subsequent surgery due to reasons unrelated to the implant material. CONCLUSIONS: The observed clinical and radiological results are encouraging for a long-term survival of the ceramic femoral component. Therefore, ceramic implants could be a promising solution not only for patients with allergies against metallic implant materials, but also for the osteoarthritic knee joint. Long-term follow-up is necessary to draw conclusions regarding the superiority of the ceramic knee implants concerning in vivo wear and long-term survivorship.

Influence of the distal femoral resection angle on the principal stresses in ceramic total knee components.

PURPOSE: A certain failure mode using a newly developed cemented ceramic femoral component in total knee replacement was observed in clinical application, i.e. fracture of the femoral component during intraoperative impaction. This may be caused by unintentional deflection of the saw blades during cutting with consecutive higher resection angle of the distal femur than desired, leading to bending of the femoral component during implantation. A finite-element-analysis was carried out to simulate implantation of the femoral component and to evaluate the influence of distal femur preparation on implant stress. SCOPE: We developed and validated a numerical model of the ceramic femoral component including a contact formulation which allowed calculating the principal stresses of the implant during implantation onto the resected femur. The analysis considered different anterior and posterior resection angles with a total of 17 variations. By increasing the femoral resection angle in the finite-element-model it could be shown that a deviation of three degrees from the intended resection angle can cause critical stress amounts during implantation. CONCLUSIONS: When implanting the ceramic component in total knee arthroplasty, the femoral resection angles should be prepared very precisely, in particular anterior saw blade deflection has to be avoided. The implant manufacturer increased implant safety through an additional resection template. Moreover, the impaction of the ceramic femoral component during cementing was not further recommended by using a hammer.

Comparison of cross-sections of different femoral components for revision total knee replacement.

UNLABELLED: PURPOSE. To compare the inner contour of the femoral component of 10 total knee replacement (TKR) designs for possible exchange in use. METHODS: Inner contours of the femoral components of 10 cemented, cruciate-retaining TKR designs (e.motion, Genesis, Genia, Innex, LCS, Multigen Plus, NexGen, PFC, Scorpio, Vanguard) were scanned and reconstructed to 2-dimensional contours. Their cross-sections were compared by superimposition and aligning at the distal and anterior cuts. The patellar notch and outer contour were not analysed. RESULTS: The maximum deviation was 5 mm in the posterior and posterior oblique cuts and 10 mm in the anterior oblique cut. Based on similarity of the inner contour, LCS and Innex was classified as group I, e.motion, Genesis, Scorpio, Vanguard, and Multigen Plus as group II, and Genia, NexGen, and PFC as group III. All 2 designs in group I were not compatible with the other 8 designs. Four of the 5 designs in group II showed good compatibility. All 3 designs in group III significantly differed in the posterior and oblique cuts. CONCLUSION: A standardised inner contour of the femoral component can increase compatibility of different TKR systems in revision surgery and reduces the extent of bone resection.

Metal hypersensitivity in total knee arthroplasty: revision surgery using a ceramic femoral component - a case report.

We present a case involving the revision of a total knee arthroplasty with a metal femoral component using a ceramic implant due to metal hypersensitivity. A 58-year-old female patient underwent total knee arthroplasty (TKA) with a standard metal bicondylar knee system. She suffered from persistent pain and strong limitations in her range of motion (ROM) associated with flexion during the early postoperative period. Arthroscopic arthrolysis of the knee joint and intensive active and passive physical treatment, in combination with a cortisone regime, temporarily increased the ROM and reduced pain. No signs of low grade infection or other causes of implant failure were evident. Histology of synovial tissue revealed lymphoplasmacellular fibrinous tissue, consistent with a type IV allergic reaction. Allergometry (skin reaction) revealed type IV hypersensitivity against nickel-II-sulfate and palladium chloride. Revision surgery of the metal components was performed with a cemented ceramic femoral component (same bicondylar design) and a cemented titanium alloy tibial component. Postoperative evaluations were performed 10days, and 3 and 12months after the revision surgery. There was an increased ROM in flexion to 90° at the 12month follow-up. No swelling or effusion was observed at all clinical examinations after the revision surgery. No pain at rest and moderate walking pain were evident. The presented case demonstrates that ceramic implants are a promising solution for patients suffering from hypersensitivity to metal ions in total knee arthroplasty.

Comparative Study of Clinical and Radiological Outcomes of Unconstrained Bicondylar Total Knee Endoprostheses with Anti-allergic Coating.

BACKGROUND: Hypersensitivity reactions to implant materials have become more important in total knee replacement (TKR). The purpose of this retrospective comparative study was to evaluate the clinical and radiological outcomes of unconstrained bicondylar total knee prostheses with and without anti-allergic titanium(niobium)nitrite (Ti(Nb)N) coating. METHODS: Twenty-four patients (25 TKRs) underwent a preoperative clinical evaluation and then a postoperative evaluation after 26.2 months in the allergy group treated with coated implants (n=13 implants) and after 24.5 months in the control group treated with uncoated implants but identical geometry (n=12) using HSS, WOMAC and SF-36 scores. Radiological evaluations were performed using standard anterior-posterior (a.p.) and lateral X-rays. RESULTS: During follow-up two patients of the allergy group had to undergo revision surgery due to non-implant-related reasons. A comparative analysis of both study groups showed a significant difference in the HSS scores at both evaluation time points (MW test p≤0.050); these findings are remarkable since the control group had a significantly lower score preoperatively (54.0 vs 65.0 points) and a significantly higher score (82.5 vs 75.0 points) postoperatively. The preoperative and postoperative WOMAC and SF-36 scores were comparable in both groups (MW test p≥0.052), although the postoperative increase in the score for the allergy group was lower. The radiological results were comparable in both groups and were unlikely to influence the results. CONCLUSIONS: This clinical study demonstrates the restricted outcome in postoperative function and quality of life in the allergy group compared to the control group.