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Apparatus to test insertion and removal torque of bone screws.

This paper describes affordable equipment for testing bone screw torque, corresponding to ASTM standard F543-00 for testing metallic medical bone screws. Correct testing of thin and long bone screws is essential due to screw failures during insertion and removal of the screws. Furthermore, insertion torque is an important factor in predicting fixation strength, screw pull-out force and effects of surface treatment of screws. The capability of the custom-built tester was determined using polytetrafluoroethylene and wood disc samples and bone screws. Bovine cortical bones allowed testing to the failure limit, i.e. the torque increased in long screws to the fracture limit. For 2.7 and 3.5 mm thick self-tapping cortical bone screws, the failure torques were 30-50 per cent higher than the minimum values required by the standard (1.0 and 2.3 N m respectively). The equipment provided reproducible results and fulfilled the ASTM standard very well. Preliminary testing with amorphous diamond coated bone screws showed good durability of the coating and on average 10-15 per cent lower torque values compared with uncoated screws. The equipment can be used to measure insertion and removal torques as described in the standard. Furthermore, it also allows testing of normal screws and bolts.

Animals↗

A proximal femoral implant preserves physiological bone deformation: a biomechanical investigation in cadaveric bones.

The aim of this study was to compare the perturbances in bone deformation patterns of the proximal femur due to a conventional cemented femoral stem and a novel uncemented implant designed on the principles of osseointegration. Five matched pairs of fresh frozen human femora were mechanically tested. Bone deformation patterns, measured with a video digitizing system under 1.5 kN joint force, showed that the cemented Spectron femoral implant caused significant alterations to the proximal femoral deformation pattern, whereas the Gothenburg osseointegrated titanium femoral implant did not significantly alter the bone behaviour (p < 0.05). Vertical micromotions measured under 1 kN after 1000 cycles were within the threshold of movement tolerable for bone ingrowth (21 microm for the Gothenburg system and 26 microm for the cemented implant).

Biomechanical Phenomena↗

Fatigue strength of a wire passing through a cannulated screw: implications for closure of the sternum following cardiac surgery.

It has been proposed that the incidence of sternal dehiscence can be decreased by passing the wires used for sternotomy closure through cannulated screws. However, there is a potential risk of fatigue failure as a result of the wire moving against the screw, e.g. during coughing and sneezing. The system of cannulated screws and wire was subjected to static tensile testing to failure. Five tests were performed and failure occurred at 388 +/- 34 N (mean +/- SD). Ten cyclic tests were then performed. Sinusoidal loading was applied at 10 Hz with peak forces in the range 10-90 per cent of the static failure force, at a constant load ratio R = 10. The test with the lowest peak force reached run-out at 6 x 10(6) cycles. The others failed by the ends of the wire closures becoming untwisted (one test), the wire fracturing at the twist (three tests) or the wire fracturing at the screw (five tests). However, calculations based on these results suggest that fatigue failure is unlikely to occur as a result of regular breathing or continuous coughing or sneezing.

Bone Screws↗

Effect of joint conformity on glenoid component fixation in total shoulder arthroplasty.

Results of shoulder replacements are inferior and must be improved. Two of the major problems of total shoulder replacements are loosening of cemented glenoid components and wear of polyethylene inlays of uncemented, metal-backed glenoid components. The aim of this study is to investigate the influence of joint conformity on glenoid-component fixation. Keeled glenoid components, with radii of curvature of 24, 25, or 29 mm, were cemented in bone substitutes, placed in a force-controlled test set-up, articulating against a 24 mm humeral head. They were loaded by a constant joint compression force (725 +/- 10 N) and a superior subluxation force (shear force), cyclically varying between 0 and 350 +/- 1 N. After 200,000 load cycles, the upper and lower glenoid component rim-displacements were measured by custom-made displacement sensors. Additionally, the shear-out strength has been measured to investigate the residual strength. The glenoid component structures with radii of curvature of 24, 25, and 29 mm showed maximum superior rim-displacements of 0.163 (SD = 0.01), 0.299 (SD = 0.0306), and 0.350 (SD = 0.0197) mm respectively, which is a significant difference (p < 0.05). The maximum shear-out strength of glenoid components with radii of curvature of 24, 25, and 29 mm was 2707 (SD = 452), 2648 (SD = 299), and 2631 (SD = 312) N respectively, which is not a significant difference (p < 0.05). However, the results indicate that a conform articulation shows smaller glenoid rim-displacements, which might be beneficial for long-term component fixation.

Arthroplasty↗

Head replacement, head rotation, and surface damage effects on metal-on-metal total hip replacements: a hip simulator study.

The possibility of replacing the femoral head alone, in either solid or articular surface replacement form, during revision operations on metal-on-metal total hip replacements remains an attractive feature of such implants. In the present investigation, laboratory simulator studies of the influence upon volumetric wear of inserting a new femoral head, of introducing some head rotation, and of damaging the femoral head by scratches have all been explored. New and rotated heads both involve an additional running-in period, but the experimental studies show that the volumetric wear associated with this process is less than the initial running-in wear. The beneficial effects upon volumetric wear of small clearances have been confirmed, while the processing of high-carbon Co-Cr-Mo materials appears to be much less influential. Scratches did not affect wear as much as head replacement or head rotation, but the ongoing wear rates were somewhat higher.

Biocompatible Materials↗

Deformation of press-fitted metallic resurfacing cups. Part 1: Experimental simulation.

The interference press fit of a metallic one-piece acetabular cup employed for metal-on-metal hip resurfacing procedures was investigated experimentally under laboratory conditions in the present study, in particular regarding the cup deformation. Tests were carried out in cadavers as well as polyurethane foams of various grades with different elastic moduli to represent different cancellous bone qualities. The cadaver test was used to establish the most suitable configuration of the foam model representing realistic support and geometrical conditions at the pelvis. It was found that a spherical cavity, with two identical areas relieved on opposite sides, was capable of creating a two-point pinching action of the ischeal and ilial columns on the cup as the worst-case scenario. Furthermore, the cup deformation produced from such a two-point loading model with a grade 30 foam was similar to that measured from the cadaver test. Therefore, such a protocol was employed in subsequent experimental tests. For a given size of the outside diameter of the cup of 60 mm, the cup deflection was shown to be dependent largely on the cup wall thickness and the diametral interference between cup and prepared cavity at implantation. For a relatively thin cup with a wall thickness between 2.3 mm (equator) and 4 mm (pole) and with a modest nominal diametral interference of 1 mm, which corresponds to an actual interference of approximately 0.5 mm, the maximum diametral cup deflection (at the rim) was around 60 microm, compared with a diametral clearance of 80-120 microm between the femoral head and the acetabular cup, generally required for fluid-film lubrication and tribological performances. Stiffening of the cup, by both thickening and lateralizing by 1 mm, reduced the cup deformation to between 30 and 50 microm with actual diametral interferences between 0.5 and 1 mm.

Arthroplasty, Replacement, Hip↗

[Extended push-out test to characterize the failure of bone-implant interface].

To study the mechanical behaviour of the implant-bone interface the push- or pull-out test was overtaken from material science. Most authors equate the maximum load (break point) with the failure of the implant integration. Extending the test procedure by acoustic emission analysis reveals the possibility to detect the failure of the interface more in detail and from its earliest beginning. The development of disconnection between host and implant was found to start long before the ultimate load is reached and can be monitored and quantified during this period. The active interface mechanisms are characterized by the distribution function of acoustic emissions and the number of hits per time defines the kinetics of the failure. From clinical studies a gradual subsidence of loaded implants is known starting long time before the definite implant failure. The presented extension of the push-out test with acoustic emission analysis allows the detection of a critical shear stress tc which demarks the onset of the gradual interface failure. We believe this value to represent the real critical load which should not be exceeded in the clinical application of intraosseous implants.

Acoustics↗

[Radiological evaluation of polyethyelene wear of cementless total hip endoprosthesis].

During the last years increasingly cementless hip endoprostheses have been implanted. Radiological wear measurement of cemented hip endoprostheses for the material couples polyethylene cup-ceramic- or metal head has been established in the literature. However, for cups encased by metal (screwing or pressfit cups), this method of measurement is not applicable. Therefore, a method has been developed to measure wear on radiographs on cementless spherical implants. The data were compared to those, obtained from conventional wear measurements on cemented hip cups. The results indicate that both techniques generate comparable results, thus validating the new technique as being suited for cementless cup implants.

Cementation↗

Stenosis of a mechanical mitral prosthetic valve in a patient with systemic lupus erythematosus.

A young woman with systemic lupus erythematosus (SLE) developed progressive heart failure several years after mitral valve replacement with a Björk-Shiley prosthesis for treating mitral stenosis due to Libman-Sacks endocarditis. She was admitted to the hospital with pulmonary oedema. Transoesophageal echocardiography revealed stenosis of the mitral prosthesis, which was covered by fibrous tissue. Replacement of the prosthesis was done but the patient died from cerebral haemorrhage three days later. Although three cases of prosthetic valve dysfunction in SLE have been documented so far, this is to our knowledge the first report of a SLE recurrence on a tilting disc mechanical valve.

Adult↗

Theories of wear and loosening in hip prostheses. Wear-induced loosening vs loosening-induced wear--a review.

The observation of perioprosthetic granulomas containing wear debris around apparently well-fixed as well as around loose-fitting prosthetic components has led to the development of the hypothesis of wear-induced loosening. However, the hypothesis of wear-induced loosening can neither explain the rapid early prosthetic migration detected by roentgen stereophotogrammetry nor the epidemiology of clinical failure without supplementary ad hoc-assumptions. By contrast, apart from explaining the rapid early prosthetic migration detected by roentgen stereophotogrammetry, the theory of early loosening can explain the development of wear granulomas as well as to a great extent the epidemiology of clinical failure.

Biocompatible Materials↗

Fixation of the acetabular cup in cemented total hip replacement: improving the anchorage hole profile using finite element method.

Long-term studies have shown that failure of the acetabular component in total hip replacement increases exponentially ten years following surgery and occurs mostly at the bone-cement interface. During the cemented fixation of the acetabular cup, straight anchorage holes, 3-15 mm diameter and 3-20 mm deep, are drilled in the acetabulum in order to increase torsional resistance at the bone-cement interface. The aim of this paper is to provide guidelines for improving the profile of anchorage holes. Results from our finite element models show that the efficiency of anchorage holes may be improved if they are drilled perpendicularly to the acetabulum floor and if they have chamfered necks. A 10 degree inclination of the anchorage hole increases Von Mises stress in the cement mantle by 6% while creating chamfered anchorage holes, instead of straight holes, decreases it by 14%. Increasing depth of anchorage holes does not improve efficiency.

Acetabulum↗

A depth profile of oxidation and gel fraction in gamma-irradiated silane crosslinked and ultra high molecular weight polyethylenes.

The depth profile of oxidation index and gel fraction has been measured for two silane crosslinked poly(ethylene) (SXLPE) acetabular cups (one gamma irradiated in air, and one non-irradiated, both with a shelf-life of 13 years) and for two UHMWPE components (one gamma irradiated in air and one non-irradiated, with shelf-lives of 13 and 7 years, respectively). Only the irradiated UHMWPE exhibited any variation in these properties with depth. The oxidation profile (maximum 1 mm below surface) has been explained to result from reduced levels of diffused oxygen with depth, giving rise to a balance of alkyl and peroxyl radicals (and hence maximum carbonyl production) just below the surface. The gel fraction profile (maximum 4 mm below surface) is also attributed to the lower levels of diffused oxygen with depth, causing crosslinking to dominate in the bulk and chain scission to dominate at the surface. The resistance to oxidative degradation in the non-irradiated SXLPE was attributed to the use of antioxidants in the polymer processing.

Cross-Linking Reagents↗

Shape optimisation to maximise crack initiation time.

Most of machine parts, artificial joints and their components used for human body contain fillets, which connects two different diameters or widths. These fillets may cause a failure for these components. So, in this paper an optimisation method is presented which calculates and predicts optimal shape of the longitudinal profile for transition length of a tension bar, which connects two different diameters, using the ANSYS program. This method is applied to maximise the crack initiation time by minimising the fatigue notch factor Kf. A specified program has been developed to calculate the fatigue notch factor using Ansys Parametric Design Language (APDL) which is associated to the ANSYS Package. It was observed that the maximisation of crack initiation time with higher value of the statistical parameter, k, is also a minimisation of stress concentration factor, kt, at the same time.A tension bar with four different transition length, t (t/d=0.333, 0.4167, 0.5 and 0.583) is considered. The crack initiation time of the optimal shape for all cases was increased by 17%, 12%, 9% and 7%, respectively. The stress concentration factor was reduced by 20%, 17%, 15% and 12.5%, respectively.

Biomechanical Phenomena↗

The importance of annealing 316 LVM stents.

The annealing process is an important key step in the manufacture of high quality and reliable 316 LVM stents. [figure: see text] The methods commonly applied for verifying the outcome of the annealing process such as microhardness testing are inappropriate and should not be used. The tension testing of tubes, processed together with stents, provides reliable results of the final material properties of stents. During the course of the investigation the grain size was reduced significantly and the break elongation improved. The surface of the strain-tested material shows substantial improvements. All results are particularly important for thin-wall stents with filigree struts.

Biocompatible Materials↗

Epidemiology of osteolysis: backside implant wear.

Osteolysis is an emerging problem in patients who undergo total hip arthroplasty and total knee arthroplasty (TKA). Before the introduction of modular components, osteolysis was not as prevalent in patients who underwent TKA. Although polyethylene wear and the generation of small-particle debris were linked to the presence of osteolysis in patients who have undergone total hip arthroplasty, the fatigue-type wear and larger wear particles often seen with TKA were not thought to invoke the cellular response that causes osteolysis. Despite the lack of an identifiable cause for the osteolysis, the number of knees that developed lesions continued to increase. Therefore, modular components were examined to determine whether this innovation in TKA was actually contributing to the manifestation of osteolysis.

Arthroplasty, Replacement, Knee↗