Aseptic loosening of the option stemmed tibial tray in the Zimmer NexGen LPS total knee arthroplasty system.

BACKGROUND: We investigated the relationship between the backside deformation of polyethylene (PE) tibial inserts and aseptic loosening of the Option stemmed tibial tray used with Zimmer NexGen posterior-stabilised (PS) devices. We hypothesized that explanted inserts used in PS designs would exhibit greater extents of PE backside deformation than those used in equivalent cruciate retaining (CR) designs and that PE inserts retrieved from total knee arthroplasties (TKAs) revised for aseptic tibial tray loosening would exhibit greater extents of backside deformation than TKAs revised for other reasons. METHODS: A total of 73 explanted fixed-bearing TKAs (42 CR and 31 PS) were examined. PE components underwent geometric examination with a coordinate measuring machine using validated techniques. Multiple regression modelling was used to identify variables associated with revision secondary to aseptic loosing and to determine factors associated with increased PE backside deformation. RESULTS: PE inserts retrieved from TKAs with aseptic loosening had significantly greater backside deformation than those retrieved from TKAs revised for other reasons (p < 0.001). Greater PE backside deformation was significantly associated with larger tray/insert clearance heights (p < 0.001), thinner inserts (p < 0.001) and PS TKAs (p = 0.001). CONCLUSION: PE backside deformation was significantly greater in the PS TKAs. This may provide one explanation for the increased rate of aseptic loosening reported with the Option tibial tray used with the Legacy Posterior Stabilised (LPS) system.

Erratum: Author Correction: The influence of HLA genotype on the development of metal hypersensitivity following joint replacement.

[This corrects the article DOI: 10.1038/s43856-022-00137-0.].

The influence of HLA genotype on the development of metal hypersensitivity following joint replacement.

Background: Over five million joint replacements are performed across the world each year. Cobalt chrome (CoCr) components are used in most of these procedures. Some patients develop delayed-type hypersensitivity (DTH) responses to CoCr implants, resulting in tissue damage and revision surgery. DTH is unpredictable and genetic links have yet to be definitively established. Methods: At a single site, we carried out an initial investigation to identify HLA alleles associated with development of DTH following metal-on-metal hip arthroplasty. We then recruited patients from other centres to train and validate an algorithm incorporating patient age, gender, HLA genotype, and blood metal concentrations to predict the development of DTH. Accuracy of the modelling was assessed using performance metrics including time-dependent receiver operator curves. Results: Using next-generation sequencing, here we determine the HLA genotypes of 606 patients. 176 of these patients had experienced failure of their prostheses; the remaining 430 remain asymptomatic at a mean follow up of twelve years. We demonstrate that the development of DTH is associated with patient age, gender, the magnitude of metal exposure, and the presence of certain HLA class II alleles. We show that the predictive algorithm developed from this investigation performs to an accuracy suitable for clinical use, with weighted mean survival probability errors of 1.8% and 3.1% for pre-operative and post-operative models respectively. Conclusions: The development of DTH following joint replacement appears to be determined by the interaction between implant wear and a patient's genotype. The algorithm described in this paper may improve implant selection and help direct patient surveillance following surgery. Further consideration should be given towards understanding patient-specific responses to different biomaterials.

Tibial tray debonding from the cement mantle is associated with deformation of the backside of polyethylene tibial inserts.

AIMS: The aim of this study was to investigate whether wear and backside deformation of polyethylene (PE) tibial inserts may influence the cement cover of tibial trays of explanted total knee arthroplasties (TKAs). METHODS: At our retrieval centre, we measured changes in the wear and deformation of PE inserts using coordinate measuring machines and light microscopy. The amount of cement cover on the backside of tibial trays was quantified as a percentage of the total surface. The study involved data from the explanted fixed-bearing components of four widely used contemporary designs of TKA (Attune, NexGen, Press Fit Condylar (PFC), and Triathlon), revised for any indication, and we compared them with components that used previous generations of PE. Regression modelling was used to identify variables related to the amount of cement cover on the retrieved trays. RESULTS: A total of 114 explanted fixed-bearing TKAs were examined. This included 76 used with contemporary PE inserts which were compared with 15 used with older generation PEs. The Attune and NexGen (central locking) trays were found to have significantly less cement cover than Triathlon and PFC trays (peripheral locking group) (p = 0.001). The median planicity values of the PE inserts used with central locking trays were significantly greater than of those with peripheral locking inserts (205 vs 85 microns; p < 0.001). Attune and NexGen inserts had a characteristic pattern of backside deformation, with the outer edges of the PE deviating inferiorly, leaving the PE margins as the primary areas of articulation. CONCLUSION: Explanted TKAs with central locking mechanisms were significantly more likely to debond from the cement mantle. The PE inserts of these designs showed characteristic patterns of deformation, which appeared to relate to the manufacturing process and may be exacerbated in vivo. This pattern of deformation was associated with PE wear occurring at the outer edges of the articulation, potentially increasing the frictional torque generated at this interface. Cite this article: Bone Joint J 2021;103-B(12):1791-1801.

The Tribology of Explanted Hip Resurfacings Following Early Fracture of the Femur.

A recognized issue related to metal-on-metal hip resurfacings is early fracture of the femur. Most theories regarding the cause of fracture relate to clinical factors but an engineering analysis of failed hip resurfacings has not previously been reported. The objective of this work was to determine the wear volumes and surface roughness values of a cohort of retrieved hip resurfacings which were removed due to early femoral fracture, infection and avascular necrosis (AVN). Nine resurfacing femoral heads were obtained following early fracture of the femur, a further five were retrieved due to infection and AVN. All fourteen were measured for volumetric wear using a co-ordinate measuring machine. Wear rates were then calculated and regions of the articulating surface were divided into "worn" and "unworn". Roughness values in these regions were measured using a non-contacting profilometer. The mean time to fracture was 3.7 months compared with 44.4 months for retrieval due to infection and AVN. Average wear rates in the early fracture heads were 64 times greater than those in the infection and AVN retrievals. Given the high wear rates of the early fracture components, such wear may be linked to an increased risk of femoral neck fracture.

Shorter, rough trunnion surfaces are associated with higher taper wear rates than longer, smooth trunnion surfaces in a contemporary large head metal-on-metal total hip arthroplasty system.

Taper wear at the head-neck junction is a possible cause of early failure in large head metal-on-metal (LH-MoM) hip replacements. We hypothesized that: (i) taper wear may be more pronounced in certain product designs; and (ii) an increased abductor moment arm may be protective. The tapers of 104 explanted LH-MoM hip replacements revised for adverse reaction to metal debris (ARMD) from a single manufacturer were analyzed for linear and volumetric wear using a co-ordinate measuring machine. The mated stem was a shorter 12/14, threaded trunnion (n=72) or a longer, smooth 11/13 trunnion (n=32). The abductor moment arm was calculated from pre-revision radiographs. Independent predictors of linear and volumetric wear included taper angle, stem type, and the horizontal moment arm. Tapers mated with the threaded 12/14 trunnion had significantly higher rates of volumetric wear (0.402 mm3/yr vs. 0.123 mm3/yr [t=-2.145, p=0.035]). There was a trend to larger abductor moment arms being protective (p=0.055). Design variation appears to play an important role in taper-trunnion junction failure. We recommend that surgeons bear these findings in mind when considering the use of a short, threaded trunnion with a cobalt-chromium head.

The clinical implications of elevated blood metal ion concentrations in asymptomatic patients with MoM hip resurfacings: a cohort study.

OBJECTIVE: To determine whether elevated blood cobalt (Co) concentrations are associated with early failure of metal-on-metal (MoM) hip resurfacings secondary to adverse reaction to metal debris (ARMD). DESIGN: Cohort study. SETTING: Single centre orthopaedic unit. PARTICIPANTS: Following the identification of complications potentially related to metal wear debris, a blood metal ion screening programme was instigated at our unit in 2007 for all patients with Articular Surface Replacement (ASR) and Birmingham MoM hip resurfacings. Patients were followed annually unless symptoms presented earlier. Symptomatic patients were investigated with ultrasound scan and joint aspiration. The clinical course of all 278 patients with 'no pain' or 'slight/occasional' pain and a Harris Hip Score greater than or equal to 95 at the time of venesection were documented. A retrospective analysis was subsequently conducted using mixed effect modelling to investigate the temporal pattern of blood Co levels in the patients and survival analysis to investigate the potential role of case demographics and blood Co levels as risk factors for subsequent failure secondary to ARMD. RESULTS: Blood Co concentration was a positive and significant risk factor (z=8.44, p=2×10(-16)) for joint failure, as was the device, where the Birmingham Hip Resurfacing posed a significantly reduced risk for revision by 89% (z=-3.445, p=0.00005 (95% CI on risk 62 to 97)). Analysis using Cox-proportional hazards models indicated that men had a 66% lower risk of joint failure than women (z=-2.29419, p=0.0218, (95% CI on risk reduction 23 to 89)). CONCLUSIONS: The results suggest that elevated blood metal ion concentrations are associated with early failure of MoM devices secondary to adverse reactions to metal debris. Co concentrations greater than 20 µg/l are frequently associated with metal staining of tissues and the development of osteolysis. Development of soft tissue damage appears to be more complex with females and patients with ASR devices seemingly more at risk when exposed to equivalent doses of metal debris.

Adverse reactions to metal debris: histopathological features of periprosthetic soft tissue reactions seen in association with failed metal on metal hip arthroplasties.

AIM: To describe the histopathology of localised adverse reactions to metal debris (ARMD) seen in association with failed metal on metal (MoM) hip arthroplasties. The nature of aseptic lymphocytic vasculitis associated lesion (ALVAL) is investigated. METHODS: Periprosthetic soft tissues biopsied at time of revision from failed MoM hip arthroplasties from January 2007 to March 2011 were analysed. The inflammatory cell response was categorised into perivascular lymphocytic cuffing (ALVAL), lymphoid aggregate formation with or without germinal centres, metallosis characterised by sheets of macrophages with intracytoplasmic metallic debris and well-defined granulomas. RESULTS: 123 patient samples were analysed, 36 males (29.2%) and 87 females (70.8%). Three cases showing complete tissue necrosis were excluded. Patients were reviewed between 3.27 to 69.6 months postarthroplasty, with an average of 30.92 months. 103 cases (85.8%) showed ALVAL, 18 cases also showed well-defined granulomas. Of the 103 cases with ALVAL, 60 cases also showed a diffuse chronic lymphocytic synovitis, and 40 cases showed lymphoid aggregates with germinal centres. 17 cases (14.2%) showed pure metallosis. Small vessels showing ALVAL expressed peripheral node addressin. CONCLUSIONS: ARMD is a spectrum of changes comprising of pure metallosis, ALVAL and granulomatous inflammation. ALVAL, a distinctive inflammatory response seen in ARMD, is a precursor of lymphoid neogenesis. Lymphoid neogenesis documented in a variety of chronic inflammatory conditions most probably contributes to tissue necrosis and prosthetic failure seen in MoM hip arthroplasties. The role of vascular changes in contributing to necrosis is unclear at this stage.

Reducing metal ion release following hip resurfacing arthroplasty.

Recent guidelines have suggested that routine postoperative care of patients with metal-on-metal hip prostheses should involve metal ion analysis. This study sought to investigate the relationship between bearing surface wear rates of metal components and serum metal ion analysis and also to quantify the incidence of excessive increases in serum metal ion concentrations post-hip resurfacing arthroplasty.

EMG analysis of lumbar paraspinal muscles as a predictor of the risk of low-back pain.

Studies of EMG power spectra have established associations between low-back pain (LBP) and median frequency (MF). This 2-year prospective study investigates the association of LBP with EMG variables over time. 120 health care workers underwent paraspinal EMG measurements and assessment of back pain disability. The EMG recordings were performed under isometric trunk extension at 2/3 maximum voluntary contraction and acquired from erector spinae muscles at the level of L4/L5. 108 (90%) subjects were reviewed at a minimum 2-year follow up. 16 out of 93 subjects with no history of chronic low-back pain became worse as measured by time off work, disability, reported pain and self-assessment rating. The value of the EMG variable half-width at inception demonstrated significant association with changes in subject's outcome measure and their own assessment of their LBP at follow up (p < 0.05). Based on self-assessment data, subjects with no history of chronic LBP with half-width of greater than 56 Hz were at threefold greater risk of developing back pain compared with the remainder of the population (p = 0.045). The value of the initial median frequency (IMF) and MF slope at inception were also associated with the subjects' own assessment of LBP at follow up. Subjects with an IMF greater than 49 Hz were at 5.8-fold greater risk of developing back pain compared with the remainder of the population (p = 0.014). EMG variables recorded from lumbar paraspinal muscles can identify a sub group of subjects at increased risk of developing low-back pain in the future.

Cup anteversion in hip resurfacing: validation of EBRA and the presentation of a simple clinical grading system.

The use of large metal on metal bearings has led to a reduction in the risk of dislocation post hip arthroplasty. Because of this, and also because of the technical difficulties associated with resurfacing surgery in particular, it could be argued that a less meticulous approach to acetabular cup placement has developed in comparison with conventional metal on polyethylene arthroplasty. Resurfacing cups may produce significant clinical problems when placed at the extremes of version, including increased production of metal debris and psoas tendonitis. Presented in this article is evidence that EBRA software (Einzel-Bild-Roentgen-Analysis, University of Innsbruck, Austria) can be used to reliably assess the version of resurfacing cups, when radiographs are of sufficient quality. The cups have characteristic appearances when placed at the extremes of version. These characteristics can allow the surgeon to identify poorly positioned cups without the use of software.

The value of electromyography of the lumbar paraspinal muscles in discriminating between chronic-low-back-pain sufferers and normal subjects.

The authors studied the surface electromyographic (EMG) spectrum of the paraspinal muscles of 350 subjects. They were classified by their history as normal (n=175), chronic low back pain (n=145), or past history (n=30). They pulled upwards on a floor-mounted load cell at two-thirds of their maximum voluntary contraction for 30 s, while the EMG was measured from the paraspinal muscles at the L4/L5 level. From the EMG signal the root-mean-square (RMS) was calculated. Power spectrum analysis allowed calculation of the median frequency slope, the initial median frequency (IMF), modal frequency, peak amplitude and spectral width at half peak amplitude (half-width). All of the variables of the chronic group were significantly different from the normal group, except the median frequency slope, RMS slope and mode. Half-width, age and maximum voluntary contraction were shown to be independent predictors of back pain classification. Half-width classified the subjects with a sensitivity of 0.65 and a specificity of 0.75.