Polyethylene wear represents a significant risk factor for the long-term success of knee arthroplasty [1]. This work aimed to develop and in vivo validate an automated algorithm for accurate and precise AI based wear measurement in knee arthroplasty using clinical AP radiographs for scientifically meaningful multi-centre studies. Twenty postoperative radiographs (knee joint AP in standing position) after knee arthroplasty were analysed using the novel algorithm. A convolutional neural network-based segmentation is used to localize the implant components on the X-Ray, and a 2D-3D registration of the CAD implant models precisely calculates the three-dimensional position and orientation of the implants in the joint at the time of acquisition. From this, the minimal distance between the involved implant components is determined, and its postoperative change over time enables the determination of wear in the radiographs. The measured minimum inlay height of 335 unloaded inlays excluding the weight-induced deformation, served as ground truth for validation and was compared to the algorithmically calculated component distances from 20 radiographs. With an average weight of 94 kg in the studied TKA patient cohort, it was determined that an average inlay height of 6.160 mm is expected in the patient. Based on the radiographs, the algorithm calculated a minimum component distance of 6.158 mm (SD = 81 µm), which deviated by 2 µm in comparison to the expected inlay height. An automated method was presented that allows accurate and precise determination of the inlay height and subsequently the wear in knee arthroplasty based on a clinical radiograph and the CAD models. Precision and accuracy are comparable to the current gold standard RSA [2], but without relying on special radiographic setups. The developed method can therefore be used to objectively investigate novel implant materials with meaningful clinical cohorts, thus improving the quality of patient care.
Current implant designs and materials provide a high grade of quality and safety, but aseptic implant loosening is still the main reason for total hip revision. Highly cross-linked polyethylene (HX-PE) is used successfully in total hip replacements (THR) since several years. The good wear properties lead to a reduction of wear debris and may contribute to a longer survival time of the THRs. Furthermore, thin HX-PE liner allows the use of larger femoral heads associated with a decreased risk of dislocation and an improved range of motion. However, the cross-linking process is associated with a loss of mechanical properties of the polyethylene material which compromise the use of thin HX-PE liner in terms of high stress situations. The aim of the present study was the experimental wear analysis of HX-PE liner under steep acetabular cup position. Furthermore, a finite element analysis (FEA) was performed in order to calculate the stress within the HX-PE material in case of steep cup position under physiological loading. Experimental wear testing was performed for 5 Mio load cycles, using highly cross-linked polyethylene (HX-PE) acetabular liner combined with 44 mm ceramic femoral heads at a standard position of the acetabular cup (30° inclination) according to ISO 14242 as well as at 60° cup inclination. The wall thickness of the HX-PE liner was 3.8 mm. A hip wear simulator, according to ISO 14242 (EndoLab GmbH, Rosenheim, Germany), was used and wear was determined gravimetrically. Moreover, finite element models of the THR system at standard and steep cup position was created by Abaqus/CAE (Dessault Systemes Providence, USA). Using the finite element software Abaqus (Dessault Systemes Providence, USA) the total hip implants were physiologically loaded with maximum force of the gait cycle (3.0 kN). Thereby, the stresses within the HX-PE material were analysed. The average gravimetrical wear rates of the HX-PE liners at standard implant position (30°) and 60° cup inclination showed small wear amounts of 3.15 ± 0.32 mg and 1.92 ± 1.00 mg per million cycles, respectively. The FEA revealed a clear increase of stresses at the HX-PE liner with respect to steep cup position (von Mises stress of 8.78 MPa) compared to ISO standard implant position (von Mises stress of 5.70 MPa). The wear simulator tests could not demonstrate significant differences of gravimetrical wear amount of HX-PE liners under steep hip cup position compared to standard implant position. The small contact surface between the femoral head and the SX-PE liner during the wear testing may lead to the low wear rate of the misaligned acetabluar cup. Moreover, the FEA showed that the effect of a misaligned acetabular cup on the stresses within the polyethylene liner can be critical. Although an increase of wear could not be detected a steeper acetabular cup position using thin HX-PE liners should be avoided due to higher stresses preventing implant failure in clinical application.
Clinically applied methods of assessing implant fixation and implant loosening are of sub-optimal precision, leading to the risk of unsecure indication of revision surgery and late recognition of bone defects. Loosening diagnosis involving measuring the eigenfrequencies of implants has its roots in the field of dentistry. The changing of the eigenfrequencies of the implant-bone-system due to the loosening state can be measured as vibrations or structure-borne sound. In research, vibrometry was studied using an external shaker to excite the femur-stem-system of total hip replacements and to measure the resulting frequencies by integrated accelerometers or by ultrasound. Since proper excitation of implant components seems a major challenge in vibrometry, we developed a non-invasive method of internal excitation creating an acoustic source directly inside the implant. In the concept proposed for clinical use, an oscillator is integrated in the implant, e.g. the femoral stem of a total hip replacement. The oscillator consists of a magnetic or magnetisable spherical body which is fixed on a flat steel spring and is excited electromagnetically by a coil placed outside the patient. The oscillator impinges inside the implant and excites this to vibrate in its eigenfrequency. The excitation within the bending modes of the implant leads to a sound emission to the surrounding bone and soft tissue. The sound waves are detected by an acoustic sensor which is applied on the patient's skin. Differences in the signal generated result from varying level of implant fixation. The sensor principle was tested in porcine foreleg specimens with a custom-made implant. Influence of the measurement location at the porcine skin and different levels of fixation were investigated (press-fit, slight loosening, advanced loosening) and compared to the pull-out strength of the implant. Evaluation of different parameters, especially the frequency spectrum resulted in differences of up to 12% for the comparison between press-fit and slight loosening, and 30% between press-fit and advanced loosening. A significant correlation between the measured frequency and the pull-out strength for different levels of fixation was found. Based on these findings, an animal study with sensor-equipped bone implants was initiated using a rabbit model. The implants comprised an octagonal cross-section and were implanted into a circular drill hole at the distal femur. Thereby, definite gaps were realized between bone and implant initially. After implantation, the bone growth around the implant started and the gaps were successively closed over postoperative period. Consequently, since the tests had been started with a loose implant followed by its bony integration, a reverse loosening situation was simulated. In weekly measurements of the eigenfrequencies using the excitation and sensor system, the acoustic signals were followed up. Finally, after periods of 4 and 12 weeks after implantation, the animals were sacrificed and pull-out tests of the implants were performed to measure the implant fixation. The measured implant fixation strengths at the endpoint of each animal trial were correlated with the acoustic signals recorded.
The prevalent cause of implant failure after total joint replacement is aseptic loosening caused by wear debris. Improvement of the wear behaviour of the articulating bearing between the cup and femoral head is essential for increased survival rate of artificial hip joints. Cross-linking of the polyethylene (PE) material is one attempt to reduce wear particle release at the articulating surface. Various cross-linked polyethylenes (X-PE) are used in orthopaedics since several years. In total hip arthroplasty (THA) the use of larger femoral head sizes has specific reasons. Larger heads lead to a decreased risk of total hip dislocation and impingement as well as an improved range of motion in comparison to smaller head sizes like 28mm or less. However, the increasing diameter of femoral head can be associated with lower thickness of the PE liner and increased wear rate. Cross-linking of PE can improve the wear rate of the liner and hence supports the use of larger femoral heads. The aim of this experimental study was to evaluate the wear of standard vs. sequential X-PE (X3-PE) liner in combination with different ceramic femoral head sizes. Wear testing was performed for 5 million load cycles using standard UHMW-PE liners (N2Vac) and X3-PE liners (each Stryker GmbH & Co. KG, Duisburg, Germany) combined with 28mm ceramic ball heads and the Trident PSL acetabular cup (Stryker). Furthermore, X3-PE liners with an internal diameter of 36mm and 44mm and decreased wall thickness (5.9mm and 3.8mm) were combined with corresponding ceramic heads. An eight station hip wear simulator according to ISO 14242 (EndoLab GmbH, Rosenheim, Germany) was used to carry out the standard wear tests. The tests were realised in temperature-controlled chambers at 37°C containing calf serum (protein content 20g/l). The average gravimetrical wear rates of the standard UHMW-PE (N2Vac) liners combined with 28mm ceramic heads amounted to 12.6 ± 0.8mg/million cycles. Wear of X3-PE liners in combination with 28 mm ceramic heads was not detectable. The average gravimetrical wear rates of the X3-PE liners in combination with 36mm and 44mm ceramic heads amounted to 2.0 ± 0.5mg and 3.1 ± 0.3mg/million cycles, respectively. The purpose of this study was to evaluate the effect of femoral head size at THA on standard and sequential X-PE liner. The wear simulator tests showed that the wear rate of PE liners with small heads (28mm) decreased by cross-linking of the PE significantly. The amount of wear at X-PE increased slightly with larger head size (36mm and 44mm). However, by sequential cross-linking, the wear rate using thinner liners and larger femoral heads is reduced to a fractional amount of wear at conventional UHMW-PE. Hence, the above-mentioned advantages of larger femoral head diameters can be realised by improved wear behaviour of sequential X-PE.
Due to increased life expectancy of human population, the amount of total knee replacements (TKR) is expected to increase. TKR reached a high grade of quality and safety, but most often it fail because of aseptic implant loosening caused by polyethylene (PE) wear debris. Wear is generated at the articulating surfaces, e.g. caused by three body particles, like bone fragments or bone cement particles. The aim of this experimental study was to compare the wear of tibial PE inserts combined with metallic and ceramic femoral components at three body wear situation induced by polymethylmethacrylate (PMMA) and zirconia (ZrO2) particles from the bone cement. Wear testing was performed for 5 Mio load cycles, using tibial standard PE inserts combined with the same CR femoral component, in two different materials, Cobalt Chromium (CoCrMo) and Biolox delta ® ceramic (Multigen Plus Knee System, Lima Corporate, Italy). A knee wear simulator, according to ISO 14243 (EndoLab GmbH, Rosenheim, Germany), was used to carry out the tests. The tests were performed in temperature-controlled test chambers at 37 °C, containing calf serum with a protein content of 30 g/l. Polymethylmethacrylate (PMMA) and zirconia (ZrO2) bone cement particles (Palacos R ®) were manufactured to a size of 30 μm. The three body particles were added at all stations onto the articulating surface of the tibial PE insert (7mg per condyle) at every 500,000 cycles. Wear was determined gravimetrically and the surfaces of tibial inserts were analysed by scanning electron microscope (SEM) after finishing the 5 million cycles. Furthermore, roughness of the PE insert surfaces and the articulating surfaces of the different femoral components were detected and the PE wear particles were analysed by SEM. The average gravimetrical wear rates of the tibial PE inserts in combination with CoCr and Biolox delta ® ceramic femoral components amounted to 6.4 ± 0.9 mg and 2.6 ± 0.4 mg per million cycles, respectively. Beside bone cement particles on the articulating surface of the PE inserts, polished surfaces and scratches were detected by SEM. In comparison to the untreated surfaces of the PE inserts at both material pairings the surface roughness at the articulating areas showed deep scratches and polished regions. Analyses of the metallic femoral components showed scratches at the articulating surfaces, none on ceramics. The present study pointed out the effect of femoral component material in an abrasive three body wear situation on the wear properties of TKR. The wear simulator tests showed that wear of PE inserts under three body wear conditions, in combination with ceramic femoral components, was significantly lower than with metallic femoral components. With regard to anti-allergic properties, ceramic femoral components are promising products for TKR.
Due to the commercial launch of newly developed ceramic-on-metal (COM) bearings, we compared the deformation and stresses in the liner with ceramic-on-ceramic (COC), metal-on-metal (MOM) as well as ceramic-on-polyethylene (COP) bearings using a finite-element (FE)-model, analyzing a variety of head size and implant position. Liner deformation in terms of change in inner diameter as well as peak stresses were evaluated. The FE-model consisting of a commercial THR, the proximal femur and a section of the hemipelvis was created based on our previously published approach. Static load and muscle forces were applied according to the maximum load during gait. Polyethylene was modelled using a nonlinear definition with isotropic hardening, cobalt-chromium was modelled elastic-plastic and ceramic was modelled linear-elastic. Validity of the model was checked using an experimental setup with artificial bone and strain gauges located at the rim of the liner. Implant material (COM vs. COC vs. MOM vs. COP), head size (28 mm vs. 36 mm) and cup position (45° inclination/15° anteversion vs. 60° incl./0° antev.) were varied.Introduction
Methods
The objective of this prospective duo-center study was to evaluate the clinical and radiological outcome of the unconstrained Multigen Plus total knee system (Lima Lto, San Daniele, Italy) with the new BIOLOXÒ Delta ceramic femoral component. 40 patients underwent cemented total knee arthroplasty in two university hospitals. Clinical evaluations were undertaken preoperatively and at 3 as well as 12 months postoperatively using the HSS-Score, WOMAC-Score and SF-36-Score. The radiological investigations included ant-post. radiographs (whole leg in two leg stance and lateral view of the knee) and patella tangential radiographs (Merchant view). During 12 months follow-up three patients underwent revision surgery. One patient had to be revised due to infection after postoperative opening of the knee joint due to direct trauma. One patient sustained an osteosynthetic procedure due to periprosthetic fracture after trauma. In one patient a retropatellar replacement was inserted one year postoperatively. Implant related complications were not found. The mean preoperative HSS-Score amounted to 57.8±11.7 points. At 3 and 12 month follow-up the mean HSS-Score was 76.0±12.3 and 83.3±11.9 points respectively. Therefore HSS, as well as WOMAC and SF-36 Score improved significantly from preoperativly to both postoperative evaluations (Wilcoxon-Test p<
0.002). Radio-lucent lines around the femoral ceramic component were found in six cases. However, subsequent long-term studies must be carried out in order to prove the good early clinical results and to clarify if progression of radiolucent lines may influence the clinical outcome of the presented newly ceramic total knee system.
Sufficient primary stability of the acetabular cup is essential for stable osseous integration of the implant after total hip arthroplasty. By means of under-reaming the cavities press-fit cups gain their primary stability in the acetabular bone stock. These metal-backed cups are inserted intra-operatively using an impact hammer. The aim of this experimental study was to obtain the forces exerted by the hammer both in-vivo and in-vitro as well as to determine the resulting primary stability of the cups in-vitro. Two different artificial bone models were applied to simulate osteoporotic and sclerotic bone. Polymeth-acrylamid (PMI, ROHACELL 110 IG, Gaugler &
Lutz, Germany) was used as an osteoporotic bone substitute, whereas a composite model made of a PMI-Block and a 4 mm thick (cortical) Polyvinyl chloride (PVC) layer (AIREX C70.200, Gaugler &
Lutz, Germany) was deployed to simulate sclerotic bone. In all artificial bone blocks cavities were reamed for a press-fit cup (Trident PSL, Size 56mm, Stryker, USA) using the original surgical instrument. The impactor of the cup was equipped with a piezoelectric ring sensor (PCB Piezotronics, Germany). Using the standard surgical hammer (1.2kg) the acetabular cups were implanted into the bone substitute material by a male (95kg) and a female (75kg) surgeon. Subsequently, primary stability of the implant (n=5) was determined in a pull-out test setup using a universal testing machine (Z050, Ziwck/Roell, Germany). For validation the impaction forces were recorded intra-operatively using the identical press-fit cup design. An average impaction force of 4.5±0.6kN and 6.3±0.4kN using the PMI and the composite bone models respectively were achieved by the female surgeon in vitro. 7.4±1.5kN and 7.7±0.8kN respectively were obtained by the male surgeon who reached an average in-vivo impaction force of 7.5±1.6kN. Using the PMI-model a pull-out force of 298±72N and 201±112N were determined for the female and male surgeons respectively. However, using the composite bone model approximately half the pull-out force was measured for the female surgeon (402±39N) compared to the male surgeon (869±208N). Our results show that impact forces measured in-vitro correspond to the data recorded in-vivo. Using the osteoporotic bone model the pull-out test revealed that too high impaction forces affect the pull-out force negatively and hence the primary implant stability is reduced, whereas higher impact forces improve primary stability considerably in the sclerotic bone model. In conclusion, the amount of impaction force contributes to the quality of the obtained primary cup stability substantially and should be adjusted intra-operatively according to the bone quality of each individual patient.
Lever-out-moments of 17 Nm were determined for both the PMI- and composite-model for the female surgeon using the PSL cup, whereas 27 Nm and 70 Nm, respectively, were reached for the EP-FIT shell. For the male surgeon using the PSL cup, lever-out moments of 15 Nm and 30 Nm for the PMI- and composite-model respectively were determined. Insertion of the EP-FIT cup resulted in lever-out moments of 10 Nm using the PMI-model and 82 Nm using the composite-model. The low machined insertion force led to average lever-out moments of 34 Nm for the PSL and 71 Nm for the EP-FIT cups using the composite-model. For the high machined force, the highest lever-out moments of 44 Nm and 99 Nm for the PSL and EP-FIT shells respectively were determined.
For orthopaedic implants the adhesive strength of bone cells on implant surfaces is of high interest. In some cases the adherence of cells is desirable, e.g. on endoprosthetic implants, in others, mainly temporarily used implants, e.g. intramedullary nails, it is not favourable for the cells to attach to the implant. Therefore, besides cell spreading and proliferation on surfaces the adhesion strength with which cells bond to the substrate is of high interest. There are different approaches to determine bone cell adhesion, but no easy to operate quantitative methods are available. For this purpose, based on the spinning disc principle, we have developed a new adhesion device in conjunction with an inverse confocal laser scanning microscope (LSM). Polished disc-shaped test samples made of Ti6Al4V were seeded with bone cells (MG-63), stained with a fluorescent dye, at defined radial positions and were incubated for 18 h with cell medium. After incubation the test samples were placed into the adhesion chamber filled with 250 ml cell medium (DMEM). The test samples were rotated at various velocities until a minimum detachment of 50% was achieved. Using the LSM the detachment of the bone cells at the defined radial positions was determined and the cell count was recorded before and after rotation by means of imaging software. An average shear stress of 50 N/m2 was determined for polished Ti6Al4V surfaces. To calculate the adhesion force, the cross-sectional cell area has to be measured by the xz-scan of the LSM. Our results are reproducible and comparable to the data found in literature. The advantage of our new approach is that the same cells can be observed before and after rotation as well as different rotational speeds can be applied to the same cell population. Further investigations e.g. using different surfaces are carried out.
In orthopedic surgery, sterilization of bone used for reconstruction of osteoarticular defects caused by malignant tumors is carried out in different ways. At present, to devitalize tumor-bearing osteochondral segments, mainly extracorporal irradiation or autoclaving is used. Both methods have substantial disadvantages, e.g. loss of biomechanical and biological integrity of the bone. In particular integration at the autograft-host junction after reimplantation is often impaired due to alterations of the osteoinductivity following irradiation or autoclaving. As an alternative approach, high hydrostatic pressure (HHP) treatment of bone is a new technology, now being used in preclinical testing to inactivate tumor cells without alteration of biomechanical properties of bone, cartilage and tendons. The aim of this study was to investigate the influence of HHP on fibronectin (FN), vitronectin (VN), and type I collagen (col. I) as major extracellular matrix proteins of bone tissue, accountable among others for the osteoinductive properties of bone. Fibronectin, vitronectin and type I collagen were subjected to HHP (300 and 600 MPa) prior to the coating of cell culture plates with these pre-treated proteins. Following the biological properties were measured by means of cell proliferation, adherence, and spreading of the human osteosarcoma cell line (Saos-2) and primary human osteoblast-like cells. Up to 600 MPa all tested matrix proteins did not show any changes, regarding the biological properties adherence, spreading and proliferation. We anticipate that, in orthopedic surgery, HHP can serve as a novel, promising methodical approach, by damaging normal and tumor cells without alteration of osteoinductive properties, thus facilitating osteointegration of the devitalized bone segment in cancer patients after reimplantation.
We have to deal with an increasing number of patients who are suffering from a femoral neck fracture. In Ger-many in 1996 135.000 patients with this kind of fracture were treated. These fractures are usually found in old people and have a high complication rate: Osteonecrosis of the femoral head: 12–43% (Kyle 1994) Pseudarthrosis: 16–28% (Rogmark 2002) The indications for a total hip replacement are: – age >
65years – presence of osteoporosis (also under 65) – daily activity possible (otherwise hemialloarthroplasty) – comorbidity such as osteoarthritis We have to consider several aspects: The mortality rate is lower if we use a hip replacement (THR ~6%, osteosynthesis ~10%) The complication rate is lower if we use hip replacement (THR ~2%, osteosynthesis ~5%) In 30% of cases we have to change from osteosynthesis to a total hip replacement due to secondary complications of osteosynthesis in mobile patients If we look at this data, we must conclude that total hip replacement is the goldstandard in the treatment of femoral neck fractures (with Garden III and IV) in the population older than 65 years. Hemialloarthroplasty is only indicated for patients who are more or less immobilized.
The cranial cup is now a standardised implant in acetabular revision surgery. In order to illustrate the positive results of a standardised implant in acetabular revision surgery in comparison to other possibilities of reconstruction, we analysed results of all data in our study group. Aseptic loosening of implants often causes segmental and cavitary acetabular deficiency. Experiences gained in radical tumour surgery with reconstruction by custommade endoprostheses induced the development of the cranial cup for revision total hip arthroplasty. This new cementless revision cup has an oval shape and a special cranial flap, as well as an intramedullary rod if necessary. This type of cranial cup has been used since 1993. From 9/97 to 1/99, we implanted 30 cranial cups in revision hip surgery and collected all data of these patients prospectively. Clinical and x-ray follow-up was documented on a regular basis. Acetabular deficiency occurred twice in type 1, five times in type 2, twenty-two times in type 3 and once in type 4. The AAOS D’Antonio score was used. Cranial cups were implanted without cranial flap in 10 cases, with cranial flap in 20 cases and once using the intramedullary rod additionally. Only 28 patients were included in our last examination because one patient had died and one was bedridden because of a reason other than the hip. The Harris hip score increased from an average of 32 points preoperatively to 63 points postoperatively. Twenty-one patients are satisfied or very satisfied with their surgery. Radiograph examinations showed an average inclination angle of 42.5° in all cranial cups. Up to now there have been complications in four patients who suffered luxations, but only one required a change of inlay. One intraoperative injury of the urinary bladder had to be revised later. Three implants showed a change of position in x-ray. One was the patient with the urinary bladder injury and possible septic loosening, the second was a patient with extreme osteoporosis, and the third was a patient who did not receive an intramedullary rod for a type 4 lesions. Currently, these three patients do not have any complaints. We have always achieved primary stability. Morselised bone autografts or bone substitute materials were used to fill remaining defects. An intramedullary rod should be used in pelvis discontinuity and is obligatory to achieve the necessary stability. Developed from the experiences of custom-made tumour endoprostheses, the cranial cup with all possible variations is an appropriate intraoperative variable implant in revision acetabular surgery.
For younger patients many surgeons recommend femoral neck endoprostheses as alternative to stemmed implants in THA. Due to metaphyseal anchorage several advantages are quoted, e.g. preservation of the femoral diaphysis for a revision implant. Determinant factor for long-term implant stability is the load transmission to the bone. Because so far only few information about the load transfer of femoral neck endoprostheses exist, a photoelastic analysis was performed. Aim of the study was the comparison of bony strain pattern before and after implantation of a femoral neck endoprosthesis. ‘Composite-femurs’ (Pacific Research Labs) were used due to of their mechanical characteristics close to human femurs but better reproducibility. Three femurs were coated with photoelastic material. The femurs were loaded prior and post implantation of a femoral neck endoprosthesis type Cigar (ESKA Implants). Test load consisted of the resulting hip joint force and muscle forces (abductors, tractus iliotibialis). Load was applied statically by a universal testing machine and additional weights. Bony strain was measured along the medial, ventral, lateral and dorsal cortex. Statistical analysis of the implant related strain alterations was based on a 99% confidence interval. The unresected femurs showed an excellent match of bony strain patterns. Implantation of femoral neck endoprostheses caused highly significant strain changes at the trochanteric region. Greatest differences were observed at the lateral cortex. Above the implant’s traction screw former areas of tension changed to compression. Along the medial cortex below the resection plane strain reductions were measured but disappeared at the latest at 40 mm below. No significant changes in strain were detected at the ventral and dorsal cortex. Implant related bony strain alterations were limited to the trochanteric region of the femur. A marked strain alteration at the lateral trochanteric aspect was measured. Whether this is of clinical importance can not be answered yet.