We present minimum 20 year results of a randomized, prospective double blinded trial (RCT) of cross-linked versus
The benefits of HXLPE in total knee arthroplasty (TKA) have not been as evident as total hip arthroplasty (THA). A systematic review and meta-analysis to assess the impact of highly-crosslinked polyethylene (HXLPE) on TKA outcomes compared to
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 wear measurement study of retrievals is the first application of a novel CMM technique to locate and quantify wear in HXL liners compared to
Introduction:. Although commonly used, the clinical performance of highly crosslinked polyethylene in total knee arthroplasty (TKA) remains unknown and concerns exist regarding fatigue resistance and oxidation, particularly in posterior-stabilized (PS) designs. The purpose of this study is to compare highly crosslinked and
Purpose. Cross-linking of polyethylene greatly reduces its wear rate in hip simulator studies. We conducted a systematic review and meta-analysis of randomized controlled trials comparing cross-linked to
Introduction. Ceramic femoral heads have proven to be more 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 survivorship and in vivo wear rates of ceramic and metal femoral heads against
Purpose. The objective of this study was to compare the wear characteristics and damage scores in highly crosslinked (XLPE) and
Introduction: Hip Simulator studies show that use of highly cross-linked polyethylene in total hip replacement reduces polyethylene (PE) wear by a factor of 85–98%. Early clinical studies using RSA or computer-aided techniques of polyethylene wear measurement show a reduction of 50–80%. There is speculation about why this discrepancy in the clinical and laboratory data should exist. The results of a randomized, prospective double blinded (surgeon and patient) trial (RCT) of cross-linked versus
Introduction. Total knee replacement (TKR) implant designs and materials have been shown to have a significant impact on tibial insert wear. A medial-pivot (MP) design theoretically should generate less wear due to a large contact area in the medial compartment and lower contact stresses. Synovial fluid aspiration studies have confirmed that a first generation MP TKR system (ADVANCE®, MicroPort Orthopedics Inc., Arlington, TN, USA) generates less wear debris than is seen with other implant designs articulating against
Purpose of the study: The limitations of
We report the outcome of 320 primary Total Hip Arthroplasties (THA) with minimum 10-year follow-up (range 10–17 years, mean 12.6 years), performed by a single surgeon in Tauranga New Zealand, with the Exeter Contemporary Flanged all-polyethylene cup and Exeter femoral stem via a posterior approach. The aim of the study is to compare the results with the published results from the design centre and create a baseline cohort for further outcomes research in this centre. All patients were prospectively followed at 6 weeks, 1 year, 5 years, 10 years, (and 15 years when available). Of 333 cases that matched the inclusion criteria, 13 procedures in 12 patents were excluded because of concomitant bone grafting and/or supplementary cage fixation, leaving 320 primary THA procedures in 280 patients, including 26 bilateral procedures in 13 patients. Mean follow-up of the surviving cases was 12.6 (range 5.0-17.1) years. There were 12 revisions – 2 for fracture, 5 for instability, 1 for impingement pain and 4 for infection. There were no revisions for aseptic cup loosening. Kaplan-Meier survivorship with revision for aseptic loosening as the endpoint was 100% at 15.0 years (with minimum 40 cases remaining at risk). All-cause acetabular revision in 12 cases result in a Kaplan-Meier survival of 95.9% (95% CI: 93.5 to 98.3%). Cemented THA with the Exeter Contemporary Flanged cup and the Exeter stem is a durable combination with results that can be replicated outside of the design centre. The Exeter Contemporary Flanged cup has excellent survivorship at 15 years when used with the Exeter stem. Cemented THA with well-proven components should be considered the benchmark against which newer designs and materials should be compared.
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
The purpose of this study was to compare oxinium versus metal-on-polyethylene wear in two consecutive prospective randomized series of low friction total hip arthroplasty at a minimum 10-year follow-up. A total of 100 patients with a median age of 60.9 years were randomized to receive either oxinium (50 hips) or metal (50 hips) femoral head. The polyethylene socket was EtO sterilized in the first 50 patients, whereas it was highly cross-linked and remelted (XLPE) in the following 50 patients. The primary criterion for evaluation was linear head penetration measurement using the Martell system by an investigator blinded to the material. Also, a survivorship analysis was performed using wear related loosening revised or not as the end point. Complete data were available for analysis in 40 hips at a median follow-up of 12.9 years (11 to 14), and in 36 hips at a median follow-up of 12.3 years (10 to 13) in the EtO sterilized and XLPE series, respectively. In the EtO sterilized series, the mean steady-state wear rate was 0.245 ± 0.080 mm/year in the oxinium group versus 0.186 ± 0.062 mm/year in the metal group (p = 0.009). In the XLPE series, the mean steady-state wear rate was 0.037±0.016 mm/year in the oxinium group versus 0.036±0.015 mm/year in the metal group (p = 0.94). The survival rate at 10 years was 100% in both XLPE series, whereas it was 82.9% (IC 95%, 65–100) and 70.5% (IC95%, 50.1–90.9) in the metal-EtO and oxinium-EtO series, respectively. This RCT demonstrated that up to 14-year follow-up, wear was significantly reduced when using XLPE, irrespective of the femoral head material. Also, no osteolysis related complication was observed in the XLPE series. In the current study, oxinium femoral heads showed no advantage over metal heads and therefore their continued used should be questioned related to their cost.
The purpose of this study was to compare the effect of femoral head material (delta ceramic versus metal) on polyethylene wear in a consecutive prospective randomized series of low friction total hip arthroplasty. A total of 110 patients with a mean age of 60.6 ± 9.3 (34–75) years were randomized (power of 90%, alpha of 5%) to receive either a metal (55 hips) or a delta ceramic (55 hips) femoral head. The polyethylene socket was moderately cross-linked (3 Mrads of gamma radiation in nitrogen) and annealed at 130°C in all hips. All other parameters were identical in both groups. The primary criterion for evaluation was linear head penetration measurement using the Martell system, performed by an investigator blinded to the material of the femoral head. Creep and steady state wear values were calculated. At the minimum of 3-year follow-up, complete data were available for analysis in 38 hips at a median follow-up of 4.4 years (3.0 to 5.7), and in 42 hips at a median follow-up of 4.0 years (3.0 to 5.4) in the metal and delta ceramic groups, respectively. The mean creep, measured as the linear head penetration at one year follow-up, was 0.42 ± 1.0 mm in the metal group versus 0.30 ± 0.81 mm in the delta ceramic group (Mann and Whitney test, p = 0.56). The mean steady state penetration rate from one year onwards measured 0.17 ± 0.44 mm/year (median 0.072) in the metal group versus 0.074 ± 0.44 mm/year (median 0.072) in the delta ceramic group (Mann and Whitney test, p = 0.48). No case of delta ceramic femoral head fracture was recorded, and no hip had signs of periprosthetic osteolysis. This study demonstrated that up to 5-year follow-up, delta ceramic femoral head did not significantly influence creep neither wear of a contemporary annealed polyethylene. Longer follow-up is necessary to further evaluate the potential clinical benefits of delta ceramic.
At 8-years the wear rate was significantly (p<
0.01) lower for Duration [0.088 ± 0.03 mm/yr (0.02–0.14)] than conventional PE [0.142 ± 0.07 mm/yr (0.05–0.31)]. This reduction (−38%) compared well to the simulator (−45%) and did not change over time (−33% at 5-years). Radiolucencies and signs of osteolysis were also less in the Duration group (n.s.).
A high proportion of complications following TKR occur at the patellofemoral articulation secondary to delami-nation and adhesive/abrasive wear. Electron beam cross-linking and melting has been shown to substantially reduce delamination and adhesive/abrasive wear in polyethylene tibial inserts. A series of in-vitro patella wear and fatigue tests were developed to explore the benefits of this material at the patellofemoral articulation. Patellae (NKII, Sulzer Orthopedics, Inc., Austin, TX) were tested on an AMTI (Watertown, MA) knee simulator articulating against the trochlear grove of the femoral component. The simulator controlled flexion/ extension and patellofemoral contact force. Each test included patellae manufactured from conventional and electron beam crosslinked and melted polyethylene. Three different simulations were created: i) normal gait (5 million cycles) with optimal component alignment, ii) stair climbing (2 million cycles) with optimal component alignment, iii) stair climbing (2 million cycles) with 4° of femoral component internal rotation to simulate a component malalignment condition. In the last two simulations all patellae were artificially aged for 35 days in 80°C air to simulate one aspect of the long term oxidative state of each material. In normal gait, the unaged conventional and highly cross-linked materials demonstrated similar behaviour. In stair climbing with optimal component alignment, the aged conventional patellae developed cracks by 2 million cycles. In stair climbing with component malalign-ment the aged conventional patellae developed cracks and delamination by 1 million cycles. None of the highly cross-linked components showed cracks or delamination. These results demonstrate the potential advantage of highly cross-linked polyethylene for the patella.
The aim of this study was to identify the effect of the manufacturing characteristics of polyethylene acetabular liners on the survival of cementless and hybrid total hip arthroplasty (THA). Prospective cohort study using linked National Joint Registry (NJR) and manufacturer data. The primary endpoint was revision for aseptic loosening. Cox proportional hazard regression was the primary analytical approach. Manufacturing variables included resin type, crosslinking radiation dose, terminal sterilization method, terminal sterilization radiation dose, stabilization treatment, total radiation dose, packaging, and face asymmetry. Total radiation dose was further divided into G1 (no radiation), G2 (> 0 Mrad to < 5 Mrad), G3 (≥ 5 Mrad to < 10 Mrad), and G4 (≥ 10 Mrad).Aims
Methods
Aims. Highly cross-linked polyethylene (HXLPE) greatly reduces wear in total hip arthroplasty, compared to