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The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 5 | Pages 593 - 600
1 May 2011
Kuzyk PRT Saccone M Sprague S Simunovic N Bhandari M Schemitsch EH

We conducted a systematic review and meta-analysis of randomised controlled trials comparing cross-linked with conventional polyethylene liners for total hip replacement in order to determine whether these liners reduce rates of wear, radiological evidence of osteolysis and the need for revision. The MEDLINE, EMBASE and COCHRANE databases were searched from their inception to May 2010 for all trials involving the use of cross-linked polyethylene in total hip replacement. Eligibility for inclusion in the review included the random allocation of treatments, the use of cross-linked and conventional polyethylene, and radiological wear as an outcome measure. The pooled mean differences were calculated for bedding-in, linear wear rate, three-dimensional linear wear rate, volumetric wear rate and total linear wear. Pooled risk ratios were calculated for radiological osteolysis and revision hip replacement. A search of the literature identified 194 potential studies, of which 12 met the inclusion criteria. All reported a significant reduction in radiological wear for cross-linked polyethylene. The pooled mean differences for linear rate of wear, three-dimensional linear rate of wear, volumetric wear rate and total linear wear were all significantly reduced for cross-linked polyethylene. The risk ratio for radiological osteolysis was 0.40 (95% confidence interval 0.27 to 0.58; I. 2. = 0%), favouring cross-linked polyethylene. The follow-up was not long enough to show a difference in the need for revision surgery


The Bone & Joint Journal
Vol. 101-B, Issue 5 | Pages 559 - 564
1 May 2019
Takemura S Minoda Y Sugama R Ohta Y Nakamura S Ueyama H Nakamura H

Aims. The use of vitamin E-infused highly crosslinked polyethylene (HXLPE) in total knee prostheses is controversial. In this paper we have compared the clinical and radiological results between conventional polyethylene and vitamin E-infused HXLPE inserts in total knee arthroplasty (TKA). Patients and Methods. The study included 200 knees (175 patients) that underwent TKA using the same total knee prostheses. In all, 100 knees (77 patients) had a vitamin E-infused HXLPE insert (study group) and 100 knees (98 patients) had a conventional polyethylene insert (control group). There were no significant differences in age, sex, diagnosis, preoperative knee range of movement (ROM), and preoperative Knee Society Score (KSS) between the two groups. Clinical and radiological results were evaluated at two years postoperatively. Results. Differences in postoperative ROM and KSS were not statistically significant between the study and control groups. No knee exhibited osteolysis, aseptic loosening, or polyethylene failure. Additionally, there was no significant difference in the incidence of a radiolucent line between the two groups. One patient from the study group required irrigation and debridement, due to deep infection, at six months postoperatively. Conclusion. Clinical results were comparable between vitamin E-infused HXLPE inserts and conventional polyethylene inserts at two years after TKA, without any significant clinical failure. Cite this article: Bone Joint J 2019;101-B:559–564


Aims. The aim of this study was to compare the migration of the femoral component, five years postoperatively, between patients with a highly cross-linked polyethylene (HXLPE) insert and those with a conventional polyethylene (PE) insert in an uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary aims included clinical outcomes and patient-reported outcome measures (PROMs). We have previously reported the migration and outcome of the tibial components in these patients. Methods. A double-blinded randomized controlled trial was conducted including 96 TKAs. The migration of the femoral component was measured with radiostereometry (RSA) at three and six months and one, two, and five years postoperatively. PROMs were collected preoperatively and at all periods of follow-up. Results. There was no clinically relevant difference in terms of migration of the femoral component or PROMs between the HXLPE and PE groups. The mean difference in migration (maximum total point motion), five years postopeatively, was 0.04 mm (95% CI -0.06 to 0.16) in favour of the PE group. Conclusion. There was no clinically relevant difference in migration of the femoral component, for up to five years between the two groups. These findings will help to establish a benchmark for future studies on migration of femoral components in TKA. Cite this article: Bone Joint J 2024;106-B(8):826–833


Aims. The primary objective of this study was to compare the five-year tibial component migration and wear between highly crosslinked polyethylene (HXLPE) inserts and conventional polyethylene (PE) inserts of the uncemented Triathlon fixed insert cruciate-retaining total knee arthroplasty (TKA). Secondary objectives included clinical outcomes and patient-reported outcome measures (PROMs). Methods. A double-blinded, randomized study was conducted including 96 TKAs. Tibial component migration and insert wear were measured with radiostereometric analysis (RSA) at three, six, 12, 24, and 60 months postoperatively. PROMS were collected preoperatively and at all follow-up timepoints. Results. There was no clinically relevant difference in terms of tibial component migration, insert wear, and PROMs between the HXLPE and PE groups. The mean difference in tibial component migration (maximal total point migration (MTPM)) was 0.02 mm (95% confidence interval (CI) -0.07 to 0.11), which is below the value of 0.2 mm considered to be clinically relevant. Wear after five years for HXLPE was 0.16 mm (95% CI 0.05 to 0.27), and for PE was 0.23 mm (95% CI 0.12 to 0.35). The mean difference in wear rate was 0.01 mm/year (95% CI -0.02 to 0.05) in favour of the HXLPE group. Wear is mainly present on the medial side of the insert. Conclusion. There is no clinically relevant difference in tibial component migration and insert wear for up to five years between the HXLPE conventional PE inserts. For the implant studied, the potential advantages of a HXLPE insert remain to be proven under clinical conditions at longer-term follow-up. Cite this article: Bone Joint J 2023;105-B(5):518–525


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 2 | Pages 196 - 201
1 Feb 2010
Hallan G Dybvik E Furnes O Havelin LI

The Norwegian Arthroplasty Register has shown that several designs of uncemented femoral stems give good or excellent survivorship. The overall findings for uncemented total hip replacement however, have been disappointing because of poor results with the use of metal-backed acetabular components. In this study, we exclusively investigated the medium-to long-term performance of primary uncemented metal-backed acetabular components.

A total of 9113 primary uncemented acetabular components were implanted in 7937 patients between 1987 and 2007. These were included in a prospective, population-based observational study. All the implants were modular and metal-backed with ultra-high-molecular-weight polyethylene liners. The femoral heads were made of stainless steel, cobalt-chrome (CoCr) alloy or alumina ceramic. In all, seven different designs of acetabular component were evaluated by the Kaplan-Meier survivorship method and Cox regression analysis.

Most acetabular components performed well up to seven years. When the endpoint was revision of the acetabular component because of aseptic loosening, the survival ranged between 87% and 100% at ten years. However, when the endpoint was revision for any reason, the survival estimates were 81% to 92% for the same implants at ten years. Aseptic loosening, wear, osteolysis and dislocation were the main reasons for the relatively poor overall performance of the acetabular components. Prostheses with alumina heads performed slightly better than those with stainless steel or CoCr alloy in subgroups.

Whereas most acetabular components performed well at seven years, the survivorship declined with longer follow-up. Fixation was generally good. None of the metal-backed uncemented acetabular components with ultra-high-molecular-weight polyethylene liners in our study had satisfactory long-term results because of high rates of wear, osteolysis, aseptic loosening and dislocation.


The Bone & Joint Journal
Vol. 102-B, Issue 1 | Pages 90 - 101
1 Jan 2020
Davis ET Pagkalos J Kopjar B

Aims

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).

Methods

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).


The Journal of Bone & Joint Surgery British Volume
Vol. 94-B, Issue 4 | Pages 459 - 465
1 Apr 2012
Nikolaou VS Edwards MR Bogoch E Schemitsch EH Waddell JP

The ideal bearing surface for young patients undergoing total hip replacement (THR) remains controversial. We report the five-year results of a randomised controlled trial comparing the clinical and radiological outcomes of 102 THRs in 91 patients who were <  65 years of age. These patients were randomised to receive a cobalt–chrome on ultra-high-molecular-weight polyethylene, cobalt–chrome on highly cross-linked polyethylene, or a ceramic-on-ceramic bearing. In all, 97 hip replacements in 87 patients were available for review at five years. Two hips had been revised, one for infection and one for peri-prosthetic fracture.

At the final follow-up there were no significant differences between the groups for the mean Western Ontario and McMaster Universities osteoarthritis index (pain, p = 0.543; function, p = 0.10; stiffness, p = 0.99), Short Form-12 (physical component, p = 0.878; mental component, p = 0.818) or Harris hip scores (p = 0.22). Radiological outcomes revealed no significant wear in the ceramic group.

Comparison of standard and highly cross-linked polyethylene, however, revealed an almost threefold difference in the mean annual linear wear rates (0.151 mm/year versus 0.059 mm/year, respectively) (p < 0.001).


The Bone & Joint Journal
Vol. 102-B, Issue 7 Supple B | Pages 105 - 111
1 Jul 2020
Engh, Jr. CA McAsey CJ Cororaton AD Ho H Hopper, Jr. RH

Aims. The purpose of this study is to examine six types of bearing surfaces implanted at a single institution over three decades to determine whether the reasons for revision vary among the groups and how long it takes to identify differences in survival. Methods. We considered six cohorts that included a total of 1,707 primary hips done between 1982 and 2010. These included 223 conventional polyethylene sterilized with γ irradiation in air (CPE-GA), 114 conventional polyethylene sterilized with gas plasma (CPE-GP), 116 crosslinked polyethylene (XLPE), 1,083 metal-on-metal (MOM), 90 ceramic-on-ceramic (COC), and 81 surface arthroplasties (SAs). With the exception of the COC, all other groups used cobalt-chromium (CoCr) femoral heads. The mean follow-up was 10 (0.008 to 35) years. Descriptive statistics with revisions per 100 component years (re/100 yr) and survival analysis with revision for any reason as the endpoint were used to compare bearing surfaces. Results. XLPE liners demonstrated a lower cumulative incidence of revision at 15 years compared to the CPE-GA and CPE-GP groups owing to the absence of wear-related revisions (4% for XLPE vs 18%, p = 0.02, and 15%, p = 0.003, respectively). Revisions for adverse local tissue reactions occurred exclusively among the MOM (0.8 re/100 year) and SA groups (0.1 re/100 year). The revision rate for instability was lower among hips with 36 mm and larger head sizes compared to smaller head sizes (0.2% vs 2%, p < 0.001). Conclusion. The introduction of XLPE has eliminated wear-related revisions through 15-year follow-up compared to CPE-GP and CPE-GA. Dislocation incidence has been reduced with the introduction of larger diameter heads but remains a persistent concern. The potential for adverse local tissue reactions with MOM requires continued follow-up. Cite this article: Bone Joint J 2020;102-B(7 Supple B):105–111


The Bone & Joint Journal
Vol. 102-B, Issue 11 | Pages 1527 - 1534
3 Nov 2020
Orita K Minoda Y Sugama R Ohta Y Ueyama H Takemura S Nakamura H

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 wear particle analysis for TKA. The aim of this study was to compare in vivo polyethylene wear particle generation between E1 and conventional polyethylene (ArCom) in TKA. Methods. A total of 34 knees undergoing TKA (17 each with ArCom or E1) were investigated. Except for the polyethylene insert material, the prostheses used for both groups were identical. Synovial fluid was obtained at a mean of 3.4 years (SD 1.3) postoperatively. The in vivo polyethylene wear particles were isolated from the synovial fluid using a previously validated method and examined by scanning electron microscopy. Results. The total number of polyethylene wear particles obtained from the knees with E1 (mean 6.9, SD 4.0 × 10. 7. counts/knee) was greater than that obtained from those with ArCom (mean 2.2, SD 2.6 × 10. 7. counts/knee) (p = 0.001). The particle size (equivalent circle of diameter) from the knees with E1 was smaller (mean 0.5 μm, SD 0.1) than that of knees with ArCom (mean 1.5, SD 0.3 μm) (p = 0.001). The aspect ratio of particles from the knees with E1 (mean 1.3, SD 0.1) was smaller than that with ArCom (mean 1.4, SD 0.1) (p < 0.001 ). Conclusion. This is the first report of in vivo wear particle analysis of E1. E1 polyethylene did not reduce the number of in vivo polyethylene wear particles compared with ArCom in early clinical stage. Further careful follow-up of newly introduced E1 for TKA should be carried out. Cite this article: Bone Joint J 2020;102-B(11):1527–1534


The Bone & Joint Journal
Vol. 101-B, Issue 10 | Pages 1192 - 1198
1 Oct 2019
Sköldenberg OG Rysinska AD Chammout G Salemyr M Mukka SS Bodén H Eisler T

Aims. Radiostereometric analysis (RSA) studies of vitamin E-doped, highly crosslinked polyethylene (VEPE) liners show low head penetration rates in cementless acetabular components. There is, however, currently no data on cemented VEPE acetabular components in total hip arthroplasty (THA). The aim of this study was to evaluate the safety of a new cemented VEPE component, compared with a conventional polyethylene (PE) component regarding migration, head penetration, and clinical results. Patients and Methods. We enrolled 42 patients (21 male, 21 female) with osteoarthritis and a mean age of 67 years (. sd. 5), in a double-blinded, noninferiority, randomized controlled trial. The subjects were randomized in a 1:1 ratio to receive a reverse hybrid THA with a cemented component of either argon-gas gamma-sterilized PE component (controls) or VEPE, with identical geometry. The primary endpoint was proximal implant migration of the component at two years postoperatively measured with RSA. Secondary endpoints included total migration of the component, penetration of the femoral head into the component, and patient-reported outcome measurements. Results. In total, 19 control implants and 18 implants in the VEPE group were analyzed for the primary endpoint. We found a continuous proximal migration of the component in the VEPE group that was significantly higher with a difference at two years of a mean 0.21 mm (95% confidence interval (CI) 0.05 to 0.37; p = 0.013). The total migration was also significantly higher in the VEPE group, but femoral head penetration was lower. We found no difference in clinical outcomes between the groups. Conclusion. At two years, this cemented VEPE component, although having a low head penetration and excellent clinical results, failed to meet noninferiority compared with the conventional implant by a proximal migration above the proposed safety threshold of RSA. The early proximal migration pattern of the VEPE component is a reason for continued monitoring, although a specific threshold for proximal migration and risk for later failure cannot be defined and needs further study. Cite this article: Bone Joint J 2019;101-B:1192–1198


Bone & Joint 360
Vol. 4, Issue 3 | Pages 12 - 14
1 Jun 2015

The June 2015 Knee Roundup360 looks at: Cruciate substituting versus retaining knee replacement; What’s behind the psychology of anterior cruciate ligament (ACL) reconstruction?; Is there a difference in total knee arthroplasty risk of revision in highly crosslinked versus conventional polyethylene?; Unicompartmental knee arthroplasty: is age the missing variable?; Satisfaction rates following total knee arthroplasty; Is knee alignment dynamic?; Unicompartmental knee arthroplasty: cemented or cementless?; Can revision knee services pay?


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 6 | Pages 770 - 776
1 Jun 2010
Sakai T Ohzono K Nishii T Miki H Takao M Sugano N

We compared a modular neck system with a non-modular system in a cementless anatomical total hip replacement (THR). Each group consisted of 74 hips with developmental hip dysplasia. Both groups had the same cementless acetabular component and the same articulation, which consisted of a conventional polyethylene liner and a 28 mm alumina head. The mean follow-up was 14.5 years (13 to 15), at which point there were significant differences in the mean total Harris hip score (modular/non-modular: 98.6 (64 to 100)/93.8 (68 to 100)), the mean range of abduction (32° (15° to 40°)/28 (0° to 40°)), use of a 10° elevated liner (31%/100%), the incidence of osteolysis (27%/79.7%) and the incidence of equal leg lengths (≥ 6 mm, 92%/61%). There was no disassociation or fracture of the modular neck. The modular system reduces the need for an elevated liner, thereby reducing the incidence of osteolysis. It gives a better range of movement and allows the surgeon to make an accurate adjustment of leg length


The Bone & Joint Journal
Vol. 106-B, Issue 3 Supple A | Pages 38 - 43
1 Mar 2024
Buckner BC Urban ND Cahoy KM Lyden ER Deans CF Garvin KL

Aims

Oxidized zirconium (OxZi) and highly cross-linked polyethylene (HXLPE) were developed to minimize wear and risk of osteolysis in total hip arthroplasty (THA). However, retrieval studies have shown that scratched femoral heads may lead to runaway wear, and few reports of long-term results have been published. The purpose of this investigation is to report minimum ten-year wear rates and clinical outcomes of THA with OxZi femoral heads on HXLPE, and to compare them with a retrospective control group of cobalt chrome (CoCr) or ceramic heads on HXLPE.

Methods

From 2003 to 2006, 108 THAs were performed on 96 patients using an OxZi head with a HXLPE liner with minimum ten-year follow-up. Harris Hip Scores (HHS) were collected preoperatively and at the most recent follow-up (mean 13.3 years). Linear and volumetric liner wear was measured on radiographs of 85 hips with a minimum ten-year follow-up (mean 14.5 years). This was compared to a retrospective control group of 45 THAs using ceramic or CoCr heads from October 1999 to February 2005, with a minimum of ten years’ follow-up.


The Bone & Joint Journal
Vol. 105-B, Issue 9 | Pages 946 - 952
1 Sep 2023
Dhawan R Young DA Van Eemeren A Shimmin A

Aims

The Birmingham Hip Resurfacing (BHR) arthroplasty has been used as a surgical treatment of coxarthrosis since 1997. We present 20-year results of 234 consecutive BHRs performed in our unit.

Methods

Between 1999 and 2001, there were 217 patients: 142 males (65.4%), mean age 52 years (18 to 68) who had 234 implants (17 bilateral). They had patient-reported outcome measures collected, imaging (radiograph and ultrasound), and serum metal ion assessment. Survivorship analysis was performed using Kaplan-Meier estimates. Revision for any cause was considered as an endpoint for the analysis.


The Bone & Joint Journal
Vol. 104-B, Issue 7 | Pages 833 - 843
1 Jul 2022
Kayani B Baawa-Ameyaw J Fontalis A Tahmassebi J Wardle N Middleton R Stephen A Hutchinson J Haddad FS

Aims

This study reports the ten-year wear rates, incidence of osteolysis, clinical outcomes, and complications of a multicentre randomized controlled trial comparing oxidized zirconium (OxZr) versus cobalt-chrome (CoCr) femoral heads with ultra-high molecular weight polyethylene (UHMWPE) and highly cross-linked polyethylene (XLPE) liners in total hip arthroplasty (THA).

Methods

Patients undergoing primary THA were recruited from four institutions and prospectively allocated to the following treatment groups: Group A, CoCr femoral head with XLPE liner; Group B, OxZr femoral head with XLPE liner; and Group C, OxZr femoral head with UHMWPE liner. All study patients and assessors recording outcomes were blinded to the treatment groups. The outcomes of 262 study patients were analyzed at ten years’ follow-up.


Bone & Joint Open
Vol. 4, Issue 11 | Pages 839 - 845
6 Nov 2023
Callary SA Sharma DK D’Apollonio TM Campbell DG

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.


The Bone & Joint Journal
Vol. 104-B, Issue 9 | Pages 1032 - 1038
1 Sep 2022
García-Rey E Cruz-Pardos A Saldaña L

Aims

A significant reduction in wear at five and ten years was previously reported when comparing Durasul highly cross-linked polyethylene with nitrogen-sterilized Sulene polyethylene in total hip arthroplasty (THA). We investigated whether the improvement observed at the earlier follow-up continued, resulting in decreased osteolysis and revision surgery rates over the second decade.

Methods

Between January 1999 and December 2001, 90 patients underwent surgery using the same acetabular and femoral components with a 28 mm metallic femoral head and either a Durasul or Sulene liner. A total of 66 hips of this prospective randomized study were available for a minimum follow-up of 20 years. The linear femoral head penetration rate was measured at six weeks, one year, and annually thereafter, using the Dorr method on digitized radiographs with a software package.


The Bone & Joint Journal
Vol. 103-B, Issue 9 | Pages 1479 - 1487
1 Sep 2021
Davis ET Pagkalos J Kopjar B

Aims

The aim of our study was to investigate the effect of asymmetric crosslinked polyethylene liner use on the risk of revision of cementless and hybrid total hip arthroplasties (THAs).

Methods

We undertook a registry study combining the National Joint Registry dataset with polyethylene manufacturing characteristics as supplied by the manufacturers. The primary endpoint was revision for any reason. We performed further analyses on other reasons including instability, aseptic loosening, wear, and liner dissociation. The primary analytic approach was Cox proportional hazard regression.


The Bone & Joint Journal
Vol. 103-B, Issue 7 Supple B | Pages 78 - 83
1 Jul 2021
Roedel GG Kildow BJ Sveom DS Garvin KL

Aims

Highly cross-linked polyethylene (HXLPE) has greatly improved the durability of total hip arthroplasty (THA) in young patients because of its improved wear characteristics. Few studies have followed this population into the second decade, and therefore the purpose of this investigation was to evaluate the clinical outcome for THA patients 50 years of age and younger at a minimum of 15 years postoperatively. The second purpose was to evaluate the radiological findings secondary to wear or mechanical failure of the implant.

Methods

Between October 1999 and December 2005, 105 THAs were performed in 95 patients (53 female, 42 male) aged 50 years and younger (mean 42 years (20 to 50)). There were 87 patients (96 hips) that were followed for a minimum of 15 years (mean 17.3 years (15 to 21)) for analysis. Posterior approach was used with cementless fixation with a median head size of 28 mm. HXLPE was the acetabular bearing for all hips. Radiographs were evaluated for polyethylene wear, radiolucent lines, and osteolysis.


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 2 | Pages 149 - 153
1 Feb 2008
García-Rey E García-Cimbrelo E Cruz-Pardos A Ortega-Chamarro J

Ultra-high-molecular-weight polyethylene sterilised in the absence of air and highly cross-linked polyethylene have been used to avoid osteolysis and loosening in total hip replacement. Our prospective randomised study has assessed the results using two different polyethylenes associated with the same prosthetic design. We assessed 45 Allofit acetabular components with a Sulene-polyethylene liner of conventional polyethylene gamma sterilised with nitrogen and 45 Allofit acetabular components with a Durasul-polyethylene liner sterilised in ethylene oxide, both matched with an Alloclassic stem with a 28 mm modular femoral head. The prostheses were implanted between May 1999 and December 2001. The mean follow-up was for 66.3 months (60 to 92). The linear penetration of the femoral head was estimated at 6 weeks, at 6 and 12 months and annually thereafter from standardised digitised radiographs using image-analysis software. There was no loosening of any prosthetic component. There were no radiolucent lines or osteolysis. The mean rate of penetration calculated from regression analysis during the first five years was 38 μm/year (. sd. 2) for the Sulene group and 6 μm/year (. sd. 1) for the Durasul group (p = 0.00002). The rate of penetration of the Durasul group was 15.7% of that of the Sulene group