Clinical and Imaging Assessment of Metal on Metal Hip Patients

A high failure rate of metal-on-metal (MoM) hip implants prompted regulatory authorities to issue worldwide product recalls. The cause for their failure and decisions surrounding the need for revision is complex due to poor understanding of the toxic effects of metal debris. In addition to local soft tissue destruction, circulating cobalt can cause rare but fatal cardiotoxicity. This thesis describes the detection of metal cobalt-chromium within the liver of a patient with highly elevated blood cobalt (587ppb) using novel MRI imaging techniques, validated by liver biopsy and micro x-ray fluorescence. The prevalence of tissue metal deposition and potential cardiotoxic effects were assessed through a prospective case controlled cohort study. Ninety patients were recruited into three age and gender-matched groups according to blood metal levels. All underwent detailed cardiovascular and liver phenotyping using MRI (for myocardial volumes and function, T2*, T1 and Extra-Cellular Volume mapping), echocardiography, and blood biomarker sampling. T2* is a novel MRI biomarker of tissue metal deposition. Blood cobalt levels among the cohort ranged 0.1 to 118ppb, which is still seen in patients presenting for clinical follow-up. No significant between-group differences were found for cardiac volume or function, nor was there any difference in tissue characterization using T1, T2* and ECV. Higher blood cobalt levels did not translate to increased metal deposition within the heart or liver.The application of these results were analsyed through a multi-disciplianary team setting designed to aid complex decisions of who, when and how to treat MoM patients surgically. By analysis of MDT recommendations compared to the treatment undertaken it was demonstrated that an MDT approach is an acceptable evidence-based aid to decision-making.This thesis concludes that cobalt tissue deposition can be detected using non-invasive MRI techniques, however metal deposition is not commonly seen with blood cobalt levels upto 118ppb with reassuringly little cardiotoxic effects. These results help reassure clinicians managing MoM patients through an MDT approach

Muscle atrophy and metal-on-metal hip implants

Background and purpose — Muscle atrophy is seen in patients with metal-on-metal (MOM) hip implants, probably because of inflammatory destruction of the musculo-tendon junction. However, like pseudotumors, it is unclear when atrophy occurs and whether it progresses with time. Our objective was to determine whether muscle atrophy associated with MOM hip implants progresses with time. Patients and methods — We retrospectively reviewed 74 hips in 56 patients (32 of them women) using serial MRI. Median age was 59 (23–83) years. The median time post-implantation was 83 (35–142) months, and the median interval between scans was 11 months. Hip muscles were scored using the Pfirrmann system. The mean scores for muscle atrophy were compared between the first and second MRI scans. Blood cobalt and chromium concentrations were determined. Results — The median blood cobalt was 6.84 (0.24–90) ppb and median chromium level was 4.42 (0.20–45) ppb. The median Oxford hip score was 34 (5–48). The change in the gluteus minimus mean atrophy score between first and second MRI was 0.12 (p = 0.002). Mean change in the gluteus medius posterior portion (unaffected by surgical approach) was 0.08 (p = 0.01) and mean change in the inferior portion was 0.10 (p = 0.05). Mean pseudotumor grade increased by 0.18 (p = 0.02). Interpretation — Worsening muscle atrophy and worsening pseudotumor grade occur over a 1-year period in a substantial proportion of patients with MOM hip implants. Serial MRI helps to identify those patients who are at risk of developing worsening soft-tissue pathology. These patients should be considered for revision surgery before irreversible muscle destruction occurs

Assessing for Cardiotoxicity from Metal-on-Metal Hip Implants with Advanced Multimodality Imaging Techniques.

BACKGROUND: High failure rates of metal-on-metal (MoM) hip implants prompted regulatory authorities to issue worldwide safety alerts. Circulating cobalt from these implants causes rare but fatal autopsy-diagnosed cardiotoxicity. There is concern that milder cardiotoxicity may be common and underrecognized. Although blood metal ion levels are easily measured and can be used to track local toxicity, there are no noninvasive tests for organ deposition. We sought to detect correlation between blood metal ions and a comprehensive panel of established markers of early cardiotoxicity. METHODS: Ninety patients were recruited into this prospective single-center blinded study. Patients were divided into 3 age and sex-matched groups according to implant type and whole-blood metal ion levels. Group-A patients had a ceramic-on-ceramic [CoC] bearing; Group B, an MoM bearing and low blood metal ion levels; and Group C, an MoM bearing and high blood metal-ion levels. All patients underwent detailed cardiovascular phenotyping using cardiac magnetic resonance imaging (CMR) with T2*, T1, and extracellular volume mapping; echocardiography; and cardiac blood biomarker sampling. T2* is a novel CMR biomarker of tissue metal loading. RESULTS: Blood cobalt levels differed significantly among groups A, B, and C (mean and standard deviation [SD], 0.17 ± 0.08, 2.47 ± 1.81, and 30.0 ± 29.1 ppb, respectively) and between group A and groups B and C combined. No significant between-group differences were found in the left atrial or ventricle size, ejection fraction (on CMR or echocardiography), T1 or T2* values, extracellular volume, B-type natriuretic peptide level, or troponin level, and all values were within normal ranges. There was no relationship between cobalt levels and ejection fraction (R = 0.022, 95% confidence interval [CI] = -0.185 to 0.229) or T2* values (R = 0.108, 95% CI = -0.105 to 0.312). CONCLUSIONS: Using the best available technologies, we did not find that high (but not extreme) blood cobalt and chromium levels had any significant cardiotoxic effect on patients with an MoM hip implant. There were negligible-to-weak correlations between elevated blood metal ion levels and ejection fraction even at the extremes of the 95% CI, which excludes any clinically important association. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence

A new approach to managing patients with problematic metal hip implants: the use of an Internet-enhanced multidisciplinary team meeting

Background: Over one million patients worldwide are estimated to have a metal-on-metal hip arthroplasty. To improve the management of these patients and reduce surgeon uncertainty regarding decision-making, we designed an Internet-enhanced multidisciplinary team (iMDT) working approach. Methods: From August 2012 to April 2014, the iMDT discussed 215 patients with 266 metal-on-metal hip arthroplasties. Of these, 236 primary arthroplasties (132 hip resurfacing and 104 total hip) were analyzed. The remaining thirty cases involved problematic revised hips and were therefore excluded. The possible recommendations of the iMDT were monitoring, further investigation, or surgery. The concordance between the recommendation and the actual management was used to assess the usefulness of this approach in reducing uncertainty in surgeon-level decision-making. Results: The median Oxford Hip Score was 35 (range, 4 to 48), and median cobalt and chromium levels in whole blood were 3.54 ppb (range, 0.18 to 161.46 ppb) and 3.17 ppb (range, 0.20 to 100.67 ppb), respectively. Magnetic resonance imaging revealed abductor muscle atrophy in ninety-two (39%) of the hips and a pseudotumor in eighty (34%). The iMDT recommended monitoring of 146 (61.9%) of the hips, further investigation of thirty (12.7%), and surgery in sixty (25.4%). The actual outcome was concordant with the recommendation in 211 (91.7%) of the hips. Conclusions: Our iMDT approach to the metal-on-metal hip burden combines the tacit knowledge of an expert panel, regulatory guidance, and up-to-date evidence to improve decision-making among surgeons. The high level of concordance between the recommendation and the actual outcome, combined with the feasibility of the methods used, suggest that this method effectively reduces uncertainty among surgeons and may lead to improved patient outcomes

Is there an increased revision rate due to early tibial component loosening with a modern total knee arthroplasty design? A retrospective analysis from a large volume arthroplasty centre

Abstract Background The Attune TKR was introduced in 2011 as a successor to its predicate design The PFC Sigma. However, following reports of early failures, there are ongoing concerns related to increased loosening rates. Given the concerns, this study aimed to compare revision rates of the Attune implant to an established predicate, and other implant designs used in a high-volume arthroplasty center. Methods We identified 10,202 patients who underwent primary cemented TKR at our institution with a minimum of 1 year follow-up, involving 2406 Attune TKR (557 S +), 4642 PFC TKR, 3154 other designs. Primary outcomes were revision for all-causes, aseptic loosening of any component, and aseptic tibial loosening. Kaplan–Meier survival and Cox regression models were used to compare groups. Matched cohorts were selected for radiographic analysis. Results 308 knees were revised. The Attune cohort had the lowest risk of revision, with a rate of 2.98 per 1000 implant-years while the PFC and All Other Implant groups had a rate of 3.15 and 4.4 respectively. Aseptic loosing was the most common cause for revision, with 76% (65/88) involving the tibia. Survival analysis showed no significant differences between the Attune and other cohorts. Radiolucent lines were detected in 7.1% of the Attune S + group, 6.8% of the standard Attune group, and 6.3% of the PFC group, with no significant differences found between them. Conclusion This study represents the largest non-registry review of the Attune TKR in comparison to a predicate and other designs. There was no significant increased revision rate for all-cause revision or aseptic loosening, or peri-implant radiolucencies. It appears that increased loosening may not be as concerning as originally thought. Level of Evidence Level III

The relationship between cobalt/chromium ratios and the high prevalence of head-stem junction corrosion in metal-on-metal total hip arthroplasty

BACKGROUND: The size of the clinical impact of corrosion of the taper junction of metal-on-metal total hip arthroplasties (MOM-THAs) is unclear. Examination of a large number of retrieved MOM resurfacings and total hip arthroplasties can help us understand the role of taper corrosion in metal ion release. METHODS: We graded the severity of corrosion at the taper junction of 395 MOM-THAs and compared the prerevision whole blood metal ion levels of these hips with 529 failed MOM hip resurfacings. RESULTS: Virtually all MOM-THA hips (n = 388) had evidence of corrosion of the head-stem taper junction and graded as severe in 31% (n = 124). The median cobalt/chromium (Co/Cr) ratio was 1.58 (0.01-13.82) and 1.08 (0-4.86) for MOM-THA and MOM hip resurfacing, respectively; this difference was significant (P < .001). THA hips with severely corroded tapers had the highest median Co/Cr ratio of 1.86 (0.01-10). CONCLUSIONS: This study demonstrates the high prevalence of severe taper corrosion, which may be related to an elevated Co/Cr ratio before revision

Ceramic Coatings Confer No Survivorship Advantages in Total Knee Arthroplasty—A Single-Center Series of 1641 Knees

Background: Ceramic coatings in total knee arthroplasty have been introduced with the aim of reducing wear and consequently improving implant survivorship. We studied both cobalt-chrome-molybdenum (CoCrMo) and ceramic-coated components of the same implant design from a single center to identify if the ceramic coating conferred any benefit. Methods: We identified 1641 Columbus total knee arthroplasties (Aesculap AG, Tüttlingen, Germany) from a prospectively collected arthroplasty database. Of the 1641, 983 were traditional CoCrMo, and 659 had the Columbus AS ceramic coating. Patients were followed up until death or revision of any component of the implant. Results: There was no significant difference in implant survivorship using any component revision as the endpoint between the CoCrMo femur and the ceramic-coated femur at a mean of 9.2 years in follow-up for the CoCrMo group and 5 years for the ceramic-coated group (37 vs 14; P = .76). There was no reduction in the proportion of components revised for aseptic loosening or infection in the ceramic-coated cohort. Conclusions: At midterm follow-up, there was no benefit in terms of implant survivorship in using a ceramic coating