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The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 8 | Pages 1106 - 1113
1 Aug 2008
Richards L Brown C Stone MH Fisher J Ingham E Tipper JL

Nanometre-sized particles of ultra-high molecular weight polyethylene have been identified in the lubricants retrieved from hip simulators. Tissue samples were taken from seven failed Charnley total hip replacements, digested using strong alkali and analysed using high-resolution field emission gun-scanning electron microscopy to determine whether nanometre-sized particles of polyethylene debris were generated in vivo. A randomised method of analysis was used to quantify and characterise all the polyethylene particles isolated. We isolated nanometre-sized particles from the retrieved tissue samples. The smallest identified was 30 nm and the majority were in the 0.1 μm to 0.99 μm size range. Particles in the 1.0 μm to 9.99 μm size range represented the highest proportion of the wear volume of the tissue samples, with 35% to 98% of the total wear volume comprised of particles of this size. The number of nanometre-sized particles isolated from the tissues accounted for only a small proportion of the total wear volume. Further work is required to assess the biological response to nanometre-sized polyethylene particles


The Bone & Joint Journal
Vol. 97-B, Issue 7 | Pages 883 - 889
1 Jul 2015
Jassim SS Patel S Wardle N Tahmassebi J Middleton R Shardlow DL Stephen A Hutchinson J Haddad FS

Oxidised zirconium (OxZi) has been developed as an alternative bearing surface for femoral heads in total hip arthroplasty (THA). This study has investigated polyethylene wear, functional outcomes and complications, comparing OxZi and cobalt–chrome (CoCr) as part of a three-arm, multicentre randomised controlled trial. Patients undergoing THA from four institutions were prospectively randomised into three groups. Group A received a CoCr femoral head and highly cross-linked polyethylene (XLPE) liner; Group B received an OxZi femoral head and XLPE liner; Group C received an OxZi femoral head and ultra-high molecular weight polyethylene (UHMWPE) liner. At five years, 368 patients had no statistically significant differences in short-form-36 (p = 0.176 mental, p = 0.756 physical), Western Ontario and McMaster Universities Osteoarthritis Index (p = 0.847), pain scores (p = 0.458) or complications. The mean rate of linear wear was 0.028 mm/year (standard deviation (. sd) 0.010). for Group A, 0.023 mm/year (. sd. 0.010) for Group B, and 0.09 mm/year (. sd. 0.045) for Group C. Penetration was significantly higher in the UHMWPE liner group compared with both XLPE liner groups (p < 0.001) but no significant difference was noted between CoCr and OxZi when articulating with XLPE (p = 0.153). In this, the largest randomised study of this bearing surface, it appears that using a XLPE acetabular liner is more important in reducing THA component wear than the choice of femoral head bearing, at mid-term follow-up. There is a non-significant trend towards lower wear, coupling OxZi rather than CoCr with XLPE but long-term analysis is required to see if this observation changes with time and becomes significant. Cite this article: Bone Joint J 2015;97-B:883–9


Bone & Joint Research
Vol. 13, Issue 3 | Pages 101 - 109
4 Mar 2024
Higashihira S Simpson SJ Morita A Suryavanshi JR Arnold CJ Natoli RM Greenfield EM

Aims. Biofilm infections are among the most challenging complications in orthopaedics, as bacteria within the biofilms are protected from the host immune system and many antibiotics. Halicin exhibits broad-spectrum activity against many planktonic bacteria, and previous studies have demonstrated that halicin is also effective against Staphylococcus aureus biofilms grown on polystyrene or polypropylene substrates. However, the effectiveness of many antibiotics can be substantially altered depending on which orthopaedically relevant substrates the biofilms grow. This study, therefore, evaluated the activity of halicin against less mature and more mature S. aureus biofilms grown on titanium alloy, cobalt-chrome, ultra-high molecular weight polyethylene (UHMWPE), devitalized muscle, or devitalized bone. Methods. S. aureus-Xen36 biofilms were grown on the various substrates for 24 hours or seven days. Biofilms were incubated with various concentrations of halicin or vancomycin and then allowed to recover without antibiotics. Minimal biofilm eradication concentrations (MBECs) were defined by CFU counting and resazurin reduction assays, and were compared with the planktonic minimal inhibitory concentrations (MICs). Results. Halicin continued to exert significantly (p < 0.01) more antibacterial activity against biofilms grown on all tested orthopaedically relevant substrates than vancomycin, an antibiotic known to be affected by biofilm maturity. For example, halicin MBECs against both less mature and more mature biofilms were ten-fold to 40-fold higher than its MIC. In contrast, vancomycin MBECs against the less mature biofilms were 50-fold to 200-fold higher than its MIC, and 100-fold to 400-fold higher against the more mature biofilms. Conclusion. Halicin is a promising antibiotic that should be tested in animal models of orthopaedic infection. Cite this article: Bone Joint Res 2024;13(3):101–109


The Bone & Joint Journal
Vol. 102-B, Issue 6 Supple A | Pages 151 - 157
1 Jun 2020
Gil D Atici AE Connolly RL Hugard S Shuvaev S Wannomae KK Oral E Muratoglu OK

Aims. We propose a state-of-the-art temporary spacer, consisting of a cobalt-chrome (CoCr) femoral component and a gentamicin-eluting ultra-high molecular weight polyethylene (UHMWPE) tibial insert, which can provide therapeutic delivery of gentamicin, while retaining excellent mechanical properties. The proposed implant is designed to replace conventional spacers made from bone cement. Methods. Gentamicin-loaded UHMWPE was prepared using phase-separated compression moulding, and its drug elution kinetics, antibacterial, mechanical, and wear properties were compared with those of conventional gentamicin-loaded bone cement. Results. Gentamicin-loaded UHMWPE tibial components not only eradicated planktonic Staphylococcus aureus, but also prevented colonization of both femoral and tibial components. The proposed spacer possesses far superior mechanical and wear properties when compared with conventional bone cement spacers. Conclusion. The proposed gentamicin-eluting UHMWPE spacer can provide antibacterial efficacy comparable with currently used bone cement spacers, while overcoming their drawbacks. The novel spacer proposed here has the potential to drastically reduce complications associated with currently used bone cement spacers and substantially improve patients’ quality of life during the treatment. Cite this article: Bone Joint J 2020;102-B(6 Supple A):151–157


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. Results. Patients in Group C were associated with increased mean liner wear rates compared to patients in Group A (0.133 mm/yr (SD 0.21) vs 0.031 mm/yr (SD 0.07), respectively; p < 0.001) and Group B (0.133 mm/yr (SD 0.21) vs 0.022 mm/yr (SD 0.05), respectively; p < 0.001) at ten years’ follow-up. Patients in Group C were also associated with increased risk of osteolysis and aseptic loosening requiring revision surgery, compared with patients in Group A (7/133 vs 0/133, respectively; p = 0.007) and Group B (7/133 vs 0/135, respectively; p = 0.007). There was a non-statistically significant trend towards increased mean liner wear rates in Group A compared with Group B (0.031 mm/yr (SD 0.07) vs 0.022 mm/yr (SD 0.05), respectively; p = 0.128). All three groups were statistically comparable preoperatively and at ten years’ follow-up when measuring normalized Western Ontario and McMaster Universities Osteoarthritis Index (p = 0.410), 36-Item Short Form Health Survey (p = 0.465 mental, p = 0.713 physical), and pain scale scores (p = 0.451). Conclusion. The use of UHMWPE was associated with progressively increased annual liner wear rates after THA compared to XLPE. At ten years’ follow-up, the group receiving UHMWPE demonstrated an increased incidence of osteolysis and aseptic loosening requiring revision surgery compared to XLPE. Femoral heads composed of OxZr were associated with trend towards reduced wear rates compared to CoCr, but this did not reach statistical significance and did not translate to any differences in osteolysis, functional outcomes, or revision surgery between the two femoral head components. Cite this article: Bone Joint J 2022;104-B(7):833–843


The Bone & Joint Journal
Vol. 103-B, Issue 4 | Pages 644 - 649
1 Apr 2021
Alsousou J Oragu E Martin A Strickland L Newman S Kendrick B Taylor A Glyn-Jones S

Aims. The aim of this prospective cohort study was to evaluate the early migration of the TriFit cementless proximally coated tapered femoral stem using radiostereometric analysis (RSA). Methods. A total of 21 patients (eight men and 13 women) undergoing primary total hip arthroplasty (THA) for osteoarthritis of the hip were recruited in this study and followed up for two years. Two patients were lost to follow-up. All patients received a TriFit stem and Trinity Cup with a vitamin E-infused highly cross-linked ultra-high molecular weight polyethylene liner. Radiographs for RSA were taken postoperatively and then at three, 12, and 24 months. Oxford Hip Score (OHS), EuroQol five-dimension questionnaire (EQ-5D), and adverse events were reported. Results. At two years, the mean subsidence of the head and tip for the TriFit stem was 0.38 mm (SD 0.32) and 0.52 mm (SD 0.36), respectively. The total migration of the head and tip was 0.55 mm (SD 0.32) and 0.71 mm (SD 0.38), respectively. There were no statistically significant differences between the three to 12 months' migration (p = 0.105) and 12 to 24 months' migration (p = 0.694). The OHS and EQ-5D showed significant improvements at two years. Conclusion. The results of this study suggest that the TriFit femoral stem achieves initial stability and is likely to be stable in the mid and long term. A long-term outcome study is required to assess late mechanisms of failure and the effects of bone mineral density (BMD) related changes. Cite this article: Bone Joint J 2021;103-B(4):644–649


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 5 | Pages 604 - 611
1 May 2009
Reay E Wu J Holland J Deehan D

We describe a cohort of patients with a high rate of mid-term failure following Kinemax Plus total knee replacement inserted between 1998 and 2001. This implant has been recorded as having a survival rate of 96% at ten years. However, in our series the survival rate was 75% at nine years. This was also significantly lower than that of subsequent consecutive series of PFC Sigma knee replacements performed by the same surgeon. No differences were found in the clinical and radiological parameters between the two groups. At revision the most striking finding was polyethylene wear. An independent analysis of the polyethylene components was therefore undertaken. Scanning electron microscopy revealed type 2 fusion defects in the ultra-high molecular weight polyethylene (UHMWPE), which indicated incomplete boundary fusion. Other abnormalities consistent with weak UHMWPE particle interface strength were present in both the explanted inserts and in unused inserts from the same period. We consider that these type 2 fusion defects are the cause of the early failure of the Kinemax implants. This may represent a manufacturing defect resulting in a form of programmed polyethylene failure


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 5 | Pages 737 - 742
1 May 2010
Verlinden C Uvin P Labey L Luyckx JP Bellemans J Vandenneucker H

Malrotation of the femoral component is a cause of patellofemoral maltracking after total knee arthroplasty. Its precise effect on the patellofemoral mechanics has not been well quantified. We have developed an in vitro method to measure the influence of patellar maltracking on contact. Maltracking was induced by progressively rotating the femoral component either internally or externally. The contact mechanics were analysed using Tekscan. The results showed that excessive malrotation of the femoral component, both internally and externally, had a significant influence on the mechanics of contact. The contact area decreased with progressive maltracking, with a concomitant increase in contact pressure. The amount of contact area that carries more than the yield stress of ultra-high molecular weight polyethylene significantly increases with progressive maltracking. It is likely that the elevated pressures noted in malrotation could cause accelerated and excessive wear of the patellar button


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 7 | Pages 855 - 858
1 Jul 2009
Wroblewski BM Siney PD Fleming PA

The design of the Charnley total hip replacement follows the principle of low frictional torque. It is based on the largest possible difference between the radius of the femoral head and that of the outer aspect of the acetabular component. The aim is to protect the bone-cement interface by movement taking place at the smaller radius, the articulation. This is achieved in clinical practice by a 22.225 mm diameter head articulating with a 40 mm or 43 mm diameter acetabular component of ultra-high molecular weight polyethylene. We compared the incidence of aseptic loosening of acetabular components with an outer diameter of 40 mm and 43 mm at comparable depths of penetration with a mean follow-up of 17 years (1 to 40). In cases with no measurable wear none of the acetabular components were loose. With increasing acetabular penetration there was an increased incidence of aseptic loosening which reflected the difference in the external radii, with 1.5% at 1 mm, 8.8% at 2 mm, 9.7% at 3 mm and 9.6% at 4 mm of penetration in favour of the larger 43 mm acetabular component. Our findings support the Charnley principle of low frictional torque. The level of the benefit is in keeping with the predicted values


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 6 | Pages 731 - 737
1 Jun 2008
Kim Y Kim J

It has been suggested that the wear of ultra-high molecular weight polyethylene (UHMWPE) in total hip replacement is substantially reduced when the femoral head is ceramic rather than metal. However, studies of alumina and zirconia ceramic femoral heads on the penetration of an UHMWPE liner in vivo have given conflicting results. The purpose of this study was to examine the surface characteristics of 30 alumina and 24 zirconia ceramic femoral heads and to identify any phase transformation in the zirconia heads. We also studied the penetration rate of alumina and zirconia heads into contemporary UHMWPE liners. The alumina heads had been implanted for a mean of 11.3 years (8.1 to 16.2) and zirconia heads for a mean of 9.8 years (7.5 to 15). The mean surface roughness values of the explanted alumina heads (Ra 40.12 nm and Rpm 578.34 nm) were similar to those for the explanted zirconia heads (Ra 36.21 nm and Rpm 607.34 nm). The mean value of the monoclinic phase of two control zirconia heads was 1% (0.8% to 1.5%) and 1.2% (0.9% to 1.3%), respectively. The mean value of the monoclinic phase of 24 explanted zirconia heads was 7.3% (1% to 26%). In the alumina group, the mean linear penetration rate of the UMWPE liner was 0.10 mm/yr (0.09 to 0.12) in hips with low Ra and Rpm values (13.22 nm and 85.91 nm, respectively). The mean linear penetration rate of the UHMWPE liner was 0.13 mm/yr (0.07 to 0.23) in hips with high Ra and Rpm values (198.72 nm and 1329 nm, respectively). This difference was significant (p = 0.041). In the zirconia head group, the mean linear penetration rate of the UHMWPE liner was 0.09 mm/yr (0.07 to 0.14) in hips with low Ra and Rpm values (12.78 nm and 92.99 nm, respectively). The mean linear penetration rate of the UHMWPE liner was 0.12 mm/yr (0.08 to 0.22) in hips with high Ra and Rpm values (199.21 nm and 1381 nm, respectively). This difference was significant (p = 0.039). The explanted zirconia heads which had a minimal phase transformation had similar surface roughness and a similar penetration rate of UHMWPE liner as the explanted alumina head


The Bone & Joint Journal
Vol. 100-B, Issue 12 | Pages 1592 - 1599
1 Dec 2018
Galea VP Connelly JW Shareghi B Kärrholm J Sköldenberg O Salemyr M Laursen MB Muratoglu O Bragdon C Malchau H

Aims. The primary aim of this study was to compare the wear properties of vitamin E-diffused, highly crosslinked polyethylene (VEPE) and one formulation of moderately crosslinked and mechanically annealed ultra-high molecular weight polyethylene (ModXLPE) in patients five years after primary total hip arthroplasty (THA). The secondary aim was to assess the clinical results of patients treated with VEPE by evaluating patient-reported outcome measures (PROMs), radiological evidence of fixation, and the incidence of mechanical failure. Patients and Methods. A total of 208 patients (221 THAs) from four international centres were recruited into a prospective study involving radiostereometric analysis (RSA) and the assessment of clinical outcomes. A total of 193 hips (87%) were reviewed at the five-year follow-up. Of these, 136 (70%) received VEPE (vs ModXLPE) liners and 68 (35%) received ceramic (vs metal) femoral heads. PROMs and radiographs were collected preoperatively and at one, two, and five years postoperatively. In addition, RSA images were collected to measure PE wear postoperatively and at one, two, and five years after surgery. Results. We observed similar bedding in one year postoperatively and wear two years postoperatively between the two types of liner. However, there was significantly more penetration of the femoral head in the ModXLPE cohort compared with the VEPE cohort five years postoperatively (p < 0.001). The only variables independently predictive of increased wear were ModXLPE (vs VEPE) liner type (β = 0.22, p = 0.010) and metal (vs ceramic) femoral head (β = 0.21, p = 0.013). There was no association between increased wear and the development of radiolucency (p = 0.866) or PROMs. No patient had evidence of osteolysis. Conclusion. Five years postoperatively, patients with VEPE (vs ModXLPE) and ceramic (vs metal) femoral heads had decreased wear. The rates of wear for both liners were very low and have not led to any osteolysis or implant failure due to aseptic loosening


The Journal of Bone & Joint Surgery British Volume
Vol. 60-B, Issue 3 | Pages 375 - 382
1 Aug 1978
Dowling J Atkinson Dowson D Charnley J

In laboratory tests, the ultra-high molecular weight polyethylene used for the acetabular cups of Charnley hip prostheses has a very low wear rate against steel. In the body radiographic measurements indicate that the polyethylene wears more rapidly. In order to investigate this higher wear rate, the sockets of acetabular cups removed at post-mortem have been examined using optical and electron microscopy. It has been shown that a socket wears predominantly on its superior part and that this is a direct consequence of the orientation of the cup in the body and the direction of loading of the hip. In the worn region the femoral head in effect bores out a new socket for itself, a process which is visible with the naked eye after approximately eight years. Electron microscopy shows that the predominant wear mechanism is adhesion, but after about eight years the appearance of surface cracks suggests that surface fatigue is taking place in addition to this. Laboratory wear tests have shown that pure surface fatigue is not sufficient to account for the high clinical wear rate. Other deformation processes are suggested and discussed with regard to the higher clinical wear rate


Bone & Joint Research
Vol. 13, Issue 11 | Pages 682 - 693
26 Nov 2024
Wahl P Heuberger R Pascucci A Imwinkelried T Fürstner M Icken N Schläppi M Pourzal R Gautier E

Aims

Highly cross-linked polyethylene (HXLPE) greatly reduces wear in total hip arthroplasty, compared to conventional polyethylene (CPE). Cross-linking is commonly achieved by irradiation. This study aimed to compare the degree of cross-linking and in vitro wear rates across a cohort of retrieved and unused polyethylene cups/liners from various brands.

Methods

Polyethylene acetabular cups/liners were collected at one centre from 1 April 2021 to 30 April 2022. The trans-vinylene index (TVI) and oxidation index (OI) were determined by Fourier-transform infrared spectrometry. Wear was measured using a pin-on-disk test.


Bone & Joint Research
Vol. 11, Issue 7 | Pages 494 - 502
20 Jul 2022
Kwon HM Lee J Koh Y Park KK Kang K

Aims

A functional anterior cruciate ligament (ACL) or posterior cruciate ligament (PCL) has been assumed to be required for patients undergoing unicompartmental knee arthroplasty (UKA). However, this assumption has not been thoroughly tested. Therefore, this study aimed to assess the biomechanical effects exerted by cruciate ligament-deficient knees with medial UKAs regarding different posterior tibial slopes.

Methods

ACL- or PCL-deficient models with posterior tibial slopes of 1°, 3°, 5°, 7°, and 9° were developed and compared to intact models. The kinematics and contact stresses on the tibiofemoral joint were evaluated under gait cycle loading conditions.


The Bone & Joint Journal
Vol. 104-B, Issue 11 | Pages 1193 - 1195
1 Nov 2022
Rajput V Meek RMD Haddad FS

Periprosthetic joint infection (PJI) remains an extremely challenging complication. We have focused on this issue more over the last decade than previously, but there are still many unanswered questions. We now have a workable definition that everyone should align to, but we need to continue to focus on identifying the organisms involved. Surgical strategies are evolving and care is becoming more patient-centred. There are some good studies under way. There are, however, still numerous problems to resolve, and the challenge of PJI remains a major one for the orthopaedic community. This annotation provides some up-to-date thoughts about where we are, and the way forward. There is still scope for plenty of research in this area.

Cite this article: Bone Joint J 2022;104-B(11):1193–1195.


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.


Bone & Joint Open
Vol. 5, Issue 4 | Pages 286 - 293
9 Apr 2024
Upadhyay PK Kumar V Mirza SB Shah N

Aims

This study reports the results of 38 total hip arthroplasties (THAs) in 33 patients aged less than 50 years, using the JRI Furlong hydroxyapatite ceramic (HAC)-coated femoral component.

Methods

We describe the survival, radiological, and functional outcomes of 33 patients (38 THAs) at a mean follow-up of 27 years (25 to 32) between 1988 and 2018.


The Bone & Joint Journal
Vol. 105-B, Issue 3 | Pages 277 - 283
1 Mar 2023
Gausden EB Puri S Chiu Y Figgie MP Sculco TP Westrich G Sculco PK Chalmers BP

Aims

The purpose of this study was to assess mid-term survivorship following primary total knee arthroplasty (TKA) with Optetrak Logic components and identify the most common revision indications at a single institution.

Methods

We identified a retrospective cohort of 7,941 Optetrak primary TKAs performed from January 2010 to December 2018. We reviewed the intraoperative findings of 369 TKAs that required revision TKA from January 2010 to December 2021 and the details of the revision implants used. Kaplan-Meier analysis was used to determine survivorship. Cox regression analysis was used to examine the impact of patient variables and year of implantation on survival time.


The Bone & Joint Journal
Vol. 105-B, Issue 10 | Pages 1099 - 1107
1 Oct 2023
Henry JK Shaffrey I Wishman M Palma Munita J Zhu J Cody E Ellis S Deland J Demetracopoulos C

Aims

The Vantage Total Ankle System is a fourth-generation low-profile fixed-bearing implant that has been available since 2016. We aimed to describe our early experience with this implant.

Methods

This is a single-centre retrospective review of patients who underwent primary total ankle arthroplasty (TAA) with a Vantage implant between November 2017 and February 2020, with a minimum of two years’ follow-up. Four surgeons contributed patients. The primary outcome was reoperation and revision rate of the Vantage implant at two years. Secondary outcomes included radiological alignment, peri-implant complications, and pre- and postoperative patient-reported outcomes.


The Bone & Joint Journal
Vol. 106-B, Issue 5 Supple B | Pages 59 - 65
1 May 2024
Liu WKT Cheung A Fu H Chan PK Chiu KY

Aims

Isolated acetabular liner exchange with a highly crosslinked polyethylene (HXLPE) component is an option to address polyethylene wear and osteolysis following total hip arthroplasty (THA) in the presence of a well-fixed acetabular shell. The liner can be fixed either with the original locking mechanism or by being cemented within the acetabular component. Whether the method used for fixation of the HXLPE liner has any bearing on the long-term outcomes is still unclear.

Methods

Data were retrieved for all patients who underwent isolated acetabular component liner exchange surgery with a HXLPE component in our institute between August 2000 and January 2015. Patients were classified according to the fixation method used (original locking mechanism (n = 36) or cemented (n = 50)). Survival and revision rates were compared. A total of 86 revisions were performed and the mean duration of follow-up was 13 years.