Metal-on-metal Group Research Articles

No Difference in Revision Rates and High Survival Rates in Large-head Metal-on-metal THA Versus Metal-on-polyethylene THA: Long-term Results of a Randomized Controlled Trial.

Pseudotumor formation is a well-known complication in metal-on-metal (MoM) THA. Pseudotumors combined with elevated serum ion levels and complaints from patients can lead to high revision rates. Long-term (> 10 years) results obtained from randomized trials comparing large-head MoM THA and conventional metal-on-polyethylene (MoP) THA are lacking regarding revision and survival rates, pseudotumor formation, functional outcomes, and serum ion levels. At 10 years of follow-up, (1) what is the difference in survival and revision rates between large-head (38 to 60 mm) MoM THA and conventional 28-mm MoP THA? (2) What is the difference in pseudotumor formation between large-head MoM THA and MoP THA? (3) Is there a difference in functional outcome between large-head MoM THA and MoP THA? (4) What is the difference in serum ion levels between large-head MoM THA and MoP THA? Between January 2006 and December 2008, 104 patients were randomized to receive either cementless MoM THA (50 patients) or cementless MoP THA (54 patients). In all, 78% (81 of 104) of patients completed the 10-year postoperative follow-up: 36 patients with MoM THA (72%; six patients lost to follow-up) and 45 with MoP THA (83%; four lost to follow-up). In the MoM group, 47% (17) were men, and the patients had a mean ± SD age of 60 ± 5 years. In the MoP group, 38% (17) were men, and the patients had a mean age of 61 ± 5 years. All baseline characteristics were similar between the groups. At 10 years of follow-up, all patient records were screened for revision surgery or complications, and the primary endpoint was survivorship free from revision for any cause at the 10-year follow-up interval, which we analyzed using a Kaplan-Meier survival analysis. All patients had a CT scan to determine the pseudotumor classification, which was reviewed by an independent radiologist. Functional outcome was measured using the patient-reported Oxford Hip Score and Harris Hip Score; the latter was assessed by a blinded nurse practitioner. Finally, serum ion cobalt and chrome concentrations were measured at 10 years postoperatively. Because the a priori sample size calculation for this randomized controlled trial was based on a different endpoint, a post hoc power analysis was performed for this long-term follow-up study, with survival as the primary outcome. It showed that considering the number of included patients, this study would have sufficient power (one-sided testing, alpha 0.05, power 80%) to discern a difference of 20% in the survival rate between the MoP and MoM groups (95% versus 75%). With the numbers available, there was no difference in survivorship free from revision for any cause between the MoP group and MoM group at 10 years (95% [95% CI 85% to 98%] versus 92% [95% CI 82% to 98%]; p = 0.6). A higher percentage of patients in the MoM group had pseudotumors on CT than those in the MoP group did, but pseudotumors were observed in both groups (56% [20 of 36] in the MoM group versus 22% [10 of 45] in the MoP group, relative risk 1.8 [95% CI 1.2 to 2.6]; p = 0.002). A higher proportion of elevated cobalt and chrome levels was found in the MoM group (19% and 14%, respectively) than in the MoP group (0% for both cobalt and chrome) (cobalt: RR 1.2 [95% CI 1.1 to 1.5]; p = 0.002; chrome: RR 1.2 [95% CI 1.0 to 1.3]; p = 0.01). In 25% of the patients with pseudotumors (5 of 20 patients), there were elevated serum cobalt levels. None of the 23 patients without pseudotumors had elevated cobalt levels (RR 1.3 [95% CI 1.0 to 1.7]; p = 0.01). There was no difference in functional outcome between study groups, nor a difference between patients with a pseudotumor and those without. This study showed that the survival of patients with large-head MoM THA was high and comparable to that of those with MoP THA, which contrasts with the high revision rates reported by others. Although some patients with MoP THAs experienced pseudotumors, the risk of a pseudotumor was much greater in MoM hips, and serum ion levels were higher in patients who received an MoM THA. For these reasons and unknown future complications, continued surveillance of patients with MoM THAs seems important. Level I, therapeutic study.

Cementless metal-on-metal versus ceramic-on-polyethylene hip arthroplasty in under-50 year-olds with 20 to 22 years’ follow-up: Was it a good idea to abandon the small-diameter metal-on-metal bearing?

In 2005 and 2011, we reported results for a comparative study of two types of 28-mm bearing (metal-on-metal (MoM) and ceramic-on-polyethylene (CoP) in active patients with respectively 5 and 12 years’ follow-up. The present report is an update at a mean 20 years’ follow-up, addressing 2 issues: (1) implant survival at a mean 20 years; and (2) long-term complications with the metal-on-metal bearing. Twenty-eight millimeters MoM bearings show good survival at 20 years in young active subjects. Two groups of cementless hip prostheses were compared: Metasul™ 28mm MoM versus 28mm CoP. The MoM group comprised 30 patients (39 hips), with a mean age of 40±6.7 years [range, 22.6–49 years], and the CoP group comprised 32 patients (39 hips), with a mean age of 40.5±8.7 years [range, 15–50 years]. The groups were matched in 2005 for age, activity level and preoperative Harris score. At a mean 20±5.3 years’ follow-up [range, 5–23 years], in the MoM group 2 hips (5%) showed limited non-progressive acetabular osteolysis, not requiring revision surgery; in the CoP group, there were 21 revision procedures (54%), including 15 for polyethylene wear. In the MoM group, the median total blood cobalt concentration was 1.03g/L [range, 0.3–3.5] and the median chromium concentration was 1.07g/L [range, 0.3–3.2]. Twenty-year all-cause survival was 100% in the MoM group, and 46% (95% CI, 37–59%) in the CoP group (p<0.0001). At long-term follow-up, MoM implants showed better survival than CoP implants in a young active population. Level of evidence: III, matched case series.

Cobalt Levels and Pseudotumor Characteristics Vary due to Metal Ion Source: Modular Femoral Neck vs Metal-on-Metal Articulations

BackgroundThis study examines cobalt levels and pseudotumor characteristics in a non-recalled modular femoral prosthesis. We sought to determine relationships between serum cobalt levels and pseudotumors following modular and metal-on-metal (MoM) total hip arthroplasty (THA), the location and size of pseudotumors, and changes to pseudotumor grade over time. MethodsWe retrospectively evaluated a cohort of 190 primary THAs implanted with a dual-modular femoral stem by one surgeon from 2005 to 2013. One hundred seventeen THAs used a cobalt-chromium modular neck (CoCrMN) component and non-MoM articulation, 63 THAs had a titanium neck component and MoM articulation, and 10 had a titanium neck component and polyethylene liner. Serum ion levels were recorded for all patients. Pseudotumor grade and location were measured by musculoskeletal-trained radiologists. ResultsCobalt levels did not correlate to time after index arthroplasty. In the CoCrMN group, cobalt levels were elevated in 11 of 19 (57.9%) patients with pseudotumor compared to 14 of 19 (73.7%) in the MoM group. Pseudotumors were more often located lateral to the hip joint in the CoCrMN group compared to anteromedial following MoM arthroplasty. In CoCrMN THAs, pseudotumors were visualized in 12 of 51 (23.5%) initial MARS MRIs within 40 months compared to 5 of 66 (7.6%) performed later (P = .02). ConclusionPseudotumor characteristics differ between patients with CoCrMN designs vs those with an MoM articulation. Normal serum cobalt levels did not exclude the presence of a pseudotumor and routine MARS MRI should be included in follow-up of patients with this CoCrMN prostheses.

Catastrophic failure of femoral stem modular junction when combined with metal-on-metal bearing in comparison to ceramic-on-ceramic: A retrospective cohort study

BackgroundMetal ion release from total hip arthroplasty's (THA) metal-on-metal (MoM) bearing surfaces or head-neck modular junction (trunnionosis) has been identified as a major cause of adverse reaction to metal debris (ARMD). No study has compared the effects of these bearing couples when combined with modular neck femoral stems (MNFS) (i.e. did a modular CoCr have a higher effect than large MoM bearings on whole blood ion concentrations and ARMD). Therefore we did a retrospective comparative analysis of prospectively collected data aiming to: (1) assess the difference in metal ion release between a group of MoM and CoC bearings implanted with a non-cemented MNFS; (2) compare the ARMD and the related revision rates between the two bearing types; (3) compare the patients’ HOOS and Harris Hip scores. HypothesisMetal ion levels and complications rate will be higher in MoM group. MethodsThirty hips received the same short MNFS with modular CoCr. Seventeen had CoC bearing (16=36mm) and 13 large diameter head (LDH) MoM bearing (mean=50mm, 44-54mm) Both groups had whole blood Cobalt (Co) and Chromium (Cr) concentrations measurements at last follow up or before revision surgery (if any) and were compared to 41 control individuals without implants. ARMD, revision rates and other complications were censed. Functional outcome differences between operative groups were assessed with HOOS and Harris Hip scores. ResultsMean whole blood Co and Cr were 1.9μg/L (0.1–10.6 min–max) and 1.2μg/L (0.2–4.6 min–max) in the CoC group and 12.7μg/L (2.5–40.7 min–max) and 8.2μg/L (2.8–40.6 min–max) for MoM group. Controls presented whole blood Co and Cr levels of 0.2μg/L (0.04–0.2 min–max) and 0.6μg/L (0.1–0.7 min–max) respectively. CoC had significantly higher whole blood metal ion concentrations than controls, while MoM had significantly higher concentrations than both (p<0.001). MoM had a 9/13 (69%) revision rate due to ARMD (with stem-neck junction corrosion and wear were present in all cases) while the CoC had none. Functional scores at last follow up did not statistically differ between groups (Harris: CoC=94.1±8.4 vs MoM 91.8±14.8 (p=0.22) and CoC HOOS 90.2±10.7 vs 75.6±21.7 (p=0.08)). ConclusionIn our study, MNFS with CoCr modular neck released metal ion systemically, as shown in CoC THAs, but when combined with MoM LDH bearings, that elevation was significantly higher. In MNFS MoM, these high metal ion levels translated into a dramatic ARMD related revision rate where stem-neck junction corrosion and wear were present in all cases. More research is required to understand the effects of MoM bearing on neck-stem junctions, and its mechanisms of corrosion. Level of evidenceIII; retrospective comparative study.

Metal Ion Release, Clinical and Radiological Outcomes in Large Diameter Metal-on-Metal Total Hip Arthroplasty at Long-Term Follow-Up.

Total hip arthroplasty (THA) with metal-on-metal (MoM) bearings have shown problems of biocompatibility linked to metal ion release at the local level causing an adverse reaction to metal debris (ARMD) and at a systemic level. The aim of this study was to evaluate clinical and radiological outcomes, and metal ion concentrations in the blood and urine of patients who underwent THA with the LIMA Met-Met hip system. Patients with ceramic-on-ceramic (CoC) bearings were included as a control group. In this study, 68 patients were enrolled: 34 with MoM THAs and 34 with CoC THAs. Patients were evaluated clinically (Harris Hip Score, SF-36) and radiologically at a median of 7.4 years after surgery. Whole blood and urinary cobalt and chromium levels were also assessed. Both types of implants were comparable in terms of clinical and functional results. Ion levels were significantly higher in the MoM group compared with CoC group 7 years after surgery. No correlations were found between metal ion levels and patient demographics, functional and radiological outcomes, and prosthesis features. Patient monitoring is thus advised to establish if prosthesis revision is necessary, especially in the case of MoM THA.

Metal on Metal Bearing in Total Hip Arthroplasty and Its Impact on Synovial Cell Count.

Introduction: The effect of different bearings on synovial white blood cell (WBC) count and polymorphonuclear percentage (PMN%) in aspirations remains unclear. Therefore, this study investigates the impact of aseptic Metal-on-Metal (MoM) bearing on synovial fluid. Methods: We searched our arthroplasty registry for aseptic painful THAs with MoM bearings between 2011 and 2018. Then, a case-matched control group was selected with septic and aseptic Total Hip Arthroplasty (THA) with ceramic on a polyethylene (PE) bearing. The matching criteria consisted of gender, age +/−10 years, and time of aspiration (+/−2years). Periprosthetic Joint Infection (PJI) was defined according to the Infectious Diseases Society of America (IDSA), and Musculoskeletal Infection Society (MSIS) using bacterial cultures, sonication and histology. Results: In total, 19 patients who underwent hip aspiration with MoM bearing were identified. Five patients had to be excluded due to insufficient synovial fluid obtained (n = 2) or bacterial growth after sonication that was initially negative with the standard microbiological cultures (n = 3). As such, 14 were included. These patients were matched with 14 aseptic and 14 septic THAs with ceramic on a PE bearing, which constituted the control group. The mean serum chrome level was 20.0 ± 15.5 nmol/L and cobalt level 18.4 ± 22.1 nmol/L. The synovial WBC and PMN% varied significantly between MoM bearing group and the aseptic THA ceramic PE group (both p < 0.001), as well as the septic THA group (WBC p = 0.016, PMN% p < 0.001). Furthermore, the septic THA group had significantly higher CRP values than the aseptic MoM group (p = 0.016). Conclusion: MoM bearing shows significantly higher synovial WBC and PMN% when compared to aseptic THA with ceramic on PE bearing above the MSIS cut-off. This is an important consideration when diagnosing periprosthetic joint infection using the MSIS guidelines.

Echocardiographic Changes in the Context of Metal-on-Metal Versus Nonmetal-on-Metal Total Hip Arthroplasty

BackgroundThe purpose of this study is to determine if there is a difference in echocardiographic results between patients with metal-on-metal (MoM) vs non-MoM total hip arthroplasty (THA) and to determine if a correlation exists between serum metal levels and echocardiographic outcomes. MethodsSeventy-five patients with the same modular THA enrolled in this prospective cohort study, and 49 had MoM bearings. All patients had serum cobalt, chromium, and titanium levels drawn at 2 study visits with a transthoracic echocardiogram at the second visit. Serum metal concentrations and echocardiographic parameters were compared with 2-way t-tests. Multiple linear regression analyses identified any significant predictors of echocardiographic outcomes. ResultsMean serum cobalt and chromium levels were significantly greater in the MoM group at both time-points (P < .001 and P < .05, respectively). Titanium levels were similar between groups (P > .05). MoM patients had significantly lower global longitudinal strain compared with the non-MoM group (18.4% vs 20.2%; P = .026). Serum cobalt concentration was found to be an independent predictor of tricuspid annular plane systolic excursion (P = .02). ConclusionMoM THA bearings are associated with increased serum cobalt and chromium levels. Patients with MoM THAs had decreased global longitudinal strain, a measure of left ventricular function, but both groups remained within normal range. The clinical impact of the positive association between serum cobalt concentration and tricuspid annular plane systolic excursion, a marker of right ventricular function, deserves further study. These findings can reassure physicians and patients that metal-induced cardiomyopathy is not typical in the setting of MoM THA. Level of EvidenceLevel II, Prospective Cohort Study.

MARS MRI Characteristics of Adverse Local Tissue Reactions in Taper Corrosion of Metal-On-Polyethylene THA Differ From Metal-On-Metal THA

BackgroundMetal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) has been recommended as a cross-sectional imaging modality in clinical evaluation of adverse local tissue reactions (ALTRs) in metal-on-metal (MoM) patients and metal-on-polyethylene (MoP) patients with taper corrosion. The aim of the study was to compare MARS MRI characteristics of ALTR in MoM total hip arthroplasty (THA) with ALTR in MoP THA with modular taper corrosion. MethodsA total of 197 patients with ALTR were evaluated: 86 patients with MoM THA; 37 MoP patients with head-neck taper corrosion; and 74 MoP patients with neck-stem dual taper corrosion. MARS MRI scans were evaluated to identify location, size, type of ALTR (I-III), and associated ALTR synovitis (cystic, solid, and mixed). ResultsMARS MRI characteristics of ALTR were significantly different between the MoM and MoP groups (P = .017). The MoP group demonstrated the highest proportion of thick-walled cystic masses type II (56.7% in head-neck taper corrosion MoP and 46.5% in dual taper corrosion MoP vs 28.7% in MoM), whereas the MoM group had the highest proportion of thin-walled cystic masses type I. MoM implants (96.8%) were significantly more likely to have ALTR in multiple locations compared with both MoP groups (P = .001). ConclusionThis study demonstrates that MARS MRI characteristics of ALTR differ by bearing type with a significantly higher percentage of mixed type and solid type ALTR in the taper corrosion MoP THA compared with MoM THA. This information provides clinically useful information in evaluation of symptomatic MoP and MoM THA patients for ALTRs.

Self-Reported Neurotoxic Symptoms in Hip Arthroplasty Patients With Highly Elevated Blood Cobalt: A Case-Control Study.

This study aimed to investigate the prevalence of self-reported neurotoxicity and cognitive defects in hip replacement patients with markedly raised blood cobalt. Case group comprised 53 patients with metal-on-metal (MoM) implants and a history of blood Co ≥20 μg/L for a median of 3 years (interquartile range, 2-5 years). The control group comprised 53 patients with ceramic-on-ceramic prostheses and blood Co <1 μg/L. Median age was 67 years (interquartile range, 60-74 years). The participants completed the Neurotoxic Symptom Checklist-60, Diabetic Neuropathy Score, Douleur Neuropathique-10, and Systemic Symptom Checklist, and underwent the Mini-Mental State Examination. The MoM and ceramic-on-ceramic groups were compared, the results were as follows: Neurotoxic Symptom Checklist-60 (median): cognitive defects (2.0 versus 1.9; P = 0.002), chest complaints (1.3 versus 1.3; P = 0.042), balance disturbances (1.3 versus 1.0; P < 0.001), sleep disturbances (2.7 versus 2.0; P = 0.004), mood disorders (2.0 versus 1.5; P = 0.001), sensorimotor disorders (1.6 versus 1.2; P < 0.001), physical complaints (2.0 versus 1.4; P = 0.009), fatigue (2.0 versus 1.6; P = 0.001), and total score (108 versus 90; P < 0.001); abnormal Diabetic Neuropathy Score/Douleur Neuropathique-10 (%): 60.3/13.2 versus 24.5/1.9 (P < 0.001/P = 0.028). Systemic Symptom Checklist (in percent): feeling cold (37.7 versus 17; P = 0.01), weight gain (18.9 versus 1.9; P = 0.008), metallic taste (26.4 versus 3.8; P = 0.002), worsening eyesight (37.7 versus 15.1; P = 0.008) and hearing (24.5 versus 7.5; 0.032), ankle swelling (32.1 versus 7.5; P = 0.002), shortness of breath on exertion (9.4 versus 5.7; P = 0.015), and generalized rash (28.3 versus 7.5; P = 0.01); and Mini-Mental State Examination (median): 29 versus 30 (P = 0.017). Patients in the MoM group were aware of their high cobalt levels and displayed a higher tendency to overreport symptoms (P < 0.001), which could have contributed to the higher scores. Frequency of reporting a number of symptoms was markedly higher in MoM patients, but clinically significant neurotoxicity was not observed (possibly due to the short exposure to elevated cobalt). Patients with repeated blood Co ≥20 μg/L measurements should be questioned about possible systemic health complaints at follow-up.

Serum cobalt concentrations remain at low levels at a minimum of 20 years following metal-on-metal total hip arthroplasty.

AimsSecond-generation metal-on-metal (MoM) articulations in total hip arthroplasty (THA) were introduced in order to reduce wear-related complications. The current study reports on the serum cobalt levels and the clinical outcome at a minimum of 20 years following THA with a MoM (Metasul) or a ceramic-on-polyethylene (CoP) bearing.MethodsThe present study provides an update of a previously published prospective randomized controlled study, evaluating the serum cobalt levels of a consecutive cohort of 100 patients following THA with a MoM or a CoP articulation. A total of 31 patients were available for clinical and radiological follow-up examination. After exclusion of 11 patients because of other cobalt-containing implants, 20 patients (MoM (n = 11); CoP (n = 9)) with a mean age of 69 years (42 to 97) were analyzed. Serum cobalt levels were compared to serum cobalt levels five years out of surgery.ResultsThe median cobalt concentration in the MoM group was 1.04 μg/l (interquartile range (IQR) 0.64 to 1.70) at a mean of 21 years (20 to 24) postoperatively and these values were similar (p = 0.799) to cobalt levels at five years. In the CoP control group, the median cobalt levels were below the detection limit (< 0.3 μg/l; median 0.15 μg/l, IQR 0.15 to 0.75) at 20 years. The mean Harris Hip Score was 91.4 points (61 to 100) in the MoM group and 92.8 points (63 to 100) in the CoP group.ConclusionThis study represents the longest follow-up series evaluating the serum cobalt levels after 28 mm head MoM bearing THA and shows that serum cobalt concentrations remain at low levels at a mean of 21 years (20 to 24) after implantation.Cite this article: Bone Joint Res. 2020;9(3):145–150.

Early Results of Our International, Multicenter, Multisurgeon, Double-Blinded, Prospective, Randomized, Controlled Trial Comparing Metal-on-Metal With Ceramic-on-Metal in Total Hip Arthroplasty

BackgroundThe aim of our prospective, multicenter, randomized, controlled trial (titled M2A-38 Ceramic-on-Metal RCT, NCT00754520) is to demonstrate noninferiority of a ceramic-on-metal (CoM) articulation compared with metal-on-metal (MoM) in total hip arthroplasty. The study arms are at 8 years since implantation, with metal ion and functional score analysis at 5 years. MethodsWe recruited 211 patients between 2009 and 2011. The patients were randomized to ceramic or metal. A cohort of these patients had whole blood metal ions performed yearly, and all patients underwent annual radiographic and clinical outcome assessment. All revisions were recorded and some explants were analyzed. Recruitment ceased earlier than planned owing to concerns raised with failure of MoM implants. ResultsNo significant difference was seen in patient demographics, radiographic parameters, or functional outcomes at any time point. Lower cobalt ion levels were seen in the CoM group (P < .01) at all time points. Chromium levels were significantly lower in the CoM group up to 3 years, but raised at 5 years. There were slightly fewer revisions for adverse reaction to metal debris in the CoM group. Explant analysis suggested a different wear pattern to those seen in the MoM group. ConclusionThe results demonstrated that the CoM articulation behaved the same as the MoM in terms of functional outcome and radiographic parameters. The CoM coupling also demonstrates raised metal ions beyond 3 years and increasing revisions for adverse reaction to metal debris. It remains difficult to see a clinical application for CoM and further exploration or use is not warranted.

A novel ceramic coating for reduced metal ion release in metal-on-metal hip surgery.

An ovine total hip arthroplasty model was developed to evaluate metal ion release, wear, the biological response and adverse tissue reaction to metal-on-metal (MoM) bearing materials. The performance of an advanced superlattice ceramic coating (SLC) was evaluated as a bearing surface and experimental groups divided into; (1) MoM articulating surfaces coated with a SLC coating (SLC-MoM), (2) uncoated MoM surfaces (MoM), and (3) metal on polyethylene (MoP) surfaces. Implants remained in vivo for 13 months and blood chromium (Cr) and cobalt (Co) metal ion levels were measured pre and postoperatively. Synovial tissue was graded using an ALVAL scoring system. When compared with the MoM group, sheep with SLC-MoM implants showed significantly lower levels of chromium and cobalt metal ions within blood over the 13-month period. Evidence of gray tissue staining was observed in the synovium of implants in the MOM group. A significantly lower ALVAL score was measured in the SLC-MoM group (3.88) when compared with MoM components (6.67) (p = 0.010). ALVAL results showed no significant difference when SLC-MOM components were compared to MoP (5.25). This model was able to distinguish wear and the effect of released debris between different bearing combinations and demonstrated the effect of a SLC coating when applied onto the bearing surface. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B: 1760-1771, 2019.

Comparative Mid-term Follow-up Study of Primary Total Hip Arthroplasty with Metal-on-metal and Metal-on-polyethylene Bearings.

To compare mid-term clinical results of total hip arthroplasty (THA) with metal-on-metal (MoM) and metal-on-polyethylene (MoP) bearings and to evaluate the biological safety of the two kinds of prostheses. Thirty-two patients who received a primary THA with an MoM articulation between January 2008 and December 2010 were selected to form the MoM group retrospectively. The MoP group consisted of 32 patients who received a THA with an MoP prosthesis during the same period. Clinical assessments, imaging examinations, laboratory tests, and metal ion concentration detections were conducted on each patient. Another 32 healthy volunteers were recruited as the control group. Twenty-seven patients in the MoM group and 28 patients in the MoP group completed the follow-up, with a mean follow-up time of 74.6 and 75.9 months, respectively. The mean Harris score at the latest follow-up was 91.5 ± 5.1 in the MoM group versus 88.9 ± 4.0 in the MoP group (P = 0.22). The MoM group showed a better range of motion in flexion, abduction, and external rotation. Co and Cr levels in the MoM group were 2.5-fold and 2.0-fold of these in the MoP group. A mild change of liver function was observed in both groups, while the values of renal function and humoral immunity stayed static. Elevated proportions of Th1 and Th17 cells and decreased proportion of Th2 cells were observed in the MoM group. The occurrence rate of pseudotumors in the MoM and MoP groups was 40.74% ± 9.45% and 14.28% ± 6.61%, respectively (P < 0.05). At the mid-term follow-up, clinical results were satisfied in both groups. MoM prosthesis could result in elevated serum metal ion levels and there is a higher risk of pseudotumor. Long follow-up is needed to evaluate the safety of MoM prostheses.

Material loss at the femoral head taper

There are limited published data detailing the volumetric material loss from tapers of conventional metal-on-polyethylene (MoP) total hip arthroplasties (THAs). Our aim was to address this by comparing the taper wear rates measured in an explanted cohort of the widely used Exeter THA with those measured in a group of metal-on-metal (MoM) THAs. We examined an existing retrieval database to identify all Exeter V40 and Universal MoP THAs. Volumetric wear analysis of the taper surfaces was conducted using previously validated methodology. These values were compared with those obtained from a series of MoM THAs using non-parametric statistical methodology. A number of patient and device variables were accounted for using multiple regression modelling. A total of 95 Exeter MoP and 249 MoM THAs were examined. The median volumetric loss from the MoM cohort was over four times larger than that from the MoP cohort (1.01 mm3 vs 0.23 mm3, p < 0.001), despite a significantly shorter median period in vivo for the MoM group (48 months vs 90 months, p < 0.001). Multiple regression modelling indicated that the dominant variables leading to greater female taper material loss were bearing diameter (p < 0.001), larger female taper angles (p < 0.001), and male titanium stem tapers (p < 0.001). Consistent with the long-term clinical success of the device, the volumetric material loss from Exeter femoral head tapers was, in general, small compared with that from larger-diameter MoM head tapers. Cite this article: Bone Joint J 2018;100-B:1310-9.

Molecular analysis of HIF activation as a potential biomarker for adverse reaction to metal debris (ARMD) in tissue and blood samples

We aimed to find a biomarker for patients with adverse reaction to metal debris (ARMD) due to a metal-on-metal (MoM) hip implant. First, we compared molecular markers of hypoxia-inducible factor (HIF) pathway activation (BNIP3, GLUT1, HO1, VEGF, and HIF1A) and inflammatory response (IL1B and COX2) in tissue from patients undergoing revision of MoM hip implant with tissue from patients undergoing primary hip replacement (PHR). Second, we compared blood levels of the above molecular markers and additional inflammatory markers: TNFA, IL18, CASPASE1, NFKB or IKB, and TLR1-4 mRNA in patients with non-failed MoM hips. We report the presence of increased expression of HIF-target genes in the periprosthetic tissue in MoM patients when compared to the PHR group. This suggests HIF pathway activation due to MoM debris and the potential of using HIF targets as a predictor of failure. Analysis of blood samples from nonoverlapping, nonfailed, MoM group showed significantly higher expression of COX2 mRNA and significant correlations between HIF1A and GLUT1 mRNA expressions, and between HIF1A mRNA and selection of inflammatory genes, including IL18, IKB, TLR1, and TLR4. HIF pathway activation in the periprosthetic tissue biopsies of patients with hip replacements may represent the first biomarker to identify early ARMD. Further studies investigating blood biomarkers could also prove beneficial in detecting ARMD that could lead to an early intervention and improved patient outcome after hip revision surgery. © 2018 Wiley Periodicals, Inc. J Biomed Mater Res Part B: Appl Biomater 107B: 1352-1362, 2019.

The inhibition of RANKL expression in fibroblasts attenuate CoCr particles induced aseptic prosthesis loosening via the MyD88-independent TLR signaling pathway

Periprosthetic osteolysis and aseptic loosening are mainly caused by wear particles (Ps) that are generated from friction interfaces. However, the mechanisms underlying the development of aseptic loosening remain unclear. Therefore, we aimed toclarify how the myeloid differentiation factor 88 (MyD88)-independent Toll-like receptor (TLR) signaling pathway mediates cobalt and chromium (CoCr)-Ps-induced osteolysis. We quantified the expression levels of TLRs, MyD88, RANKL, and inflammatory factors in patients experiencing aseptic loosening after primary total hip arthroplasty (THA) with metal-on-metal (MoM) bearings and hip osteoarthritis (hOA). We observed the in vitro and in vivo levels of RANKL, TLRs, and MyD88 in fibroblasts challenged with CoCr Ps by applying shMyD88 interference lentivirus vectors to block the MyD88-independent TLR pathway. The levels of TLRs, MyD88, RANKL, and inflammatory factors in the revision THA (rTHA) with MoM group were higher than those in the hOA group. Our data collectively revealed that inhibiting MyD88 expression could reduce osteoclastogenesis in vitro and CoCr-Ps-induced osteolysis in vivo. Our findings suggested that osteoclastogenesis is promoted by the CoCr-Ps-induced expression of RANKL in fibroblasts and that MyD88 is a potential target in the treatment of wear Ps-induced osteolysis.

What Is the Long-term Survival for Primary THA With Small-head Metal-on-metal Bearings?

Large-head metal-on-metal (MoM) bearing hip replacements have been shown to have a much higher rate of revision than other bearing surfaces. However, small-head (≤ 32 mm) MoM bearing surfaces have been in use for many years with several reports of satisfactory mid- to long-term survivorship. It is unclear whether the long-term survival of small-head MoM devices will continue to be satisfactory or whether the same concerns seen with the large-head MoM devices will ultimately become more prevalent. We analyzed a large national registry to ask: (1) What is the 15-year Kaplan-Meier survivorship of primary conventional THA using small-head (≤ 32 mm) MoM bearing surfaces compared with large-head MoM bearing surfaces in primary THA? (2) Is there an increased rate of revision for adverse reaction to metal debris (ARMD) in this group of patients over time? The Australian Orthopaedic Association National Joint Replacement Registry longitudinally maintains data on all primary and revision joint arthroplasties with nearly 100% capture. We analyzed all conventional primary THAs performed from Registry inception in September 1999 until December 31, 2015, in patients with a diagnosis of osteoarthritis and using MoM bearing surfaces ≤ 32 mm in diameter, defined as small-head MoM. The study group included 4838 primary THA with ≤ 32-mm MoM bearing surfaces. There were 2506 (51.8%) male patients and the median age of patients undergoing THA with a small-head MoM bearing surface was 64 years (range, 20-92 years of age). The outcome measure was the cumulative percent revision defined as the time to first revision using Kaplan-Meier estimates of survivorship at 15 years; reasons for revision and type of revision were also examined. We specifically investigated whether there was an increased risk of revision for ARMD in this MoM group compared with all other bearing surfaces. We compared these results with large-head MoM THAs (femoral head size > 32 mm). The cumulative percent revision for small-head MoM designs at 15 years was 8.5% (95% confidence interval [CI], 7.3-9.9). The cumulative percent revision for large-head MoM at 14 years was 27.4% (95% CI, 24.8-30.2). Prostheses with a large-head MoM articulation have a higher rate of revision than small-head MoM bearing surfaces (hazard ratio after 6 years, 5.14; 95% CI, 4.1-6.5; p < 0.001). Over time, there was a gradual increase in the diagnosis of ARMD for small-head MoM and the cumulative incidence of revision for ARMD was 0.8% at 15 years. Despite survival that is substantially greater than that of large-head MoM THAs, there has been a marked decrease in the use of small-head MoM designs in our registry. Although the reasons for this are likely multifactorial, the increasing incidence of revisions for ARMD among small-head MoM THAs is concerning. Level III, therapeutic study.

High blood metal ion levels in 19 of 22 patients with metal-on-metal hinge knee replacements

Background and purpose — There has been increasing alarm regarding metal-on-metal (MoM) joint replacements leading to elevated levels of metal ions and adverse reactions to metal debris (ARMDs). There is little information available concerning the prevalence of and risk factors for these adverse reactions, except with MoM hip joint replacements. We determined the levels of metal ions in blood and the rate of revision due to ARMDs in patients treated with MoM hinge total knee arthroplasty (TKA).Patients and methods — 22 patients with TKAs and MoM hinge connecting mechanisms were studied for whole-blood chromium and cobalt levels at 6 months, 1 year, and/or ≥2 years after surgery. Possible ARMDs were investigated by MRI. 12 patients with TKAs and metal-on-polyethylene (MoP) connecting mechanisms served as controls.Results — The cobalt levels were over 5 ppb in 19 of the 22 patients in the MoM group and in 1 of the 12 patients in the MoP group. The chromium levels were over 5 ppb in 11 of the 22 patients in the MoM group and in none of the 12 patients in the MoP group. Pseudotumors were operated in 4 of the 22 patients in the MoM group and in none of the patients in the MoP group.Interpretation — Our results clearly show that the MoM hinge TKA carries a high risk of increased levels of systemic metal ions and also local ARMD, leading to complicated knee revisions. We therefore discourage the use of MoM hinge TKA.

Metal-on-polyethylene versus metal-on-metal bearing surfaces in total hip arthroplasty

The long term biological effects of wear products following total hip arthroplasty (THA) are unclear. However, the indications for THA are expanding, with increasingly younger patients undergoing the procedure. This prospective, randomised study compared two groups of patients undergoing THA after being randomised to receive one of two different bearing surfaces: metal-on-polyethylene (MoP) n = 22 and metal-on-metal (MoM) n = 23. We investigated the relationship between three variables: bearing surface (MoP vs MoM), whole blood levels of chromium (Cr) and cobalt (Co) and chromosomal aberrations in peripheral lymphocyte pre-operatively and at one, two and five years post-surgery. Our results demonstrated significantly higher mean cobalt and chromium (Co and Cr) blood levels in the MoM group at all follow-up points following surgery (p &lt; 0.01), but there were no significant differences in the chromosomal aberration indices between MoM and MoP at two or five years (two years: p = 0.56, p = 0.08, p = 0.91, p = 0.51 and five years: p = 0.086, p = 0.73, p = 0.06, p = 0.34) for translocations, breaks, loss and gain of chromosomes respectively. Regression analysis showed a strong linear relationship between Cr levels and the total chromosomal aberration indices in the MoM group (R2 = 0.90016), but this was not as strong for Co (R2 = 0.68991). In the MoP group, the analysis revealed a poor relationship between Cr levels and the total chromosomal aberration indices (R2 = 0.23908) but a slightly stronger relationship for Co (R2 = 0.64292). Across both groups, Spearman’s correlation detected no overall association between Co and Cr levels and each of the studied chromosomal aberrations. There remains no clear indication which THA bearing couple is the most biocompatible, especially in young active patients. While THA continues to be very successful at alleviating pain and restoring function, the long-term biological implications of the procedure still require further scrutiny. Cite this article: Bone Joint J 2015;97-B:1183–91.

Functional outcome following a large head total hip arthroplasty: A retrospective analysis of mid term results.

Background:One of the reasons that hip resurfacing and large head metal on metal (MOM) total hip arthroplasty (THA) became popular in Asia was the possible increased range of movement and thereby improved function of the hip joint. Due to concerns of MOM articulation an alternative bearing was sought. Hence, a shift from large head MOM to large head ceramic on ceramic (COC) was made. The aim of this study was to compare the functional outcome including range of motion (ROM) and dislocation rates following large head MOM and large head COC THA.Materials and Methods:Retrospectively, 39 primary THA with large head MOM with a mean age of 56 years (range 36-72 years) and average followup of 54 months (range 38-70 months) were compared with 23 primary THA with large head COC bearing with a mean age of 48 years (range 36-68 years) and an average followup of 18 months (range 12-26 months). Functional outcome was assessed using the Modified Harris Hip Score. Dislocation rate and ROM were compared.Results:Global ROM averaged 248 degrees with MOM group and 252 degrees with the COC group. One patient with metal bearing had dislocation at an average 3 year followup which required revision THA while there were no complications in the COC group. MHHS averaged 89 points in MOM and 94 in COC THR.Conclusion:This study has shown that large head ceramic on ceramic THA is a good alternative to large head metal on metal THA with comparable dislocation rates and range of movements and without complications of metallosis in Asian patients.