The ability to create patient-specific implants (PSI) at the point-of-care has become a desire for clinicians wanting to provide affordable and customized treatment. While some hospitals have already adopted extrusion-based 3D printing (fused filament fabrication; FFF) for creating non-implantable instruments, recent innovations have allowed for the printing of high-temperature implantable polymers including polyetheretherketone (PEEK). With interest in FFF PEEK implants growing, it is important to identify methods for printing favorable implant characteristics such as porosity for osseointegration. In this study, we assess the effect of porous geometry on the cell response and mechanical properties for FFF-printed porous PEEK. We also demonstrate the ability to design and print customized porous implants, specifically for a sheep tibial segmental defect model, based on CT images and using the geometry of triply periodic minimal surfaces (TPMS). Three porous constructs – a rectilinear pattern and gyroid/diamond TPMSs – were designed to mimic trabecular bone morphology and manufactured via PEEK FFF. TPMSs were designed by altering their respective equation approximations to achieve desired porous characteristics, and the meshes were solidified and shaped using a CAD workflow. Printed samples were mCT scanned to determine the resulting pore size and porosity, then seeded with pre-osteoblast cells for 7 and 14 days. Cell proliferation and alkaline phosphatase activity (ALP) were evaluated, and the samples were imaged via SEM. The structures were tested in compression, and stiffness and yield strength values were determined from resulting stress-strain plots. Roughness was determined using optical profilometry. Finally, our process of porous structure design/creation was modified to establish a proof-of-concept workflow for creating PSIs using geometry established from segmented sheep tibia CT images.Introduction
Methods
Pitting damage on implants has been reported and attributed to use of electrocautery. This study aimed to distinguish how different TKA bearing surfaces are susceptible to this type of damage and whether surgeons were aware that this damage can occur. A survey was sent to Hip and Knee Society members to determine what percentage of adult reconstructive surgeons use electrocautery after implantation of components. Three bearing surfaces for primary TKA were selected: CoCr, Oxinium, and zirconium nitride (ZrN) to be damaged by electrocautery with a monopolar (MP, Bovie) and bipolar (BP, Aquamantys) electrocautery with three different energy settings. A comparison of surface damage and backscatter elemental analysis using SEM was performed. Average roughness (Ra), maximal peak-to-valley height (Rz,), kurtosis (Rk), and skewness (Rsk) measurements were collected using a profilometer (DektakXT, Bruker, Tucson, AZ) with a 2.5µm radius stylus to assess an area of 3.8mm by 3.2mm in the central portion of the area for each MP and BP energy setting used to impart damage to the bearing surfaces. A similar undamaged area for each bearing surface was also measured for roughness parameter comparison.Introduction
Methods
The ability to manufacture implants at the point-of-care has become a desire for clinicians wanting to provide efficient patient-specific treatment. While some hospitals have adopted extrusion-based 3D printing (fused filament fabrication; FFF) for creating non-implantable instruments with low-temperature plastics, recent innovations have allowed for the printing of high-temperature polymers such as polyetheretherketone (PEEK). Due to its low modulus of elasticity, high yield strength, and radiolucency, PEEK is an attractive biomaterial for implantable devices. Though concerns exist regarding PEEK for orthopaedic implants due to its bioinertness, the creation of porous networks has shown promising results for bone ingrowth. In this study, we endeavor to manufacture porous PEEK constructs via clinically-used FFF. We assess the effect of porous geometry on cell response and hypothesize that porous PEEK will exhibit greater preosteoblast viability and activity compared to solid PEEK. The work represents an innovative approach to advancing point-of-care 3D printing, cementless fixation for total joint arthroplasty, and additional applications typically reserved for porous metal. Three porous constructs – a rectilinear pattern and two triply period minimal surface (TPMSs) - were designed to mimic the morphology of trabecular bone. The structures, along with solid PEEK samples for use as a control, were manufactured via FFF using PEEK. The samples were mCT scanned to determine the resulting pore size and porosity. The PEEK constructs were then seeded with pre-osteoblast cells for 7 and 14 days. Cell proliferation and alkaline phosphatase activity (ALP) were evaluated at each time point, and the samples were imaged via SEM.Introduction
Methods
Corrosion at modular junctions of total hip replacements has been identified as a potential threat to implant longevity, resulting in efforts to determine appropriate countermeasures. Visual scoring and volumetric material loss measurements have been useful tools to elucidate various clinical and design factors associated with corrosion damage. However, corrosion involves electron exchange that results in chemical changes to biomedical alloys, and electrochemical assessment may therefore be a more appropriate approach to understand the phenomenon. The purpose of this pilot study was to electrochemically distinguish the severity of corrosion in retrieved femoral heads. A secondary goal was to identify the potential of electrochemical impedance spectroscopy (EIS) as a method to identify different forms of corrosion damage. Twenty femoral heads were identified from a larger study of total hip replacements, obtained as part of an ongoing multi- center IRB-approved retrieval program. Using a previously established 4-point scoring method, components were binned by taper damage: 10 components were identified as having severe damage, 7 with moderate damage and 2 with mild damage. One (1) unimplanted control was included to represent minimal corrosion damage. All components were then characterized using electrochemical impedance spectroscopy under the frequency domain: a 10 mV sinusoidal voltage, ranging from 20 kHz to 2 mHz, was applied to the taper of a femoral head (working electrode) filled with a 1M solution of PBS, a platinum counter electrode and a chlorided silver reference electrode. Absolute impedance at 2 mHz (|Z0.002|), and max phase angle (θ) were assessed relative to taper damage severity. After least-squares fitting of the EIS data to a Randles circuit with a constant phase element, circuit elements: polarization resistance (Rp), CPE-capacitance, and CPE-exponent were also evaluated. The seven (7) most severely corroded components were further examined with scanning electron microscopy to identify corrosion modes. For all statistical analyses, significance was determined at alpha=0.05.Introduction
Methods
Much effort has been aimed at strategies for patient optimization, perioperative standards of care, and postoperative risk stratification to reduce the incidence of SSI. Examples include, newer dressing modalities, antibiotic-impregnated bone cement, intra-wound powdered antibiotics, as well as novel suture types and techniques, all of which have shown great potential. However, the question remains as to whether these changes in practice have led to lower overall infections over the past few years. Therefore, the purpose of this study was to track the annual rates and trends of: 1) overall; 2) deep; and 3) superficial SSI following total hip arthroplasty (THA) using the most recent data (2012 to 2016) from a large nationwide database. The National Surgical Quality Improvement Program database was queried for all primary THAs (CPT code 27130) between 2012 and 2016, yielding 122,451 cases. Cases with reported superficial and/or deep SSIs were combined for an overall rate, and then independently analyzed as deep and superficial SSIs. The infection incidence for each year was calculated. After an overall 5-year correlation and trends, univariate analysis was also performed to compare the most recent year, 2016, with each of the preceding 4 years. Furthermore, a comparison of overall and deep SSI incidences from this study were compared to meta-analysis of pooled data from 2001 to 2011. Pearson correlation coefficients and chi-squared tests were used to determine correlation and statistical significance which was maintained at a p-value less than 0.05.Background
Methods
We report on an innovative surface grafting to highly crosslinked (HXLPE) bearing for THA using a biocompatible-phospholipid-polymer poly (2-methacryloyloxyethyl phosphorylcholine) (PMPC). Such hydrophilic surfaces mimic articular cartilage and are hypothesized to improve lubrication and thereby reduce friction and wear. We performed in vitro testing of wear and friction of ceramic-on-polyethylene THRs with the PMPC treatment, and compared them with untreated controls. Highly cross-linked UHMWPE bearings, gamma-ray-irradiated at different levels with and without vitamin E (HXL Vit. E: 125 kGy, HXL: 75 kGy, respectively) were divided so half were PMPC treated (n=3 for all four groups). All were paired with identical 40 mm diameter zirconia-toughened-alumina ceramic heads. Testing was carried-out on an AMTI hip simulator for 10 million simulated walking cycles with standard lubricant and conditions (ISO-14242-1). Wear was measured gravimetrically at 21 intervals, and so was frictional torque with a previously described and tested methodology. PMPC treatment produced a statistically significant 71% in wear reduction of HXL poly (1.70±1.36 mg/Mc for PMPC vs. 5.86±0.402 mg/Mc for controls, p=0.013). A similar significant wear reduction was found for PMPC treated HXL with Vit. E liners (0.736±0.750 mg/Mc, vs. 2.14±0.269 mg/Mc, p=0.035). The improvements were associated with 12% and 5% reductions in friction of the HXL and Vit. E HXL respectively (statistically significant p=0.003, and marginal p=0.116, one tailed). These results were an important step in the quest for lower wearing, thin and strong UHMWPE liners for larger diameter femoral heads with the potential benefit of longevity and less risk of dislocation after surgery.
To improve the longevity of total hip replacements (THR), it is necessary to prevent wear of the ultra-high molecular weight polyethylene (UHMWPE) bearing, as wear debris can cause osteolysis and aseptic loosening. Highly cross-linked UHMWPE reduces wear, sometimes stabilized with vitamin E to preserve its mechanical properties and prevent oxidative degeneration. An extra novel solution has been grafting the surface of UHMWPE with poly(2-methacryloyloxyethyl phosphorylcholine) (PMPC). This treatment uses a hydrophilic (wettable) phospholipid polymer to improve lubrication and reduce friction and wear of the bearing material. We set out to test the wear and friction of ceramic-on-polyethylene (COP) THRs that had the PMPC surface treatment, or left untreated for control. Four groups of UHMWPE bearings were tested against identical 40mm ceramic heads (zirconia-toughened alumina). The UHMWPE bearings were highly cross-linked with/without vitamin E (HXL Vit. E: 125 kGy radiation dose / HXL: 75 kGy). In each group, half underwent the PMPC treatment (n = 3 for all four groups). Testing was conducted on an AMTI hip simulator for 10 million walking cycles of ISO-14242-1, at 1 Hz, with diluted bovine serum (30 g/L protein concentration) as lubricant, at 37ºC, and with fluid absorption errors corrected with active soak controls. Using a previously published method, frictional torques and a frictional factor around three orthogonal axes about the femoral head were measured/computed, by data processing of the measurements of a 6-DOF load cell on each station of the hip simulator. Such friction measurements and stops for specimen weighing were carried out at regular intervals throughout the wear test. The HXL liners without and with the PMPC treatment wore at 5.86±0.402 mg/Mc and 1.70±1.36 mg/Mc, respectively (p=0.013) (Fig. 1). The HXL Vit. E liners without and with the PMPC treatment wore at 2.14±0.269 mg/Mc and 0.736±0.750 mg/Mc, respectively (p=0.035). The wear rates of the untreated HXL and HXL Vit. E liners were significantly different (p=0.0002) but no difference in wear rate was found between the two PMPC treated groups (p=0.179), although, as mentioned above, the PMPC treatment very significantly reduced wear in each case. The ceramic femoral heads showed little wear (weight loss) themselves. In general, the THRs showed decreasing friction over the 10 Mc, with the PMPC types showing a slight increase in friction towards the end of the test (Fig. 2). PMPC HXL liners showed the lowest friction factor (0.022±0.001) which was significantly lower (p<0.001) than the friction of the untreated liners (0.028±0.002) (Fig. 3). The PMPC HXL Vit. E liners showed lower friction factors than the untreated HXL Vit. E liners (0.034±0.002, 0.036±0.004, respectively), although this difference was not significant (p=0.116). Overall, the liners with the PMPC treatment displayed statistically significantly lower friction factors (p=0.003) than those untreated. The coincidence of some reduction of surface friction with larger wear reduction obviously suggests some but not necessarily full causality. PMPC successfully reduced both the friction and the wear in these COP THRs during this extended 10 Mc test. This likely would translate to improved implant longevity in patients.
Total knee arthroplasty (TKA) is a successful procedure for end stage arthritis of the knee that is being performed on an exponential basis year after year. Most surgeons agree that soft tissue balancing of the TKA is a paramount to provide a successful TKA. We utilized a set of retrieved lower extremities with an existing TKA to measure the laxity of the knee in all three planes to see if wear scores of the implants correlated to the laxity measured. This data has never been reported in the literature. IRB approval was obtained for the local retrieval program. Each specimen was retrieved after removing the skin, subcutaneous tissue and muscle from mid thigh to mid tibia. The femur, tibia and fibula were then transversely cut to remove the specimen for testing. Each specimen was then imaged using a flouroscopic imaging unit (OEC, Inc) in the AP, Lateral and sunrise views. These images were used to analyze whether there were any signs of osteolysis. Each specimen was mounted into a custom knee testing machine (Little Rock AR). Each specimen then was tested at full extension, 30, 60, and 90 degrees of flexion. At each flexion angle the specimen was subjected to a 10Nm varus and valgus torque, a 1.5Nm internal and external rotational torque and a 35N anterior and posterior directed force. Each specimen's implants were removed to record manufacturer and lot numbers. Polyethylene damage scores (Hood et al. JBMR 1983) were then calculated in the medial, lateral and backside of the polyethylene insert as well as on the medial and lateral femoral condyle. (Figure 1) Correlation coefficients were then calculated to show any relationship with soft tissue balancing in all three planes and wear scores.Introduction
Methods
Utilization of reverse total shoulder arthroplasty (RTSA) has steadily increased since its 2003 introduction in the American market. Although RTSA was originally indicated for elderly, low demand patients, it is now being increasingly used to treat rotator cuff arthropathy, humeral fractures, neoplasms and failed total and hemi shoulder arthroplasty. There is, therefore, a growing interest in bearing surface wear of RTSA polyethylene humeral liners. In the current study, we examined humeral liners retrieved as part of an IRB approved study to determine the amount of bearing surface wear. We hypothesized that wear of the bearing surface by intentional contact with the glenosphere (mode I) would be minor compared to that produced by scapular notching and impingement of the humeral liner (mode II). Twenty-three retrieved humeral liners were retrieved at revision surgery after an average of 1.5 years implantation time. The average age at implantation was 68 years (range 50–85). Shoulders were revised for loosening (7), instability (6), infection (6), pain (2), and other/unknown reasons (2). The liners were scanned using microCT at a resolution of 50 µm and then registered against unworn surfaces to estimate the bearing surface wear depth. The depth of surface penetration due to impingement of the liner with surrounding structures was measured and the location of the deepest penetration was noted. Mode I wear of the bearing surface was detectable for five of the retrieved liners. The penetration depth was 100 µm or less for four of the liners and approximately 250 microns for the fifth liner. It was noted that the liners with discernable mode I wear were those with longer implantation times (average 2.4 years). Material loss and abrasion of the rim due to mode II wear was noted with measurable penetration in 18 of the liners. Mode II wear penetrated to the bearing surface in 11 liners. It was generally noted that volumetric material loss was dominated by mode II wear (Figure 1). In this study of short to medium term retrieved RTSA humeral liners, mode I wear of the bearing surface was a minor source of material loss. Mode II wear due to scapular notching or impingement of the rim was the dominant source of volumetric wear. This is in agreement with a previous study that we have performed on a smaller cohort of seven liners. It is noteworthy that we were able to detect measurable mode I wear for liners with moderate implantation times. The quantity of bearing surface wear that will be seen in long term retrievals remains unknown at this time.
Previous studies of CoCr alloy femoral components for total knee arthroplasty (TKA) have identified 3rd body abrasive wear, and apparent inflammatory cell induced corrosion (ICIC) [1] as potential damage mechanisms. The association between observed surface damage on the femoral condyle and metal ion release into the surrounding tissues is currently unclear. The purpose of this study was to investigate the damage on the bearing surface in TKA femoral components recovered at autopsy and compare the damage to the metal ion concentrations in the synovial fluid. 12 autopsy TKA CoCr femoral components were collected as part of a multi-institutional orthopedic implant retrieval program. The autopsy components included Depuy Synthes Sigma Mobile Bearing (n=1) and PFC (n=1), Stryker Triathlon (n=1) and Scorpio (n=3), and Zimmer Nexgen (n=4) and Natural Knee (n=2). Fluoro scans of all specimens prior to removal was carried out to assure no signs of osteolysis or aseptic loosening were present. Third-body abrasive wear of CoCr was evaluated using a semi-quantitative scoring method similar to the Hood method [2]. ICIC damage was reported as location of affected area and confirmed using a digital optical microscope with 4000X magnification. Synovial fluid was aspirated from the joint capsule prior to removal of the TKA device. The synovial fluid was spun at 1600 rpm for 20 minutes in a centrifuge with the cell pellet removed. The supernatant was analyzed in 1 mL quantities for ICP-MS (inductively coupled plasma mass spectrometry) by Huffman Hazen Laboratories. Data was expressed as ppb.Introduction
Methods
There is considerable interest in the orthopaedic community in understanding the multifactorial process of taper fretting corrosion in total hip arthroplasty (THA). Previous studies have identified some patient and device factors associated with taper damage, including length of implantation, stem flexural rigidity, and head offset. Due to the complexity of this phenomenon, we approached the topic by developing a series of matched cohort studies, each attempting to isolate a single implant design variable, while controlling for confounding factors to the extent possible. We also developed a validated method for measuring material loss in retrieved orthopaedic tapers, which contributed to the creation of a new international standard (ASTM F3129-16). Based on our implant retrieval collection of over 3,000 THAs, we developed independent matched cohort studies to examine (1) the effect of femoral head material (metal vs. ceramic, n=50 per cohort) and (2) stem taper surface finish (smooth vs. microgrooved, n=60 per cohort). Within each individual study, we adjusted for confounding factors by balancing implantation time, stem taper flexural rigidity, offset, and, when possible, head size. We evaluated fretting and corrosion using a four-point semiquantitative score. We also used an out-of-roundness machine (Talyrond 585) to quantify the material loss from the tapers. This method was validated in a series of experiments of controlled material removal on never-implanted components.Introduction
Methods
Sequentially annealed, highly crosslinked polyethylene (HXLPE) has been used clinically in total knee arthroplasty (TKA) for over a decade[1]. However, little is known about the reasons for HXLPE revision, its surface damage mechanisms, or its Four hundred and fifty-six revised tibial inserts in two cohorts (sequentially annealed and conventional UHMWPE control) were collected in a multicenter retrieval program between 2000 and 2016. We controlled for implantation time between the two cohorts by excluding tibial inserts with a greater implantation time than the longest term sequentially annealed retrieval (9.5 years). The mean implantation time (± standard deviation) for the sequentially annealed components was 1.9 ± 1.7 years, and for the control inserts, 3.4 ± 2.7 years (Figure 1). Reasons for HXLPE revision were assessed based on medical records, radiographs, and examinations of the retrieved components. Surface damage mechanisms were assessed using the Hood method[2]. Oxidation was measured at the bearing surface, the backside surface, the anterior and posterior faces, as well as the post (when available) using FTIR (ASTM F2102). Surface damage and oxidation analyses were available for 338 of the components. We used nonparametric statistical testing to analyze for differences in oxidation and surface damage when adjusting for polyethylene formulation as a function of implantation time.Background
Methods
During revision surgery with a well-fixed stem, a titanium sleeve can be used in conjunction with a ceramic head to achieve better stress distribution across the taper surface. Previous studies have observed that the use of a ceramic head can mitigate the extent of corrosion damage at the taper. Moreover, Thirty sleeved ceramic heads (Biolox Option: CeramTec) were collected during revision surgery as part of a multi-center retrieval program. The sleeves were used in conjunction with a zirconia-toughened alumina femoral head. The femoral heads and sleeves were implanted between 0.0 and 3.25 years (0.8±0.9, Figure 1). The implants were revised predominantly for instability (n=14), infection (n=7), and loosening (n=5). Fifty percent of the retrievals were implanted during a primary surgery, while 50% had a history of a prior revision surgery. Fretting corrosion was scored using a previously described 4-point, semi-quantitative scoring system proposed by Higgs [2].Introduction
Materials and Methods
Previous registry studies of ceramic-on-polyethylene (C-PE) and ceramic-on-ceramic (COC) have focused on revision outcomes following primary surgery. Less is known about the effect of ceramic bearings on infection, dislocation, and mortality as outcomes following primary total hip arthroplasty (THA) for the Medicare population. We asked (1) does the use of C-PE bearings influence outcomes following THA as compared with metal-on-polyethylene (M-PE); and (2) does the use of COC bearings influence outcomes following THA as compared with M-PE? A total of 315,784 elderly Medicare patients (65+) who underwent primary THA between 2005 and 2014 with known bearing types were identified from the Medicare 100% inpatient sample administrative database. Outcomes of interest included relative risk of 90-day readmission, infection, dislocation, revision, or mortality at any time point after primary surgery. Propensity scores were developed to adjust for selection bias in the choice of bearing type at index primary surgery. Cox regression incorporating propensity score stratification (10 levels) was then used to evaluate the impact of bearing surface selection on outcomes, after adjusting for patient-, hospital-, and surgeon-related factors.Introduction
Methods
Thermally treated 1st generation highly crosslinked polyethylenes (HXLPE) have demonstrated reduced penetration and osteolysis rates, however, concerns still remain with respect to oxidative stability and mechanical properties of these materials. To address these concerns, manufacturers have introduced the use of antioxidants to quench free radicals while maintaining the mechanical properties of the HXLPE. Two common antioxidants are α-tocopherol (Vitamin-E) and pentaerythritol tetrakis (PBHP). These may be either mixed prior to consolidation, or diffused throughout the polymer after consolidation and irradiation. Between 2010 and 2015, 73 anti-oxidant HXLPE components were collected as a part of an IRB approved, multi-institutional retrieval analysis program during routine revision surgery. Of the seventy-three components, 30 (41%) were acetabular liners, whereas, 43 were tibial inserts. The components were fabricated from three different materials: Vitamin-E Diffused HXLPE (n=30; E1, Biomet), Vitamin-E Blended (n = 41; Vivacit-E, Zimmer) and PBHP blended (n = 2, AOX, DePuy). The hip and knee components were implanted for 0.7 ± 0.8 years (Range: 0.0–2.25 years) and 0.8 ± 1.1 years (Range: 0.0–4.5 years), respectively. Implantation time, patient weight, age, gender, and activity levels were similar between hip and knee components (Table 1). For oxidation analysis, thin slices (∼200μm) were taken from medial condyle and central eminence of the tibial inserts or the superior/inferior axis from hip components. The slices were boiled in heptane for six hours to extract lipids absorbed Introduction
Methods
Initial large-scale clinical studies of porous tantalum implants have been generally promising with well-fixed implants and few cases of loosening [1–3]. An initial retrieval study suggests increased bone ingrowth in a modular tibial tray design compared to the monoblock design [4]. Since micromotion at the bone-implant interface is known to influence bone ingrowth [5], the goal of this study was to determine the effect of implant design, bone quality and activity type on micromotion at the bone-implant interface, through FE modeling. Our case-specific FE model of bone was created from CT data (68 year-old female, right tibia, Fig-1). Isotropic properties of cortical and trabecular bone were derived from the calibrated CT data. Modular and monoblock porous tantalum tibial implants were virtually placed in the tibia following surgical guidelines. All models parts were 3D meshed with 4-noded tetrahedral elements (MSC.MARC-Mentat 2013, MSC Software Corporation, USA). Frictional contact was applied to the bone-tantalum interface (µ=0.88) and UHWMPE-Femoral condyle interface (µ=0.05) with all other interfaces bonded. Loading was applied to simulate walking, standing up and descending stairs. For each activity, a full load cycle [6] was applied to the femoral condyles in incremental steps. The direction and magnitude of micromotions were calculated by tracking the motions of nodes of the bone, projected onto the tibial tray. Micromotions were calculated parallel to the implant surface (shear), and perpendicularly (tensile). We report the maximum (resultant) micromotion that occurred during a cycle of each activity. The bone properties were varied to represent a range in BMD (−30%BMD, Norm, +30%BMD). We compared design type, bone quality and activity type considering micromotion below 40 µm to be favorable for bone ingrowth [5].Introduction
Patients & Methods
Previous studies of long-term CoCr alloy femoral components for TKA have identified 3rd body abrasive wear and inflammatory cell induced corrosion (ICIC). The extent of femoral condyle surface damage in contemporary CoCr femoral components is currently unclear. The purpose of this study was to investigate the prevalence and morphology of damage (3rd body scratches and ICIC) at the bearing surface in retrieved TKA femoral components from contemporary designs. 308 CoCr femoral TKA components were collected as part of an ongoing, multi-institutional orthopedic implant retrieval program. The collection included contemporary designs from Stryker (Triathlon n=48, NRG n=10, Scorpio n=31), Depuy Synthes (PFC n=27) and Zimmer (NexGen n=140, Persona n=1) and Biomet (Vanguard n=51). Hinged knee designs and unicondylar knee designs were excluded. Components were split into groups based on implantation time: short-term (1–3y, n=134), intermediate-term (3–5y, n=73) and long-term (6–15y, n=101). Each grouping was mainly revised for instability, infection and loosening. Third-body abrasive wear of CoCr was evaluated using a semi-quantitative scoring method similar to the Hood method (Figure 1). A score of 1 had minimal damage and a score of 4 corresponded to damage covering more than 50% of the evaluated area. ICIC damage was reported as location of affected area. A white light interferometer (Zygo New View 5000) was also used to analyze the topography of severe damage of the bearing surface. For this analysis, three representative components from each cohort were selected and analyzed in three locations on the apex of the bearing surface. We analyzed the following roughness parameters: Ra, Rsk, and Rku.Introduction
Methods
Highly crosslinked polyethylene (HXLPE) was clinically introduced approximately a decade and a half ago to reduce polyethylene wear rates and subsequent osteolysis. Clinical and radiographic studies have repeatedly shown increased wear resistance, however concerns of rim oxidation and fatigue fracture remain. Although short to intermediate term retrieval studies of these materials are available, the long-term behavior of these materials remains unclear. Between 2000 and 2015, 115 1st generation HXLPE acetabular liners implanted for 5 or more years were collected and analyzed as part of an ongoing, multi-institutional orthopaedic implant retrieval program. There were two material cohorts based on thermal processing (annealed (n=45) and remelted (n=70)). Each cohort was stratified into two more cohorts based on implantation time (5 – 10 years and >10 years). For annealed components, the intermediate-term liners (n=30) were implanted on average (±SD) for 7.3 ± 1.7 years while the long-term liners (n=15) were implanted for 11.3 ± 1.8 years. For remelted components, the intermediate-term liners (n=59) were implanted on average (±SD) for 7.2 ± 1.3 years while the long-term liners (n=11) were implanted for 11.3 ± 1.2 years. For each cohort, the predominant revision reasons were loosening, instability, and infection (Figure 1). Short-term liners (in-vivo <5ys) from previous studies were analyzed using the same protocol for use as a reference. For oxidation analysis, thin slices (∼200 μm) were taken from the superior/inferior axis and subsequently boiled in heptane for 6 hours to remove absorbed lipids that may interfere with the oxidation analysis. 3mm line profiles (in 100μm increments) were taken perpendicular to the surface at each region of interest. Oxidation indices were calculated according to ASTM 2102. Penetration was measured directly using a calibrated micrometer (accuracy=0.001mm).Introduction
Methods
Previous studies of ceramic-on-polyethylene (C-PE) and ceramic-on-ceramic (COC) hip bearings have focused on outcomes following primary surgery. Less is known about the utilization or outcomes of ceramic bearings in revision total hip arthroplasty (R-THA) for the Medicare population in the US. We asked (1) what is the utilization of ceramic bearings for R-THA in the Medicare population and how has it evolved over time; (2) does the use of C-PE bearings influence outcomes following R-THA as compared with metal-on-polyethylene (M-PE); and (3) does the use of COC bearings influence outcomes following R-THA as compared with M-PE? A total of 31,809 Medicare patients (aged > 65y) who underwent R-THA between 2005 and 2013 with known bearing types were identified from the Medicare 100% inpatient sample administrative database. Outcomes of interest included relative risk of readmission (90 days) or infection, dislocation, rerevision, or mortality at any time point after revision. Propensity scores were developed to adjust for selection bias in the choice of bearing type at revision surgery. Cox regression incorporating propensity score stratification (10 levels) was then used to evaluate the impact of bearing surface selection on outcomes, after adjusting for patient-, hospital-, and surgeon-related factors.Introduction
Methods
Previous studies of retrieved CoCr alloy femoral heads have identified imprinting of the stem taper surface features onto the interior head bore, leading researchers to hypothesize that stem taper microgrooves may influence taper corrosion. However, little is known about the role of stem taper surface morphology on the magnitude of in vivo corrosion damage. We designed a matched cohort retrieval study to examine this issue. From a multi-institutional retrieval collection of over 3,000 THAs, 120 femoral head-stem pairs were analyzed for evidence of fretting and corrosion using a visual scoring technique based on the severity and extent of fretting and corrosion damage observed at the taper. A matched cohort design was used in which 60 CoCr head-stem pairs with a smooth stem taper were matched with 60 CoCr head-stem pairs having a micro-grooved surface, based on implantation time, flexural rigidity, apparent length of taper engagement, and head size. This study was adequately powered to detect a difference of 0.5 in corrosion scores between the two cohorts, with a power of 82% and 95% confidence. Both cohorts included CoCr and Ti-6-4 alloy femoral stems. A high precision roundness machine (Talyrond 585, Taylor Hobson, UK) was used to measure surface morphology and categorize the stem tapers into smooth vs. micro-grooved categories. Fretting and corrosion damage at the head/neck junction was characterized using a modified semi-quantitative adapted from the Goldberg method by three independent observers. This method separated corrosion damage into four visually determined categories: minimal, mild, moderate and severe damage.Introduction
Methods
In total joint replacement devices, material loss from the taper junctions is a clinical concern. Previous studies of explanted orthopedic devices have relied on visual scoring methods to quantify the fretting-corrosion damage on the component interfaces. Previous research has shown that visual fretting-corrosion evaluation is correlated to the volume of material loss [1], but scoring is semi-qualitative and does not provide a quantitative measure of the amount of material removed from the surface. The purpose of this study was to develop and validate a quantitative method for measuring the volume of material lost from the surfaces of explanted devices at the taper-trunnion junction. 10 new exemplar taper adapter sleeves (Ceramtec, Plochingen, Germany) were used for method validation. By using exemplar devices we were able to create clinically realistic taper damage in a controlled and repeatable manner using machining tools. Taper surfaces were measured before and after in vitro material removal using a roundness machine (Talyrond 585, Taylor Hobson, UK). Axial traces were measured on each taper surface using a diamond stylus. The mass of artificially removed material was also measured gravimetrically using a microgram balance (Sartorius, CPA225D, accuracy = ± 0.00003g). Surface profiles were analyzed using a custom MatLab script and Talymap software was used to provide 3D visualizations of the pattern of material loss. Calculated volumetric material loss was compared to the gravimetric value. A sensitivity analysis was conducted to determine the optimum number of traces to characterize the material loss from taper junctions.Introduction
Methods
Mechanically assisted crevice corrosion of taper interfaces was raised as a concern in total hip arthroplasty (THA) approximately 20 years ago (Gilbert 1993). In total shoulder replacement, however, comparatively little is known about the prevalence of fretting assisted crevice corrosion or the biomechanical and patient factors that influence this phenomenon. Given the comparatively lower loading experienced in the shoulder compared to the hip, we asked: (1) What is the prevalence of fretting assisted corrosion in modular total shoulder replacements, and (2) What patient and implant factors are associated with corrosion? Modular components were collected from 48 revision shoulder arthroplasties as part of a multi-center, IRB approved retrieval program. For anatomic shoulders, this included 40 humeral heads, 32 stems and four taper adapters from seven manufacturers. For reverse shoulders, there were eight complete sets of retrieved components from three manufacturers. The components were predominantly revised for instability, loosening and pain. Anatomical shoulders were implanted for an average of 3.1 years (st dev 3.8; range 0.1–14.5). Reverse shoulders were implanted for an average of 2.2 years (st dev 0.7; range 1.3–3.3). Modular components were disassembled and examined for taper damage. The modular junctions were scored for fretting corrosion using a semi-quantitative four-point scoring system adapted from Goldberg, et al. (Goldberg, 2002, Higgs 2013). The scoring system criteria was adapted from Goldberg and Higgs which is comprised of a one to four grading system (with one indicating little-to-no fretting/corrosion and four indicating extensive fretting/corrosion). The component alloy composition was determined using the manufacturer's laser markings and verified by x-ray fluorescence. Patient age, gender, hand dominance, alloy, flexural rigidity of the trunnion and taper geometry were assessed independently as predictors for fretting corrosion.INTRODUCTION
METHODS
In THA, fretting corrosion at the head-stem taper junction has emerged as a clinical concern that may result in adverse local tissue reactions, even in patients with a metal-on-polyethylene bearing [1]. Taper junctions that employ a ceramic head have demonstrated reduced corrosion at the interface [2]. However, during revision surgery with a well-fixed stem, a titanium sleeve is used in conjunction with a ceramic head to ensure proper fit of the head onto the stem and better stress distribution. In vitro testing has suggested that corrosion is not a concern in sleeved ceramic heads [3]; however, little is known about the in vivo fretting corrosion of the sleeves. The purpose of this study was to investigate fretting corrosion in sleeved ceramic heads. Between 2001 and 2014, 35 sleeved ceramic heads were collected during revision surgery as part of a multi-center retrieval program. The sleeves were all fabricated from titanium alloy and manufactured by 4 companies (CeramTec (n=14), Smith & Nephew (Richards, n=11), Stryker (n=5), and Zimmer (n=5)). The femoral heads were made from 3 ceramics (Alumina (n=7), Zirconia (n=11), and Zirconia-toughened Alumina (n=17)). Sleeve dimensions (length and thickness) were measured using calibrated calipers. Fretting corrosion of the sleeves and available associated stems was scored using a 4-point, semi-quantitative scoring system [4], with 1 being little-to-no damage, and 4 corresponded to severe fretting corrosion. Five sleeves could not be extracted; thus the external surface was not scored.Introduction
Materials and Methods
Retrieval analysis is an important aspect of medical device development. Examination of retrieved devices allows device developers to close the design loop, understand the performance of devices, and validate assumptions made and methods used during preclinical testing. We provide an overview of the implant retrieval analysis performed at the Implant Research Center at Drexel University on reverse total shoulder systems retrieved after short to medium term implantation. We have examined 18 reverse total shoulders, retrieved at revision surgery after short to mid-term implantation (average 1.4 years, maximum 3.3 years). The average age at revision was 71 years old (st dev 11 years). Our evaluations included analysis of glenosphere bearing surface damage, evaluation of tribocorrosion at the modular junctions, visual assessment of polyethylene humeral bearing surface damage, quantitative analysis of polyethylene wear.INTRODUCTION
METHODS
A variety of porous coatings and substrates have been used to obtain fixation at the bone-implant interface. Clinical studies of porous tantalum, have shown radiographically well-fixed implants with limited cases of loosening. However, there has been limited retrieval analysis of porous tantalum hip implants. The purpose of this study was to investigate factors affecting bone ingrowth into porous tantalum hip implants. 126 porous tantalum acetabular shells and 7 femoral stems, were collected under an IRB-approved multicenter retrieval program. Acetabular shells that were grossly loose, cemented or complex revisions were excluded. Shells with visible bone on the surface were chosen. 20 acetabular shells (10 primary) and all femoral stems were dehydrated, embedded, sectioned, polished and bSEM imaged (Figure-1). Main shell revision reasons were infection (n=10,50%), femoral loosening (n=3,15%) and instability (n=3,15%). Analyzed implants were implanted for 2.3±1.7 years (shells) and 0.3±0.3 years (stems). Eight slices per shell and 5–7 slices per stem were analyzed. The analysis included bone area/pore area (BA/PA), BA/PA zonal depth analysis, extent of ingrowth and maximum depth of bone ingrowth. BA/PA zone depths were: Zone-1 (0–500um), Zone-2 (500–1000um) and Zone-3 (1000um-full depth). Nonparametric statistical tests investigated differences in bone measurements by location within an implant and implant type (Friedman's Variance and Kruskal-Wallis). Post-hoc Dunn tests were completed for subsequent pairwise comparisons. Spearman's rank correlation identified correlations between bone measurements and patient related variables (implantation time, age, height, weight, UCLA Activity Score). Statistical analyses were performed using PASW Statistics package.Introduction
Methods
The release of metal debris and ions has raised concerns in joint arthroplasty. In THA metal debris and ions can be generated by wear of metal-on-metal bearing surfaces and corrosion at modular taper interfaces, currently understood to be mechanically assisted crevice corrosion (MACC) [1]. More recently, inflammatory-cell induced corrosion (ICIC) has been identified as a possible source of metal debris and/or ions [2]. Although MACC has been shown to occur at modular junctions in TKA, little is known about the prevalence of other sources. The purpose of this study was to determine the sources of metallic debris and ion release in long-term implanted (in vivo > 15y) TKA femoral components. Specific attention was paid to instances of ICIC as well as damage at the implant-bone interface. 1873 retrieved TKA components were collected from 2002–2013 as part of a multi-center, IRB-approved retrieval program. Of these, 52 CoCr femoral condyles were identified as long term TKA (Average: 17.9±2.8y). These components were predominantly revised for loosening, PE wear and instability. 40/52 of the components were primary surgeries. Components were examined using optical microscopy to confirm the presence of 5 damage mechanisms (polyethylene failure, MACC corrosion of modular tapers, corrosion damage between cement and backside, third-body wear, and ICIC). Third-body wear was evaluated using a semi-quantitative scoring method based on the percentage of damaged area. A score of 1 had minimal damage and a score of 4 corresponded to severe damage. Polyethylene components were scored using the Hood method and CoCr components were scored similarly to quantify metal wear. The total area damaged by ICIC was quantified using photogrammetry. Images were taken using a digital SLR with a calibrated ruler in the same focal plane. Using known pixel dimensions, the ICIC damaged area was calculated.Introduction
Methods
This study assesses oxidation, mechanical behavior and revision reasons of 2nd generation HXLPE used in total hip and knee arthroplasty. While oxidation was low for both X3 and E1 HXLPEs, oxidative regional variations were detected in the sequentially annealed cohort. First generation highly crosslinked polyethylenes (HXPLEs) have proven successful in lowering both penetration and osteolysis rates. However, 1st generation annealing and remelting thermal stabilization have been associated with in vivo oxidation or reduced mechanical properties. Thus, 2nd generation HXLPEs were developed to improve oxidative stability while still maintaining material properties. Little is known about the in vivo clinical failure modes of these 2nd generation HLXPEs. The purpose of this study was to assess the revision reasons, wear, oxidative stability, and mechanical behavior of retrieved sequentially annealed Vitamin E diffused HXLPE in THA and TKA.Summary Statement
Introduction
Fretting and corrosion has been identified as a clinical problem in modular metal-on-metal THA, but remains poorly understood in modern THA devices with polyethylene bearings. This study investigates taper damage and if this damage is associated with polyethylene wear. Degradation of modular head-neck tapers was raised as a concern in the 1990s (Gilbert 1993). The incidence of fretting and corrosion among modern, metal-on-polyethylene and ceramic-on-polyethylene THA systems with 36+ mm femoral heads remains poorly understood. Additionally, it is unknown whether metal debris from modular tapers could increase wear rates of highly crosslinked PE (HXLPE) liners. The purpose of this study was to characterise the severity of fretting and corrosion at head-neck modular interfaces in retrieved conventional and HXLPE THA systems and its effect on penetration rates.Summary Statement
Introduction
First generation highly crosslinked polyethylenes (HXPLEs) have proven successful in lowering both penetration and osteolysis rates. However, 1st generation annealing and remelting thermal stabilization have been associated with in vivo oxidation or reduced mechanical properties. Thus, 2nd generation HXLPEs were developed to improve oxidative stability while still maintaining material properties. Little is known about the in vivo clinical failure modes of these 2nd generation HLXPEs. The purpose of this study was to assess the revision reasons, wear, oxidative stability, and mechanical behavior of retrieved sequentially annealed Vitamin E diffused HXLPE in THA and TKA. 251 2nd Generation HXLPE hip and knee components were consecutively retrieved during revision surgeries and continuously analyzed in a prospective, IRB approved, multicenter study. 123 acetabular liners (Implanted 1.2y; Range 0–5.0y) and 117 tibial inserts (Implanted 1.6y; Range 0–5.8y) were highly crosslinked and annealed in 3 sequential steps (X3). Five acetabular liners (Implanted 0.6y; Range 0–2.0y) and six tibial inserts (Implanted 1.3y; Range 0.5–1.8y) were diffused with Vitamin E (E1). Patient information was collected from medical records (Table 1). Linear penetration of liners was measured using a calibrated digital micrometer (accuracy: 0.001 mm). Surface damage of tibial components was assessed using the Hood method. Thin sections were taken from the acetabular liners (along the superior/inferior axis) and the tibial components (along the medial condyle and central spine) for oxidation analysis and analyzed according to ASTM 2102. Mechanical behavior was assessed via the small punch test (ASTM 2183).Introduction:
Methods:
Previous studies regarding modular head-neck taper corrosion were largely based on cobalt chrome (CoCr) alloy femoral heads. Less is known about head-neck taper corrosion with ceramic femoral heads. We asked (1) whether ceramic heads resulted in less taper corrosion than CoCr heads; (2) what device and patient factors influence taper fretting corrosion; and (3) whether the mechanism of taper fretting corrosion in ceramic heads differs from that in CoCr heads.Background:
Questions/purposes:
Degradation of modular head-neck tapers was raised as a concern in the 1990s (Gilbert 1993). The incidence of fretting and corrosion among modern, metal-on-polyethylene and ceramic-on-polyethylene THA systems with 36+ mm femoral heads remains poorly understood. Additionally, it is unknown whether metal debris from modular tapers could increase wear rates of highly crosslinked PE (HXLPE) liners. The purpose of this study was to characterize the severity of fretting and corrosion at head-neck modular interfaces in retrieved conventional and HXLPE THA systems and its effect on penetration rates. 386 CoCr alloy heads from 5 manufacturers were analyzed along with 166 stems (38 with ceramic femoral heads). Metal and ceramic components were cleaned and examined at the head taper and stem taper by two investigators. Scores ranging from 1 (mild) to 4 (severe) were assigned in accordance with the semi-quantitative method adapted from a previously published technique. Linear penetration of liners was measured using a calibrated digital micrometer (accuracy: 0.001 mm). Devices implanted less than 1 year were excluded from this analysis because in the short-term, creep dominates penetration of the head into the liner.Introduction:
Patients & Methods:
Sequentially annealed highly crosslinked polyethylenes (HXLPEs) were introduced in total knee replacement (TKR) starting in 2005 to reduce wear and particle-induced osteolysis. Few studies have reported on the clinical performance of HXLPE knees. In this study, we hypothesized that due to the reduced free radicals, sequentially annealed HXLPE would have lower oxidation levels than gamma inert-sterilized controls. 145 tibial components were retrieved at consecutive revision surgeries at 7 different surgical centers. 74 components were identified as sequentially annealed HXLPE (X3, Stryker) while the remainder (n = 71) were conventional gamma inert sterilized polyethylene. The sterilization method was confirmed by tracing the lot numbers by the manufacturer. The conventional inserts were implanted for 1.7 years (Range: 0.0–9.3 years), while the X3 components were implanted 1.1 years (Range: 0.0–4.5 years). Surface damage was assessed using the Hood method. Oxidation analysis was performed in accordance with ASTM 2102 following submersion in boiling heptane for 6 hours to remove absorbed lipids. 30 of the conventional and 29 of the HXLPE inserts were available for oxidation analysis.Introduction
Methods
Wear debris generation in metal-on-metal (MOM) total hip arthroplasty (THA) has emerged as a compelling issue. In the UK, clinically significant fretting corrosion was reported at head-taper junctions of MOM hip prostheses from a single manufacturer (Langton 2011). This study characterizes the prevalence of fretting and corrosion at various modular interfaces in retrieved MOM THA systems used in the United States. 106 MOM bearing systems were collected between 2003 and 2012 in an NIH-supported, multi-institutional retrieval program. From this collection, 88 modular MOM THA devices were identified, yielding 76 heads and 31 stems (22 modular necks) of 7 different bearing designs (5 manufacturers) for analysis. 10 modular CoCr acetabular liners and 5 corresponding acetabular shells were also examined. Mean age at implantation was 58 years (range, 30–85 years) and implantation time averaged 2.2 ± 1.8 years (range, 0–11.0 years). The predominant revision reason was loosening (n=52). Explants were cleaned and scored at the head taper, stem taper, proximal and distal neck tapers (for modular necks), liner, and shell interfaces in accordance with the semi-quantitative method of Goldberg et al. (2002).Introduction
Methods and Materials
The purpose of this multicenter study was to assess the oxidative stability, mechanical behavior, wear and reasons for revision of 2nd generation sequentially annealed HXLPE, X3, and compare it to 1st generation XLPE, Crossfire. We hypothesized that X3 would exhibit similar wear rates but lower oxidation than Crossfire. 182 hip liners were consecutively retrieved during revision surgeries at 7 surgical centers and continuously analyzed over the past 12 years in a prospective, multicenter study. 90 were highly crosslinked and annealed (Crossfire; Implanted 4.2±3.4 years, max: 11 years), and 92 were highly crosslinked and annealed in 3 sequential steps (X3; Implanted 1.2±1.5 years; max: 5 years). Oxidation was characterized in accordance with ASTM 2102 using transmission FTIR performed on thin sections (∼200μm) from the superior/inferior axis. Mechanical behavior was assessed via the small punch test (ASTM 2183).Introduction
Methods
An increased mortality associated with hip fractures has been recognized, but the impact of vertebral osteoporotic compression fractures (VCF) is still underestimated. The aim of this study was to report on the difference in survival for VCF patients following non-operative and operative [Balloon Kyphoplasty (BKP) or Vertebroplasty (VP)] treatments. Operated and non-operated VCF patients were identified from the US Medicare database in 2006 and 2007 and followed for a minimum of 24 months. Patients diagnosed with pathological and traumatic VCFs in the prior year were excluded. Overall survival was estimated by the Kaplan-Meier method, and the differences in mortality rates (operated vs non-operated; balloon kyphoplasty vs vertebroplasty) were assessed by Cox regression, with adjustments for patient demographics, general and specific co-morbidities, that have been previously identified as possible causes of death associated with osteoporotic VCFs.Introduction/Aims
Methods
Squeaking is a rare complication of hard-on-hard hip bearings. Occasionally the noise is troublesome enough to warrant revision surgery. The purpose of this study is to contribute to the understanding of the mechanism(s) underlying squeaking. We analyzed 10 alumina ceramic-on-ceramic bearings from squeaking hips collected at revision surgery. The reason for revision was given as squeaking (6 cases) or squeaking and pain (4 cases). Six of the 10 patients were male, average patient age was 48. Bearings were retrieved after an average of 23 months in service (11 to 61 months). There were 4 different designs of acetabular component from 2 different manufacturers. Nine have an elevated metal rim which is proud of the ceramic and one does not. Two bearings were 36mm in diameter, 6 were 32mm and 2 were 28mm. All 10 bearings showed evidence of edge loading wear. Mean dimensions of the wear patch were 37mm by 12mm on the acetabular component and 32mm by 13mm on the femoral heads. Wear dimension was not related to bearing diameter. Seven of the 10 implants also had evidence of impingement of the femoral neck against the elevated metallic rim or the ceramic insert or both. There was no chipping or fracture of any of the ceramic components. Squeaking is a recently recognized complication of hard on hard bearing surface. This retrieval study is the first of its kind, to our knowledge attempting to unravel the mechanism of this undesirable complication. Although impingement seems to be present in majority of cases, the latter does not seem to be necessary. Edge loading wear was the common factor in all cases and this may prove to be a critical mechanism.
Starting in the 1970s, long-term survivorship of total hip and knee arthroplasty has been under investigation for the Scandinavian population with the aid of implants registries. In the United States, no national arthroplasty registry currently exists. Nationwide inpatient discharge databases in the United States have proven useful when comparing the revision burden in the United States and Scandinavia. For this study, we compared the implant survivorship in the Medicare population with contemporaneous registry-based data from well-established and validated Scandinavian arthroplasty registries. The 5% systematic sample of Medicare claims from 1997 to 2004 were examined for primary and revision THA and TKA claims. The Medicare beneficiary ID was used to follow patients longitudinally between primary and revision surgery. De-identified data from the Norwegian and Swedish national hip and knee registry were also obtained for the same time period. During the 8-year study period, 30,583 and 62,878 elective primary total hip or knee replacements, respectively, were extracted from the Medicare data. In the same time period, 41,823 and 15,927 primary total hips or knees replacements were identified from the Norwegian registry. 82,037 primary total hips were identified from the Swedish registry. Survivorship was assessed by the Kaplan-Meier method, and Cox regression was used to evaluate the effect of patient attributes and cross-country comparisons. The K-M estimate showed that 8 years post-primary surgery, 93.6% of THA and 96.2% of TKA remained revision-free among the elderly Medicare population. By comparison, among Norwegians aged 65 and above, 96.0% of THA and 93.6% of TKA remained revision-free. In the US, men had a significantly higher risk of knee revision than women, but no significant gender difference among hip revision. In Norway, men had a significantly higher risk of hip revision, but no differences in knee revisions. In Sweden, men had a significantly higher risk of hip revision (5.4% vs. 3.3%). Older patients had a reduced risk of revision as compared with younger patients, in both the US and in Norway. The survival of THA is significantly better in Norway than in the US with a hazard ratio of 1.64 (p<
0.05). On the other hand, TKA had a better survival experience in the US than in Norway, with a hazard ratio of 0.55 (p<
0.05). This is the first study to evaluate the utility of Medicare as a source of THA and TKA survivorship data and to compare prosthesis outcomes in Medicare with those from Scandinavian arthroplasty registries. Unlike the Norwegian and Swedish registry data, the reasons for revision (e.g., femoral loosening) are not captured and thus greatly limited the value of the Medicare data as a tool to understand the need for revision, thereby helping to improve implant longevity and to reduce the associated cost and burden to the patient and care provider.
We removed 23 Charité artificial discs in 19 patients due to severe back-and legpain and performed an anterior as well posterior fusion. Mean interval between insertion and retrieval is 8,4 years (3,0–16,0 years). The mean age at retrieval is 49,4 years (40–72 years). The cause of persistent or recurrent pain was one or more of several problems thought to be related to the pain: subsidence, migration, wear with or without breakage of the metal marker ring, facetjoint or adjacent degeneration. In all cases wear of the polyethylene core was seen in major or minor degree. The wear was related to posterior impingement possibly due to hyperlordosis and extension instability and was subsequently more pronounced in the peripheral rim than in the central dome. Also a relationship was noted to in vivo oxidation of the polyethylene, especially in the rim. In the periprosthetic tissue an inflammatory reaction was found, more in the severe wear cases. Polyethylene loaded macrophages were seen, also polyethylene particles lying freely in the tissue. The macrophages proved positive for Interleukin 6. The wear pattern and the inflammatory reaction resembles the pattern seen in total hips and knees. Probably a substantial number of patients will exhibit these wear changes some years after insertion. It is questionable whether changes in sterilization and packaging and better insertion and sizing techniques will prevent wear development in the future.
There has been renewed interest in metal-on-metal bearings as hip resurfacing components for treatment in young, active patients. This study examines the effects of fixation (cemented or uncemented heads) and bone-implant interface conditions (stem-bone and head-bone) on the biomechanics of the Birmingham hip resurfacing (BHR) arthroplasty, using high resolution, 3-d computational models of the bilateral pelvis from a 45-year-old donor. Femoral bone stress and strain in the natural and BHR hips were compared. Bone remodelling stimuli were also determined for the BHR hips using changes in strain energy. Proximal femoral bone stress and strain were non-physiological when the BHR femoral component was fixed to bone. The reduction of strain energy within the femoral head was of sufficient magnitude to invoke early bone resorption. Less reduction of stress was demonstrated when the BHR femoral component was completely debonded from bone. Bone apposition around the distal stem was predicted based on the stress and strain transfer through the stem. Femoral stress or strain patterns were not affected by the type of fixation medium used (cemented vs. Uncemented). Analysis of proximal stress and strain shielding in the BHR arthroplasty provides a plausible mechanism for overall structural weakening due to loss of bony support. It is postulated that the proximal bone resorption and distal bone formation may progress to neck thinning as increasing stress and strain transfer occurs through the stem. This may be further exacerbated by additional proximal bone loss through avascular necrosis. Medium term retrieval specimens have shown bone remodelling that is consistent with our results. It is unclear if the clinical consequences of neck thinning will become more evident in longer-term follow-ups of the BHR.
One potential limitation with uncemented, hemispherical metal-backed acetabular components is stress shielding of bony structures due to the mismatch in elastic modulus between the metal backing and the peri-prosthetic bone. A proposed substitute is a horseshoe-shaped acetabular component, which replicates the bony anatomy. One such device, the Cambridge cup, has shown successful clinical and radiological outcomes at five years follow-up (Brooks 2004, Field 2005). We conducted a study of the Cambridge cup from a biomechanical perspective, using validated, high-resolution computational models of the bilateral hip. Peri-prosthetic stress and strain fields associated with the Cambridge cup were compared to those for the natural hip and a reconstructed hip with a conventional metal-backed hemispherical cup during peak gait loading. We found that the hemispherical cup caused an unphysiologic distribution of bone stresses in the superior roof and unphysiologic strain transfer around the acetabular fossa. These stress distributions are consistent with bone remodelling. In contrast, the peri-acetabular stresses and strains produced by the Cambridge cup differed from the natural hip but were more physiologic than the conventional hemispherical design. With the Cambridge cup, stresses in the superior acetabular roof, directly underneath the central bearing region, were greater than with the conventional design. Despite the thin bearing, the peak liner stresses in the Cambridge cup (max. tensile stress: 1.2 MPa; yield stress: 4.5 MPa) were much lower than the reported material strengths. Fossa loading by the hemispherical cup has been suggested as a possible mechanism for decreased implant stability (Widmer 2002). Conversely, the Cambridge cup produced semi-lunar peri-prosthetic stress fields, consistent with contact regions measured in natural hips (Widmer 2002). These analyses provide a better understanding of the biomechanics of the reconstructed acetabulum and suggest that a change in component geometry may promote long-term fixation in the pelvis.
