Objectives

The aims of this piece of work were to: 1) record the background concentrations of blood chromium (Cr) and cobalt (Co) concentrations in a large group of subjects; 2) to compare blood/serum Cr and Co concentrations with retrieved metal-on-metal (MoM) hip resurfacings; 3) to examine the distribution of Co and Cr in the serum and whole blood of patients with MoM hip arthroplasties; and 4) to further understand the partitioning of metal ions between the serum and whole blood fractions.

There is widespread concern regarding the incidence of adverse soft-tissue reactions after metal-on-metal (MoM) hip replacement. Recent National Joint Registry data have shown clear differences in the rates of failure of different designs of hip resurfacing. Our aim was to update the failure rates related to metal debris for the Articular Surface Replacement (ASR). A total of 505 of these were implanted.

Kaplan-Meier analysis showed a failure rate of 25% at six years for the ASR resurfacing and of 48.8% for the ASR total hip replacement (THR). Of 257 patients with a minimum follow-up of two years, 67 (26.1%) had a serum cobalt concentration which was greater than 7 μg/l. Co-ordinate measuring machine analysis of revised components showed that all patients suffering adverse tissue reactions in the resurfacing group had abnormal wear of the bearing surfaces. Six THR patients had relatively low rates of articular wear, but were found to have considerable damage at the trunion-taper interface. Our results suggest that wear at the modular junction is an important factor in the development of adverse tissue reactions after implantation of a large-diameter MoM THR.

This systematic review of the literature summarises the clinical experience with ceramic-on-ceramic hip bearings over the past 40 years and discusses the concerns that exist in relation to the bearing combination. Loosening, fracture, liner chipping on insertion, liner canting and dissociation, edge-loading and squeaking have all been reported, and the relationship between these issues and implant design and surgical technique is investigated. New design concepts are introduced and analysed with respect to previous clinical experience.

Several bisphosphonates are now available for the treatment of osteoporosis. Porous hydroxyapatite/collagen (HA/Col) composite is an osteoconductive bone substitute which is resorbed by osteoclasts. The effects of the bisphosphonate alendronate on the formation of bone in porous HA/Col and its resorption by osteoclasts were evaluated using a rabbit model. Porous HA/Col cylinders measuring 6 mm in diameter and 8 mm in length, with a pore size of 100 μm to 500 μm and 95% porosity, were inserted into a defect produced in the lateral femoral condyles of 72 rabbits. The rabbits were divided into four groups based on the protocol of alendronate administration: the control group did not receive any alendronate, the pre group had alendronate treatment for three weeks prior to the implantation of the HA/Col, the post group had alendronate treatment following implantation until euthanasia, and the pre+post group had continuous alendronate treatment from three weeks prior to surgery until euthanasia. All rabbits were injected intravenously with either saline or alendronate (7.5 μg/kg) once a week. Each group had 18 rabbits, six in each group being killed at three, six and 12 weeks post-operatively. Alendronate administration suppressed the resorption of the implants. Additionally, the mineral densities of newly formed bone in the alendronate-treated groups were lower than those in the control group at 12 weeks post-operatively. Interestingly, the number of osteoclasts attached to the implant correlated with the extent of bone formation at three weeks.

In conclusion, the systemic administration of alendronate in our rabbit model at a dose-for-weight equivalent to the clinical dose used in the treatment of osteoporosis in Japan affected the mineral density and remodelling of bone tissue in implanted porous HA/Col composites.

In this study of 41 patients, we used proteomic, Western blot and immunohistochemical analyses to show that several reactive oxygen species scavenging enzymes are expressed differentially in patients with primary osteoarthritis and those with non-loosening and aseptic loosening after total hip replacement (THR). The patients were grouped as A (n = 16, primary THR), B (n = 10, fixed THR but requiring revision for polyethylene wear) and C (n = 15, requiring revision due to aseptic loosening) to verify the involvement of the identified targets in aseptic loosening. When compared with Groups A and B, Group C patients exhibited significant up-regulation of transthyretin and superoxide dismutase 3, but down-regulation of glutathione peroxidase 2 in their hip synovial fluids. Also, higher levels of superoxide dismutase 2 and peroxiredoxin 2, but not superoxide dismutase 1, catalase and glutathione perioxidase 1, were consistently detected in the hip capsules of Group C patients.

We propose that dysregulated reactive oxygen species-related enzymes may play an important role in the pathogenesis and progression of aseptic loosening after THR.

The mechanical performance of the cement-in-cement interface in revision surgery has not been fully investigated. The quantitative effect posed by interstitial fluids and roughening of the primary mantle remains unclear. We have analysed the strength of the bilaminar cement-bone interface after exposure of the surface of the primary mantle to roughening and fluid interference. The end surfaces of cylindrical blocks of cement were machined smooth (Ra = 200 nm) or rough (Ra = 5 μm) and exposed to either different volumes of water and carboxymethylcellulose (a bone-marrow equivalent) or left dry. Secondary blocks were cast against the modelled surface. Monoblocks of cement were used as a control group. The porosity of the samples was investigated using micro-CT. Samples were exposed to a single shearing force to failure.

The mean failure load of the monoblock control was 5.63 kN (95% confidence interval (CI) 5.17 to 6.08) with an estimated shear strength of 36 MPa. When small volumes of any fluid or large volumes were used, the respective values fell between 4.66 kN and 4.84 kN with no significant difference irrespective of roughening (p > 0.05). Large volumes of carboxymethylcellulose significantly weakened the interface. Roughening in this group significantly increased the strength with failure loads of 2.80 kN (95% CI 2.37 to 3.21) compared with 0.86 kN (95% CI 0.43 to 1.27) in the smooth variant. Roughening of the primary mantle may not therefore be as crucial as has been previously thought in clinically relevant circumstances.

We report the minimum five-year follow-up of 352 primary total hip replacements using the uncemented hydroxyapatite-coated ANCA-Fit femoral component with a modular neck and head. The series comprised 319 patients (212 men, 107 women) with a mean age at operation of 64.4 years (28 to 97). The principal diagnosis was osteoarthritis. A total of 18 patients (21 hips) died before their follow-up at five years, nine patients (11 hips) were lost to follow-up, and four (four hips) declined further follow-up. Patient-reported outcomes have been recorded for 288 patients (316 hips).

Their mean Oxford Hip Score improved significantly from 41 points (16 to 57) pre-operatively to 20 points (12 to 44) at five-year follow-up. Radiological assessment showed good bony stability in 98% of implants. There were two cases of aseptic loosening of the femoral component. There were no clinical or radiological complications related to modularity. In our series we did not see the high rate of intra-operative fracture previously reported for this implant.

This medium-term follow-up study demonstrates that the clinical outcome of the ANCA-Fit femoral component is, to date, comparable with that of other metaphyseal loading femoral components.

We have reviewed our experience of the removal of deep extremity orthopaedic implants in children to establish the nature, rate and risk of complications associated with this procedure. A retrospective review was performed of 801 children who had 1223 implants inserted and subsequently removed over a period of 17 years. Bivariate analysis of possible predictors including clinical factors, complications associated with implant insertion and indications for removal and the complications encountered at removal was performed. A logistical regression model was then constructed using those predictors which were significantly associated with surgical complications from the bivariate analyses. Odds ratios estimated in the logistical regression models were converted to risk ratios.

The overall rate of complications after removal of the implant was 12.5% (100 complications in 801 patients), with 48 (6.0%) major and 52 (6.5%) minor. Children with a complication after insertion of the initial implant or with a non-elective indication for removal, a neuromuscular disease associated with a seizure disorder or a neuromuscular disease in those unable to walk, had a significantly greater chance of having a major complication after removal of the implant. Children with all four of these predictors were 14.6 times more likely to have a major complication.

The presence of pseudotumours, which are soft-tissue masses relating to the hip, after metal-on-metal hip resurfacing arthroplasty has been associated with elevated levels of metal ions in serum, suggesting that pseudotumours occur when there is increased wear. We aimed to quantify the wear in vivo of implants revised for pseudotumours (eight) and of a control group of implants (22) revised for other reasons of failure.

We found that the implant group with pseudotumours had a significantly higher rate of median linear wear of the femoral component at 8.1 μm/year (2.75 to 25.4) than the 1.79 μm/year (0.82 to 4.15; p = 0.002) of the non-pseudotumour group. For the acetabular component a significantly higher rate of median linear wear of 7.36 μm/year (1.61 to 24.9) was observed in the pseudotumour group compared with 1.28 μm/year (0.81 to 3.33, p = 0.001) in the other group. Wear of the acetabular component in the pseudotumour group always involved the edge of the implant, indicating that edge-loading had occurred.

Our findings are the first direct evidence that pseudotumour is associated with increased wear at the metal-on-metal articulation. Furthermore, edge-loading with the loss of fluid-film lubrication may be an important mechanism of generation of wear in patients with a pseudotumour.

Implantation of a large-diameter femoral head prosthesis with a metal-on-metal bearing surface reduces the risk of dislocation, increases the range of movement, minimises the risk of impingement and, in theory, results in little wear.

Between February 2004 and March 2007 we implanted 100 consecutive total hip replacements with a metal-on-metal bearing and a large femoral head into 92 patients. There were 51 men and 41 women with a mean age of 50 years (18 to 70) at the time of surgery.

Outcome was assessed using the Western Ontario McMaster University osteoarthritis index and the Harris hip score as well as the Devane activity score. These all improved significantly (p < 0.0001). At the last follow-up there were no cases of dislocation, no impingement, a good range of movement and no osteolysis, but seven revisions, two for infection and five for aseptic loosening. The probability of groin pain increased if the other acetabular component inclination exceeded 50° (p = 0.0007). At 4.8 years of follow-up, the projected survival of the Durom acetabular component, with revision for any reason, was 92.4% (sd 2.8) (95% confidence interval 89.6 to 95.2).

The design of the component made it difficult both to orientate and seat, which when combined with a poor porous coating, produced unpredictable fixation and a low survival at five years.

Between 2002 and 2008, 130 consecutive ankles were replaced with an hydroxyapatite (HA) and titanium-HA-coated Ankle Evolutive System total ankle prosthesis. Plain radiographs were analysed by two independent observers. Osteolytic lesions were classified by their size and location, with cavities > 10 mm in diameter considered to be ‘marked’. CT scanning was undertaken in all patients with marked osteolysis seen on the plain radiographs.

Osteolytic lesions were seen on the plain films in 48 (37%) and marked lesions in 27 (21%) ankles. The risk for osteolysis was found to be 3.1 (95% confidence interval 1.6 to 5.9) times higher with implants with Ti-HA porous coating.

Care should be taken with ankle arthroplasty until more is known about the reasons for these severe osteolyses.

Hip simulators have been used for ten years to determine the tribological performance of large-head metal-on-metal devices using traditional test conditions. However, the hip simulator protocols were originally developed to test metal-on-polyethylene devices. We have used patient activity data to develop a more physiologically relevant test protocol for metal-on-metal devices. This includes stop/start motion, a more appropriate walking frequency, and alternating kinetic and kinematic profiles.

There has been considerable discussion about the effect of heat treatments on the wear of metal-on-metal cobalt chromium molybdenum (CoCrMo) devices. Clinical studies have shown a higher rate of wear, levels of metal ions and rates of failure for the heat-treated metal compared to the as-cast metal CoCrMo devices. However, hip simulator studies in vitro under traditional testing conditions have thus far not been able to demonstrate a difference between the wear performance of these implants.

Using a physiologically relevant test protocol, we have shown that heat treatment of metal-on-metal CoCrMo devices adversely affects their wear performance and generates significantly higher wear rates and levels of metal ions than in as-cast metal implants.

This study reports on ceramic-on-metal (CoM) bearings in total hip replacement. Whole blood metal ion levels were measured. The median increase in chromium and cobalt at 12 months was 0.08 μg/1 and 0.22 μg/1, respectively, in CoM bearings. Comparable values for metal-on-metal (MoM) were 0.48 μg/1 and 0.32 μg/1. The chromium levels were significantly lower in CoM than in MoM bearings (p = 0.02). The cobalt levels were lower, but the difference was not significant. Examination of two explanted ceramic heads revealed areas of thin metal transfer. CoM bearings (one explanted head and acetabular component, one explanted head and new acetabular component, and three new heads and acetabular components) were tested in a hip joint simulator. The explanted head and acetabular component had higher bedding-in. However, after one million cycles all the wear rates were the same and an order of magnitude less than that reported for MoM bearings. There were four outliers in each clinical group, primarily related to component malposition.

The management of bone loss in revision replacement of the knee remains a challenge despite an array of options available to the surgeon. Bone loss may occur as a result of the original disease, the design of the prosthesis, the mechanism of failure or technical error at initial surgery. The aim of revision surgery is to relieve pain and improve function while addressing the mechanism of failure in order to reconstruct a stable platform with transfer of load to the host bone. Methods of reconstruction include the use of cement, modular metal augmentation of prostheses, custom-made, tumour-type or hinged implants and bone grafting.

The published results of the surgical techniques are summarised and a guide for the management of bone defects in revision surgery of the knee is presented.

Early failure associated with adverse reactions to metal debris is an emerging problem after hip resurfacing but the exact mechanism is unclear. We analysed our entire series of 660 metal-on-metal resurfacings (Articular Surface Replacement (ASR) and Birmingham Hip Resurfacing (BHR)) and large-bearing ASR total hip replacements, to establish associations with metal debris-related failures. Clinical and radiological outcomes, metal ion levels, explant studies and lymphocyte transformation tests were performed. A total of 17 patients (3.4%) were identified (all ASR bearings) with adverse reactions to metal debris, for which revision was required. This group had significantly smaller components, significantly higher acetabular component anteversion, and significantly higher whole concentrations of blood and joint chromium and cobalt ions than asymptomatic patients did (all p < 0.001). Post-revision lymphocyte transformation tests on this group showed no reactivity to chromium or cobalt ions. Explants from these revisions had greater surface wear than retrievals for uncomplicated fractures. The absence of adverse reactions to metal debris in patients with well-positioned implants usually implies high component wear.

Surgeons must consider implant design, expected component size and acetabular component positioning in order to reduce early failures when performing large-bearing metal-on-metal hip resurfacing and replacement.

A clinical and radiological study was conducted on 97 total hip replacements performed for congenital hip dislocation in 79 patients between 1989 and 1998 using a three-dimensional custom-made cementless stem. The mean age at operation was 48 years (17 to 72) and the mean follow-up was for 123 months (83 to 182).

According to the Crowe classification, there were 37 class I, 28 class II, 13 class III and 19 class IV hips. The mean leg lengthening was 25 mm (5 to 58), the mean pre-operative femoral anteversion was 38.6° (2° to 86°) and the mean correction in the prosthetic neck was −23.6° (−71° to 13°). The mean Harris hip score improved from 58 (15 to 84) to 93 (40 to 100) points. A revision was required in six hips (6.2%). The overall survival rate was 89.5% (95% confidence interval 89.2 to 89.8) at 13 years when two hips were at risk.

This custom-made cementless femoral component, which can be accommodated in the abnormal proximal femur and will correct the anteversion and frontal offset, provided good results without recourse to proximal femoral corrective osteotomy.

Metal-on-metal bearings for total hip replacement (THR) are becoming increasingly popular. Improved wear characteristics mean that these articulations are being inserted into younger patients in the form of THR and resurfacing procedures. This has led to concerns regarding potential carcinogenicity because of the increased exposure to metal ions that the procedure brings.

We have studied the serum cobalt and chromium concentrations in patients who had primary, well-fixed Ring metal-on-metal THRs for more than 30 years. The levels of cobalt and chromium were elevated by five and three times, respectively compared with those in our reference groups. Metal-on-metal articulations appear to be the source of metal ions throughout the life of the prosthesis. In three patients who had undergone revision of a previous metal-on-metal THR to a metal-on-polyethylene replacement the levels of metal ions were within the normal range. The elevations of cobalt and chromium ions seen in our study were comparable with those in patients with modern metal-on-metal THRs.

We have evaluated the results of total hip replacement in patients with congenital hip disease using 46 cemented all-polyethylene Charnley acetabular components implanted with the cotyloplasty technique in 34 patients (group A), and compared them with 47 metal-backed cementless acetabular components implanted without bone grafting in 33 patients (group B). Patients in group A were treated between 1988 and 1993 and those in group B between 1990 and 1995. The mean follow-up for group A was 16.6 years (12 to 18) and the mean follow-up for group B was 13.4 years (10 to 16).

Revision for aseptic loosening was undertaken in 15 hips (32.6%) in group A and in four hips (8.5%) in group B. When liner exchange was included, a total of 13 hips were revised in group B (27.7%). The mean polyethylene wear was 0.11 mm/yr (0.002 to 0.43) and 0.107 mm/yr (0 to 0.62) for groups A and B, respectively. Polyethylene wear in group A was associated with linear osteolysis, and in group B with expansile osteolysis.

In patients with congenital hip disease, when 80% cover of the implant can be obtained, a cementless acetabular component appears to be acceptable and provides durable fixation. However, because of the type of osteolysis arising with these devices, early exchange of a worn liner is recommended before extensive bone loss makes revision surgery more complicated.

We evaluated the survival of moulded monoblock and modular tibial components of the AGC total knee replacement in patients with rheumatoid arthritis. Between 1985 and 1995, 751 knees with this diagnosis were replaced at our institution. A total of 256 tibial components were of the moulded design and 495 of the modular design. The mean follow-up of the moulded subgroup was 9.6 years (0.5 to 14.7), and that of the modular group 7.0 years (0.1 to 14.7).

The groups differed significantly from each other in Larsen grade, cementing of components and patellar resurfacing, but no statistically significant difference between the survival of the components was found (Log rank test, p = 0.91). The cumulative success rate of the moulded group was 96.8% (95% confidence interval 93.6% to 98.4%) at five years and 94.4% (95% confidence interval 90.4% to 96.7%) at ten years, and of the modular group 96.2% (95% confidence interval 94% to 97.6%) and 93.6% (95% confidence interval 89.7% to 96%), respectively. Revision was required in 37 total knee replacements, the main causes were infection, pain, loosening of the tibial component and patellar problems. Survival rates for both components were satisfactory.