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.
Recent total knee arthroplasty (TKA) designs have featured more anatomic morphologies and shorter tibial keels. However, several reports have raised concerns regarding the impact of these modifications on implant longevity. This study's purpose is to report the early performance of a modern, cemented TKA design. All patients who received a primary, cemented TKA from 2012 to 2017 with a minimum two-year follow-up were included. This implant features an asymmetric tibial baseplate and a shortened keel. Patient demographics, Knee Society Scores (KSS), and component alignment were recorded, and Kaplan-Meier survivorship analyses were performed.Introduction
Methods
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
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
Studies of retrieved total knee replacement (TKR) components demonstrate that Eleven retrieved ultra-high molecular weight polyethylene (UHMWPE) cruciate-retaining tibial liner components from ten separate patients (implantation time = 8.6±5.6 years) had matching gait trials of normal level walking for each knee. Volume loss on retrieved components was calculated using a coordinate measuring machine and autonomous reconstruction.3 Motion analysis of normal level walking gait had been conducted between 1986 and 2005 for various previous studies and stored in a consented Human Mechanics Repository, ranging from pre-operative to long-term post-operative testing. Contact location between the femoral component and the tibial component on the medial and lateral plateaus were calculated throughout stance.4 A previously validated and fine-tuned parametric numerical model was used to calculate TKR contact forces for each gait trial.5 Vertical contact forces and contact paths on the medial and lateral plateaus were input as normal force and sliding distance to a simplified Archard equation for wear with material wear constant = 2.42 × 10−7 mm3/Nm2,6 to compute average wear per gait cycle. Wear rates were calculated using linear regression, and Pearson correlation examined correlations between modeled and measured wear.Introduction
Methods
This study explores whether subjects with bicruciate retaining TKRs (BiCR) have more normal knee biomechanics during level walking and stair ascent than subjects with posterior cruciate retaining TKRs (PCR). Due to anterior cruciate ligament (ACL) preservation, we expect BiCR subjects will not show the reduced flexion and altered muscle activation patterns characteristic of persons with TKRs. Motion and electromyography (EMG) data were collected during level walking and stair climbing for 16 BiCR subjects (4/12 m/f, 65±3 years, 30.7±7.0 BMI, 8/8 R/L), 17 PCR subjects (2/15 m/f, 65±7 years, 30.4±5.1 BMI, 7/10 R/L), and 17 elderly healthy control subjects (8/9 m/f, 55±10 years, 25.8±4.0 BMI, 10/7 R/L), using the point cluster marker set. Surface EMG electrodes were placed on the vastus medialis obliquus (VMO), rectus femoris (RF), biceps femoris (BF), and semitendinosus (ST) muscles. EMG data are reported as percent relative voluntary contraction (%RVC), normalized to the average peak EMG signals during level walking. Statistical nonparametric mapping was used for waveform analysis.Introduction
Methods
There are numerous concerns associated with femoral stems that feature a modular neck design, including the potential for corrosion, modular neck fracture, and adverse local tissue reactions. These stems have a higher-than-anticipated rate of failure in registry results, but large single-center cohort studies are lacking. This is a retrospective, single-surgeon cohort of 133 hips in 119 patients implanted with a single dual-tapered titanium alloy stem with a modular titanium alloy neck (Profemur® Z; Wright Medical Technology, Arlington, TN). Several bearing surface combinations were used, including metal-on-polyethylene, ceramic-on-polyethylene, metal-on-metal, and ceramic-on-ceramic couples. Patients were evaluated at a mean of 4.5 years (range 2.0–9.0 years) with Harris Hip scores (HHS), radiographic analysis, and metal ion testing.Background
Methods
There is renewed concern surrounding the potential for corrosion at the modular head-neck junction to cause early failure in modern hip implants. Although taper corrosion involves a complex interplay of many factors, previous studies have correlated decreasing flexural rigidity of the femoral trunnion with an increased likelihood of corrosion at retrieval. A multicenter retrieval analysis of 85 modular femoral stems was performed to calculate the flexural rigidity of various femoral trunnions. Stems were implanted between 1991–2012 and retrieved between 2004–2012. There were 10 different taper designs from 16 manufacturers. Digital calipers were used to measure taper geometries by two independent observers. Mean flexural rigidity was 262 Nm2, however there was a wide range of values among the various stems spanning nearly an order of magnitude between the most flexible (80 Nm2) and most rigid (623 Nm2) trunnions, which was due in part to the taper geometry and in part to the material properties of the base alloy. There was a modest but significant negative correlation between flexural rigidity of the trunnion and release date of the stem. This wide variability in flexural rigidity may predispose particular stem designs to an increased risk of corrosion at the modular head-neck taper, and may in part explain why taper corrosion is being seen with increasing frequency in modern hip arthroplasty.
Taper corrosion at modular junctions can cause a spectrum of adverse local tissue reactions (ALTR) in the periprosthetic soft tissues in patients who have undergone total hip arthroplasty (THA). Because these reactions are usually painful, taper corrosion has become part of the differential diagnosis of hip pain following THA. However these destructive lesions may not always cause pain, and can occasionally result in other atypical presentations. The purpose of this study is to describe a cohort of patients presenting with late and recurrent instability following THA due to underlying ALTR and taper corrosion. This is a multicenter retrospective case series of fourteen patients presenting with late instability secondary to ALTR and corrosion at the modular head-neck taper. The cohort included nine women and five men with a mean age of 66.8 years (range, 49 to 74). All patients had a metal (CoCr)-on-polyethylene bearing surface, but had a range of CoCr and Ti-alloy stem designs from three different manufacturers. Seven patients had 28 mm heads, while the rest had 32–40 mm heads. Patients experienced a mean of 3.4 dislocations (range, 2 to 6) at an average of 5.2 years (range, 0.4 to 17.0) following their index surgery. Although most reported some degree of discomfort around the hip, instability was the primary presenting symptom in all fourteen patients, and four were otherwise completely asymptomatic. Serum metal levels demonstrated a greater elevation of cobalt (mean 3.13 ng/mL) than chromium (mean 2.33 ng/mL). Preoperative infection workup including serum inflammatory markers and a hip aspiration documented the absence of sepsis.Introduction
Methods
The Conserve® Plus (Wright Medical Technology Inc., Arlington, TN) was introduced clinically in the United States in 1996. A study of the serum cobalt and chromium ion levels was started in 2000 in our center to monitor the metal ion levels over time as part of an FDA clinical trial. Thirteen male and five female patients received this resurfacing for idiopathic osteoarthritis (14), post-traumatic degenerative changes (3) or developmental dysplasia (1). Fourteen received a unilateral implant but four subsequently received a contralateral device from 52 to 86 months post-op. Four patients had bilateral resurfacings done in a one-stage procedure. All surgeries were performed by the senior author. None of these patients had known exposure to cobalt or chromium, kidney disease or other metal implants elsewhere in their bodies. Each prospectively provided blood samples and then yearly thereafter to measure cobalt and chromium levels for up to 11 years. Metal levels were measured using atomic absorption spectrophotometry and inductively coupled plasma mass spectrometry by a specialized trace element analysis laboratory. Acetabular component position was evaluated using Einzel-Bild-Röentgen-Analysis (EBRA) software. Contact patch to rim (CPR) distance was computed as described by Langton et al JBJS Br 91: 2009. A mixed model linear regression analysis was performed to evaluate long term trends, and multivariate analysis was performed to examine effects of implant and patient covariates on the metal ion levels. One bilateral patient underwent revision for femoral loosening, all other patients were clinically well-functioning at the time of last follow-up (ave 89 mos). The median pre-operative Co was below the detection limit (d.l) of 0.3μg/L and the median pre-operative Cr was 0.069μg/L (d.l. 03μg/L). Metal levels increased within the first year then decreased and stabilized (fig 1). For unilaterals over all time intervals, the median Co was 1.06 μg/L, while the median Cr was 1.58 μg/L. For bilaterals, the mean post-operative Co was 2.80 μg/L, while the mean Cr was 5.80 μg/L. Generally, Cr levels were higher at all time points than Co. Bilateral patients had Co values 1.96 times greater on average than the unilateral patients (p<0.001). None of the possible covariates studied (femoral size, cup abduction angle, cup anteversion, CPR distance, activity, BMI and testing method) were related to the assay values. The results of this study have shown that serum metal levels in well functioning implants can be low and do not increase over time. These are among the lowest levels reported for resurfacing devices and comparable to levels reported for well functioning small diameter metal-on-metal total hips. The study is limited due to the relatively small sample size and limited range of values for the covariates studied. However, it included patients who were active, female or bilateral and we collected ion levels up to 11 years. We now recommend that patients who have well-oriented Conserve Plus components with stable radiographic interfaces and no incidences of unexplained pain or hip noises be scheduled for follow-up every 2–3 years, rather than annually.
