Serum Metal Ion Levels Research Articles

Metal ion levels after metal-on-metal hip resurfacing: A single-center longitudinal study of Chinese patients.

This study aimed to investigate the long-term serum metal ion levels of patients who received metal-on-metal hip resurfacing arthroplasty (MoM HRA). We conducted a retrospective study of 99 patients (110 hips) from March 2006 to May 2017 who underwent MoM HRA. The Harris Hip Score (HHS) and the University of California at Los Angeles (UCLA) activity score were measured, and the patients underwent clinical and radiological management. Serum levels of cobalt (Co), chromium (Cr), and molybdenum (Mo) were measured using inductively coupled plasma mass spectrometry (ICPMS) at 1, 6, and 12 months, and each year follow-up after prosthesis implantation. Patients were followed up from 1 to 156 months, with a mean of 98 months. No complications occurred. Metal ion analysis revealed significantly elevated levels compared to preoperative levels. The metal ions levels increased and reached a peak after surgery, and then the levels began to decline gradually. Approximately 84-108 months after surgery, the metal ion levels increased again to approximately peak levels. Then, up to 156 months after surgery, the metal ions levels will drop approximately to preoperative levels. The serum levels of Cr in women were higher than those in men, with the difference being statistically significant. Patients with a body mass index (BMI) of ≥24.9 kg/m2 Co levels were significantly higher than those of normal-weight patients. The serum levels of metal ions showed no significant differences between the prostheses. The use of the MoM HRA was clinically effective, and the Co, Cr, and Mo levels increased significantly after HRA; however, upon long-term follow-up, serum metal ion levels tended to decrease to preoperative levels. Longer follow-up periods and larger study samples are needed to establish the long-term outcome of patients undergoing HRA with MoM bearings. Level IV, Therapeutic Study.

LONG-TERM SURVIVORSHIP OF METAL-ON-METAL HIP RESURFACING ARTHROPLASTY: COMPARATIVE COHORT STUDY AT 15 YEARS

In 1997 the Birmingham Hip Resurfacing was introduced to address the needs of young active patients. Alternative designs were introduced to try and improve wear performance. The aim of this study was a comparative cohort study of two types of metal-on-metal bearing to determine the mechanism of failure at 15 years.The study reviewed 91 Brimingham Hip Resurfacings (BHR) (Smith and Nephew) and 715 DUROM hip resurfacing (Zimmer) procedures in prior to 2009. Failure was defined as revision of either component for any reason. Kaplan-Meyer survivorship analysis performed. Routine follow-up with serum metal ion levels and radiographs.Mean follow-up was 17.9 years (range 15.2 – 25.1). The mean age at operation was 51.6 years (SD 8.6, range 20.7 to 70.2), including 299 women (37.1%). The Birmingham resurfacing demonstrated 92.3% survivorship at 15 years (SE 2.8, 95% CI 3.9 – 7.8) and 90.0% at latest follow-up (SE 3.5, 95% CI 4.9 to 9.4). By comparison, the DUROM survivorship at 15 years was 89.1% at 15 years (SE 1.2, 95% CI 2.0 to 2.5) and 87.4% (SE 1.3, 95% CI 2.5 to 2.3) at latest follow-up. There was no statistically significant difference in survivorship between groups (p= 0.32). Survival in male patients was 92.7% compared to 80.0% in females. The reported failures occurred from Adverse Reaction to Metal Debris (32 patients), periprosthetic femoral neck fracture (6) and aseptic loosening (41), PJI (12) and undiagnosed pain (6). The mean cobalt and chromium levels at last follow-up were 33.4 nmol/L and 36.5 nmol/L respectively.This study demonstrates two differently designed metal-on-metal hip resurfacing provided a durable alternative to total hip replacement, particularly in younger male patients with osteoarthritis. Differences in design did determine the reason for revision with acetabular fixation being one of the principal failure mechanisms for the DUROM compared to elevated ion levels.

Birmingham Hip Resurfacing at 25 years.

The Birmingham Hip Resurfacing (BHR) was introduced in 1997 to address the needs of young active patients using a historically proven large-diameter metal-on-metal (MoM) bearing. A single designer surgeon's consecutive series of 130 patients (144 hips) was previously reported at five and ten years, reporting three and ten failures, respectively. The aim of this study was to extend the follow-up of this original cohort at 25 years. The study extends the reporting on the first consecutive 144 resurfacing procedures in 130 patients for all indications. All operations were undertaken between August 1997 and May 1998. The mean age at operation was 52.1 years (SD 9.93; 17 to 76), and included 37 female patients (28.5%). Failure was defined as revision of either component for any reason. Kaplan-Meier survival analysis was performed. Routine follow-up with serum metal ion levels, radiographs, and Oxford Hip Scores (OHSs) was undertaken. Overall implant survival was 83.50% (95% confidence interval (CI) 0.79 to 0.90) at 25 years, and the number at risk was 79. Survival in male patients at 25 years was 89.5% (95% CI 0.83 to 0.96) compared to 66.9% for female patients (95% CI 0.51 to 0.83). Ten additional failures occurred in the period of ten to 25 years. These involved an adverse reaction to metal debris in four patients, a periprosthetic femoral neck fracture affecting five patients, and aseptic loosening in one patient. The median chromium levels were 49.50 nmol/l (interquartile range (IQR) 34 to 70), and the median cobalt serum levels were 42 nmol/l (IQR 24.50 to 71.25). The median OHS at last follow-up was 35 (IQR 10 to 48). During the 25-year study period, 29 patients died. Patient survival at 25 years was 75.10% (95% CI 0.67 to 0.83). This study demonstrates that MoM hip resurfacing using the BHR provides a durable alternative to total hip arthroplasty (THA), particularly in younger male patients with osteoarthritis wishing to maintain a high level of function. These results compare favourably to the best results for THAs.

Metal artifact reduction sequence-MRI abnormalities in asymptomatic patients with dual-mobility hip prostheses.

Modular dual-mobility (DM) articulations are increasingly used during total hip arthroplasty (THA). However, concerns remain regarding the metal liner modularity. This study aims to correlate metal artifact reduction sequence (MARS)-MRI abnormalities with serum metal ion levels in patients with DM articulations. A total of 45 patients (50 hips) with a modular DM articulation were included with mean follow-up of 3.7 years (SD 1.2). Enrolled patients with an asymptomatic, primary THA and DM articulation with over two years' follow-up underwent MARS-MRI. Each patient had serum cobalt, chromium, and titanium levels drawn. Patient satisfaction, Oxford Hip Score, and Forgotten Joint Score-12 (FJS-12) were collected. Each MARS-MRI was independently reviewed by fellowship-trained musculoskeletal radiologists blinded to serum ion levels. Overall, two patients (4.4%) had abnormal periprosthetic fluid collections on MARS-MRI with cobalt levels > 3.0 μg/l. Four patients (8.9%) had MARS-MRI findings consistent with greater trochanteric bursitis, all with cobalt levels < 1.0 μg/l. A seventh patient had a periprosthetic fluid collection with normal ion levels. Of the 38 patients without MARS-MRI abnormalities, 37 (97.4%) had cobalt levels < 1.0 μg/l, while one (2.6%) had a cobalt level of 1.4 μg/l. One patient (2.2%) had a chromium level > 3.0 μg/l and a periprosthetic fluid collection. Of the 41 patients with titanium levels, five (12.2%) had titanium levels > 5.0 μg/l without associated MARS-MRI abnormalities. Periprosthetic fluid collections associated with elevated serum cobalt levels in patients with asymptomatic DM articulations occur infrequently (4.4%), but further assessment is necessary due to implant heterogeneity.

The Evaluation of Serum Metal Ion Levels and Metallosis in Graduated Patients With Magnetically Controlled Growing Rods.

Magnetically controlled growing rods (MCGR) aim to control curve progression while limiting surgical burden in children with early-onset scoliosis. Systemic and local distribution of metal debris has been documented in children with spinal implants. The aim of the study was to assess serum metal ion levels and local metal debris-related changes at the conclusion of MCGR treatment. Between February 2019 and September 2022, all patients who had a conversion to definitive fusion at the completion of MCGR treatment in our institution were invited to participate in this study. Consenting patients had serum metal ion levels drawn (titanium, cobalt, and chromium) and histologic analyses of peri-implant tissue samples. We enrolled 24 children who underwent definitive fusion post-MCGR treatment for early-onset scoliosis. The average age at definitive fusion was 13.3 years (range: 11 to 17 y). The average length of MCGR treatment was 4.8 years (range: 1.5 to 6.8 y). At the end of the MCGR treatment, 23 (96%) patients had elevated serum metal ion levels. Mean serum titanium levels were 165.4 nmol/L (range: 30 to 390 nmol/L), mean serum cobalt levels were 4.6 nmol/L (range: 1.2 to 14 nmol/L), and mean serum chromium levels were 14 nmol/L (range: 2.4 to 30 nmol/L). Peri-implant soft tissue histologic analysis demonstrated local metal debris and foreign body reactions in all patients. At the completion of MCGR treatment, the majority of patients demonstrate elevated serum metal ion levels and local metal debris-related peri-implant soft tissue changes. Although there is no current literature to suggest these findings are harmful, further research as to the clinical significance is required. Level IV.

Metallosis in Total Hip Arthroplasty.

» Metallosis is a rare but significant complication that can occur after total hip arthroplasty (THA) for a variety of reasons but most commonly in patients with metal-on-metal implants.» It is characterized by the visible staining, necrosis, and fibrosis of the periprosthetic soft tissues, along with the variable presence of aseptic cysts and solid soft tissue masses called pseudotumors secondary to the corrosion and deposition of metal debris.» Metallosis can present with a spectrum of complications ranging from pain and inflammation to more severe symptoms such as osteolysis, soft tissue damage, and pseudotumor formation.» Workup of metallosis includes a clinical evaluation of the patient's symptoms, imaging studies, serum metal-ion levels, and intraoperative visualization of the staining of tissues. Inflammatory markers such as erythrocyte sedimentation rate and C-reactive protein along with intraoperative frozen slice analysis may be useful in certain cases to rule out concurrent periprosthetic joint infection.» Management depends on the severity and extent of the condition; however, revision THA is often required to prevent rapid progression of bone loss and tissue necrosis.

Cross-Sectional Study of Serum Metal Ions in Patients With Metal Implants in the Maxillofacial Region.

The purpose of the present study was to measure the serum metal ion levels (titanium, cobalt, chromium) in patients who have metal implants in the maxillofacial region. The investigators implemented a cross sectional study on patients treated with procedures requiring metal implants for management of maxillofacial trauma, fixation for orthognathic surgery, and total temporomandibular joint replacement (TJR). Inductively coupled plasma mass spectrometry was used as an analytical method to detect metal ions in serum samples. The study comprised of 50 patients who were divided into 4 groups- group I- total TJR (n = 18), group II- orthognathic (n = 8), group III- trauma (n = 8), and group IV- control (n = 16). The mean values of metal ions level were raised than the control group. The present study's results suggest a rise in serum metal ion levels after the metal implantation in maxillofacial region. None of the patients had any abnormal signs and symptoms due to raised metal levels. Further studies are warranted to correlate the serum metal ion levels and their clinical relevance.

Long-term Follow-up on Revisions of a Recalled Large Head Metal-on-metal Hip Prosthesis: A Single Surgeon Series.

In 2010, a recall was issued for a specific monoblock large head metal-on-metal (MoM) hip prosthesis due to short-term revision rates of 12%-13% (articular surface replacement, DePuy Orthopaedics, Inc., Warsaw, IN). High complication, infection, and rerevision rates for revised MoM implants have been reported. The purpose of the study is to report long-term outcomes and trend metal ion levels of this recalled MoM prosthesis from a single surgeon series. Retrospective chart review was performed on all patients that underwent revision of large MoM hip replacements between 2010 and 2015. Pre- and post-revision Harris Hip Score (HHS), cup abduction angles, anteversion angles, and cup sizes were compared. Survivorship and HHS were the primary outcomes measured; serum cobalt and chromium levels were secondary outcomes. Multivariate linear regression was used to examine the correlation between prerevision serum metal ion levels and HHS. A total of 24 hips (21 patients) met inclusion criteria. Mean time to revision was 4.12 years ± 1.1. Mean follow-up was 10.0 years (7-11.9 years). Mean HHS increased significantly after revision from 48.5 to 89.5 (P < .001). Higher prerevision cobalt levels were correlated with lower prerevision HHS (cobalt R= 0.25; chromium R= 0.3160). There was no correlation with prerevision cobalt (P= .2671) or chromium (P= .3160) with postrevision HHS. Most recent metal ion testing revealed a significant decrease in both cobalt (P= .0084) and chromium (P= .0115). Survival rate is 100%. Our study showed excellent survivorship and outcomes at 10 years. There were no failures for any reason including infection. This differs from previous studies and confirms excellent long-term results are possible with revision of this recalled MoM implant.

METAL ARTIFACT REDUCTION SEQUENCE MRI ABNORMALITIES IN ASYMPTOMATIC PATIENTS WITH DUAL MOBILITY HIP PROSTHESES

Modular dual mobility (DM) articulations are increasingly utilized during total hip arthroplasty (THA). However, concerns remain regarding the metal liner modularity. This study aims to correlate metal artifact reduction sequence (MARS) magnetic resonance imaging (MRI) abnormalities with serum metal ion levels in patients with DM articulations.All patients with an asymptomatic, primary THA and DM articulation with &gt;2-year follow-up underwent MARS-MRI of the operative hip. Each patient had serum cobalt, chromium, and titanium levels drawn. Patient satisfaction, Oxford Hip Score, and Forgotten Joint Score-12 (FJS-12) were collected. Each MARS-MRI was independently reviewed by fellowship-trained musculoskeletal radiologists blinded to serum ion levels.Forty-five patients (50 hips) with a modular DM articulation were included with average follow-up of 3.7±1.2 years. Two patients (4.4%) had abnormal periprosthetic fluid collections on MARS-MRI with cobalt levels &gt;3.0 μg/L. Four patients (8.9%) had MARS-MRI findings consistent with greater trochanteric bursitis, all with cobalt levels &lt; 1.0 μg/L. A seventh patient had a periprosthetic fluid collection with normal ion levels. Of the 38 patients without MARS-MRI abnormalities, 37 (97.4%) had cobalt levels &lt;1.0 μg/L, while one (2.6%) had a cobalt level of 1.4 μg/L. One patient (2.2%) had a chromium level &gt;3.0 μg/L and a periprosthetic fluid collection. Of the 41 patients with titanium levels, five (12.2%) had titanium levels &gt;5.0 μg/L without associated MARS-MRI abnormalities.Periprosthetic fluid collections associated with elevated serum cobalt levels in patients with asymptomatic dual mobility articulations occur infrequently (4.4%), but further assessment of these patients is necessary.Level of Evidence: Level IV

O113 ELEVATED METAL ION LEVELS CAN BE TOLERATED BY SOME PATIENTS

Abstract Introduction Ten years following withdrawal and revision of large diameter metal on metal hips (MOM), there remains an uncertainty in how best to manage asymptomatic patients with abnormal imaging and/or raised blood metal ion levels. This study investigates the trajectories of symptoms, serological metal ion tests and cross-sectional imaging in these patients. Methods 523 patients with 707 acceptable functioning MOM hips (defined as Oxford Hip Score (OHS) &amp;gt;30) on active monitoring were identified. Surveillance at two time intervals included: patient-reported pain and function (OHS), blood metal ion (Cobalt (Col) and Chromium (Chr)) and/or cross-sectional imaging with MRI. Results Mean serum metal ion levels in parts per billion (ppb) were Co1 4.5 (S.D. 11.5), Co2 4.7 (S.D. 11.6) and Ch1 3.0 (S.D. 4.8) and Ch2 3.2 (S.D. 4.9). Median OHS was 42 (IQR 28–27). OHS was not significantly correlated to serum metal ion levels (Col Pearson correlation = -0.105 P = 0.106, Chr Pearson correlation = -.125 P = 0.054). There was no significant change in Col (-0.48, P = 0.414) and Chr levels (-0.25, P = 0.325) between the two time intervals. 45 patients had metal ion levels &amp;gt;7 ppb, 64.4% had OHS &amp;gt;30. 6 patients had metal ions level greater than 50 ppb, with no significant deterioration of OHS. Conclusion Our results indicate that there are a subset of patients with high metal ion levels, stable imaging and acceptable function who can safely be actively monitored thereby assisting in joint decision making with this challenging patient group.

METAL ION RELEASE ACCORDING TO LEG LENGTH DISCREPANCY IN CERAMIC-ON-METAL HIP ARTHROPLASTY.

The ceramic-on-metal (CoM) bearing has the theoretical advantages over ceramic-on-ceramic (CoC) and metal-on-metal bearings. This study aimed to analyze factors affecting the metal ion release of CoM bearings and compare clinical performance with CoC bearings. The 147 patients were divided into 96 patients in group 1 (CoM group) and 51 patients in group 2 (CoC group). Additionally, within group1, 48 patients and 30 patients were sub-categorized into group 1-A with leg length discrepancy (LLD) less than 1cm and group 1-B greater than 1 cm. The level of serum metal ions, functional scores and plain radiographs were obtained for the analysis. The level of cobalt (Co) 2-years after surgery and chromium (Cr) 1-year after surgery showed significantly higher in the group1 than the group2. LLD indicated statistically significant positive correlation between serum metal ion levels among CoM bearing THAs. In comparison of the average metal ions level changes, group 1-B showed higher level of metal ion than group 1-A. In patients underwent THA with CoM bearings, large LLD have a higher risk of complications associated to metal ions. Therefore, it is critical to reduce the LLD to 1 cm or less in using CoM bearing. Level of Evidence III; Case Control Study.

Systemic Metal Ion Concentrations in Patients With Hip and Knee Megaprostheses: A Prospective Cohort Study.

Local tissue and serum metal ions have been shown to be elevated in some metal-on-metal and metal-on-polyethylene joint replacements. Local elevations have been linked to adverse local tissue reactions in some patients, and systemic elevation has been less commonly implicated cardiac and neurologic issues. Using a prospective study design, we aimed to identify the changes in serum metal ion levels after hip or knee megaprosthesis reconstruction. Furthermore, we will evaluate the occurrence of adverse effects and complications, possibly linked to metal ion elevation. Fourteen consecutive patients receiving a Modular Universal Tumor Revision System megaprosthesis were enrolled. Blood samples were collected preoperatively and postoperatively to determine the serum ion concentrations of aluminum, chromium, cobalt, and silver. To evaluate the safety of the megaprostheses and the subsequently possible related (elevated) serum metal ion concentrations, all adverse effects and complications were registered until last outpatient clinic visit at the time of this study. Compared to the preoperative median serum concentrations, the postoperative median serum concentrations of chromium, silver, and cobalt increased 11-fold, 62-fold, and 64-fold, respectively. The median serum concentration of aluminum increased with 16%. Elevations were primarily noted in patients with knee prostheses. Eight patients had no adverse effects or complications during the period between preoperative and postoperative blood sampling. One adverse effect directly related to the serum metal ion concentrations, namely argyria, was observed. This study documents significantly elevated concentrations of the metal ions, but only one adverse effect directly related to the metal ion concentrations was observed. Future studies are needed to further assess the impact of elevated metal ion levels after megaprostheses, specifically knee implants, which are metal-on-metal.

Careful patient selection together with optimal implant positioning may reduce but does not eliminate the risk of elevated serum cobalt and chrome levels following metal-on-metal hip resurfacing.

Elevated serum chrome (sCr) and cobalt (sCo) concentrations are associated with local tissue adverse reactions to metal debris following metal-on-metal hip resurfacing (MoM-HR). Serum metal ions <2 µg/l are probably of little clinical relevance and a pragmatic "safe" threshold <5 µg/l has been suggested.The primary aim of this study was to evaluate if a careful selection of patients combined with optimal implant positioning could eliminate cases with "unsafe" serum metal ion levels. A secondary aim was to study the association between different risk factors and having Co and/or Cr levels >5 µg/l. This is a retrospective, single-institution cohort study of 410 consecutive patients operated on with a Birmingham Hip Resurfacing (BHR) implant between 2001 and 2014. 288 of these had a unilateral MoM-HR, pelvic and true lateral radiographs, and a related sCo and sCr sample, and were included in the final analysis. They were allocated to either a presumed "optimal group" consisting of only men aged <60 years old, with femoral head component >48 mm diameter, and with a cup positioned within Lewinnek's safe zones, or a "suboptimal group" consisting of the remaining patients. Fisher's exact test and multiple logistic regression analyses were performed. In the optimal group 48% (47/97) had serum metal ions >2 µg/l and 8% (8/97) >5 µg/l compared to 61% (116/191) and 18% (34/191) in the suboptimal group, p = 0.059 and p = 0.034 respectively. Acetabular cups with an anteversion <5 degrees had the highest odds ratio, 6.5 (95% CI, 3.0-14.3), of having sCo and sCr concentrations exceeding 5 µg/l. A well oriented BHR acetabular component in a presumably "optimal" patient reduces the risk of having elevated serum metal ions but does not eliminate it. Insufficient cup anteversion seems to be the strongest associated factor of elevated serum metals.

Serum metal ion levels following spinal deformity surgery: a case-control study of 182 individuals

PurposeThe aim of this study is to evaluate the levels of chromium (Cr), cobalt (Co), and titanium (Ti) after instrumented fusion for scoliosis.MethodsSerum samples were collected at median 2.24 (range 0.1–38.8) years after fusion surgery for scoliosis in 91 individuals, of which 71 had been treated with steel implants and 20 with titanium implants. 91 sex and age-matched non-surgically treated individuals with scoliosis were used as controls. Levels of Cr, Co, and Ti were measured.ResultsIn the 91 surgically treated individuals median levels of Cr were 0.54 µg/l vs 0 µg/l in the 91 controls, p < 0.001. Corresponding results for Co were 0.29 µg/l vs. 0.24 µg/l, p = 0.19, and for Ti were 0 µg/l vs. 0 µg/l, p < 0.001.In the individuals with steel implants and their corresponding controls median Cr levels were 0.63 µg/l vs. 0.00 µg/l, p < 0.001 and Co levels 0.27 µg/l vs. 0.23 µg/l, p = 0.36. No Ti was detected.In the individuals with titanium implants, median Cr levels were 0 µg/l vs. 0 µg/l in their corresponding controls, p = 0.38. Corresponding results for Co was 0.39 µg/l vs. 0.31 µg/l, p = 0.27 and for Ti 4.31 µg/l vs. 0 µg/l, p < 0.001.In the individuals with steel implants a negative correlation between implant time in situ and levels of Cr was found (rho = − 0.52, p < 0.001) but not with Co (rho = − 0.14, p = 0.23). Ti was not detected.In the individuals with titanium implants, there was no correlation between implant time in situ and levels of Cr (rho = 0.36, p = 0.12), Co (rho = − 0.12, p = 0.60) or Ti (rho = 0.22, p = 0.35).ConclusionThe use of stainless steel and titanium implants in spinal fusion surgery is associated with elevated metal ion concentrations several years after surgery.

No Change in Serum Metal Ions Levels After Primary Total Hip Replacement With an Additively Manufactured Dual Mobility Acetabular Construct

BackgroundModular junctions of mixed metals have been associated with fretting and corrosion, and in extreme circumstances, adverse local tissue reactions. Since modular dual mobility (MDM) hip constructs involve a titanium shell with a modular cobalt-chromium liner, the aim of this study was to evaluate serum metal ions at minimum 1 year following total hip arthroplasty (THA) in a cohort of patients with these types of implants. MethodsA single surgeon enrolled 30 patients in a prospective study in which all patients were evaluated preoperatively with serum cobalt, chromium, and titanium metal ion levels. Patients underwent primary THA with an additively manufactured titanium acetabular shell, MDM cobalt-chromium liner, titanium cementless stem, and ceramic head. A “Four Quadrant Test” was used to ensure proper liner seating intraoperatively. At minimum 1 year following surgery, clinical and radiographic evaluation was conducted, and repeat metal ion levels were collected. Patient-reported outcome measures were collected preoperatively and postoperatively. ResultsTwenty-five patients completed 1-year follow-up. All patients had normal metal ion levels for cobalt (<1 μg/L), chromium (<5 μg/L), and titanium (sensitivity test) preoperatively and postoperatively. Patient-reported outcome measures improved significantly after primary THA: Veterans RAND-12 Physical Component Score (31.05 to 45.02, P < .001), Visual Analogue Scale Pain score (70.68 to 7.77, P < .001), Hip Disability and Osteoarthritis Outcomes Score, Joint Replacement (51.99 to 86.97, P < .001). ConclusionsNo significant elevation was detected in serum metal ion levels 16 months following THA using an additively manufactured titanium acetabular shell, a cobalt-chromium MDM liner, and titanium stem with a ceramic head.

A Novel Multilayer-Coating for Total Knee Arthroplasty Implants is Safe – 10-Year Results From a Randomized-Controlled Trial

BackgroundThis randomized-controlled trial was initiated to compare a new multilayer hypoallergenic coating system with the standard implant in total knee arthroplasty (TKA) in terms of serum metal ion levels, patient-reported outcomes (PROs), and implant survival. MethodsA total of 120 patients were randomized to receive a coated or standard TKA of the same knee system. Serum metal ion levels (ie, cobalt, chromium, molybdenum, and nickel) as well as knee function (Oxford Knee Score, OKS), quality of life (SF-36), and physical activity (UCLA activity scale) were assessed before surgery and until the 10 year follow-up. A total of 24 patients died and there was one revision in each group. This resulted in 85 patients who completed follow-up. ResultsBoth groups demonstrated equally good improvement in PROs after surgery and constant score values thereafter. The majority of patients had metal ion serum levels below detection limit. Only cobalt levels demonstrated a slight increase in the standard group at 5- and 10-year follow-up. However, all patients displayed values below 3 μg/L. The cumulative 10-year survival was 98% in both groups. ConclusionThere were no problems with the new coating system. No relevant increase in metal ion serum levels were measured. A slight increase in cobalt serum levels in the standard TKA was noted, thus not reaching critical values. The new coating system demonstrated equally good PROs as the standard TKA. Excellent implant survival was observed in both groups. Level of evidenceI.

Analysis of serum metal ion levels in dental implant patients

Background: Dental implants have been widely used for the replacement of missing teeth in fully and partially edentulous patients. Titanium (Ti) has been the material of choice for dental implants due to its superior corrosion resistance behaviour and desirable mechanical properties. Hence; the present study was undertaken for assessing the serum metal ion levels in Dental Implant Patients. Materials &amp; methods: A total of 20 subjects with missing mandibular first molar and scheduled for prosthetic rehabilitation for same using dental implant therapy were enrolled. Blood samples were obtained at baseline and sent to laboratory where auto-analyser was used for evaluation of metal ions levels. All the dental implant procedures were carried out under the hands of skilled implantologists. After placement of dental implants, blood samples were obtained at 8 weeks and 6 months follow-up. Metal ions were assessed at subsequent follow-ups. All the results were analysed by SPSS software. Results: Mean serum titanium concentration at baseline, 8 weeks and 6 months was fond to be 2.39 mg/dL, 2.35 mg/dL and 2.38 mg/dL respectively. Mean serum aluminium concentration at baseline, 8 weeks and 6 months was fond to be 4.19 mg/dL, 4.16 mg/dL and 4.18 mg/dL respectively.

Risk Stratification and Pain Outcomes Following Revision Total Hip Arthroplasty for Adverse Local Tissue Reactions

BackgroundRevision total hip arthroplasty (THA) for adverse local tissue reactions (ALTRs) secondary to head-neck taper corrosion is associated with a high complication rate. Diagnosis of ALTR is based on risk stratification using the patient’s history and examination, implant risk, serum metal ion levels, and imaging. The purpose of this study was to determine if stratification using similar risk factors is predictive of outcomes following revision THA for metal-on-polyethylene (MoP) ALTR. MethodsWe performed a retrospective review on 141 patients revised for ALTR due to head-neck taper corrosion. Pain outcomes following surgery were analyzed using a generalized linear mixed model. Complications were defined as instability/dislocation, infection, fracture, nerve palsy, leg-length discrepancy, or reoperation. ResultsThe overall complication rate was 17.7%. The odds of having pain decreased by 44% after revision surgery (Odds Ratio = 0.56, 95% Confidence Interval: 0.324 to 0.952). There was no significant difference in instability/dislocation based on either increased or decreased head-neck offset (P = .67) or magnetic resonance imaging findings of abductor loss, effusion size, and degree of ALTR (P = .73). Increased serum cobalt (P = .31) and chromium (P = .08) levels did not predict complications; however, a decreased cobalt-chromium ratio was associated with postoperative complications (2.8 versus 3.5; P = .002). ConclusionThese findings are the first to suggest that patients who have ALTR after MoP THA undergoing revision surgery demonstrated major pain relief. Increasing femoral head offset did not change rates of instability/dislocation. In clinical scenarios where preoperative cobalt-chromium femoral head offsets were greater than available ceramic head offsets, a mandatory decrease in femoral head offset did not increase rates of instability/dislocation.

Clinical Outcomes, Metal Ion Levels, Lymphocyte Profiles, and Implant Survival Following Five Different Bearings of Total Hip Arthroplasty: A Mean 10-year Follow-up Study

BackgroundDifferent bearings have been used in total hip arthroplasty (THA), but the long-term performance is still controversial. The purpose of this study was to investigate whether there are differences when comparing THAs with 5 different bearings at a long-term follow-up of more than 10 years. MethodsFrom January 2010 to May 2012, 101 THA patients (134 hips) were divided into metal-on-metal group (MoM, 31 hips), metal-on-polyethylene group (MoP, 23 hips), ceramic-on-metal group (CoM, 21 hips), ceramic-on-ceramic group (CoC, 33 hips), and ceramic-on-polyethylene group (CoP, 26 hips). The mean follow-up period was 10.3 years. The Harris hip score (HSS), Western Ontario and McMaster Universities Osteoarthritis Index scores (WOMAC), range of motion (ROM), blood cell count, and liver-kidney function were measured. Serum and urine metal ion levels were measured using high-resolution inductively coupled plasma-mass spectrometry (ICP-MS) and a blood lymphocytes analysis was counted by flow cytometry. ResultsNo difference was observed in the HSS, WOMAC, ROM, blood cell count, or liver-kidney function among any of the 5 groups. Metal ion levels were significantly elevated in metal-containing bearings. Flow cytometry showed that no differences were found. Revision was performed due to pseudotumor in 3 patients. The implant survival rate was 96.7% and 93.3% for the MoM and CoC groups, which was significantly lower compared with other groups. ConclusionsMetal ion levels were elevated significantly in metal-containing bearings, especially in MoM THA patients. The implant survival rate was significantly lower in CoC and MoM THAs, which was mainly due to pseudotumor formation. Level of EvidenceTherapeutic Level II.

Serum metal ion levels in adolescent idiopathic scoliosis (AIS) patients 25years after treated with Harrington rod instrumentation or bracing.

Surgical instrumentation in children with adolescent idiopathic scoliosis (AIS) is performed early in life and the implants are left in situ for the rest of the patient's life. Concern has been raised regarding persistent elevated levels of serum metal ions, but only a few studies on the topic have been published. The aim of this study was to compare the levels of serum metal ions in patients with AIS treated with either Harrington rod instrumentation or bracing. AIS patients treated with Boston brace (BB) or posterior spinal fusion with Harrington rod instrumentation (HR) from 1983 to 1990 were requested to return to clinic. One hundred fifty-nine (73%) of 219 patients were available for follow-up of whom 115 agreed to have a blood draw. The proportion of patients who agreed to have a blood draw were similar in the BB (48 of 100, 48%) and HR (67 of 115, 60%, p = 0.085) groups. None of the surgical patients had their implants removed; mean age at follow-up (BB: 43.2 years vs HR: 43.5 years, p = 0.566) and mean length of follow-up (BB: 26.5 years vs HR: 24.5 years). Mean chromium serum levels were similar between the BB (2.7nmol/L) and the HR (2.9nmol/L, p = 0.827). Mean Cobalt serum levels were also similar between the BB (2.6nmol/L) and the HR (2.8nmol/L, p = 0.200). Serum metal ions were similar in AIS patients treated with bracing or Harrington rod instrumentation 25years after initiation of treatment.