The purpose of this randomized controlled trial was to evaluate serum metal levels in patients undergoing total hip arthroplasty (THA) with a conventional compared to a modular dual-mobility bearing. Patients undergoing primary THA for osteoarthritis were randomized to receive either a modular dual-mobility or conventional polyethylene bearing. All patients received the same titanium acetabular and femoral component and a ceramic femoral head. Serum metal levels were drawn pre-operatively then annually for a minimum of two years postoperatively. An Forty-six patients were randomized to a modular dual-mobility (n=25) or conventional bearing (n=21) with 40 at a minimum follow-up of two years. No differences in serum cobalt (mean 0.14 ppb [range, 0.075–0.29] vs. 0.20 ppb [range, 0.075–0.57], p=0.39) or chromium levels (mean 0.14 ppb [range, 0.05–0.50] vs. 0.12 ppb [range, 0.05–0.35], p=0.65) were identified between the modular dual-mobility and conventional cohorts, respectively. There was no statistically significant difference in serum Co or Cr at two years postoperatively in subjects implanted with a ceramic head and this particular dual mobility bearing in comparison to a ceramic head and a conventional acetabular component. While modest expected elevations in serum Co and Cr were observed in the dual mobility group, in no case did the Co level exceed the laboratory reference range nor the threshold of one part per billion that has been associated with adverse local tissue reactions to mechanically-assisted crevice corrosion.
Ceramic-on-ceramic (CoC) articulations in total hip arthroplasty (THA) have low wear, but the unique risk of fracture. After revision for CoC fracture, ceramic third bodies can lead to runaway wear of cobalt chrome (CoCr) causing extremely elevated blood cobalt. We present five cases of ceramic liner fractures revised to a CoCr head associated with the rapid development of severe cobalt toxicity. We identified 5 cases of fractured CoC THA treated with revision to CoCr on highly cross-linked polyethylene (HXLPE) – three to conventional bearings and two to modular dual mobility bearings (CoCr acetabular liner, CoCr femoral head, and HXLPE). Mean follow up was 2.5 years after CoCr/HXLPE re-revision. Symptoms of cobalt toxicity occurred at average 9.5 months after revision for ceramic fracture (range 6–12). All patients developed vision and hearing loss, balance difficulties, and peripheral neuropathy. Several had cardiomyopathy, endocrinopathy, and local skin discoloration. Two reported hip pain. Re-revision for cobalt toxicity occurred at an average of 22 months (range 10–36) after revision for ceramic fracture. Average serum cobalt level at re-revision was 991 μg/L (range 734–1302, normal <1 μg/L). All CoCr heads exhibited massive wear with asphericity; deep tissues exhibited prominent metallosis. Treatment consisted of debridement and revision to a ceramic head with HXLPE. Serum cobalt improved to an average of 25 μg/L at final follow up. All patients reported partial improvement in vision and hearing; peripheral neuropathy and balance did not recover. Systemic cobalt toxicity is a rare but devastating complication of ceramic fracture in THA treated with cobalt-alloy bearings. Cobalt alloy bearings should be avoided in this setting. The diagnosis of systemic cobalt toxicity requires a high index of suspicion and was typically delayed following systemic symptoms. Debridement and revision to a ceramic-on-HXLPE leads to improvement but not resolution of cobalt toxicity complications.
We created TiO2 nanotubes (TNTs) on the surface of titanium (Ti) implants with subsequential loading with gentamicin and chitosan, acting as a control release agent, by electrophoretic deposition (EPD). We hypothesized femoral implants with TNTs loaded with gentamicin and chitosan would localize antibiotic to the implant and surgical site and prevent PJI in a mouse model. Ti-6Al-4V ELI wires underwent TNT surface modification by two-step anodization. EPD was then used to load gentamicin and chitosan onto the Ti wire with surface TNTs. Control Ti wires contained TNTs with EPD of chitosan only. 12-week-old male C57BL/6J mice underwent received a right femoral intramedullary implant followed by inoculation at the surgical site with 1×103 CFUs of bioluminescent Xen36 Over 14 days assessment following wire implantation and inoculation with Ti femoral implants modified with surface TNTs and coated with gentamicin and chitosan through EPD prevented PJI in all mice through 14 days. In comparison, all control mice demonstrated evidence of PJI over 14 days. Implants with TNTs and EPD of gentamicin were highly effective in this mouse PJI model.
Both total joint arthroplasty (TJA) and Alzheimer's Disease (AD) are prevalent in elderly populations. It is the goal of this study to determine if the presence of implant metals originating from TJA correlates with the onset with higher implant metal content in the brain and AD pathology. Tissue samples from four brain regions of 701 (229 with TJA) participants from an ongoing longitudinal cohort study (Rush Memory and Aging Project) was analyzed including the inferior-temporal-cortex (ITC), which is associated with early onset of AD. Implant metal (Co, Cr, Mo, Ti, Al) content was determined by ICP-MS. Comparisons were conducted between the no-TJA-group and a TJA group. Due to the higher likelihood of Co release the TJA group was further differentiated in a THA (N=146) and a TKA/TSA (N=83) group. Diffuse and neuritic amyloid plaques and phosphorylated tau were assessed and summarized as standard measures of AD pathology. We used separate linear regression models adjusted for age, sex, education, and APOɛ4-status for the associations of all metals (log-transformed) with global AD pathology, amyloid plaques, and phosphorylated tau. The THA group had higher cobalt content across all brain regions (p=0.003) and within the ITC (p=0.051) compared to the no-TJA group, whereas the TKA/TSA group did not. Across all tissue samples, Co was associated with higher amyloid load (β=0.35, p=0.027), phosphorylated tau (β=0.47, p=0.011), and global AD pathology (β=0.19, 0.0004) in the ITC. The presence of TJA itself was not associated with AD pathology. We showed that only Co content was higher within the ITC in persons with THA. We found among all tested metals that Co was consistently associated with AD pathology. Although we found an association of cobalt with AD pathology, the cross-sectional nature of this study does not allow the determination of cause and effect.
The purpose of this randomized controlled trial was to evaluate serum metal ion levels in patients undergoing THA with either a standard or modular dual-mobility bearing. Patients undergoing primary THA for osteoarthritis were randomized to receive either a modular dual-mobility or a standard polyethylene bearing. All patients received the same titanium acetabular and femoral component and a ceramic femoral head. Only patients without a prior history of metal implants in their body were eligible for inclusion, thus isolating serum metal ions to the prosthesis itself. Serum metal ion levels were drawn pre-operatively and at 1 year postoperatively. Power analysis determined that 40 patients (20 in each group) were needed to identify a clinically relevant difference in serum cobalt of 0.35 ng/ml (ppb) at 90% power assuming a pooled standard deviation of 0.31 ppb and alpha=0.05; an additional 30% were enrolled to account for potential dropouts. 53 patients were enrolled, with 22 patients in the modular dual-mobility group and 20 in the standard cohort with data available at one-year. No differences in the serum cobalt (0.17 ppb [range 0.07 to 0.50] vs. 0.19 ppb [range 0.07 to 0.62], p = 0.51) or chromium levels (0.19 ppb [range 0.05 to 0.56] vs. 0.16 ppb [range 0.05 to 0.61], p = 0.23) were identified. At 1 year postoperatively, no differences in serum cobalt or chromium levels were identified with this design of a modular dual mobility bearing when compared to a standard polyethylene bearing.
Total hip replacement failure due to fretting-corrosion remains a clinical concern. We recently described that damage within CoCrMo femoral heads can occur either by mechanically-dominated fretting processes leading to imprinting (via rough trunnions) and surface fretting (via smooth trunnions), or by a chemically-dominated etching process along preferential corrosion sites, termed “column damage”. These corrosion sites occur due to banding of the alloy microstructure. Banding is likely caused during thermo-mechanical processing of the alloy and is characterized by local molybdenum depletion. It was the objective of this study to quantify material loss from femoral heads with severe corrosion, identify the underlying damage modes, and to correlate the damage to the alloy's microstructure. 105 femoral heads with a Goldberg score 4 were evaluated. Coordinate measuring machine data was used to compute material loss and visualize damage features. Time Introduction
Methods
The aim of this study was to develop a novel computational model for estimating head/stem taper mechanics during different simulated assembly conditions. Finite element models of generic cobalt-chromium (CoCr) heads on a titanium stem taper were developed and driven using dynamic assembly loads collected from clinicians. To verify contact mechanics at the taper interface, comparisons of deformed microgroove characteristics (height and width of microgrooves) were made between model estimates with those measured from five retrieved implants. Additionally, these models were used to assess the role of assembly technique—one-hit versus three-hits—on the taper interlock mechanical behaviour.Aims
Methods
Improper seating during head/stem assembly can lead to unintended micromotion between the femoral head and stem taper—resulting in fretting corrosion and implant failure.1 There is no consensus—either by manufacturers or by the surgical community—on what head/stem taper assembly method maximizes modular junction stability in total hip arthroplasty (THA). A 2018 clinical survey2 found that orthopedic surgeons prefer applying one strike or three, subsequent strikes when assembling head/stem taper. However, it has been suggested that additional strikes may lead to decreased interference strength. Additionally, the taper surface finish—micro-grooves—has been shown to affect taper interference strength and may be influenced by assembly method. The objective of this study was to employ a novel, micro-grooved finite element (FEA) model of the hip taper interface and assess the role of head/stem assembly method—one vs three strikes—on modular taper junction stability. A two-dimensional, axisymmetric FEA model representative of a CoCrMo femoral head taper and Ti6Al4V stem taper was created using median geometrical measurements taken from over 100 retrieved implants.3 Surface finish—micro-grooves—of the head/stem taper were modeled using a sinusoidal function with amplitude and period corresponding to retrieval measurements of micro-groove height and spacing, respectively. Two stem taper micro-groove geometries— “rough” and “smooth”—were modeled corresponding to the median and 5th percentile height and spacing measurements from retrievals. All models had a 3' (0.05°), proximal-locked angular mismatch between the tapers. To simulate implant assembly during surgery, multiple dynamic loads (4kN, 8kN, and 12kN) were applied to the femoral head taper in a sequence of one or three strikes. The input load profile (Figure 1) used for both cases was collected from surgeons assembling an experimental setup with a three-dimensional load sensor. Models were assembled and meshed in ABAQUS Standard (v 6.17) using four-node linear hexahedral, reduced integration elements. Friction was modeled between the stem and head taper using surface-to-surface formulation with penalty contact (µ=0.2). A total of 12 implicit, dynamic simulations (3 loads × 2 assembly sequences × 2 stem taper surface finishes) were run, with 2 static simulations at 4kN for evaluating inertial effects. Outcome variables included contact area, contact pressure, equivalent plastic strain, and pull-off force.Introduction
Methods
As adverse events related to metal on metal hip
arthroplasty have been better understood, there has been increased
interest in toxicity related to the high circulating levels of cobalt ions.
However, distinguishing true toxicity from benign elevations in
cobalt levels can be challenging. The purpose of this review is
to examine the use of cobalt alloys in total hip arthroplasty, to
review the methods of measuring circulating cobalt levels, to define
a level of cobalt which is considered pathological and to review
the pathophysiology, risk factors and treatment of cobalt toxicity.
To the best of our knowledge, there are 18 published cases where
cobalt metal ion toxicity has been attributed to the use of cobalt-chromium
alloys in hip arthroplasty. Of these cases, the great majority reported
systemic toxic reactions at serum cobalt levels more than 100 μg/L.
This review highlights some of the clinical features of cobalt toxicity,
with the goal that early awareness may decrease the risk factors
for the development of cobalt toxicity and/or reduce its severity. Take home message: Severe adverse events can arise from the release
of cobalt from metal-on-metal arthroplasties, and as such, orthopaedic
surgeons should not only be aware of the presenting problems, but
also have the knowledge to treat appropriately. Cite this article:
