Increase in early polyethylene wear after sterilization with ethylene oxide: radiostereometric analyses of 201 total hips

We evaluated polyethylene wear by measuring femoral head penetration in 201 THA (median age 62 (31-81) years, 117 women) extracted from 5 randomized studies aimed to assess various fixation principles. There were 30 cemented all-polyethylene Lubinus cups sterilized by gamma irradiation in a reduced oxygen environment, 65 porous-coated Trilogy cups with liners gamma-sterilized in inert gas. Moreover, 37 cemented cups were sterilized with ethylene oxide (Reflection all-poly) and 69 porous-coated cups had liners sterilized in ethylene oxide (Reflection). 28 mm femoral heads were used in all cups. The patients were followed with repeated radiostereometric measurements (RSA) up to 2 years. The activity level of the patients was evaluated by a questionnaire. After 2 years, cups with polyethylene sterilized in EtO had almost twice the proximal and 3D penetration rates, as compared with gamma-sterilized polyethylene. The penetration did not differ between the gamma-irradiated designs. Using stepwise linear regression analysis, we found that the type of sterilization, age and weight were the most important predictors and that they determined the direction of the proximal penetration rate. Activity score, male gender and proximal migration of the cup had little effect. The accelerated wear observed with the EtO-sterilized polyethylene causes concerns about long-term problems and especially in younger patients.     

Increase in early polyethylene wear after sterilization with ethylene oxideRadiostereometric analyses of 201 total hips

We evaluated polyethylene wear by measuring femoral head penetration in 201 THA (median age 62 (31-81) years, 117 women) extracted from 5 randomized studies aimed to assess various fixation principles. There were 30 cemented all-polyethylene Lubinus cups sterilized by gamma irradiation in a reduced oxygen environment, 65 porous-coated Trilogy cups with liners gamma-sterilized in inert gas. Moreover, 37 cemented cups were sterilized with ethylene oxide (Reflection all-poly) and 69 porous-coated cups had liners sterilized in ethylene oxide (Reflection). 28 mm femoral heads were used in all cups. The patients were followed with repeated radiostereometric measurements (RSA) up to 2 years. The activity level of the patients was evaluated by a questionnaire. After 2 years, cups with polyethylene sterilized in EtO had almost twice the proximal and 3D penetration rates, as compared with gamma-sterilized polyethylene. The penetration did not differ between the gamma-irradiated designs. Using stepwise linear regression analysis, we found that the type of sterilization, age and weight were the most important predictors and that they determined the direction of the proximal penetration rate. Activity score, male gender and proximal migration of the cup had little effect. The accelerated wear observed with the EtO-sterilized polyethylene causes concerns about long-term problems and especially in younger patients.     

Wear and migration of highly cross‐linked and conventional cemented polyethylene cups with cobalt chrome or Oxinium femoral heads: A randomized radiostereometric study of 150 patients

This randomized study was performed to compare wear and migration of five different cemented total hip joint articulations in 150 patients. The patients received either a Charnley femoral stem with a 22.2 mm head or a Spectron EF femoral stem with a 28 mm head. The Charnley articulated with a γ‐sterilized Charnley Ogee acetabular cup. The Spectron EF was used with either EtO‐sterilized non‐cross‐linked polyethylene (Reflection All‐Poly) or highly cross‐linked (Reflection All‐Poly XLPE) cups, combined with either cobalt chrome (CoCr) or Oxinium femoral heads. The patients were followed with repeated RSA measurements for 2 years. After 2 years, the EtO‐sterilized non‐cross‐linked Reflection All‐Poly cups had more than four times higher proximal penetration than its highly cross‐linked counterpart. Use of Oxinium femoral heads did not affect penetration at 2 years compared to heads made of CoCr. Further follow‐up is needed to evaluate the benefits, if any, of Oxinium femoral heads in the clinical setting. The Charnley Ogee was not outperformed by the more recently introduced implants in our study. We conclude that this prostheses still represents a standard against which new implants can be measured. © 2011 Orthopaedic Research Society Published by Wiley Periodicals, Inc. J Orthop Res 29: 1222–1229, 2011     

In vivo wear and migration of highly cross-linked polyethylene cups a radiostereometry analysis study

In 50 cemented hip arthroplasties, wear and migration of the polyethylene (PE) cups were measured with radiostereometric analysis for a period of 2 years. Twenty had a normal gamma-in-air-sterilized PE, another 20 had a PE sterilized with 30000 Gy followed by heat stabilization (Duration; Stryker Orthopaedics, Mahwah, NJ), and 10 had highly cross-linked PE cups irradiated with 100000 Gy (Crossfire; Stryker Orthopaedics). In the initial 2 months, head penetration (creep) was 63 microm on average for the 3 groups. From 2 to 24 months, the mean proximal head penetration (wear) was 156 microm for standard PE, 138 microm for stabilized PE (P = .45), and 23 microm for highly cross-linked PE (P < .001; analysis of variance). The low in vivo wear rate for highly cross-linked cups was not at the expense of higher migration or less favorable clinical outcome and looks promising.     

Polyethylene sterilized without irradiation in a polished uncemented acetabular component-a clinical and radiographic analysis

Clinical and radiographic analysis of the Reflection uncemented acetabular component was performed. Features of this component include a polished inner shell and ethylene oxide sterilization. Clinical information was available for 158 hips (mean, 4.6 years follow-up). A total of 19 hips have undergone or were recommended revision, 8 for aseptic loosening or wear (5%). Wear analysis was performed for 38 hips with more than 5 years of follow-up (mean, 6.7 years). Osteolysis was present in 20 of these patients. Penetration rate averaged 0.15 mm/y. Patients with uncemented femoral fixation (vs cemented) had a significantly higher penetration rate. Increased volumetric wear was seen with uncemented femoral fixation, thin liners, and ceramic heads. This component demonstrated relatively high penetration and osteolysis rates. Continued surveillance is recommended, particularly for active patients with thin liners.     

The influence of acetabular inclination angle on the penetration of polyethylene and migration of the acetabular component: a prospective, radiostereometric study on cemented acetabular components

In this prospective study we studied the effect of the inclination angle of the acetabular component on polyethylene wear and component migration in cemented acetabular sockets using radiostereometric analysis. A total of 120 patients received either a cemented Reflection All-Poly ultra-high-molecular-weight polyethylene or a cemented Reflection All-Poly highly cross-linked polyethylene acetabular component, combined with either cobalt-chrome or Oxinium femoral heads. Femoral head penetration and migration of the acetabular component were assessed with repeated radiostereometric analysis for two years. The inclination angle was measured on a standard post-operative anteroposterior pelvic radiograph. Linear regression analysis was used to determine the relationship between the inclination angle and femoral head penetration and migration of the acetabular component. We found no relationship between the inclination angle and penetration of the femoral head at two years' follow-up (p = 0.9). Similarly, our data failed to reveal any statistically significant correlation between inclination angle and migration of these cemented acetabular components (p = 0.07 to p = 0.9).     

Analysis of survivorship after total hip arthroplasty using a ceramic head

To determine the clinical efficacy of an alumina ceramic head, 119 cemented total hip arthroplasties in 97 patients using an alumina head coupled with ethylene oxide gas sterilized polyethylene were reviewed. Eighty-two patients (101 hips) with greater than 10 years followup were evaluated clinically and radiographically (range, 10-17.6 years), and 97 patients (119 hips) were evaluated for survivorship analysis (range, 0.6-17.6 years). The average functional hip scores according to Merle d'Aubigné and Postel improved from 8.6 preoperatively to 15.0 at the final followup, and 57 patients (64 hips) had no pain. The average polyethylene wear rate was 0.15 mm/year (range, 0.04-0.34 mm/year). Patients with polyethylene wear greater than 3 mm showed significantly higher rates of acetabular loosening. Fifteen-year survival rates (with 95% confidence intervals) with radiographic evidence of aseptic loosening as the end point were 46.8% +/- 13.4% in acetabular components and 91.9% +/- 6.6% in femoral components. Fifteen-year survival rates of hip arthroplasties with revision because of aseptic loosening as the end point were 75.3% +/- 10.2% and 97.9% +/- 3.0%, respectively. Results of the current study suggest that using an alumina head instead of a metal head may not be beneficial when coupled with ethylene oxide gas sterilized polyethylene.     

Long-term in vivo wear performance of porous-coated acetabular components sterilized with gamma irradiation in air or ethylene oxide

This study evaluated the long-term in vivo wear performance of 2 groups of well-functioning cementless acetabular cups sterilized by different methods. The first group included 31 hips that were implanted with AML TriSpike cups (DePuy, Warsaw, IN) sterilized by gamma-irradiation in air. The second group included 28 hips implanted with Arthropor cups (Joint Medical Products, Stamford, CT) that were sterilized with ethylene oxide. Time-dependent variations in the radiographic wear rates were compared within each group. Changes in the wear rates between 4- and 16-year follow-up times for the TriSpike cups were not significant (P=.09), and there was no evidence to suggest a trend toward substantially increasing wear rates with longer follow-up times. Among the Arthropor cups, the wear rates remained relatively constant between 2 and 14 years of follow-up evaluation. Although clinically apparent late increases in radiographic head penetration rates were not evident, we will continue to monitor all patients for evidence of accelerated wear at late follow-up.     

The Otto Aufranc Award. Highly cross-linked polyethylene in total hip arthroplasty: randomized evaluation of penetration rate in cemented and uncemented sockets using radiostereometric analysis

The annual wear rate in polyethylene articulations should be 0.1 mm or less to avoid future osteolysis. Highly cross-linked polyethylene shows an 80 to 90% wear reduction in hip simulator testing, but the clinical documentation of this new polyethylene is still inadequate. We evaluated the highly cross-linked polyethylene in two prospective randomized clinical studies. Thirty-two patients (12 men, 20 women; 64 hips) with a median age of 48 years (range, 29-70 years) with bilateral primary or secondary arthrosis of the hip had hybrid total hip arthroplasty with liners made of highly cross-linked polyethylene on one side and conventional polyethylene on the other. Twenty-seven patients in this study have passed 2 years followup. A further group, comprised of 60 patients (61 hips) with a median age of 55 years (range, 35-70 years), was randomized to receive either highly cross-linked polyethylene or conventional cemented all-polyethylene of the same design. Forty-nine of these 60 patients have been observed for 3 years. In both studies all patients received Spectron stems with 28-mm Co-Cr heads. Radiostereometric examinations with the patient supine or standing were done at regular intervals. Wear was measured in the supine position from the first postoperative week, whereas standing examinations were initiated 3 months after the operation. The penetration rate almost was identical in the study and control groups at 6 months after the operation. Thereafter, the penetration rate leveled out in the two groups with highly cross-linked polyethylene. At 2 years the highly cross-linked polyethylene liner showed 62% lower proximal penetration and 31% lower total (three-dimensional) penetration when the patients were examined in supine position. The highly crosslinked all-polyethylene cemented cups showed lower proximal penetration in both positions. The better wear performance of highly cross-linked polyethylene could increase the implant longevity. Longer followup is needed to evaluate if this new material is associated with less occurrence of osteolysis.     

Total hip arthroplasty in patients less than 40 years old with avascular necrosis of the femoral head. A 5 to 19-year follow-up study

We evaluated 34 total hip arthroplasties (THA) for avascular necrosis of the femoral head in 26 patients who were younger than 40 years at the time of the index operation. The average age at the time of THA was 283 (17-38) years. The mean follow-up was 10.9 (5-19) years. We used 6 cemented and 28 cementless acetabular components and a cemented polished tapered stem in all hips. The mean Charnley modified Merle d' Aubigné Postel score was 8.9 points preoperatively and 16.6 points at final follow-up. Two cemented metal-backed cups were revised because of aseptic loosening at 10 years, one cemented polyethylene cup failed at 12 years and 2 more all polyethylene cups had pending failure. The metal-backed cemented cups and the all polyethylene cups had a longer follow-up than the uncemented cups. Therefore and because of the proven unfavourable long-term outcome of the cemented metal-backed Exeter cup we are not able to draw any firm conclusions regarding the preferred choice between cemented and uncemented cups in this particular group of patients. On the femoral site none of the stems had to be revised. Our results show that a cemented polished tapered femoral component has an excellent survival in primary total hip replacement in young patients with avascular necrosis of the femoral head.     

Cementless acetabular replacement in the young. A 5- to 10-year prospective study

This article presents a prospective clinical and radiologic review of 55 total hip replacements in 50 patients in which the cementless Harris-Galante porous-coated acetabular component was used. All patients were 50 years of age or younger. The cups were inserted by 15 different surgeons. The minimum followup was 5 years, with a mean of 7 years. No acetabular component has been revised for loosening, and none have migrated. Three (5.5%) cups have progressive bone-component radiolucent lines, two (3.6%) of which are complete. Six (10.9%) acetabular liners have been replaced for excessive polyethylene wear, and an additional four (7.3%) show sufficient wear to produce obvious radiographic eccentricity of the femoral head. All of the revised liners had 32-mm femoral heads and an initial polyethylene thickness of less than 6 mm. Although the results reflect excellent fixation of this component in the medium term, the incidence of exchange of the polyethylene liner for excessive wear is unacceptably high. The reduction in polyethylene thickness associated with the use of a metal-backed component and a 32-mm articulation was one of the factors contributing to the accelerated wear patterns seen in this series.     

The pros and cons of polyethylene sterilization with gamma irradiation

This retrospective study evaluated the implant, patient and surgical factors associated with polyethylene wear for one type of porous-coated hemispheric total hip arthroplasty cup. Radiographic wear measurements among 567 Duraloc cups (512 patients) revealed that liners sterilized by gamma-irradiation wore 0.085 mm/year less than those that were sterilized by gas-plasma, a noncross-linking chemical surface treatment. The substantially decreased wear rate associated with gamma-irradiation was attributed to sterilization-induced polyethylene cross-linking. Shelf-aging adversely affected liners that were gamma irradiated in air. On average, highly crystalline Hylamer liners showed a 0.064 mm/year increase in wear rates for each year of shelf storage after terminal sterilization with gamma-irradiation in air. Among conventional Enduron liners, the effect of shelf aging after gamma-irradiation in air was more modest, increasing wear rates by 0.014 mm/year for each year of shelf storage. Because Hylamer's wear performance degraded at about five times the rate of Enduron's, the improved wear resistance associated with gamma-irradiation in air would be lost after 1.3 years of shelf aging for Hylamer compared with 6.1 years for Enduron. For every additional year of age at the time of surgery, the wear rate decreased by 0.003 mm/year. Increased body mass index, a preoperative diagnosis of inflammatory arthritis, and a ceramic femoral head also were associated with decreased wear rates.     

Porous-coated cups fixed with screws: A 12-year clinical and radiostereometric follow-up study of 50 hips

Background?Excellent mid-term results have stimulated the use of hemispherical porous-coated cups in hip replacement. With longer follow-up, there have been problems related to polyethylene wear and liner fixation, and osteolysis has been documented in reports of selected cases. We evaluated the clinical and radiographic results of 50 patients followed for 12 years.

Patients and methods?58 consecutive patients (58 hips), mean age 55 years, were operated with Harris-Galante (HG) I or II cups using line-to-line fit and additional screw fixation. Polyethylene linersγ-sterilized in air and 32-mm ceramic heads were used. 8 patients died within 12 years, leaving 50 patients with a complete 12year follow-up. 23 of the cups were also evaluated with radiostereometry (RSA) for migration, liner stability, and wear.

Results?All metal shells were still in situ after 12 years. 4 hips had been revised due to femoral loosening. In these revisions, the liner had been exchanged due to wear and/or instability, resulting in a cup survival rate of 89%. 28 cups displayed osteolytic lesions, mainly in relation to screws. RSA revealed minimum translations, but in many cases there were pronounced liner rotations suggesting unstable liners within the metal shell. The annual proximal wear was 0.09 mm and the three-dimensional wear was 0.16 mm.

Interpretation?RSA can predict the long-term performance of cup fixation. Low migration during the initial years after implantation indicates excellent long-term results regarding fixation of the metal shell. The main problem with this design appears to be liner instability and osteolysis, factors that are probably interrelated. Because these phenomena are clinically silent, we recommend regular follow-up of patients with HG cups to avoid sudden loosening and complicated revisions.     

Very low wear of non-remelted highly cross-linked polyethylene cups: An RSA study lasting up to 6 years

Background and purpose?Highly cross-linked polyethylenes (PEs) all appear to reduce wear dramatically in laboratory studies, although there is substantial variation in this respect between manufacturers. Nonremelted cross-linked PE is almost as tough as unirradiated PE, but is not completely stable and can oxidize in vivo, as has been shown in recent retrievals studies.

We had reported low wear and good clinical performance after 2 years for 10 non-remelted highly crosslinked PE cups compared to 16 conventional PE cups sterilized by gamma-in-air.

Method?Because of possible degradation by free radicals, we followed up both cohorts for 5 years (conventional PE) and 6 years (highly cross-linked PE).

Result?Mean (CI) proximal head penetration over the observation time was linear and measured 0.08 (0.02–0.13) mm for cross-linked PE and 0.42 (0.23–0.62) mm for conventional PE, and total penetration was 0.23 (0.1–0.35) mm and 0.75 (0.05–1.4) mm respectively. After subtracting creep, the annual wear for non-remelted highly cross-linked PE was below 6 µm. The cups had equally low migration and few radiolucencies.

Interpretation?The theoretical possibility of oxidation in non-remelted highly cross-linked PE may not show clinically. However, it may be that cemented cups with their thicker PE are more forgiving than metal-backed cups with thin PE moving in the locking mechanism. So far, we can conclude that the Crossfire highly crosslinked polyethylene cups performed very well clinically, with extremely low wear even after almost 6 years. This is reassuring, but care should be taken in extrapolating these results to other cross-linked PEs or uncemented cups where toughness of PE is more of an issue.     

Very low wear of non-remelted highly cross-linked polyethylene cups: an RSA study lasting up to 6 years

Background and purpose Highly cross-linked polyethylenes (PEs) all appear to reduce wear dramatically in laboratory studies, although there is substantial variation in this respect between manufacturers. Nonremelted cross-linked PE is almost as tough as unirradiated PE, but is not completely stable and can oxidize in vivo, as has been shown in recent retrievals studies.

We had reported low wear and good clinical performance after 2 years for 10 non-remelted highly crosslinked PE cups compared to 16 conventional PE cups sterilized by gamma-in-air.

Method Because of possible degradation by free radicals, we followed up both cohorts for 5 years (conventional PE) and 6 years (highly cross-linked PE).

Result Mean (CI) proximal head penetration over the observation time was linear and measured 0.08 (0.02-0.13) mm for cross-linked PE and 0.42 (0.23-0.62) mm for conventional PE, and total penetration was 0.23 (0.1-0.35) mm and 0.75 (0.05-1.4) mm respectively. After subtracting creep, the annual wear for non-remelted highly cross-linked PE was below 6 µm. The cups had equally low migration and few radiolucencies.

Interpretation The theoretical possibility of oxidation in non-remelted highly cross-linked PE may not show clinically. However, it may be that cemented cups with their thicker PE are more forgiving than metal-backed cups with thin PE moving in the locking mechanism. So far, we can conclude that the Crossfire highly crosslinked polyethylene cups performed very well clinically, with extremely low wear even after almost 6 years. This is reassuring, but care should be taken in extrapolating these results to other cross-linked PEs or uncemented cups where toughness of PE is more of an issue.     

Effect of sterilization method and other modifications on the wear resistance of acetabular cups made of ultra-high molecular weight polyethylene. A hip-simulator study

BACKGROUND: Wear of ultra-high molecular weight polyethylene acetabular cups in hip prostheses produces billions of submicrometer wear particles annually that can cause osteolysis and loosening of the components. Thus, substantial improvement of the wear resistance of ultra-high molecular weight polyethylene could extend the clinical life span of total hip prostheses. It has become apparent that the conditions under which ultra-high molecular weight polyethylene cups have been sterilized can markedly affect their long-term wear properties, and new sterilization methods and other modifications have been developed to minimize the negative effects. METHODS: In the present study, a hip-joint simulator was used to assess whether it is preferable to sterilize ultra-high molecular weight polyethylene cups without gamma irradiation, to avoid radiation-induced oxidative degradation, or to sterilize with gamma irradiation while the cups are packaged in a suitable low-oxygen atmosphere to minimize oxidation while retaining the increased wear resistance conferred by the radiation-induced cross-linking. Ion-implanted cups and cups made of a highly crystalline polyethylene (Hylamer) also were investigated. Cups made of each material were subjected to wear-testing prior to and after artificial thermal aging to accelerate oxidative degradation. RESULTS: The results of the present study demonstrated that the cross-linking induced by gamma irradiation improves the wear resistance of ultra-high molecular weight polyethylene, while oxidation reduces it. Without thermal aging, the two types of cups that were sterilized with gamma irradiation while in low-oxygen packaging exhibited about a 50 percent lower rate of wear than did either the nonsterilized cups or the nonirradiated cups sterilized with gas plasma. There was a comparable advantage in the rate of wear after fourteen days of thermal aging. However, after thirty days of aging, the cups sterilized with gamma irradiation in low-oxygen packaging wore several times faster than did the nonirradiated cups. Ion-implanting improved the wear resistance without thermal aging, but after extensive thermal aging the oxidation and wear were greater than those of the controls. Hylamer cups (that is, those that were sterilized with gas plasma) exhibited wear properties very close to those of the nonsterilized ultra-high molecular weight polyethylene cups (the controls) with or without aging. CONCLUSIONS: Sterilizing an ultra-high molecular weight polyethylene acetabular cup without radiation (for example, with ethylene oxide or gas plasma) avoids immediate and long-term oxidative degradation of the implant but does not improve the inherent wear resistance of the polyethylene. Sterilizing with use of gamma irradiation with the implant packaged in a low-oxygen atmosphere avoids immediate oxidation and cross-links the polyethylene, thereby increasing its wear resistance, but long-term oxidation of the residual free radicals may markedly reduce the wear resistance. Ideally, cross-linking with gamma irradiation to reduce wear should be done in a manner that avoids both immediate and long-term oxidation.     

Fixation and bone remodeling around a low-modulus stem seven-year follow-up of a randomized study with use of radiostereometry and dual-energy x-ray absorptiometer

Thirty-eight patients (40 hips) randomly received either an uncemented fully porous-coated composite stem (Epoch; Zimmer, Warsaw, Ind) or an uncemented proximally porous-coated solid stem (Anatomic; Zimmer). Patients were followed up for 7 years using radiostereometry, dual-energy x-ray absorptiometry, conventional radiography, the Harris Hip Score, and a pain questionnaire. Both stem designs achieved excellent outcome for fixation (stem subsidence and stem rotations close to zero) and clinical outcome, without any difference between the 2 groups (P > .12). Median wear rates were low despite use of conventionally gamma-sterilized polyethylene. No stem was radiographically loose on the postoperative radiographs. The low-modulus composite stem had positive effects on early proximal bone remodeling in Gruen regions 1, 2, 6, and 7 (P < .04). However, at 7 years, this bone-sparing effect persisted in only the calcar region (Gruen region 7).     

Long-term results of uncemented acetabular cups with an ACS polyethylene liner. A 14–16-year follow-up study

We assessed the clinical and radiographic results of 40 porous-coated acetabular cups with an Acetabular Cup System polyethylene liner over a minimum 14-year follow-up. Femoral head penetration was estimated using a software package. Fifteen cups were revised, 11 due to polyethylene liner rupture. All cups but two were radiographically stable, and 11 hips showed acetabular osteolysis. The overall femoral head penetration rate in hips without liner fracture with reference to the early penetration point was 0.1188+/-0.070 mm per year. Polyethylene liner fractures were associated with higher early femoral head penetration (P<0.0001) and a vertical cup position (P=0.0016). The 14-year survival without cup revision for any reason was 63.9%, 71.8% with no ACS polyethylene liner fracture and 65.3% with no acetabular osteolysis. Most cups showed a good clinical outcome in general, but major Acetabular Cup System liner failure and osteolysis were frequent. Patients with the ACS cups still in place should be monitored closely.     

Primary total hip arthroplasty in patients with rheumatoid arthritis

Twenty-eight (11 cemented and 17 noncemented) total hip arthroplasties (THA) were performed in 20 patients with rheumatoid arthritis (RA). The average age at operation was 42.1 years and the average follow-up was 10.8 years. There were two deep infections requiring removal of the prosthesis. Three cemented acetabular cups and one cemented femoral component were revised due to aseptic loosening. One cemented cup was loosened radiologically. One PCA polyethylene liner was revised because of significant wear. Both cemented and noncemented femoral components are capable of providing respectable results in RA patients. The relatively inferior results of THA among RA patients is due not only to the fixation method, but also to the poorer bone quality.