Introduction. Wear of polyethylene tibial inserts has been cited as being responsible for up to 25% of revision surgeries, imposing a very significant cost burden on the health care system and increasing patient risk. Accurate measurement of material loss from retrieved knee bearings presents difficult challenges because gravimetric methods are not useful with retrievals and unworn reference dimensions are often unavailable. Geometry and the local anatomy restrict in vivo radiographic
Purpose: Implant retrieval analysis provides valuable information to researchers, clinicians and manufactures about the in vivo wear characteristics.
Purpose: Efforts to decrease polyethylene wear have lead to advances in polyethylene and counter-face technology for total hip replacement. In particular, the use of highly cross-linked polyethylene (XLPE) and more recently, oxidized zirconium (Oxinium) heads, have demonstrated significant in-vitro improvements in THR wear. This study reports on the early clinical performance and wear (measured with RSA) of an randomized controlled trial (RCT) comparing Oxinium and CoCr heads on XLPE and conventional polyethylene (CPE). Method: Forty patients were enrolled in a RCT and stratified to receive either an Oxinium (Ox) or CoCr head against either XLPE or CPE (ie 10 patients in each group). All patients had otherwise identical THRs and had tantalum beads inserted in the pelvis and polyethylene for
Current implant designs and materials provide a high grade of quality and safety, but aseptic implant loosening is still the main reason for total hip revision. Highly cross-linked polyethylene (HX-PE) is used successfully in total hip replacements (THR) since several years. The good wear properties lead to a reduction of wear debris and may contribute to a longer survival time of the THRs. Furthermore, thin HX-PE liner allows the use of larger femoral heads associated with a decreased risk of dislocation and an improved range of motion. However, the cross-linking process is associated with a loss of mechanical properties of the polyethylene material which compromise the use of thin HX-PE liner in terms of high stress situations. The aim of the present study was the experimental
Wear debris released from bearing surfaces has been shown to
provoke negative immune responses in the recipient. Excessive wear
has been linked to early failure of prostheses. Analysis using coordinate
measuring machines (CMMs) can provide estimates of total volumetric
material loss of explanted prostheses and can help to understand
device failure. The accuracy of volumetric testing has been debated,
with some investigators stating that only protocols involving hundreds
of thousands of measurement points are sufficient. We looked to
examine this assumption and to apply the findings to the clinical
arena. We examined the effects on the calculated material loss from
a ceramic femoral head when different CMM scanning parameters were
used. Calculated wear volumes were compared with gold standard gravimetric
tests in a blinded study. Objectives
Methods
There are many methods for analysing wear volume in failed polyethylene acetabular components. We compared a radiological technique with three recognised We tested 18 ultra-high-molecular-weight polyethylene acetabular components revised for wear and aseptic loosening, of which 13 had pre-revision radiographs, from which the wear volume was calculated based upon the linear wear. We used a shadowgraph technique on silicone casts of all of the retrievals and a coordinate measuring method on the components directly. For these techniques, the wear vector was calculated for each component and the wear volume extrapolated using mathematical equations. The volumetric wear was also measured directly using a fluid-displacement method. The results of each technique were compared. The series had high wear volumes (mean 1385 mm3; 730 to 1850) and high wear rates (mean 205 mm3/year; 92 to 363). There were wide variations in the measurements of wear volume between the radiological and the other techniques. Radiograph-derived wear volume correlated poorly with that of the fluid-displacement method, co-ordinate measuring method and shadowgraph methods, becoming less accurate as the wear increased. The mean overestimation in radiological wear volume was 47.7% of the fluid-displacement method wear volume. Fluid-displacement method, coordinate measuring method and shadowgraph determinations of wear volume were all better than that of the radiograph-derived linear measurements since they took into account the direction of wear. However, only radiological techniques can be used Interpretation of radiological measurements of acetabular wear must be done judiciously in the clinical setting.
Ceramic-on-metal (COM) bearings have shown reduced wear and friction compared with metal-on-metal (MOM) bearings in-vitro. Lower wear has been attributed to a reduction in corrosive wear, smoother surfaces, improved lubrication and differential hardness reducing adhesive wear. Clinical studies have also shown reduced metal ion levels in-vivo compared with MOM bearings. The aim of this study was to examine two explanted COM bearings (one head and cup, one head only), and to assess the effect of in-vivo changes on the wear performance of the COM bearings by comparing the wear of the explanted bearings with three new COM implants in a hip wear simulator. Two 28mm diameter COM bearings were provided for analysis. These were visually examined and surface profilometry was performed using a 2-D contacting profilometer (Form Talysurf, Taylor Hobson, UK). Scanning electron microscopy was used to image the regions of transfer on the ceramic heads, and EDX to assess the transfer composition (Philips XL30 ESEM). Hip simulator testing was conducted for 2 million cycles (Mc) comparing the explanted bearings with three new 28mm COM bearings. Tests were performed in a Prosim simulator (SimSol, UK), which applied a twin peak loading cycle, with a peak load of 3kN. Flexion-extension of − 15 to 30 degrees was applied to the head and internal-external rotation of +/− 10 degrees was applied to the cup, components were mounted in the anatomical position. The lubricant was 25% (v/v) calf serum supplemented with 0.03% (w/v) sodium azide and was changed approximately every 0.33Mc. Wear was measured gravimetrically at 0.5, 1 and 2 Mc. Regions of material transfer, identified on both ceramic explant heads, were shown to be CoCr material by EDX analysis, suggesting metallic transfer from the metal cup. Profilometry traces across metallic transfer showed comparable surface roughness measurements compared to unworn material. The overall mean wear rate for the new COM bearings at 2Mc was 0.047 ± 0.06mm3/Mc. The mean wear rate for the explanted head articulated with a new cup was slightly lower at 0.034mm3/Mc. The mean wear rate for the explanted head and cup was highest at 0.15mm3/Mc. It was noted that the explanted head/cup had higher bedding in wear compared with the other bearings, but still significantly less than a new MOM bearing (mean bedding-in wear rate 2.03 ± 2.59 mm3/Mc). The steady-state wear was comparable with the new bearings. As the orientation of these implants in-vivo was unknown, it is proposed that the elevated wear during bedding-in of the explanted head/cup bearing may be due to the alignment of the components. The wear rates of the explanted ceramic head against a new cup were comparable with the new bearings, suggesting that the presence of metallic transfer on the ceramic head does not adversely affect the wear behaviour of COM bearings.
Previous studies have suggested that metal-on-metal (MoM) Pinnacle (DePuy Synthes, Warsaw, Indiana) hip arthroplasties implanted after 2006 exhibit higher failure rates. This was attributed to the production of implants with reduced diametrical clearances between their bearing surfaces, which, it was speculated, were outside manufacturing tolerances. This study aimed to better understand the performance of Pinnacle Systems manufactured before and after this event. A total of 92 retrieved MoM Pinnacle hips were analyzed, of which 45 were implanted before 2007, and 47 from 2007 onwards. The ‘pre-2007’ group contained 45 implants retrieved from 21 male and 24 female patients, with a median age of 61.3 years (interquartile range (IQR) 57.1 to 65.5); the ‘2007 onwards’ group contained 47 implants retrieved from 19 male and 28 female patients, with a median age of 61.8 years (IQR 58.5 to 67.8). The volume of material lost from their bearing and taper surfaces was measured using coordinate and roundness measuring machines. These outcomes were then compared statistically using linear regression models, adjusting for potentially confounding factors.Objectives
Methods
In Total Hip Arthroplasty (THA), polyethylene wear reduction is key to implant longevity. Oxidized Zirconium (OxZi) unites properties of a ceramic bearing surface and metal head, producing less wear in comparison to standard Cobalt-Chromium (CoCr) when articulating with Cross-linked polyethylene (XLPE) in vitro. This study investigates in vivo polyethylene (PE) wear, outcomes and complications for these two bearing couples in patients at 5 year follow-up 400 patients undergoing THA across four institutions were prospectively randomised into three groups. Group I received a cobalt-chrome (CoCr) femoral head/ cross-linked polyethylene (XLPE) liner; Group II received an OxZi femoral head/ ultrahigh molecular weight polyethylene (UHMWPE) liner; Group III received an OxZi femoral head/XLPE liner. All bearing heads were 32 mm. Linear wear rate was calculated with Martell computer software. Functional outcome and complications were recorded.Introduction
Methods
Introduction. Ceramic femoral heads have superior scratch resistant with better wettability and improved wear characteristics compared to metal heads in the laboratory setting. The objective of this study was to compare long-term in vivo wear rates of ceramic and metal femoral heads against conventional polyethylene articulation with cementless stems in young, active patients. Materials and Methods. Thirty-one matched pair of alumina and metal (Cr-Co) femoral heads against conventional polyethylene in young patients (between 45 and 65 years old) were analyzed for wear and failures for mechanical reasons. The match was based on gender and age at the time of surgery. All procedures were performed between June 1989 and May 1992 by a single surgeon via posterolateral approach, using cementless RB (Ranawat-Bernstein) stems, HG II (Harris-Galante) cups, 4150 conventional polyethylene and 28 mm femoral heads. Hospital for Special Surgery (HSS) hip score was used for clinical
Trunnionosis, due to mechanical wear and/or corrosion at the head stem taper junction, can occur in metal on polyethylene (MOP) hip implants. In some patients this results in severe soft tissue destruction or Adverse Reaction to Metal Debris (ARMD). The amount of material required to cause ARMD is unknown but analyses of retrieved hips may provide the answer to this clinically important question. We collected implants from 20 patients with failed hips with MOP bearings, revised due to ARMD. We collected clinical, imaging and blood test data. We graded the severity of taper corrosion (1 to 4), and quantified the volume of material loss from this junction. We compared our results with previous data collected for metal-on-metal (MOM) hips. The median time to revision of the MOP hips was 51.3 (23.1–56.4) months. All head tapers were moderately to severely corroded with a median corrosion score of 4. The median (range) of total material loss at the taper of the MOP hips was 3.9 mm3 (2.96 – 7.85 mm3) and the material loss rate was 1.4 mm3 / year (0.56 – 1.82). Comparison with MOM hips revealed no significant difference in taper material loss (p=0.7344) with a median rate of 0.81 mm3 / year (0.01–3.45). We are the first to quantify the volume of material loss at the head taper of hip implants with MOP bearings that were revised due to trunnionosis. This data indicates that a clinically significant dose of cobalt and chromium to induce ARMD is approximately 1.4 mm3 / year. We have identified a clinically significant volume of taper material loss in MOP hips.
Highly cross-linked polyethylene liners in total hip replacement (THR) have allowed the use of larger diameter femoral heads. Larger heads allow for increased range of motion, decreased implant impingement, and protection against dislocation. The purpose of this study is to report the clinical and radiographic outcomes of patients with large femoral heads with HXLPE at 5 years post-op. A group of 124 patients (132 THRs) who had a primary THR with a 36mm or larger cobalt-chrome femoral head and a Durasul or Longevity liner (Zimmer; Warsaw, IN) were prospectively enrolled in this study. 93 THRs (88 patients) had minimum 5 year follow-up. All patients received a cementless acetabular shell (Trilogy or Inter-op, Zimmer Inc, Warsaw IN) and a highly cross-linked polyethylene liner with an inner diameter of 36 or 38mm. The median radiographic follow-up was 5.6 years (range 5.0–8.0), and patients were assessed clinically by Harris Hip score, UCLA activity score, EQ-5D, and SF-36 functional scores. Femoral head penetration was measured using the Martell Hip Analysis Suite. No osteolysis was seen in the pelvis or proximal femur, and no components failed due to aseptic loosening. Four patients have questionable signs of bone changes around the acetabular shell with future CT scans scheduled to help reach a final determination. The median acetabular shell abduction and anteversion were 44° (30–66°) and 13° (3–33°) respectively. There was no evidence of cup migration, screw breakage, or eccentric wear on the liner. Regarding the femoral component, there were no episodes of loosening, migration, osteolysis, or fracture. There was no significant difference in the median penetration rate from post-op to longest follow-up between the 36mm (24 patients) and 38mm (4 patients) femoral head groups (0.056±0.10mm/yr and 0.060±0.05mm/yr respectively). Therefore, the data were pooled into one group. Using every post-op to follow-up comparison, the linear regression penetration rate of this combined group was 0.003 mm/yr which is within the error detection of the Martell method. The median femoral head penetration rate during the first post-op year measured 0.59±1.04 mm/yr. In contrast, the median steady state wear rate from the 1yr film to the longest follow-up measured -0.009±0.15mm/yr. A linear regression steady state wear rate from the 1 year film to every follow-up of −0.031 mm/yr indicated no correlation between the magnitude of polyethylene wear and time. The mid-term results on this series of patients with THRs with a 36 or 38mm femoral head articulating with highly cross-linked polyethylene showed excellent clinical, radiographic, and wear results. The lack of early signs of osteolysis with the use of these large diameter femoral heads is encouraging. Continued and longer-term follow-up is needed to provide survivorship data.
Introduction. Patella implant research is often overlooked despite its importance as the third compartment in a total knee replacement. Wear and fracture of resurfaced patellae can lead to implant failure and revision surgeries. New simulation techniques have been developed to analyze the performance of patella designs as they interact with the trochlear groove in total knee components, and clinical validation is sought to ensure that these simulations are appropriate. The objective of this work was to subject several patellar designs to patient-derived deep knee bend (DKB) inputs on a 6 degree of freedom (DOF) simulator and compare the resultant wear scars to clinical retrievals. Materials and Methods. Previously reported DKB profiles were developed based on in vivo patellofemoral data and include a wide range of patient variability. The profiles chosen for this body of work were based on the stress in the patellar lateral facet; maximizing this stress whilst maintaining the ability to run the profile stably on the simulator. Load/kinematic profiles were run on three patellar designs (n=3 per group) for 220,000 cycles at 0.8Hz on an AMTI VIVO joint simulator. A comparison cohort of clinically retrieved devices of the same design was identified in an IRB-approved database. Exclusion criteria included gross delamination, cracking secondary to oxidation, and surgeon-reported evidence of malalignment leading to mal-tracking. 29 Patellae were included for analysis: PFC. ®. All Poly (n=14), ATTUNE. ®. Anatomic (n=6), and ATTUNE. ®. Medialized Dome (n=9). Mean in vivo duration was 70.1 months. Patellae were analyzed under optical microscope in large-depth-of-field mode to map the surface damage profile. Burnishing ‘heat-maps’ were generated for retrievals and simulated patellae by normalizing the patellar size and overlaying silhouettes from each component of the same type using a custom-developed MatLAB code. Results. Burnishing heat-map comparisons between retrievals and simulator specimens for each of the three designs were compared. Retrievals show more variation than simulator devices, however the general loci and relative area of burnished regions is closely aligned for each of the three designs. The retrieved and simulated burnishing scar heat-maps on all-poly PFC. ®. patellae are centered medio-laterally with a wider profile on the lateral aspect. The burnishing marks are continuous. A similar observation may be made of the ATTUNE. ®. medialized dome, retrievals and simulator specimens, though the contact areas appear to be more concentrated away from the apex. The anatomic patellae show two primary regions of contact, and minimal burnishing at the apex. The simulator specimens likewise show two principal regions of contact. Discussion.
Background. Polyethylene (PE) as a bearing material for total joint replacements (TJR) represents the golden standard for the past forty years. However, over the past decade it becomes apparent that PE wear and the biological response to wear products are the limiting factor for the longevity of TJRs. For this reason research has focused onto PE
Medical advances and an ageing population mean that more people than ever rely on artificial joints. In the past years, shoulder joint replacement has developed rapidly and the numbers of shoulder prostheses implanted increased dramatically. Wear is one of the main contributors to the failure of shoulder implants. It is therefore important to measure the wear properties of the articulating surfaces within the joint Imperial shoulder simulator was designed with six articulating stations and one loaded soak control station for anatomical shoulder system wear simulation. It gives an adduction-abduction (AA) range of-15° to 55°, flexion-extension (FE) range of −90° to 90° and internal external rotation (IER) range of 15° to −90°. The rotations are applied simultaneously to the humeral implants by using stepper motors with integral position encoders. Axial and shear loadings to each glenoid implant were applied using pneumatic cylinders. Force controlled translations were recorded using load cells and LVDTs, and a data acquisition system. Pneumatic cylinders were also installed to work to counterbalance weights during the motion of adduction-abduction. All bearing pairs are within isolated and sealed test chambers to prevent loss of fluid through evaporation, and cross contamination of third body wear (as recommended in F1714-96). The simulator is controlled by LabVIEW program allowing to reproduce shoulder activities of daily living.Background
Materials and Methods
While there are many variation laboratory and clinical studies using metal-on-metal (MOM) bearings after introduction of the 28mm MOM THR in 1988, the mapping of wear phenomena in such retrieval cases has been mimimal. In laboratory study, 28mm MOM bearing’s wear-rate was low with “run-in” and “steady-state” than large diameter MOM without theory of fluid-filum lubrication. In clinical results were not superior to the same way of laboratory study. We present a detailed analysis of 33 retrieved MOM hip bearings with 1–11 years follow-up, We compiled 33 retrieval cases (MetasulTM: Zimmer/CenterPulse Inc., Austin, TX) including clinical information, ion concentrations from ball diameters, cup designs and stripe wear damage. The bearing surfaces were mapped using reflected light microscope (RLM), white light interferometer (Zygo Newview 600, Zygo.) and SEM(XL-30 FEG). Wear maps were constructed according to types of surface wear identified. Patients ranged from 36 to 76 years of age (Means: 56.9 years); 54% were males. Main causes for revision were progressive radiographic lines around the cups, osteolysis and pain. The 28mm ball diameter was used in 86% of cases (largest = 52mm ball). The CoCr liner incorporated a polyethylene adaptor in 75% of cases. Cup diameter >
50mm was present in 75% of cases. Eight femoral stems were recovered and all showed major impingement marks around the neck and five also had a metallosis (Mode-4A). Stripe wear was evident on 71% of CoCr balls with medial stripes twice as common as lateral. Stripe wear was identified in 25% of CoCr liners and extended 25–160° circumference around the liners. Clear liner rim damage was present in 10 (30%) and 3 demostrated severe damage of polyethelene adaptors. There are many limitations to such retrieval studies. These data are biased to cases that failed due to hip pain, radiographic signs of progressive osteolysis and some with high levels of metal ions. There was also the bias of having predominantly a CoCr sandwich design (polyethylene adaptor in 75% of cases). In early 1980s, the thin walled UHMWPE cup was introduced and used larger diameter balls for decreased risk of dislocation. However, unfortunally these big-ball cups produced significant PE wear debris, and diameter trends were returned to the Chanley’s small-ball paradigm again. In the same time (late of 1980’s), these second-generation MOM (28,32mm) was introduced for low wear characteristics alternate THR bearings, with sacrificing of joint stability and motion range. However, use of the small ball added well-known risks of impingement, subluxation and dislocation with rigid cups. In this study, using the ‘damage modes’ from McKellop, normal mode-1 wear occurred in only 14% of cases whereas modes 2–4 had an incidence approaching 30% each and signs of cup impingement were evident in 64% of cases. Thus summarizing MOM wear phenomena in “small” 28mm sandwich cup designs, there was retrieval evidence showing that damage modes 2–4 likely placed these patients at risk for adverse wear effects.
Aims. Vitamin E-infused highly cross-linked polyethylene (E1) has recently been introduced in total knee arthroplasty (TKA). An in vitro wear simulator study showed that E1 reduced polyethylene wear. However there is no published information regarding in vivo wear. Previous reports suggest that newly introduced materials which reduce in vitro polyethylene wear do not necessarily reduce in vivo polyethylene wear. To assist in the evaluation of the newly introduced material before widespread use, we established an in vivo polyethylene
Introduction. The first highly crosslinked and melted polyethylene acetabular component for use in total hip arthroplasty was implanted in 1998 and femoral heads larger than 32mm in diameter introduced 2004. The purpose of this study was to re-assemble a previous multi-center patient cohort in order to evaluate the radiographic and