Aims. Radiostereometric analysis (RSA) is the most accurate radiological method to measure in vivo wear of highly cross-linked polyethylene (XLPE) acetabular components. We have previously reported very low wear rates for a sequentially irradiated and annealed X3 XLPE liner (Stryker Orthopaedics, USA) when used in conjunction with a 32 mm femoral heads at ten-year follow-up. Only two studies have reported the long-term wear rate of X3 liners used in conjunction with larger heads using plain radiographs which have poor sensitivity. The aim of this study was to measure the ten-year wear of thin X3 XLPE liners against larger 36 or 40 mm articulations with RSA. Methods. We prospectively reviewed 19 patients who underwent primary cementless THA with the XLPE acetabular liner (X3) and a 36 or 40 mm femoral head with a resultant liner thickness of at least 5.8 mm. RSA radiographs at one week, six months, and one, two, five, and ten years postoperatively and femoral head penetration within the acetabular component were measured with UmRSA software. Of the initial 19 patients, 12 were available at the ten-year time point. Results. The median proximal, 2D, and 3D wear rates calculated between one and ten years were all less than 0.005 mm/year, with no patient recording a proximal wear rate of more than 0.021 mm/year. Importantly, there was no increase in the wear rate between five and ten years. Conclusion. The very low wear rate of X3 XLPE liners with larger articulations remains encouraging for the future clinical performance of this material. Cite this article: Bone Jt Open 2023;4(11):839–845

Introduction. Highly cross-linked polyethylene has been introduced to decrease osteolysis secondary to polyethylene wear debris generation, but there are few long-term data on revision total hip arthroplasty using highly cross-linked polyethylene liners. The purpose of this study was to report the long-term radiographic and clinical outcomes of a highly cross-linked polyethylene liner in revision total hip arthroplasty. Materials & Methods. We analyzed 63 revision total hip arthoplasties that were performed in 63 patients using a highly cross-linked polyethylene liner between April 2000 and February 2005. Of these, nine died and four were lost to follow-up before the end of the 10-year evaluation. Thus, the final study cohort consisted of 50 patients (50 hips). There were 26 males and 24 females with a mean age at time of revision total hip arthoplasty of 53 years (range, 27–75 years). Mean duration of follow-up was 11 years (range, 10–14 years). Results. Mean Harris hip score improved from 44 points preoperatively to 85 points at final follow-up. No radiographic evidence of osteolysis was found in any hip. One hip required re-revision surgery for acetabular cup loosening at 6.5 years postoperatively. One required re-revision with a constrained liner because of recurrent dislocation. Three sustained deep infections requiring additional surgical procedures. Kaplan-Meier survivorship with an end point of re-revision for any reason was 91.0% and for aseptic cup loosening was 97.9% at 11 years (Figs. 1 and 2). Conclusions. At a minimum of 10 years, the highly cross-linked polyethylene liners showed excellent clinical performance and implant survivorship, and were not associated with osteolysis in our group of patients with revision total hip arthoplasties

Introduction. Technological advances in the processing of polyethylene have led to improved survivorship of total hip arthroplasty. The purpose of this study was to determine if a second generation highly cross-linked polyethylene could improve upon wear rates compared to conventional and first generation cross-linked polyethylene in patients undergoing primary total hip arthroplasty. Methods. Linear and volumetric wear rates of a second generation highly cross-linked polyethylene were evaluated following primary total hip arthroplasty. There were 44 patients with an average age of 68.6 years and mean follow-up of 5.3 years. Patients were evaluated at six weeks, one, two and five years. Wear rates were determined from digitized AP Pelvis radiograph by an independent observer using Martell's software. Acetabular inclination and femoral head size were also evaluated to determine variability in wear rates. Results. The mean linear wear rate for the entire group was 0.015mm/year (±0.055). There was a 64% decrease in linear wear rate when compared to a first generation highly cross-linked polyethylene from the same institution. There was a 90% decrease in wear rate compared to conventional polyethylene. There were no differences in the linear wear rate between the 32mm vs. larger head sizes (36mm and 40mm). However, there was a 30% increase in volumetric wear rate with larger head sizes. The mean wear rate in patients with cup inclination less than 45 degrees was 0.006mm/year compared with 0.024mm/year for those with an inclination greater than 45 degrees. The amount of linear wear was increased by 4 times in patients with a cup inclination of greater than 45 degrees. There was no evidence of any osteolysis in this group of patients. Conclusion. Our data with a mean follow-up of 5.3 years, using a second generation highly cross-linked polyethylene, demonstrates a dramatic decrease in incidents of linear wear compared to conventional polyethylene and first generation highly cross-linked polyethylene (Figure 1). Of concern is the higher volumetric wear rate noted with larger head sizes and increased linear wear rates with cup inclination angles of greater than 45 degrees. Despite improvements in wear rates using a second generation highly cross-linked polyethylene, cup orientation and choice of head size play significant roles in implant survivorship

Oxidized zirconium (Oxinium) and highly cross-linked polyethylene (HXLPE) were developed with the purpose of minimizing wear, and subsequent osteolysis, in Total Hip Arthroplasty (THA). However, few articles have been published on long-term results of Oxinium on highly cross-linked polyethylene. The purpose of this investigation is to report minimum 10-year HXLPE wear rates and the clinical outcome of patients in this group and compare this population to a control group of cobalt chrome and ceramic. One hundred forty THAs were performed for 123 patients using an Oxinium head with an HXLPE liner. Ninety-seven had 10 years of clinical follow-up (avg. 14.5). Harris Hip Scores (HHS) were collected preoperatively and at the most recent follow-up. Radiographs of 85 hips were available for a minimum 10-year follow-up (avg. 14.5) and used to calculate wear using PolyWare software. Control groups of cobalt chrome and ceramic articulation on HXLPE with a minimum 10-year follow-up were studied. Clinical follow-up of the Oxinium group showed a statistical improvement compared to preoperative and was similar to the control group of patients. Radiographic evaluation found the linear and volumetric wear rates for the Oxinium group of 0.03 mm/year (range 0.00–0.08) and 3.46 mm. 3. /year (range 1.0 to 15.0) respectively. There was no statistically significant difference in linear or volumetric wear rate between the groups (P-value 0.92 and 0.55 respectively). None of these patients underwent revision of their hip for any reason. Oxinium on highly cross-linked polyethylene has performed exceptionally with wear rates comparable to those of cobalt chrome or ceramic on HXLPE

Introduction and Aims: Modular acetabular designs are widely used in THA procedures and now accommodate highly cross-linked polyethylene liners. However, polymer processing influences material properties, including a decrease in resistance to crack propagation. This study comparatively evaluated locking mechanism integrity of three modular acetabular designs, which employ conventional and highly cross-linked polyethylene liners. Method: Locking mechanism integrity was established for both conventional and highly cross-linked polymers through push-out (n=3) and lever-out (n=3) testing of fully seated liners. When possible, liners were reinserted and forcibly disassembled. Results: The push out and lever out strengths measured for the highly cross-linked polyethylene acetabular liners in this study indicated that short-term disassociation of these components is no more likely than that for the conventional polyethylene liners of each design. Student t-tests confirmed the null hypothesis. In addition, when compared to the strengths of clinically successful modular designs none of the systems evaluated presents any great risk of short-term disassociation. Significant reductions in locking mechanism strength after liner reinsertion were also noted for both polymers. Conclusion: Short-term static disassociation failure of highly cross-linked polyethylene liners were found to be equivalent to conventional polyethylene liners. Given their touted improvement in wear reduction, they would appear to be a reasonable alternative in the young patient requiring THA. Secondarily, neither conventional nor highly cross-linked polymers should be re-inserted for any reason at the time of surgery

Introduction: Wear simulator studies have predicted that highly cross-linked polyethylenes can reduce linear wear by 50–90% when compared to traditional polyethylene (gamma sterilized in air). Clinical experience with a highly cross-linked polyethylene which was irradiated to 10 megarads and cold anneled but not remelted (Crossfire) began in October 1998. Methods: 72 Crossfire implants (69 patients) were implanted and have a minimum 3 year follow-up (mean 3.85 years). 31 of these implants (29 patients) have a minimum 4 year follow-up (mean 4.64 years). Linear wear utilizing a validated computerized technique was measured and compared to 38 hips (37 patients) implanted with a non-cross-linked polyethylene (gamma irradiated – N2 vac) with a mean follow-up of 4.96 years. Results: The mean wear in millimeters per year for the highly cross-linked Crossfire polyethylene with minimum 3 year follow-up was 0.054 (sd=0.032). At minimum 4 year follow-up wear was 0.057 mm/yr (sd=0.036). The wear for the N2 vac non-cross-linked polyethylene was 0.138 mm/yr (sd=0.066). Using a standard t-test the difference in wear was highly significant at p=< 0.001. Discussion & Conclusion: Cross-linking is the only material characteristic shown to improve wear performance of polyethylene. Our clinical experience demonstrates a 50% reduction in wear over N2 vac irradiated polyethylene during the first three years with no significant change out to a mean of 4.64 years. Cross-linked polyethylenes hold great hopes for significant reduction in wear and osteolysis and prolonged life of hip arthroplasty in patients of all ages

Introduction: Electron beam irradiated highly cros-slinked polyethylene has been used in total hip arthroplasty for over 8 years. Due to its low wear characteristics, the use of femoral heads that are greater than 32mm in diameter is now available, allowing for an increase in range of motion and increased stability against dislocation when necessary. The purpose of this study is to provide a summary report on the radiographic analysis of the longest term data available on primary THR patients receiving highly cross-linked polyethylene and to compare the results of two methods of measuring femoral head penetration. Methods: Three prospective clinical studies involving electron beam irradiated highly cross-linked polyethylene have been initiated at our center. To date, the results of: 200 hips with a minimum of 6 year follow-up with conventional sized femoral heads (primarily 28 and 32mm); 45 hips with minimum 5 year follow-up with larger sized femoral heads (primarily 36 and 38mm); and 30 hips with 5 year follow-up enrolled in a Radiostereometric analysis (RSA) study (15 patients with 28mm and 15 patients with 36mm diameter femoral heads); were available for this summary report. Data from patient administered questionnaires (Harris Hip score, UCLA activity score, and WOMAC), radiographic review, and wear analysis using RSA or the Martell Hip Analysis Suite™. In addition, for comparative purposes, wear was measured in a subset of patients using the Devane Polyware™ program. Results: All hips had good clinical outcome at longest follow-up regardless of which femoral head size was used. There were no revisions due to polyethylene wear and no evidence of peri-prosthetic osteolysis. In general, after the bedding in period, there was no significant increase in femoral head penetration regardless of head size. For RSA, the wear rate for the 28mm femoral head group was 0.05±0.02 while the 36mm femoral head group was 0.03±0.02, p=0.13. For the Martell analysis, the average steady-state wear rate was −0.002 ± 0.01 mm per year and −0.026 ± 0.13 mm per year for 28mm and 32mm head sizes, respectively, p=0.62. There was no correlation between wear and time in situ or femoral head size for any of the clinical studies. In comparing the Martell and Devane programs, the total average wear rates were significantly different, 0.07±0.05 and 0.03±0.06mm/year respectively, p=0.01. However, when the absolute values of the Martell results were used, there was no difference, p=0.22. Conclusion: The mid-term follow-up of a large group of primary THR patients receiving highly cross-linked polyethylene components have shown no problems related to the new bearing material. Extremely low wear and lack of peri-prosthetic osteolysis are encouraging results requiring further long-term study

Highly cross-linked polyethylene (HXLPE) is now a common used bearing surface in total hip arthroplasty. Current studies report superior wear rates with the use of HXLPE in total hip arthroplasty. However, there are few studies to support its long term use. The aim of this study is to measure the long term wear of HXLPE and evaluate patient satisfaction at more than 10 years follow up. 44 total hip arthroplasties were performed through a direct lateral approach by a single surgeon. All patients received the same uncemented acetabular component, mean liner thickness was 6.91mm (SD= 0.68). 16 of the femur components were cemented. Outcomes analysed include wear rates, osteolysis, revision rates, SF12 and Oxford hip scores. Wear rate was calculated using computer software (Polyware®) using edge detection software. Mean age at surgery was 58.9 years (SD= 11.67). The mean follow up was 11.3 years (SD= 1.19). There was no evidence of osteolysis and none had undergone revision surgery. Mean two dimensional wear was 0.38mm (SD= 0.25) and mean wear rate per year was 0.03mm (SD= 0.02, range 0.009 to 0.078). Oxford hip score at last follow up indicated satisfactory joint function (mean= 42 SD= 6.2). Our results support the use of highly cross-linked polyethylene in primary total hip replacements. The absence of osteolysis and need for revision surgery over a mean of 11.3 years is very encouraging

Introduction and Aims: While highly cross-linked polyethylene has achieved widespread clinical use based on laboratory testing showing significant wear reduction, there is little clinical information demonstrating its benefits in vivo. This study reports the early clinical and wear performance of a prospective randomised controlled trial comparing highly cross-linked to standard polyethylene. Method: One hundred patients were enrolled in a prospective randomised controlled trial in which all patients received a hybrid THR (cemented Versys stem, Triology cementless acetabulum). The two groups were virtually identical in terms of age, weight, male/female ratio and received identical hip implants, except that one half (50 patients) randomly received a highly cross-linked polyethylene liner. Clinical outcomes were determined using Harris hip, WOMAC and SF-12 scores. Two-dimensional (2D) and three-dimensional (3D) wear rates were determined using a validated radiographic technique based on AP and lateral radiographs at six weeks and one, two and three years post-operatively. Results: At two years minimum follow-up (range two to four years), there were no differences in Harris hip, WOMAC or SF-12 scores. No patients were lost to follow-up, although five patients had died of unrelated causes. There were no infections, dislocations or revisions to date. Wear analysis at one-year post-op showed high penetration rates for both groups (mean 3D wear approximately 0.25 mm/year) consistent with the bedding-in phenomena. At most recent radiographic follow-up (two or three years), there was a statistically significant although modest difference in wear rates between the two groups with a 2D and 3D wear rate of 0.14±0.10 mm/yr and 0.15±0.02 mm/yr respectively for conventional polyethylene compared to 0.09±0.04 mm/yr and 0.11±0.02 mm/yr for cross-linked polyethylene. This represented a 32 and 29 percent reduction in 2D and 3D wear rates respectively with cross-linked polyethylene. Conclusion: At early follow-up, there were no clinical differences. There was a modest wear reduction (approximately 30%) with highly cross-linked polyethylene, considerably less than expected based on laboratory testing. Longer follow-up, after the bedding-in process is completed, is required to demonstrate the wear reduction afforded by highly cross-linked polyethylene

Background. Cross-linked polyethylene has much less wear than conventional polyethylene and can used in a more bone conserving thickness of 4 mm. We have used it for hip resurfacing since 2001. Questions/Purposes. This study evaluated the effectiveness of a highly cross-linked polyethylene acetabular component for hip resurfacing in patients under age 50. I posed 5 questions: (1) What are the functional results, (2) What are the complications, (3) What is the 10-year implant survivorship, (4) What is the femoral head penetration into the polyethylene, and (5) What is the bone conservation?. Participants and Methods. There were 160 resurfacing procedures (144 participants) using a 2 piece acetabular shell and a cobalt chromium femoral component (fig. 1). Participants averaged 43 years of age at the time of surgery (range, 23 – 49.5 years) and 70% were women. Inclusion criteria were patients with adequate acetabular bone and a high enough head-neck ratio so that the reconstruction would not violate the femoral neck cortices or medial acetabular wall. The largest cross-linked polyethylene available was 49 mm so only patients with smaller femoral geometries were included. The Harris, WOMAC, and UCLA hip scores were used to assess pain, activity, and function and participants were asked about their satisfaction with the procedure. Digital radiography and computed tomographic scans were used to evaluate femoral head penetration and osteolysis. Removed polyethylene liners were analyzed. Results. The median follow-up was 11.5 years (range, 10 – 14 years). One participant was lost to follow-up and 1 died. The mean Harris Hip Score was 95 and 95% of the participants rated the results of their procedure as excellent. The average UCLA activity score was 8. One patient underwent successful revision surgery for acetabular loosening. Four participants underwent successful revision to a total hip replacement because of femoral neck fracture (2), femoral loosening, or infection. The Kaplan-Meier survivorship was 96%. There were no revisions for polyethylene wear and there were no instances of osteolysis. The medial acetabular wall thickness averaged 7.3 mm (range, 1.5 mm – 14.9 mm). The mean inclination angle was 39°. The mean femoral head penetration was 0.05 mm/year (range, .028 – .09 mm/year). Conclusions. Hip resurfacing with a highly cross-linked polyethylene acetabular component is a reliable procedure at mid-term follow-up. The rate of polyethylene wear is below the osteolytic threshold of .1 mm/yr. The preservation of both acetabular and femoral bone is reasonable even in comparison to thin metal shells available for metal-on-metal resurfacing and total hip replacement. The functional results are comparable to those of metal-on-metal resurfacing without the concerns of a metal bearing couple. The procedures are demanding and patient selection is critical to the success of the procedure. Although long-term follow-up is needed to determine if implant survivorship with highly cross-linked polyethylene acetabular components will equal that of metal-on-metal prostheses, the low rate of femoral head penetration suggests that many years of use in young highly active participants are possible

Background. The advent of highly cross-linked polyethylene has resulted in improved wear rates and reduced osteolysis with at least intermediate follow-up when compared to conventional polyethylene. However, the role of alternative femoral head bearing materials in decreasing wear is less clear. The purpose of this study was to determine in-vivo polyethylene wear rates across ceramic, Oxinium, and cobalt chrome femoral head articulations. Methods. A review of our institutional database was performed to identify patients who underwent a total hip arthroplasty using either ceramic or oxidized zirconium (Oxinium) femoral head components on highly cross-linked polyethylene between 2008 and 2011. These patients were then matched on implant type, age, sex and BMI with patients who had a cobalt chrome bearing implant during the same time period. RSA analysis was performed using the center index method to measure femoral head penetration (polyethylene wear). Secondary quality of life outcomes were collected using WOMAC and HHS Scores. Paired analyses were performed to detect differences in wear rate (mm/year) between the cobalt chrome cohorts and their matched ceramic and Oxinium cohorts. Additional independent group comparisons were performed by analysis of variance with the control groups collapsed to determine wear rate differences between all three cohorts. Results. A total of 75 patients underwent RSA analysis. 20 patients with a ceramic femoral head component and 16 patients with an Oxinium femoral head component along with the same number of matched patients with cobalt chrome femoral head component were included in the analysis. The time in vivo for the Oxinium (5.17 +/− 0.96 years), Oxinium matched cohort (5.13 +/− 0.72 years), ceramic (5.15 +/− 0.76 years) and ceramic matched cohort (5.36 +/− 0.63 years) were comparable. The demographics of all bearing surface cohorts were similar. The paired comparison between the Oxinium and cobalt chrome cohorts (0.32 vs. 0.28 mm/year, p=0.427) and ceramic vs cobalt chrome cohorts (0.28 vs. 0.22 mm/year, p=0.202) did not demonstrate a significant difference in wear rate. The independent groups analysis revealed a significantly higher wear rate of Oxinium (0.33 mm/year) compared to cobalt chrome (0.24 mm/year) (p = 0. 038). There were no differences in HHS and WOMAC scores between the Oxinium and cobalt chrome cohorts (HHS: p = 0.71, WOMAC: p=0.08) or the ceramic and cobalt chrome cohorts (HHS: p=0.15, WOMAC: p =023). Conclusion. This study presents evidence of a greater wear rate (mm/year) of the Oxinium femoral head component compared to a cobalt chrome femoral head component. This difference was not demonstrated in the ceramic femoral head component. Despite this difference, there were no clinical differences as measured by the HHS and WOMAC. Future research should focus on factors that may contribute to the higher wear rate seen in the Oxinium cohort. Level of Evidence – Level II. Disclosures - Institutional support provided by Depuy, Stryker, and Smith and Nephew

The advent of highly cross-linked polyethylene has resulted in improved wear rates and reduced osteolysis with at least intermediate follow-up when compared to conventional polyethylene. However, the role of alternative femoral head bearing materials in decreasing wear is less clear. The purpose of this study was to determine in-vivo polyethylene wear rates across ceramic, Oxinium, and cobalt chrome femoral head articulations. A review of our institutional database was performed to identify patients who underwent a total hip arthroplasty using either ceramic or oxidised zirconium (Oxinium) femoral head components on highly cross-linked polyethylene between 2008 and 2011. These patients were then matched on implant type, age, sex and BMI with patients who had a cobalt chrome bearing implant during the same time period. RSA analysis was performed using the centre index method to measure femoral head penetration (polyethylene wear). Secondary quality of life outcomes were collected using WOMAC and HHS Scores. Paired analyses were performed to detect differences in wear rate (mm/year) between the cobalt chrome cohorts and their matched ceramic and Oxinium cohorts. Additional independent group comparisons were performed by analysis of variance with the control groups collapsed to determine wear rate differences between all three cohorts. A total of 68 patients underwent RSA analysis. Fifteen patients with a ceramic femoral head component and 14 patients with an Oxinium femoral head component along with the same number of matched patients with cobalt chrome femoral head component were included in the analysis. The time in vivo for the Oxinium (5.17 +/− 0.96 years), Oxinium matched cohort (5.13 +/− 0.72 years), ceramic (5.15 +/− 0.76 years) and ceramic matched cohort (5.36 +/− 0.63 years) were comparable. The demographics of all bearing surface cohorts were similar. The paired comparison between the Oxinium and cobalt chrome cohorts (0.33 vs. 0.29 mm/year, p=0.284) and ceramic vs cobalt chrome cohorts (0.26 vs. 0.20 mm/year, p=0.137) did not demonstrate a significant difference in wear rate. The independent groups analysis revealed a significantly higher wear rate of Oxinium (0.33 mm/year) compared to cobalt chrome (0.24 mm/year) (p = 0. 038). There were no differences in HHS and WOMAC scores between the Oxinium and cobalt chrome cohorts (HHS: p = 0.71, WOMAC: p=0.08) or the ceramic and cobalt chrome cohorts (HHS: p=0.15, WOMAC: p=023). This study presents evidence of a greater wear rate (mm/year) of the Oxinium femoral head component compared to a cobalt chrome femoral head component. This difference was not demonstrated in the ceramic femoral head component. Despite this difference, there were no clinical differences as measured by the HHS and WOMAC. Future research should focus on factors that may contribute to the higher wear rate seen in the Oxinium cohort

Highly cross-linked polyethylene (HXLPE) is one of the most widely utilized bearing surfaces for total hip arthroplasty (THA). The first patients to receive XLPE will be 10 years post-op as of December 31, 2008. The purpose of this study is to report the long-term clinical and radiographic outcomes of patients implanted with HXLPE. A group of 247 primary total hip replacements (224 patients) using HXLPE liners (Longevity or Durasul, Zimmer Inc.) with 22, 26, 28, or 32mm femoral heads were implanted between 1999 and 2001. Clinical evaluation measures included the Harris hip, EQ-5D, SF-36 functional scores, and UCLA activity scores. In addition to plain radiograph assessment, the computerized Martell method was used to measure head penetration over time. A matched group of 241 primary total hip replacements (201 patients) with the same head sizes using conventional polyethylene (PE) with a minimum of 7 years follow-up was used as a Martell method control group. The steady state penetration rate was defined as the slope of the linear regression line of the plot of head penetration from the 1 year film to each subsequent film to discount the early bedding-in process. A student’s t-test was used to compare wear rates between head sizes in each group, and a repeated-measures mixed model ANOVA was used to compare the groups for the 28mm head size. There were no osteolytic lesions around the cup or stem, and no revisions were performed for polyethylene wear or liner fracture. Clinical outcome scores were averaged: Harris Hip 88.1±11.97, EQ-5D 74.0±27.0, SF-36 physical activity scores 53.3±8.4, SF-36 mental score 46.9±11.1, and UCLA activity 6.4±2.1. The steady state wear of the conventional polyethylene patients increased with time for both 26 and 28mm head sizes (0.144 and 0.127mm/year, respectively). No significant difference was found between the head sizes coupled with conventional polyethylene (p=0.14). Femoral head penetration in the highly cross-linked polyethylene did not increase over time after the first year. The steady state wear rates of HXLPE liners with 28mm or 32mm femoral heads were not significantly different than a slope of zero (p=0.54 for both head sizes). Clinical follow-up results are typical of a primary THR patient population, and the radiographic results are excellent with no signs of peri-prosthetic osteolysis. Patients with PE show wear rates that are significantly different than zero indicating significant wear of the material. Conversely, patients with HXLPE display no measureable wear at 7–9 years as the wear rates were within the error detection of the Martell method. This long-term clinical and radiographic follow-up study for this new bearing material shows excellent clinical outcomes with very low in vivo wear

Introduction. Total hip replacements using highly cross-linked polyethylene show excellent clinical outcomes, low wear, and minimal lysis at 5 years follow-up. A recent RSA study reports a significant increase in femoral head penetration between 5 and 7 years. This study is a multi-center radiographic analysis to determine whether the RSA observation is present in a large patient cohort. Methods. Six centers were enrolled for radiographic analysis of primary total hip arthroplasty for standard head sizes (26mm, 28mm, or 32mm). Radiographic inclusion criteria required a minimum of four films per patient at the following time points: 1 year; 2–4.5 years; 4.5–5.5 years; and 5.5–11 years. The Martell Hip Analysis Suite was used to analyze pelvic radiographs resulting in head penetration values. Wear rates were determined in two ways: the longest follow-up radiograph compared to the 1 year film, and individual linear regressions for the early and late periods. For both methods, average wear rates from the early period (1 to 5.5 years) and late period (>5.5 years) were compared using t-tests. Results. We present the completed analysis of 235 of the 250 hips under active analysis with 3160 film comparisons. Average follow-up was 7.2±0.99 years (range 5.4–10.1). Based on latest follow-up, the average wear rate was not significantly different during the early and late periods (10.1±95μm/year and −3.8±235μm/year respectively, p=0.518). Based on the group regression, the average wear rate was not significantly different during the early and late periods (7.5μm/year and −36μm/year respectively, p=0.13). Conclusion. In this large multicenter radiographic study, we found no late increase in femoral head penetration into highly cross-linked polyethylene as suggested by the RSA report. Additional centers and patients are being recruited in order to reduce the variation in the late period

Highly cross-linked polyethylene (HXLPE) has decreased wear and revision rates in total hip replacement (THR) at a long-term. However, the effect of HXLPE manufacturing characteristics on femoral head penetration has not been clearly defined yet. We report this single-institution study to investigate the clinical and radiological results of different HXLPE liners in THR. In this retrospective cohort analysis of our prospective database, we identified 904 THRs performed between 2000 and 2013. Seven different HXLPE liner types were assessed: remelted (3), annealed (2), sequentially annealed (1) and vitamin E-infused (1). The linear femoral head penetration rate was measured at six weeks, one year, and annually thereafter, using the Roman Software v1.70 package. Thirty hips were revised for the following reasons: aseptic loosening (11), dislocation (12), periprosthetic femoral fracture (6), and infection (1). No hip was revised for wear or osteolysis. 741 THRs were evaluated for a mean follow-up of 15 years (range, 10 to 20). The mean total penetration 15 years after THR was 0.17 mm in the sequentially annealed, and 0.16 mm in the vitamin E-infused groups, whereas it was 0.26 mm in the melted 95 kGy, 0.27 mm in the melted 5 Mrad and 0.25 mm in the melted 100 kGy groups (p=0.001). From one to 15 years after surgery, the mean wear was 0.206 mm in cups with an acetabular inclination greater than 50º and 0.105 mm in those placed between 35º and 50º (p<0.001). Although HXLPE characteristics can result in a different wear performance in patients undergoing THR at a mean follow-up of 15 years, the clinical results are excellent. The position of the acetabular component can influence on the femoral head penetration of modern HXLPEs. Nevertheless, these patients should continue to be monitored to detect future problems

Studies of patients having primary THR using highly cross-linked polyethylene show excellent clinical outcomes and very low radiographic wear results at a minimum of 5 years follow-up. Recently, a radiostereometric analysis (RSA) study of a small group of patients reported that after no detectable wear during years 1–5, they found a significant increase in femoral head penetration between 5 and 7 years follow-up. However, this increase in head penetration after 5 years has not been confirmed in a larger patient cohort. The purpose of this study was to organize a multicenter radiographic study involving leading medical centers in the U.S. having the longest-term follow-up available on this type of highly cross-linked polyethylene in order to determine if the RSA observation can be confirmed in a larger study. Six academic centers agreed to contribute radiographic data to this study. All patients received primary total hip replacements with Longevity polyethylene liners (Zimmer, Warsaw, IN) coupled with 26, 28, and 32mm cobalt chrome femoral heads. The radiographic inclusion criteria required a minimum of four radiographs per patient: one at 1 year; at least one from 2 to 4.5 years; one 4.5 to 5.5 years; and at least one from 5.5 to 9 years follow-up. The Martell Hip Analysis Suit-eTM software was used for the wear analysis. All wear values were determined by calculating head penetration between the follow-up radiograph and the 1-year radiograph to remove creep, the majority of which has been shown to occur during the first year. Separate linear regressions, representing the wear rates, were computed for the early period from 1 year to 5.5 years and the late period from 5.5 years to 9 years follow-up. The Zar test was used to determine the significance of the difference between these two linear regressions. We present the completed analysis of 165 hips. When the early and late data points were combined into one data set, the second-order regression indicated an inflection point at 6.3 years with a slightly positive inflection. There were 402 film comparisons in the early time period, and the slope and confidence interval of the regression line was 4.9μm/yr (95% CI of −28μm/yr to 38μm/yr). There were 188 film comparisons in the late period, and slope of the regression line for the late period was 10.8 μm/yr (95% CI of −58μm/yr to 80μm/yr). The Zar test showed no significant difference between the two slopes (Figure 1, p=0.886). No significant increase in femoral head penetration was found for the late period after 5 years compared to the early period before 5 years follow-up in either analysis. Additionally, no significant late increase in wear was seen within individuals. While we continue to enroll patients, at this time we do not observe the increase in wear seen in the RSA study after 5 years

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. Vitamin-E (VE, dl-α-tocopherol) is a powerful antioxidant for highly cross-linked polyethylene (XLPE). It was previously reported that VE-stabilized XLPE succeeded in retaining no measurable oxidation even after accelerated aging tests combined with cyclic loading or lipid absorption. Thus, VE-stabilized XLPE is nowadays recognized worldwide as one of the new standard materials in total hip arthroplasty (THA). However, the effects of such VE addition on physical behavior of polyethylene remain to be fully elucidated by contrast to the clear statement of its chemical role (i.e., the enhanced oxidation resistance) in the published literature. In this presentation, we shall attempt to provide those missing notations and to explore the microstructural and biomechanical role of VE in XLPE acetabular liner on the molecular scale. Methods. The two different types of XLPE acetabular liners, VE-blended and VE-free (no VE-blended) component (n=3 for each sample), were investigated by means of laser-scanning confocal polarized micro-Raman spectroscopy. In both components, the cross-linking was achieved by electron-beam irradiation with a total dose of 300kGy in vacuum. Raman spectroscopy offers non-destructive, contactless, and high-resolution analyses of polymer morphologies. In this study, we performed an in-depth profiling of crystalline and non-crystalline phase (i.e., amorphous and intermediate phase between crystalline and amorphous regions) percentages and degree of molecular orientation in the above two liners before and after introducing the 10% plastic deformation via uniaxial compression loading at room temperature. These results were also compared to the morphological analyses under the same compression conditions performed on the virgin conventional polyethylene (Virgin liner) without radiation crosslinking as well as VE blending. Results. In the deformed state, Virgin and VE-blended liner showed a pronounced development of the surface crystalline texture. On the other hand, deformation-induced texturing occurred at much less extent in VE-free liner. According to the results of phase percentages, there was no crystallinity change in VE-blended liner by contrast to the marked increase of crystallinity in Virgin and VE-free liner after compression deformation. Alternatively, amorphous-to-intermediate phase transition was confirmed in VE-blended liner. Discussion/Conclusion. We found molecular rearrangement and phase transitions in crystalline and non-crystalline phase as a reconstruction process after plastic deformation in the investigated samples, which can be deeply related to their wear and mechanical properties. The morphological comparisons between Virgin and VE-free liner suggested that the intermolecular cross-linked networks in polyethylene highly restricted the molecular chain mobility as evidenced by few texture evolutions in VE-free liner. On the other hand, the comparisons between VE-free/-blended liner indicated that the presence of VE might promote molecular chain mobility even in the cross-linked structure, resulting in the significant surface texturing. These physical and structural aspects of VE blending would imply the possibility of the increased micromechanical wear through the strain-softening and weakening phenomena due to the molecular reorientation during in-vivo service. However, in other words, wear resistance of VE-blended liner might be further maximized by the more rigid control of molecular movements

Introduction A biomechanical model was developed to measure wear of all-polyethylene patellar components as it relates to femoral component mal-rotation. The model, based on high load and flexion activities such as stair climbing, was used to differentiate the effects of femoral mal-rotation and differing materials on a single patellar design. Methods The patellar components (Scorpio®, Stryker-Howmedica-Osteonics) were cemented onto metal fixtures and articulated against “aligned” and “mal-aligned” (six degrees internally rotated) femoral components. The patellar components were subjected to a constant force and articulated against femoral components flexing from 600 to 1200. Patellae of identical geometry, made of conventional and highly cross-linked ultra-high molecular weight polyethylene, were tested to 1x106 cycles. Following testing, patellar wear was determined by gravimetric measurement relative to soaked control specimens. Results All conventional polyethylene patellae demonstrated damage in the form of burnishing and scratching of the articular surface. The mal-aligned conventional ultra-high molecular weight patellae demonstrated increased weight loss or wear relative to the aligned components (p=.048). All rotationally mal-aligned highly cross-linked polyethylene components sustained polyethylene fracture or catastrophic failure of the cement-polyethylene construct. Conclusions Rotational mal-alignment of the femoral component will result in increased wear of polyethylene patellar components. The newer highly cross-linked materials failed to resolve this wear problem and sustained catastrophic failure when mal-aligned. Attention needs to be given to the patella-femoral articulation when implanting knee components and when developing new polyethylene as the forces in this articulation may result in polyethylene behaviour that varies dramatically from the femoraltibial articulation. In relation to the conduct of this study, one or more of the authors has received, or is likely to receive direct material benefits

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 analysis of HX-PE liner under steep acetabular cup position. Furthermore, a finite element analysis (FEA) was performed in order to calculate the stress within the HX-PE material in case of steep cup position under physiological loading. Experimental wear testing was performed for 5 Mio load cycles, using highly cross-linked polyethylene (HX-PE) acetabular liner combined with 44 mm ceramic femoral heads at a standard position of the acetabular cup (30° inclination) according to ISO 14242 as well as at 60° cup inclination. The wall thickness of the HX-PE liner was 3.8 mm. A hip wear simulator, according to ISO 14242 (EndoLab GmbH, Rosenheim, Germany), was used and wear was determined gravimetrically. Moreover, finite element models of the THR system at standard and steep cup position was created by Abaqus/CAE (Dessault Systemes Providence, USA). Using the finite element software Abaqus (Dessault Systemes Providence, USA) the total hip implants were physiologically loaded with maximum force of the gait cycle (3.0 kN). Thereby, the stresses within the HX-PE material were analysed. The average gravimetrical wear rates of the HX-PE liners at standard implant position (30°) and 60° cup inclination showed small wear amounts of 3.15 ± 0.32 mg and 1.92 ± 1.00 mg per million cycles, respectively. The FEA revealed a clear increase of stresses at the HX-PE liner with respect to steep cup position (von Mises stress of 8.78 MPa) compared to ISO standard implant position (von Mises stress of 5.70 MPa). The wear simulator tests could not demonstrate significant differences of gravimetrical wear amount of HX-PE liners under steep hip cup position compared to standard implant position. The small contact surface between the femoral head and the SX-PE liner during the wear testing may lead to the low wear rate of the misaligned acetabluar cup. Moreover, the FEA showed that the effect of a misaligned acetabular cup on the stresses within the polyethylene liner can be critical. Although an increase of wear could not be detected a steeper acetabular cup position using thin HX-PE liners should be avoided due to higher stresses preventing implant failure in clinical application