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[Metal/metal--a new (old) hip bearing system in clinical evaluation. Prospective 7-year follow-up study].

The problems of wear debris of bearing systems containing polyethylene used in hip arthroplasty have led to an increased trend to hard on hard bearing surfaces. Based on our own good experiences with the cementless Zweymüller-Alloclassic system, we implanted the same system with metal-on-metal bearing surfaces (Metasul) in 100 cases between October 1993 and November 1994. In order to record potential side effects, specific questioning and a clinical and radiological survey were carried out before surgery and in regular intervals thereafter. Up to date almost all of the patients have had good and excellent results with an average of more than 90 points in the Harris hip score (47.8 before surgery). There were no cases of revision surgery as a result of aseptic loosening. Two revisions were performed for other reasons (change of the insert, deep infection). No disadvantageous phenomena related to Metasul in the surrounding tissue were found on macroscopic and histologic investigation. The radiological examination did not show any specific signs pertaining to the use of a metal-on-metal bearing system. We also have no grounds to suppose that there are systemic reactions due to chromium or cobalt ions. Up to now, the new metal-on-metal bearing system in connection with a proven hip arthroplasty system has lived up to clinical expectations. With regard to less wear debris, it is justified to implant it in younger patients as well. Other open questions, in particular the possibly improved long-term results, have to be answered by continuation of the study.

Aged↗

Zirconia femoral head fractures: a clinical and retrieval analysis.

Zirconia femoral heads provide increased fracture strength, but 343 zirconia head failures have been documented since 2000. Retrieval analysis of 6 fractured heads, 4 suspect heads, 4 control zirconia heads, and 2 failed alumina heads was performed. Zirconia failures have been isolated to heads sintered in a "tunnel" furnace introduced in 1998. The monoclinic composition at the taper surface of fractured and nonfractured heads was significantly elevated (21% to 68%) compared to that of control zirconia heads (less than 5%). Electron microscopy identified circular fracture footprints unique to the zirconia heads produced in the tunnel furnace. Cobalt chrome heads were used in the urgent revision setting due to Morse taper damage. Partial capsulectomy was performed in an effort to reduce future third body wear. Monoclinic phase transformation following implantation remains a potential mechanism of ceramic head failure. We recommend that patients with recalled zirconia heads be advised of a potential fracture risk.

Adult↗

Invited commentary.

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Equipment Failure Analysis↗

Investigation of the activation of a human serum complement protein, C3, by orthopedic prosthetic particulates.

Myriad molecular, cellular, and physiological processes underlie the inflammatory and osteolytic processes induced by particles of biomaterials resulting from the wear of implants such as total joint replacement prostheses. The objective this study was to investigate the role that the complement system may be playing in these phenomena. The aim was to evaluate the degree to which particles of selected orthopaedic materials--high density and ultrahigh molecular weight polyethylene, polymethylmethacrylate, and commercially pure titanium--cause the elevation of a key complement molecule, C3a, in an in vitro assay that directly measured the concentration of C3a. The results demonstrated that HDPE particles, at high concentration, are capable of causing the elevation of C3a in the in vitro assay. This finding is discussed in the context of other work and the mechanics of the complement system as it may affect the osteolytic process.

Biocompatible Materials↗

Cyclic loading response of bioprosthetic heart valves: effects of fixation stress state on the collagen fiber architecture.

Biologically derived, chemically modified collagenous tissues are being increasingly used to fabricate cardiac valve prostheses and as biomaterials in cardiovascular repair. A stress-free state during chemical modification has been shown to preserve the collagen fiber architecture of the native tissue, potentially preserving native mechanical properties and improving prostheses durability. However, it is not known if the native collagen fiber architecture is stable during long-term in vivo operation. To address this question, we obtained porcine aortic valves chemically treated at (i) 0 mmHg transvalvular pressure (with 40 mmHg aortic pressure) and (ii) 4 mmHg transvalvular pressure, then subjected the valves to 0, 1 x 10(6), 50 x 10(6), and 200 x 10(6) in vitro accelerated wear testing (AWT) cycles. The resulting changes in collagen fiber architecture were quantified using small angle light scattering analysis (SALS). SALS measurements indicated that collagen fibers in the 0 mmHg pressure-fixed leaflets became more aligned between 1 x 10(6) and 50 x 10(6) AWT cycles. In contrast, only minor changes (not statistically significant) in collagen fiber orientation occurred in the 4 mmHg pressure-fixed valvular tissue with cycling. It was also noted that although the 0 mmHg group was fixed without transvalvular pressure, distention of the root induced significant changes in collagen structure of the leaflets. Overall, our observations suggest that the native collagen fiber crimp of the 0 mmHg pressure-fixed leaflets were rapidly lost after only 50 x 10(6) AWT cycles (equivalent to approximately 1.6 patient years) and thus may not be maintained over a sufficient period of time to be clinically beneficial. Further, the collagen structure of the native aortic valve is exquisitely sensitive to dimensional change in the aortic root-independent of the presence of transvalvular pressure. Our findings also suggest that without in vivo remodeling, any collagenous tissue used to fabricate BHV may undergo similar degenerative, irreversible changes in vivo.

Aortic Valve↗

Probabilistic analysis of the influence of the bonding degree of the stem-cement interface in the performance of cemented hip prostheses.

The long-term behavior of the stem-cement interface is one of the most frequent topics of discussion in the design of cemented total hip replacements, especially with regards to the process of damage accumulation in the cement layer. This effect is analyzed here comparing two different situations of the interface: completely bonded and debonded with friction. This comparative analysis is performed using a probabilistic computational approach that considers the variability and uncertainty of determinant factors that directly compromise the damage accumulation in the cement mantle. This stochastic technique is based on the combination of probabilistic finite elements (PFEM) and a cumulative damage approach known as B-model. Three random variables were considered: muscle and joint contact forces at the hip (both for walking and stair climbing), cement damage and fatigue properties of the cement. The results predicted that the regions with higher failure probability in the bulk cement are completely different depending on the stem-cement interface characteristics. In a bonded interface, critical sites appeared at the distal and medial parts of the cement, while for debonded interfaces, the critical regions were found distally and proximally. In bonded interfaces, the failure probability was higher than in debonded ones. The same conclusion may be established for stair climbing in comparison with walking activity.

Cementation↗

An investigation of the effects of hydroxyapatite coatings on the fixation strength of cortical screws.

Hydroxyapatite (HA) are commonly applied to orthopaedic implants for acceleration of osteointegration and so overcoming the loosening problems such as in cortical screws. Electrophoretic deposition (EPD) of hydroxyapatite was applied for coating of cortical screws in this work. The effects of hydroxyapatite-coated and uncoated cortical screws on insertion and extraction torque were investigated through in vivo experiments. Three groups of screws were undertaken: first group with no coating, second group coated with HA and the third group coated with HA+interlayer, a synthetic calcium silicate compound. Five sheep were operated, and 60 cortical (20 x 3) screws from those of groups were implanted in cortical femurs to observe the effect of HA and interlayer on screws. Results show that as an alternative to plasma spray coating method, the EPD process enables to produce a quick, easy, cheap and uniform adjustable coating layer. Also from biomechanical and SEM examinations, HA coating by EPD method of cortical screws resulted in extremely improved fixation with reduced risk of loosening problem.

Animals↗

Validation of a digital image processing software package for the in vivo measurement of wear in cemented Charnley total hip arthroplasties.

Computer-generated images were used to assess image processing software employed in the radiographic evaluation of penetration in total hip replacement. The images were corrupted using Laplacian noise and smoothed to simulate different modulation transfer functions in a range associated with hospital digital radiographic systems. With no corruption, the penetration depth measurements were both precise and accurate. However, as the noise increased so did the inaccuracy and imprecision to levels that may make changes in the penetration observed clinically difficult to discern between follow-up assessments. Simulated rotation of the wire marker produced significant bias in the measured penetration depth. The use of these simulated radiographs allows the evaluation of the software used to process the digital images alone rather than the whole measurement system.

Arthroplasty, Replacement, Hip↗

The evolution of hip resurfacing arthroplasty.

Metal-on-metal hip resurfacing, a significant recent development in hip arthroplasty, preserves proximal femoral bone stock, optimizes stress transfer to the proximal femur, and offers inherent stability and optimal range of movement. The results of hip resurfacing in the 1970s and 1980s were disappointing, and the procedure was largely abandoned by the mid-1980s. The renaissance of metal-on-metal articulations for total hip arthroplasty has enabled the introduction of new hip resurfacings, and many implant manufacturers have introduced such systems. Early results are encouraging, and complications commonly seen in the 1970s and 1980s, such as early implant loosening and femoral neck fracture, are rare. Background research and better understanding of implant failure suggest that current hip resurfacing technology has developed beyond that of an experimental procedure.

Arthroplasty, Replacement, Hip↗

Analysis of a retrieved UHMWPE acetabular cup crosslinked in air with 1000 kGy of gamma radiation.

The oxidation and degradation that accompany high dose gamma irradiation in air for crosslinking and sterilization are important because they could affect the clinical performance of polyethylene total joint implants. We report a clinical case of a 1000 kGy gamma-irradiated, highly crosslinked ultra-high molecular weight polyethylene acetabular cup retrieved 24 years postoperatively. Performance evaluations included absorbed radiation dose, total wear penetration, average wear rate, crystallinity, oxidation, and equibiaxial tensile properties. A retrieved acetabular cup of the same grade of polyethylene but gamma-sterilized using a conventional dose was used as control. The highly crosslinked and control cups took in about 1300 and 30 kGy of radiation, respectively, as measured using a trans-vinylene index. Direct dimensional measurements revealed average wear rates of the highly crosslinked and control cups were 0.04 and 0.06 mm/year, respectively. The oxidation index of the highly crosslinked cup was very high (0.679), but equivalent to that of a 1000 kGy irradiated reference cup. The retrieved highly crosslinked cup showed much higher equibiaxial ultimate tensile strength than the retrieved control cup. Based on these observations, the increased wear resistance and equibiaxial tensile properties that resulted from extensive crosslinking in the presence of air were partially offset by the adverse effects caused by immediate oxidation during the process.

Aged↗

Comparative in vitro study on the long term performance of cemented hip stems: validation of a protocol to discriminate between "good" and "bad" designs.

The long-term clinical success of cemented hip stems is influenced both by the implant design, and by the surgical procedure. A methodology is proposed for discriminating between implant designs with different clinical outcomes. The protocol was designed with industrial pre-clinical validation in mind. Two cemented stem types were tested, one (Lubinus SPII) having good and the other (Müller Curved) having poor clinical outcomes. Three implants for each type were subjected to a mechanical in vitro test of one million loading cycles. Each cycle reproduced the load components of stair climbing. Interface shear micromotion was measured during the test in the direction of rotation and along the stem axis. The stem roughness before and after the test was compared. After the test, the cement mantles were retrieved and inspected through dye penetrants to detect evidences of micro-damage. For each specimen, the events of the loosening process were examined, based on the in vitro data available, so as to analyze the whole failure mechanism. The protocol developed was sensitive to the implant design, with significantly different results being found for the two stem types, both in terms of stem-cement micromotions, surface roughness alteration, and cement mantle damage. The information yielded by the three different investigation techniques was consistent for each of the two groups of specimens tested, allowing a better understanding of the failure process. In vitro inducible micromotion and permanent migration measurements, together with cement-stem interface fretting damage and cement fatigue damage, can help predicting the clinical performance of cemented stems.

Bone Cements↗

The effect of metallic radial head arthroplasty on radiocapitellar joint contact area.

OBJECTIVE: This study determined the effect of metallic radial head arthroplasty on radiocapitellar joint contact area. DESIGN: The contact area of eight intact radiocapitellar joints was assessed during simulated compressive loading. Subsequently, the same experiments were repeated after reconstruction with three different radial head implant sizes. BACKGROUND: There has been an increasing use of metal radial head implants relative to silicone implants. However, the contact characteristics with the metal reconstruction have not been determined. METHODS: A 100 N compressive load was applied to the radiocapitellar joint at three different flexion angles for the native joint and three different sizes of a metal head implant. An impression material was employed to quantify joint contact area. RESULTS: Following metallic radial head arthroplasty, the contact area decreased by approximately two-thirds relative to the native radiocapitellar joint (P<0.001). Smaller implant sizes resulted in slightly larger contact areas (P<0.05). In addition, contact area decreased as joint flexion angle increased (P<0.04). CONCLUSIONS: Selection of radial head implant size is likely not a significant factor with regard to contact area mechanics of the radiocapitellar articulation. RELEVANCE: The effect of radial head implant size on the contact area produced with the native capitellum is not known. This study shows that the design or selection of a metallic radial head implant from the viewpoint of size is likely not an important factor with regard to minimizing joint contact stresses.

Aged↗

THA loading arising from increased femoral anteversion and offset may lead to critical cement stresses.

Aseptic loosening of artificial hip joints is believed to be influenced by the design and orientation of the implant. It is hypothesised that variations in implant anteversion and offset lead to changes in the loading of the proximal femur, causing critical conditions to both the bone and cement. The goal of this study was therefore to analyse the role of these parameters on loading, bone strains and cement stresses in total hip arthroplasty (THA). A validated musculo-skeletal model was used for the analysis of muscle and joint contact forces during walking and stair climbing. Two different anteversion angles (4 degrees vs. 24 degrees ) and prostheses offsets (standard vs. long) were analysed. The loads for each case were applied to a cemented THA finite element model. Generally, stair climbing caused higher bone strains and cement stresses (max. +25%) than walking. Variations in anteversion and offset caused changes in the loading environment, bone strain distribution and cement stresses. Compared to the standard THA configuration, cement stresses were raised by increasing anteversion (max. +52%), offset (max. +5%) and their combination (max. +67%). Femoral anteversion, offset and their combination may therefore lead to an increased risk of implant loosening. Analyses of implant survival should consider this as a limiting factor in THA longevity. In clinical practice, implant orientation, especially in regard to pre- and post-operative anteversion, should be considered to be more critical.

Arthroplasty, Replacement, Hip↗

Factors contributing to rapid wear and osteolysis in hips with modular acetabular bearings made of hylamer.

There have been several reports of osteolysis associated with rapid wear of Hylamer. A detailed analysis of retrieved implants and tissues can identify factors contributing to rapid wear and osteolysis. The mean linear wear rate of 12 liners was 0.49 mm/y, and 11 of 12 hips had progressive retroacetabular osteolysis. The average patient age was 50 years, and the mean implantation time was 50 months. All liners were sterilized by gamma irradiation in air. There was an 11-month difference in the average shelf-life of the 3 liners that were white and those that were darker in color. The volumetric wear rate of the white liners was 30% less than that of the others, suggesting a difference in the wear resistance of the liners as a function of shelf life. The mean average surface roughness (Ra) and the mean maximum surface roughness (R(max)) of the femoral heads were increased 3-fold and 50-fold compared with typical values for unused femoral heads. Evidence of 3-body wear, such as metal particles embedded in the liners, was commonly present. The pattern of backside liner deformation and burnishing was consistent with relative motion between the liner and the shell. In addition to generating Hylamer wear particles, repetitive axial motion between the liner and shell could generate fluid pressure, which transmitted through holes in the acetabular shell could cause or contribute to the development of retroacetabular osteolysis. Hylamer particles of variable shape and size, consistent with generation by several wear modes, were isolated from periprosthetic tissues.

Acetabulum↗