Fiona Berryman

The Effectiveness of Blood Metal Ions in Identifying Patients with Unilateral Birmingham Hip Resurfacing and Corail-Pinnacle Metal-on-Metal Hip Implants at Risk of Adverse Reactions to Metal Debris.

BACKGROUND We investigated whether blood metal ions could effectively identify patients with metal-on-metal hip implants with two common designs (Birmingham Hip Resurfacing [BHR] and Corail-Pinnacle) who were at risk of adverse reactions to metal debris. METHODS This single-center, prospective study involved 598 patients with unilateral hip implants (309 patients with the BHR implant and 289 patients with the Corail-Pinnacle implant) undergoing whole blood metal ion sampling at a mean time of 6.9 years. Patients were classified into two groups, one that had adverse reactions to metal debris (those who had to undergo revision for adverse reactions to metal debris or those with adverse reactions to metal debris on imaging; n = 46) and one that did not (n = 552). Three metal ion parameters (cobalt, chromium, and cobalt-chromium ratio) were compared between groups. Optimal metal ion thresholds for identifying patients with adverse reactions to metal debris were determined using receiver operating characteristic analysis. RESULTS All ion parameters were significantly higher (p < 0.0001) in the patients who had adverse reactions to metal debris compared with those who did not. Cobalt maximized the area under the curve for patients with the BHR implant (90.5%) and those with the Corail-Pinnacle implant (79.6%). For patients with the BHR implant, the area under the curve for cobalt was significantly greater than that for the cobalt-chromium ratio (p = 0.0005), but it was not significantly greater than that for chromium (p = 0.8483). For the patients with the Corail-Pinnacle implant, the area under the curve for cobalt was significantly greater than that for chromium (p = 0.0004), but it was similar to that for the cobalt-chromium ratio (p = 0.8139). Optimal blood metal ion thresholds for identifying adverse reactions to metal debris varied between the two different implants. When using cobalt, the optimal threshold for identifying adverse reactions to metal debris was 2.15 μg/L for the BHR group and 3.57 μg/L for the Corail-Pinnacle group. These thresholds had good sensitivities (88.5% for the BHR group and 80.0% for the Corail-Pinnacle group) and specificities (84.5% for the BHR group and 76.2% for the Corail-Pinnacle group), high negative predictive values (98.8% for the BHR group and 98.1% for the Corail-Pinnacle group), and low positive predictive values (34.3% for the BHR group and 20.0% for the Corail-Pinnacle group). The authority thresholds proposed by the United States (3 μg/L and 10 μg/L) and the United Kingdom (7 μg/L) missed more patients with adverse reactions to metal debris at 2.0% to 4.7% (twelve to twenty-eight patients) compared with our implant-specific thresholds at 1.2% (seven patients missed). CONCLUSIONS Patients who underwent metal-on-metal hip arthroplasty performed with unilateral BHR or Corail-Pinnacle implants and who had blood metal ions below our implant-specific thresholds were at low risk of adverse reactions to metal debris. These thresholds could be used to rationalize follow-up resources in asymptomatic patients. Analysis of cobalt alone is acceptable. Implant-specific thresholds were more effective than currently recommended fixed authority thresholds for identifying patients at risk of adverse reactions to metal debris requiring further investigation. LEVEL OF EVIDENCE Diagnostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Birmingham Hip Resurfacing: A Single Surgeon Series Reported at a Minimum of 10 Years Follow-Up.

We report outcomes on 120 Birmingham Hip Resurfacings (BHRs) (mean age 50 years) at a minimum of ten-years follow-up. Cases were performed by one surgeon and included his learning curve. Six hips were revised, with no revisions for infection, dislocation, or adverse reaction to metal debris. Ten-year survival was 94.2% (95% confidence interval (CI) 88.8%-98.7%) for all revisions and 96.1% (95% CI 91.5%-99.8%) for revisions for aseptic loosening. Gender (P = 0.463) and head size (P = 0.114) did not affect revision risk. Mean post-operative Harris hip score was 84.0. Contrary to previous independent reports, good outcomes into the second decade were achieved with the BHR in both men and women. Longer term follow-up will confirm whether these promising outcomes in women continue.

Predicting high blood metal ion concentrations following hip resurfacing.

Purpose To determine whether gender, femoral head size, acetabular inclination, and time since surgery predicted high blood metal ion concentrations following Birmingham Hip Resurfacing (BHR). Methods BHR patients with unilateral bearings at one specialist centre with blood cobalt and chromium concentrations measured up to May 2013 were included. This comprised a mixed (at-risk) group including symptomatic patients and asymptomatic individuals with specific clinical and/or radiological findings. Blood sampling was at a mean of 7.5 years (range 1-15.4 years) postoperatively. Results Of 319 patients (mean age 49.3 years; 53% male), blood metal ions greater than 7 µg/l were observed in 9% (n = 28). Blood metal ions were significantly higher in females (p<0.001), femoral head sizes ≤48 mm (p<0.01), and cup inclinations >55° (p<0.001). Linear regression demonstrated femoral head size was responsible for the highest proportion of variance in blood metal ions (cobalt p<0.001, R2 = 8%; chromium p<0.001, R2 = 11%). Analysis of femoral head size and inclination together demonstrated 36% of BHRs with head sizes of 38-44 mm and inclination >55° had blood metal ions >7 µg/l. BHR 10-year survival for this at-risk group was 91% (95% confidence intervals 86.0%-95.0%) with 30 hips revised. Conclusions If blood metal ions are used to screen hip resurfacing patients for adverse reactions to metal debris it is recommended those with small femoral head sizes (38-44 mm) and high acetabular inclinations (>55°) are targeted. These findings require validation in other cohorts as they may not be applicable to all hip resurfacing devices given the differences in radial clearance, coverage arc, and metallurgy.

Blood Metal Ion Thresholds to Identify Patients with Metal-on-Metal Hip Implants at Risk of Adverse Reactions to Metal Debris: An External Multicenter Validation Study of Birmingham Hip Resurfacing and Corail-Pinnacle Implants.

Background: The authors of recent studies have reported newly devised implant-specific blood metal ion thresholds to predict adverse reactions to metal debris (ARMD) in patients who have undergone unilateral or bilateral metal-on-metal (MoM) hip arthroplasty. These thresholds were most effective for identifying patients at low risk of ARMD. We investigated whether these newly devised blood metal ion thresholds could effectively identify patients at risk of ARMD after MoM hip arthroplasty in an external cohort of patients. Methods: We performed a validation study involving 803 MoM hip arthroplasties (323 unilateral Birmingham Hip Resurfacing [BHR], 93 bilateral BHR, and 294 unilateral Corail-Pinnacle implants) performed in 710 patients at 3 European centers. All patients underwent whole-blood metal ion sampling, and were divided into 2 groups: those with ARMD (leading to revision or identified on imaging; n = 75) and those without ARMD (n = 635). Previously devised implant-specific blood metal ion thresholds (2.15 &mgr;g/L of cobalt for unilateral BHR; 5.5 &mgr;g/L for the maximum of either cobalt or chromium for bilateral BHR; and 3.57 &mgr;g/L of cobalt for unilateral Corail-Pinnacle implants) were applied to the validation cohort, and receiver operating characteristic curve analysis was used to establish the discriminatory characteristics of each threshold. Results: The area under the curve, sensitivity, specificity, and positive and negative predictive values for the ability of each implant-specific threshold to distinguish between patients with and without ARMD were, respectively, 89.4% (95% confidence interval [CI] = 82.8% to 96.0%), 78.9%, 86.7%, 44.1%, and 96.9% for unilateral BHR; 89.2% (CI = 81.3% to 97.1%), 70.6%, 86.8%, 54.5%, and 93.0% for bilateral BHR; and 76.9% (CI = 63.9% to 90.0%), 65.0%, 85.4%, 24.5%, and 97.1% for unilateral Corail-Pinnacle implants. Using the implant-specific thresholds, we missed 20 patients with ARMD (2.8% of the patients in this series). We missed more patients with ARMD when we used the fixed thresholds proposed by regulatory authorities: 35 (4.9%) when we used the U.K. threshold of 7 &mgr;g/L for both cobalt and chromium (p = 0.0003), 21 (3.0%) when we used the U.S. threshold of 3 &mgr;g/L for both cobalt and chromium (p = 1.0), and 46 (6.5%) when we used the U.S. threshold of 10 &mgr;g/L for both cobalt and chromium (p < 0.0001). Conclusions: This external multicenter validation study confirmed that patients with blood metal ion levels below new implant-specific thresholds have a low risk of ARMD after MoM hip arthroplasty. Using these implant-specific thresholds, we missed fewer patients with ARMD compared with when the thresholds currently proposed by regulatory authorities were used. We therefore recommend using implant-specific blood metal ion thresholds when managing patients who have undergone MoM hip arthroplasty. Level of Evidence: Diagnostic Level III. See Instructions for Authors for a complete description of levels of evidence.

The measurement of the normal thorax using the Haller index methodology at multiple vertebral levels.

The Haller index is a ratio of thoracic width and height, measured from an axial CT image and used to describe the internal dimensions of the thoracic cage. Although the Haller index for a normal thorax has been established (Haller et al. 1987; Daunt et al. 2004), this is only at one undefined vertebral level in the thorax. What is not clear is how the Haller index describes the thorax at every vertebral level in the absence of sternal deformity, or how this is affected by age. This paper documents the shape of the thorax using the Haller index calculated from the thoracic width and height at all vertebral levels of the thorax between 8 and 18 years of age. The Haller Index changes with vertebral level, with the largest ratio seen in the most cranial levels of the thorax. Increasing age alters the shape of the thorax, with the most cranial vertebral levels having a greater Haller index over the mid thorax, which does not change. A slight increase is seen in the more caudal vertebral levels. These data highlight that a ‘one size fits all’ rule for chest width and depth ratio at all ages and all thoracic levels is not appropriate. The normal range for width to height ratio should be based on a patients age and vertebral level.

What is the variability in shoulder, axillae and waist position in a group of adolescents?

The clinical assessment of scoliosis is based on the recognition of asymmetry. It is not clear what the degree of asymmetry is in a population without scoliosis, which could make the differentiation between abnormal and normal uncertain. This study defines the range of normality in certain parameters of torso shape that are also associated with the clinical assessment of scoliosis. This was done by analysing the surface topography of a group of 195 children serially measured over a 5‐year period. The analysis considered both the spinal curvature and the relative position of shoulders, axillae and waist on each side. The bivariate relationships were examined using 95% confidence interval data ellipses. Our results showed that a degree of spinal curvature was seen, either as a main thoracic or main thoracolumbar curve. The distribution of the data about a mean point is illustrated by 95% confidence interval (CI) data ellipses with shoulder, axilla and waist data plotted against spinal curvature. The mean values were close to zero (exact symmetry) for all of the measured parameters, with the ellipses showing little differences in the distributions. We conclude that mild asymmetry of the measured torso parameters is normal. These results define what is normal and beyond what point asymmetry becomes abnormal. This information is of use for those managing and counselling patients with scoliosis both before and after surgery.

Do the SRS-22 self-image and mental health domain scores reflect the degree of asymmetry of the back in adolescent idiopathic scoliosis?

BackgroundPatient-reported outcomes are becoming increasingly recognised in the management of patients with adolescent idiopathic scoliosis (AIS). Integrated Shape Imaging System 2 (ISIS2) surface topography is a validated tool to assess AIS. Previous studies have failed to demonstrate strong correlations between AIS and patient-reported outcomes highlighting the need for additional objective surface parameters to define the deformities associated with AIS. The aim of this study was to examine whether the Scoliosis Research Society-22 (SRS-22) outcome questionnaire reflects the degree of measurable external asymmetry of the back in AIS and thus is a measure of patient outcome for external appearance.MethodsA total of 102 pre-operative AIS patients were identified retrospectively. Objective parameters were measured using ISIS2 surface topography. The associations between these parameters and the self-image and mental health domains of the SRS-22 questionnaire were investigated using correlation coefficients.ResultsAll correlations between the parameters of asymmetry and SRS-22 self-image score were of weak strength. Similarly, all correlations between the parameters of asymmetry and SRS-22 mental health score were of weak strength.ConclusionThe SRS-22 mental health and self-image domains correlate poorly with external measures of deformity. This demonstrates that the assessment of mental health and self-image by the SRS-22 has little to do with external torso shape. Whilst the SRS-22 assesses the patient as a whole, it provides little information about objective measures of deformity over which a surgeon has control.

The use of growth standards and corrective formulae to calculate the height loss caused by idiopathic scoliosis

BackgroundLoss of trunk height caused by scoliosis has been previously assessed using different mathematical formulae. However, these are of differing algebraic construction and will give a range of values for the same size of scoliosis curve. As such, the following study attempted to determine the most valid published formulae for calculating height loss caused by idiopathic scoliosis based on reported growth charts.MethodsThe height and sitting height for a group with idiopathic scoliosis were measured. These were plotted on published growth standards. The size of the coronal curves and the thoracic kyphosis was measured. Height was corrected for the size of the scoliosis using the formulae and replotted on the growth standards. The data spread on the standard was analysed for significant differences between the median and the 5th or 95th centile, and between data outside the 5th and 95th centile.ResultsThe sitting to standing height ratio growth standard was used in the analysis as it minimised errors across the different growth standards, given that these standards come from different original populations. In the female group significant differences in the data spread were seen using the formulae of Bjure, Ylikoski and Hwang. Non-significant results were seen for the Kono and Stokes formulae. All formulae caused no significant differences in data spread across the growth standard in the males group.ConclusionsWhen assessing against growth standards, the formulae of Kono and Stokes are the most valid at determining height loss caused by idiopathic scoliosis.