Articulation of the polyethylene (PE) insert between the metal femoral and tibial components in total knee replacements (TKR) results in wear of the insert which can necessitate revision surgery. Continuous PE advancements have improved wear resistance and durability increasing implant longevity. Keeping up with these material advancements, this study utilises model-based radiostereometric analysis (mbRSA) as a tool to measure in vivo short-term linear PE wear to thus predict long-term wear of the insert. Radiographic data was collected from the QEII Health Sciences Centre in Halifax, NS. Data consisted of follow-up RSA examinations at post-operative, six-, 12-, and 24-month time periods for 72 patients who received a TKR. Implanted in all patients were Stryker Triathlon TKRs with a fixed, conventional PE bearing of either a cruciate retaining or posterior stabilised design. Computer-aided design (CAD) implant models were either provided by the manufacturer or obtained from 3D scanned retrieved implants. Tibial and femoral CAD models were used in mbRSA to capture pose data in the form of Cartesian coordinates at all follow-ups for each patient. Coordinate data was manually entered into a 3D modeling software (Geomagic Studio) to position the implant components in virtual space as presented in the RSA examinations. PE wear was measured over successive follow-ups as the linear change in joint space, defined as the shortest distance between the tibial baseplate and femoral component, independently for medial and lateral sides. A linear best-fit was applied to each patient's wear data; the slope of this line determined the annual wear rate per individual patient. Wear rates were averaged to provide a mean rate of in vivo wear for the Triathlon PE bearing. Mean linear wear per annum across all 72 patients was 0.088mm/yr (SD: 0.271 mm/yr) for the medial condyle and 0.032 mm/yr (SD: 0.230 mm/yr) for the lateral condyle. Cumulative linear wear at the 2-year follow-up interval was 0.207mm (SD: 0.565mm) and 0.068mm (SD: 0.484mm) for the medial and lateral condyles, respectively. Linear PE
The purpose of this study was to examine the influence of weight-bearing on the measurement of in vivo wear of total knee replacements using model-based RSA at 1 and 2 years following surgery. Model-based RSA radiographs were collected for 106 patients who underwent primary TKR at a single institution. Supine RSA radiographs were obtained post-operatively and at 6-, 12-, and 24-months. Standing (weight-bearing) RSA radiographs were obtained at 12-months (n=45) and 24-months (n=48). All patients received the same knee design with a fixed, conventional PE insert of either a cruciate retaining or posterior stabilized design. Ethics approval for this study was obtained. In order to assess in vivo wear, a highly accurate 3-dimensional virtual model of each in vivo TKA was developed. Coordinate data from RSA radiographs (mbRSA v3.41, RSACore) were applied to digital implant models to reconstruct each patient's replaced knee joint in a virtual environment (Geomagic Studio, 3D Systems). Wear was assessed volumetrically (digital model overlap) on medial and lateral condyles separately, across each follow-up. Annual rate of wear was calculated for each patient as the slope of the linear best fit between wear and time-point. The influence of weight-bearing was assessed as the difference in annual wear rate between standing and supine exams. Age, BMI, and Oxford-12 knee improvement were measured against wear rates to determine correlations. Weight bearing
Purpose. The purpose of this study was to examine the influence of weight-bearing on the measurement of in vivo wear of total knee replacements using model-based RSA at 1 and 2 years following surgery. Methods. Model-based RSA radiographs were collected for 106 patients who underwent primary TKR at a single institution. Supine RSA radiographs were obtained post-operatively and at 6-, 12-, and 24-months. Standing (weight-bearing) RSA radiographs were obtained at 12-months (n=45) and 24-months (n=48). All patients received the same knee design with a fixed, conventional PE insert of either a cruciate retaining or posterior stabilized design. Ethics approval for this study was obtained. In order to assess in vivo wear, a highly accurate 3-dimensional virtual model of each in vivoTKA was developed. Coordinate data from RSA radiographs (mbRSA v3.41, RSACore) were applied to digital implant models to reconstruct each patient's replaced knee joint in a virtual environment (Geomagic Studio, 3D Systems). Wear was assessed volumetrically (digital model overlap) on medial and lateral condyles separately, across each follow-up. Annual rate of wear was calculated for each patient as the slope of the linear best fit between wear and time-point. The influence of weight-bearing was assessed as the difference in annual wear rate between standing and supine exams. Age, BMI, and Oxford-12 knee improvement were measured against wear rates to determine correlations. Results. Weight bearing
BACKGROUND:. Although most radiographs used for polyethylene
Introduction. Periprosthetic osteolysis following total hip arthroplasty is caused mainly by polyethylene wear particles and necessitates revision surgery at some stage even in the presence of well-fixed implants. Therefore, methods to estimate the polyethylene wear become important, with manual
Introduction. Reverse total shoulder arthroplasty (RTSA) is a semi-constrained joint replacement with an articulating cobalt-chromium glenosphere and ultra-high molecular weight polyethylene (PE). Because of its limited load bearing, surgeons and implant manufacturers have not elicited the use of highly cross-linked PE in the shoulder, and to date have not considered excessive PE wear in the reverse shoulder a primary concern. As the number of shoulder procedures is expected to grow exponentially in the next decade, however, it is important to evaluate how new designs and bearing materials interact and to have an understanding of what is normal in well-functioning joint replacements. Currently, no in vivo investigation into RTSA PE wear has been conducted, with limited retrieval and simulation studies. In vitro and in silico studies demonstrate a large range in expected wear rates, from 14.3 mm. 3. /million cycles (MC) to 126 mm. 3. /MC, with no obvious relationship between wear rate and polyethylene diameter. The purpose of this study is to evaluate, for the first time, both volumetric and linear wear rates in reverse shoulder patients, with a minimum six-year follow-up using stereo radiographic techniques. Methods. To date, seven patients with a self-reported well-functioning Aequalis Reversed II (Wright Medical Group, Edina, MN, USA) RTSA implant system have been imaged (mean years from surgery = 7.0, range = 6.2 to 9). Using stereo radiographs, patients were imaged at the extents of their range of motion in internal and external rotation, lateral abduction, forward flexion, and with their arm at the side. Multiple arm positions were used to account for the multiple wear vectors associated with activities of daily living and the shoulder's six degrees of motion. Using proprietary software, the position and orientation of the polyethylene and glenosphere components were identified and their transformation matrices recorded. These transformation matrices were then applied to the CAD models of each component, respectively, and the apparent intersection of the glenosphere into the PE recorded. Using previously validated in-house software, volumetric and maximum linear
The PowerPoint (2007 Version; Microsoft, Redmond, Wash) method is reported to have improved repeatability and reproducibility and is better able to detect differences in radiographs than previously established manual
Metal-on-polyethylene (MoP) is the most commonly used bearing couple in total hip replacements (THRs). Retrieval studies (Cooper A 6-station anatomical hip joint simulator was used to investigate material loss at the articulating and taper-trunnion surfaces of 32mm diameter metal-on-cross-linked polyethylene (MoXLPE) joints for 5 million cycles (Mc) with a sixth joint serving as a dynamically loaded soak control. Commercially available cobalt-chromium-molybdenum (CoCrMo) femoral heads articulating against XLPE acetabular liners (7.5Mrad) were used with a diluted new-born-calf-serum lubricant. Each CoCrMo femoral head was mounted on a 12/14 titanium alloy trunnion. The test was stopped every 0.5Mc, components were cleaned and gravimetric measurements performed following ISO 14242-2 and the lubricant was changed. Weight loss (mg) obtained from gravimetric measurements was converted into volume loss (mm3) and wear rates were calculated from the slopes of the linear regression lines in the volumetric loss versus number of cycles plot for heads, liners and trunnions. Additionally, volumetric measurements of the head tapers were obtained using a coordinate measuring machine (CMM) post-test. The surface roughness (Sa) of all heads and liners was measured pre and post-test. At the end of the test, the femoral heads were cut and the roughness of the worn and unworn area was measured. Statistical analysis was performed using a paired-t-test (for roughness measurements) and an independent sample t-test (for wear rates).Introduction
Methods
Polyethylene wear represents a significant risk factor for the long-term success of knee arthroplasty [1]. This work aimed to develop and in vivo validate an automated algorithm for accurate and precise AI based
Each in vivo
The use of fourth generation ceramic as an orthopaedic biomaterial has proved to be a very efficient and has gained popularity for primary hip surgery in the last 8–10 years. Cumulative percentage probability of revision after 7 years for un-cemented CoC is 3.09% and for hybrid CoC is 2.00%, this compares favourably with traditional metal-on-UHMWPE un-cemented at 3.05% and hybrid at 2.35% (12th Annual Report - NJR, 2015). Such ceramic-on-ceramic hip prostheses are being implanted in ever younger, more active patients, and yet very few long-term large cohort retrieval studies are yet to be carried out due to the survivorship of the implants. It has been seen in previous studies that levels of wear in ceramic-on-ceramic bearing surface can be of the order of 0.2 mm. 3. /million cycles (Al-Hajjar, Fisher, Tipper, Williams, & Jennings, 2013). This is incredibly low when compared to studies that characterize wear in other bearing surface combinations. It has also been reported that an unusual stripe pattern of wear can occur in some in-vivo retrieved cups (Macdonald & Bankes, 2014) and it has further been postulated that this is caused by cup edge loading (Walter, Insley, Walter, & Tuke, 2004). The combined measurement challenge of stripe wear occurring at the edge of a low-wear ceramic-on-ceramic device is considerable, a solution to which is presented here. Current literature on
Introduction. Highly cross-linked (HXL) polyethylene has demonstrated clinical advantages as a wear resistant acetabular bearing material in total hip arthroplasty (THA) [1]. In vitro wear testing has predicted a tenfold reduction in the wear rate of HXL polyethylene, as compared to its conventional, non-HXL counterpart [2]. To date, radiographic studies of head penetration represent the state-of-the-art in determining clinical wear of polyethylene hip liners [3]. However, as the amount of wear drops to very low levels, it becomes important to develop a precise and reliable method for measuring wear, facilitating a comparison of clinical results to expectations. This study focuses on locating and quantifying the maximum linear wear of retrieved acetabular poly liners using a coordinate measuring machine (CMM). Specifically, HXL liners are compared to a baseline of conventional, non-HXL bearings. Methods. An IRB-approved retrieval laboratory received 63 HXL acetabular bearing retrievals from 5 manufacturers with in vivo durations of 1.01–14.85 years. These were compared with 32 conventional, non-HXL controls (including gas plasma, gamma-barrier and EtO) from 3 manufacturers with in vivo durations of 1.03–20.89 years. Liners were mounted in a tripod of axial contacts with the liner face positioned in a vertical plane. Each bearing was scanned with a CMM dual-probe head, with one horizontal probe scanning the articular surface and the other scanning the non-articular, sequentially. Surface-normal wall thickness values along each latitude were calculated using a custom developed algorithm (Figure 1). Because the liners are axially symmetric as manufactured, deviation in wall thickness at a given latitude represents linear wear [4]. Results. Total wear penetration for the HXL liners ranged from 0.02 to 1.03 mm, and for the conventional, non-HXL controls ranged from 0.07 to 6.85 mm. The HXL liners had an average linear wear rate of 0.02 mm/year, compared to 0.20 mm/year for the conventional, non-HXL controls (Figure 2). The direction of maximum wear, as measured in degrees from the cup pole, ranged from 8.32 to 73.86 degrees. Differences in wear rates as a function of crosslinking dose, as well as presence/absence of a lip can be identified. Discussion. This
Introduction. Temporary use of antibiotic-impregnated polymethylmethacrylate (PMMA) bone cement spacers in two-stage revisions is considered to be standard of care for patients with a chronic infection of a joint replacement. Spacers should be wear resistant and load-bearing to avoid prolonged immobilisation of the patient and to reduce morbidity. Most cement spacers contain barium sulphate or zirconium dioxide as radio-opaque substrate. Both are quite hard materials that may negatively influence the wear behaviour of the spacer. Calcium carbonate is another radio-opaque substrate with lower hardness potentially increasing the wear resistance of the spacer materials. The purpose of the study was to compare a prototype PMMA knee spacer (calcium carbonate loaded) with a commercially available spacer (containing barium sulphate) regarding the wear performance and particle release in a knee wear simulator. Material and Methods. Spacer K (TECRES, Italy) was used as barium sulphate (10%) containing spacer material. A prototype material (Heraeaus Medical, Germany) with 15% calcium carbonate was compared. Both were gentamicin impregnated, ready-made for clinical application (preformed) and consist of a tibial and a femoral component. Force-controlled simulation was carried out on an AMTI knee simulator. The test parameters were in accordance to ISO 14243–1 with a 50% reduced axial force (partial weight bearing). Tests were carried out at 37 °C in closed chambers filled with calf serum. Tests were run for 500,000 cycles at a frequency of 1 Hz. For wear analysis, gravimetric
Introduction. Fretting corrosion at the taper interface has been implicated as a possible cause of implant failure. Using in-vitro testing, fretting wear observed at tapers of retrieved implants may be reproduced (Marriott, EORS-2014). In order to reduce time and cost associated with experimental testing, a validated finite element method (FE) can be employed to study the mechanics at the taper. In this study we compared experimental and representative FE simulations of an accelerated fretting test set-up. Comparison was made by between the FE wear score and volumetric material loss from the testing. Methods. Experimental test set-up: An accelerated wear test was developed that consistently reproduced fretting wear features observed in retrievals. Biomet stems with smooth 4° Type-1 tapers were combined with Ti6Al4V Magnum +9 mm adaptors using a 2 or 15 kN assembly force. The head was replaced with a custom head fixture to increase the offset and apply a torque at the taper interface. The stems were potted according to ISO 7206-6:2013. The set-up was submerged in a test medium containing PBS and 90gl-1 NaCl. The solution was pH adjusted to 3 using HCl and maintained at 37°C throughout the tests. For each assembly case, n=3 tests were cyclically loaded between 0.4–4 kN for 10 Million cycles. Volumetric
Introduction. It is important to measure 2-dimensional (2D) polyethylene wear in total hip arthroplasty (THA) accurately in order to estimate value of wear performance. However, wear vector direction is usually defined in a coordinate system specific manner, which sometimes leads to confusion and makes it difficult to compare measures between techniques. We systematically evaluated the influence of four different coordinate system definitions for the measurement of 2D wear in acetabular cups form radiographs. Materials and Methods. We performed 2D
Introduction. Durable bone fixation of uncemented porous-coated acetabular cups can be observed at a long-term, however, polyethylene (PE) wear and osteolysis may affect survivorship. Accurate
Radiostereometric analysis (RSA) has become the gold standard technique for measuring implant migration and wear following joint replacement due to its high measurement precision and accuracy. However, RSA is conventionally performed using two oblique radiographic views with the presence of a calibration cage. Thus, a second set of radiographs must be acquired for clinical interpretation, for example anterior-posterior and cross-table lateral views following total hip arthroplasty (THA). We propose a modification to the RSA setup for examining THA, in which RSA measurements are performed from anterior-posterior and lateral views, with the calibration cage images acquired separately from the patient images. The objective of the current study was to compare the accuracy and precision of the novel technique to the conventional technique using a phantom. X-ray cassette holders were developed to enable simultaneous acquisition of anterior-posterior and cross-table lateral radiographs with the patient in a supine position in the RSA suite. A Sawbones phantom with total hip implant components was attached to a micrometer-driven stage. The femoral component was translated known distances relative to the acetabular cup in all planes, mimicking head penetration due to wear. Double RSA examinations were acquired for each increment using the traditional and novel radiograph orientations. Translations were measured from the radiographic images using RSA software. For both techniques, accuracy was calculated by comparing the measured translations to the known translation from the micrometer, and reported as the 95% confidence interval. Precision was measured by comparing the measured translations between the double exams, and reported as the standard deviation. Accuracy was greater for the conventional technique in the inferior-superior axis (p = 0.03), greater for the novel technique in the anterior-posterior axis (p = 0.01), and equivalent in the medial-lateral axis (p = 0.06). Overall accuracy for both the conventional and novel techniques was identical at ±0.022 mm. Precision was equivalent between both techniques for the medial-lateral (p = 0.68), inferior-superior (p = 0.14), and anterior-posterior axes (p = 0.86). Overall precision for the conventional technique was ±0.127 mm and for the novel technique was ±0.095 mm. Utilising standard clinical radiograph view angles within an RSA exam had no detrimental effect on
Introduction. Variations in component position can lead to dynamic separation and edge loading conditions. In vitro methods have been developed to simulate edge loading conditions and replicate stripe wear, increased wear rate, and bimodal wear debris size distribution, as observed clinically [1, 2]. The aim of this study was to determine the effects of translational and rotational positioning on the occurrence of dynamic separation and severity of edge loading, and then investigate the wear rates under the most severe separation and edge loading conditions on an electromechanical hip joint simulator. Materials and Methods. A hip joint simulator (ProSim EM13, Simulation Solutions, UK) was set up with 36mm diameter ceramic-on-ceramic (BIOLOX®delta, PINNACLE®, DePuy Synthes, UK) hip replacements. Three axes of rotation conditions (ISO 14242-1 [3]) was applied to the femoral head. This study was in two parts. I) A biomechanical test was carried out at 45° (n=3) and 65° (n=3) cup inclination angles with 1, 2, 3 and 4 (mm) medial-lateral translational mismatch between the centres of the head and cup. The amount of dynamic separation displacement between the head and cup was measured using a position sensor. The severity of edge loading was determined from the area under the axial force and medial-lateral force outputs during the time of separation [4]. II) A wear test was carried out at 45° (n=6) and 65° (n=6) cup inclination angles for three million cycles with translational mismatch of 4mm between the head and cup. The lubricant used was diluted new-born calf serum (25% v/v). Volumetric
Introduction. The long-term wear performance of highly cross-linked polyethylene (HXLPE) in cemented total hip arthroplasty (THA) has rarely been reported. Here we report a prospective randomized comparative analysis of radiographic wear after a minimum follow-up of 10 years in cemented THAs with either HXLPE or conventional polyethylene (CPE), and assess its clinical relevance. Patients and Methods. From 1999 to 2001, we conducted 94 primary cemented THAs with a 22.225-mm head at our hospital as part of a prospective randomized trial. All surgeries were performed using a direct lateral approach with a trochanteric osteotomy (Dall's approach). The patients were divided into 4 groups. Twenty-six hips in group A were implanted with CPE sockets against zirconia heads and Charnley-type stems. HXLPE sockets (Aeonian, Kyocera Medical Corp) were implanted in all hips in the other 3 groups. Twenty-five hips in group B were implanted with zirconia heads and KC stems (Kyocera Medical Corp), 23 hips in group C with zirconia heads and distal cylindrical stems, and 20 hips in group D with stainless steel heads and C-stem (DePuy Inc). The sockets were highly cross-linked by gamma irradiation at a dose of 35 kGy, heat annealed at 110ºC, and sterilized with 25 kGy of gamma irradiation in nitrogen. For radiographic evaluation, anteroposterior radiograms were taken for each patient annually, and every two years postoperatively for wear analyses. Two-dimensional head penetration was measured on each postoperative radiogram using a computer-aided technique. Results.
Wear testing of THR has chaperoned generations of improved UHMWPE bearings into wide clinical use. However, previous in vitro testing failed to screen many metal-on-metal hips which failed. This talk tours hip wear testing and associated standards, giving an assortment of THR wear test results from the author's laboratory as examples. Two international hip wear-simulator standards are used: ISO-14242-1 (anatomic configuration) and ISO-14242-3 (orbital-bearing). Both prescribe 5 million (MC) force-motion cycles involving cross-shear synchronized with compression simulating walking gate of ideally aligned THRs. ISO-14242-1 imposes flexion (flex), abduction-adduction (ad-ab) and internal-external (IE) rotations independently and simultaneously. An orbital-bearing simulator more simply rotates either a tilted femoral head or acetabular component, switching from flexion-dominated to ad-ab-dominated phases in each cycle with some IE. In the latter, the acetabular component is typically placed below the femoral head to accentuate abrasive conditions, trapping third-body-wear debris. Wear is measured (ISO-14242-2) gravimetrically (or volumetrically in some hard-on-hard bearings). Wear-rate ranges from negligible to >80mg/MC beyond what causes osteolysis. This mode-1 adhesive wear can therefore “discriminate” to screen hip designs-materials in average conditions. Stair-climbing, sitting, squatting and other activities may cause THR edge-loading and even impingement with smaller head-to-neck ratios or coverage angle, naturally worse in metal-on metal hips. Deformation of thin acetabular components during surgical impaction may cause elevated friction or metal-metal contact, shedding more metal-ions and accelerating failure. Surgical misalignments in inclination angle, version and tilt can make this worse, even during modest activities in hard-on-hard bearings. Abrasive particulate debris from bone or bone-cement, hydroxyapatite, neck-impingement, normal wear, or corrosion can compound the above. Such debris can scratch the femoral head surface, or embed in the UHMWPE liner compromising the wear of even metal-on-plastic hips. Much of the belated standardization activity for higher demand hip testing is in response to the metal-metal failures. ASTM F3047M is a recent non-prescriptive guide for what more rigorous testing can generally be done. Third-body particulate can be intentionally introduced or random scratching of the femoral component surface in extra abrasion testing. Also, the compressive load can be increased, more frequent start-stops to disrupt lubrication, and steepening acetabular shell-liner angles to reduce contact area and cause edge-loading, made harsher when combined with version misalignment. Transient separation can occur between head and liner during the swing phase in a lax THR joint with low coverage angle and misalignments; the separated head impacts the liner rim when reseating. An edge-loading ISO test is currently being discussed where (so-called) “microseparation” to a known distance is directly imposed by a lateral spring force in a hip simulator. Friction testing of a THR in a pendulum-like setup undergoing flexion or abduction swings is being discussed in the ASTM, and so have multi-dimensional THR friction measurements during a long-term wear test simultaneously measuring and separating friction of three rotational (flex, ad-ab, and IE) axes. THR wear test methods continue to evolve to address more challenges such as novel duo-mobility THR designs, where UHMWPE bearings cannot be removed for gravimetric