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The Bone & Joint Journal
Vol. 101-B, Issue 5 | Pages 540 - 546
1 May 2019
Juneau D Grammatopoulos G Alzahrani A Thornhill R Inacio JR Dick A Vogel KI Dobransky J Beaulé PE Dwivedi G

Aims. Cardiac magnetic resonance (CMR) was used to assess whether cardiac function or tissue composition was affected in patients with well-functioning metal-on-metal hip resurfacing arthroplasties (MoMHRA) when compared with a group of controls, and to assess if metal ion levels correlated with any of the functional or structural parameters studied. Patients and Methods. In all, 30 participants with no significant cardiac history were enrolled: 20 patients with well-functioning MoMHRA at mean follow-up of 8.3 years post-procedure (ten unilateral, ten bilateral; 17 men, three women) and a case-matched control group of ten non-MoM total hip arthroplasty patients (six men, four women). The mean age of the whole cohort (study group and controls) at the time of surgery was 50.6 years (41.0 to 64.0). Serum levels of cobalt and chromium were measured, and all patients underwent CMR imaging, including cine, T2* measurements, T1 and T2 mapping, late gadolinium enhancement, and strain measurements. Results. None of the MoMHRA patients showed clinically significant cardiac functional abnormality. The MoMHRA patients had larger indexed right and left end diastolic volumes (left ventricular (LV): 74 ml/m. 2. vs 67 ml/m. 2. , p = 0.045; right ventricular: 80 ml/m. 2. vs 71 ml/m. 2. , p = 0.02). There was a small decrease in T2 time in the MoMHRA patients (median 49 ms vs 54 ms; p = 0.0003). Higher metal ion levels were associated with larger LV volumes and with shorter T2 time. Conclusion. Although cardiac function is not clinically adversely affected in patients with well-functioning MoMHRA, modern imaging is able to demonstrate subtle changes in structure and function of the heart. As these changes correlate with systemic ion measurements, they may be consequences of wear debris deposition. Longer, longitudinal studies are necessary to determine whether cardiac function will become affected. . Cite this article: Bone Joint J 2019;101-B:540–546


The Bone & Joint Journal
Vol. 97-B, Issue 7 | Pages 917 - 923
1 Jul 2015
Singh G Nuechtern JV Meyer H Fiedler GM Awiszus F Junk-Jantsch S Bruegel M Pflueger G Lohmann CH

The peri-prosthetic tissue response to wear debris is complex and influenced by various factors including the size, area and number of particles. We hypothesised that the ‘biologically active area’ of all metal wear particles may predict the type of peri-prosthetic tissue response. . Peri-prosthetic tissue was sampled from 21 patients undergoing revision of a small diameter metal-on-metal (MoM) total hip arthroplasty (THA) for aseptic loosening. An enzymatic protocol was used for tissue digestion and scanning electron microscope was used to characterise particles. Equivalent circle diameters and particle areas were calculated. Histomorphometric analyses were performed on all tissue specimens. Aspirates of synovial fluid were collected for analysis of the cytokine profile analysis, and compared with a control group of patients undergoing primary THA (n = 11) and revision of a failed ceramic-on-polyethylene arthroplasty (n = 6). . The overall distribution of the size and area of the particles in both lymphocyte and non-lymphocyte-dominated responses were similar; however, the subgroup with lymphocyte-dominated peri-prosthetic tissue responses had a significantly larger total number of particles. . 14 cytokines (interleukin (IL)-1ß, IL-2, IL-4, IL-5, IL-6, IL-10, IL-13, IL-17, interferon (IFN)-γ, and IFN-gamma-inducible protein 10), chemokines (macrophage inflammatory protein (MIP)-1α and MIP-1ß), and growth factors (granulocyte macrophage colony stimulating factor (GM-CSF) and platelet derived growth factor) were detected at significantly higher levels in patients with metal wear debris compared with the control group. . Significantly higher levels for IL-1ß, IL-5, IL-10 and GM-CSF were found in the subgroup of tissues from failed MoM THAs with a lymphocyte-dominated peri-prosthetic response compared with those without this response. . These results suggest that the ‘biologically active area’ predicts the type of peri-prosthetic tissue response. The cytokines IL-1ß, IL-5, IL-10, and GM-CSF are associated with lymphocyte-dominated tissue responses from failed small-diameter MoM THA. Cite this article: Bone Joint J 2015;97-B:917–23


The Journal of Bone & Joint Surgery British Volume
Vol. 92-B, Issue 1 | Pages 28 - 37
1 Jan 2010
Jameson SS Langton DJ Nargol AVF

We present the early clinical and radiological results of Articular Surface Replacement (ASR) resurfacings in 214 hips (192 patients) with a mean follow-up of 43 months (30 to 57). The mean age of the patients was 56 years (28 to 74) and 85 hips (40%) were in 78 women. The mean Harris hip score improved from 52 (11 to 81) to 95 (27 to 100) at two years and the mean University of California, Los Angeles activity score from 3.9 (1 to 10) to 7.4 (2 to 10) in the same period. Narrowing of the neck (to a maximum of 9%) was noted in 124 of 209 hips (60%). There were 12 revisions (5.6%) involving four (1.9%) early fractures of the femoral neck and two (0.9%) episodes of collapse of the femoral head secondary to avascular necrosis. Six patients (2.8%) had failure related to metal wear debris. The overall survival for our series was 93% (95% confidence interval 80 to 98) and 89% (95% confidence interval 82 to 96) for hips with acetabular components smaller than 56 mm in diameter. The ASR implant has a lower diametrical clearance and a subhemispherical acetabular component when compared with other more frequently implanted metal-on-metal hip resurfacings. These changes may contribute to the higher failure rate than in other series, compared with other designs. Given our poor results with the small components we are no longer implanting the smaller size


The Bone & Joint Journal
Vol. 97-B, Issue 11 | Pages 1470 - 1474
1 Nov 2015
Selvarajah E Hooper G Grabowski K Frampton C Woodfield TBF Inglis G

Polyethylene wear debris can cause osteolysis and the failure of total hip arthroplasty. We present the five-year wear rates of a highly cross-linked polyethylene (X3) bearing surface when used in conjunction with a 36 mm ceramic femoral head. This was a prospective study of a cohort of 100 THAs in 93 patients. Pain and activity scores were measured pre- and post-operatively. Femoral head penetration was measured at two months, one year, two years and at five years using validated edge-detecting software (PolyWare Auto). At a mean of 5.08 years (3.93 to 6.01), 85 hips in 78 patients were available for study. The mean age of these patients was 59.08 years (42 to 73, the mean age of males (n = 34) was 59.15 years, and females (n = 44) was 59.02 years). All patients had significant improvement in their functional scores (p < 0.001). The steady state two-dimensional linear wear rate was 0.109 mm/year. The steady state volumetric wear rate was 29.61 mm. 3. /year. No significant correlation was found between rate of wear and age (p = 0.34), acetabular component size (p = 0.12) or clinical score (p = 0.74). Our study shows low steady state wear rates at five years in X3 highly cross-linked polyethylene in conjunction with a 36 mm ceramic femoral head. The linear wear rate was almost identical to the osteolysis threshold of 0.1 mm/year recommended in the literature. Cite this article: Bone Joint J 2015;97-B:1470–4


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 9 | Pages 1152 - 1157
1 Sep 2008
Khan M Kuiper J Richardson JB

Wear of metal-on-metal bearings causes elevated levels of cobalt and chromium in blood and body fluids. Metal-on-metal bearings have two distinct wear phases. In the early phase, the wear rate is high. Later, it decreases and the bearing enters a steady-state phase. It is expected that as the wear rates decline, the level of cobalt detected in plasma will also decrease. We studied the baseline and exercise-related cobalt rise in 21 patients (13 men and eight women) with a mean age of 54 years (38 to 80) who had undergone successful hip resurfacing at a mean of 44 months (10 to 96) earlier. Our results showed that circulating baseline cobalt levels were not significantly correlated with the time since implantation (r = 0.08, p = 0.650). By contrast, the exercise-related cobalt rise was directly correlated with the inclination angle of the acetabular component (r = 0.47, p = 0.032) and inversely correlated with the time since implantation (r = −0.5, p = 0.020). Inclination of the acetabular component should be kept less than 40° to decrease the production of wear debris


The Journal of Bone & Joint Surgery British Volume
Vol. 88-B, Issue 4 | Pages 472 - 476
1 Apr 2006
Savarino L Greco M Cenni E Cavasinni L Rotini R Baldini N Giunti A

Modern metal-on-metal bearings produce less wear debris and osteolysis, but have the potential adverse effect of release of ions. Improved ceramic-on-ceramic bearings have the lowest wear of all, but the corrosion process has not been analysed. Our aim was to measure the serum ion release (ng/ml) in 23 patients having stable hip prostheses with a ceramic-on-ceramic coupling (group A) and to compare it with the release in 42 patients with a metal-on-metal bearing (group B) in the medium term. Reference values were obtained from a population of 47 healthy subjects (group C). The concentrations of chromium, cobalt, aluminium and titanium were measured. There was a significant increase of cobalt, chromium and aluminium levels (p < 0.05) in group B compared with groups A and C. Group A did not differ significantly from the control group. Despite the apparent advantage of a metal-on-metal coupling, especially in younger patients with a long life expectancy, a major concern arises regarding the extent and duration of ion exposure. For this reason, the low corrosion level in a ceramic-on-ceramic coupling could be advantageous


The Bone & Joint Journal
Vol. 95-B, Issue 3 | Pages 333 - 338
1 Mar 2013
Jack CM Molloy DO Walter WL Zicat BA Walter WK

The practice of removing a well-fixed cementless femoral component is associated with high morbidity. Ceramic bearing couples are low wearing and their use minimises the risk of subsequent further revision due to the production of wear debris. A total of 165 revision hip replacements were performed, in which a polyethylene-lined acetabular component was revised to a new acetabular component with a ceramic liner, while retaining the well-fixed femoral component. A titanium sleeve was placed over the used femoral trunnion, to which a ceramic head was added. There were 100 alumina and 65 Delta bearing couples inserted. . The mean Harris hip score improved significantly from 71.3 (9.0 to 100.0) pre-operatively to 91.0 (41.0 to 100.0) at a mean follow up of 4.8 years (2.1 to 12.5) (p < 0.001). No patients reported squeaking of the hip. There were two fractures of the ceramic head, both in alumina bearings. No liners were seen to fracture. No fractures were observed in components made of Delta ceramic. At 8.3 years post-operatively the survival with any cause of failure as the endpoint was 96.6% (95% confidence interval (CI) 85.7 to 99.3) for the acetabular component and 94.0% (95% CI 82.1 to 98.4) for the femoral component. The technique of revising the acetabular component in the presence of a well-fixed femoral component with a ceramic head placed on a titanium sleeve over the used trunnion is a useful adjunct in revision hip practice. The use of Delta ceramic is recommended. Cite this article: Bone Joint J 2013;95-B:333–8


The Journal of Bone & Joint Surgery British Volume
Vol. 90-B, Issue 7 | Pages 847 - 851
1 Jul 2008
Pandit H Glyn-Jones S McLardy-Smith P Gundle R Whitwell D Gibbons CLM Ostlere S Athanasou N Gill HS Murray DW

We report 17 patients (20 hips) in whom metal-on-metal resurfacing had been performed and who presented with various symptoms and a soft-tissue mass which we termed a pseudotumour. Each patient underwent plain radiography and in some, CT, MRI and ultrasonography were also performed. In addition, histological examination of available samples was undertaken. All the patients were women and their presentation was variable. The most common symptom was discomfort in the region of the hip. Other symptoms included spontaneous dislocation, nerve palsy, a noticeable mass or a rash. The common histological features were extensive necrosis and lymphocytic infiltration. To date, 13 of the 20 hips have required revision to a conventional hip replacement. Two are awaiting revision. We estimate that approximately 1% of patients who have a metal-on-metal resurfacing develop a pseudotumour within five years. The cause is unknown and is probably multifactorial. There may be a toxic reaction to an excess of particulate metal wear debris or a hypersensitivity reaction to a normal amount of metal debris. We are concerned that with time the incidence of these pseudotumours may increase. Further investigation is required to define their cause


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 11 | Pages 1443 - 1447
1 Nov 2009
Zenz P Stiehl JB Knechtel H Titzer-Hochmaier G Schwagerl W

Cementless acetabular fixation has demonstrated superior long-term durability in total hip replacement, but most series have studied implants with porous metal surfaces. We retrospectively evaluated the results of 100 consecutive patients undergoing total hip replacement where a non-porous Allofit component was used for primary press-fit fixation. This implant is titanium alloy, grit-blasted, with a macrostructure of forged teeth and has a biradial shape. A total of 81 patients (82 hips) were evaluated at final follow-up at a mean of 10.1 years (8.9 to 11.9). The Harris Hip Score improved from a mean 53 points (23 to 73) pre-operatively to a mean of 96 points (78 to 100) at final review. The osseointegration of all acetabular components was radiologically evaluated with no evidence of loosening. The survival rate with revision of the component as the endpoint was 97.5% (95% confidence interval 94 to 100) after 11.9 years. Radiolucency was found in one DeLee-Charnley zone in four acetabular components. None of the implants required revision for aseptic loosening. Two patients were treated for infection, one requiring a two-stage revision of the implant. One femoral stem was revised for osteolysis due to the production of metal wear debris, but the acetabular shell did not require revision. This study demonstrates that a non-porous titanium acetabular component with adjunct surface fixation offers an alternative to standard porous-coated implants


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 555 - 564
1 Jun 2024
Leal J Holland CT Cochrane NH Seyler TM Jiranek WA Wellman SS Bolognesi MP Ryan SP

Aims

This study aims to assess the relationship between history of pseudotumour formation secondary to metal-on-metal (MoM) implants and periprosthetic joint infection (PJI) rate, as well as establish ESR and CRP thresholds that are suggestive of infection in these patients. We hypothesized that patients with a pseudotumour were at increased risk of infection.

Methods

A total of 1,171 total hip arthroplasty (THA) patients with MoM articulations from August 2000 to March 2014 were retrospectively identified. Of those, 328 patients underwent metal artefact reduction sequence MRI and had minimum two years’ clinical follow-up, and met our inclusion criteria. Data collected included demographic details, surgical indication, laterality, implants used, history of pseudotumour, and their corresponding preoperative ESR (mm/hr) and CRP (mg/dl) levels. Multivariate logistic regression modelling was used to evaluate PJI and history of pseudotumour, and receiver operating characteristic curves were created to assess the diagnostic capabilities of ESR and CRP to determine the presence of infection in patients undergoing revision surgery.


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 Journal of Bone & Joint Surgery British Volume
Vol. 81-B, Issue 1 | Pages 46 - 50
1 Jan 1999
Sieber H Rieker CB Köttig P

Osteolysis is due to particulate wear debris and is responsible for the long-term failure of total hip replacements. It has stimulated the development of alternative joint surfaces such as metal-on-metal or ceramic-on-ceramic implants. Since 1988 the second-generation metal-on-metal implant Metasul has been used in over 60 000 hips. Analysis of 118 retrieved specimens of the head or cup showed rates of wear of approximately 25 μm for the whole articulation per year in the first year, decreasing to about 5 μm per year after the third. Metal surfaces have a ‘self-polishing’ capacity. Scratches are worn out by further joint movement. Volumetric wear was decreased some 60-fold compared with that of metal-on-polyethylene implants, suggesting that second-generation metal-on-metal prostheses may considerably reduce osteolysis


The Journal of Bone & Joint Surgery British Volume
Vol. 86-B, Issue 1 | Pages 34 - 38
1 Jan 2004
Duffy P Sher JL Partington PF

The ABG I cementless hip prosthesis has demonstrated unacceptably high rates of wear and osteolysis in our patients. We performed a retrospective study of 97 hips implanted between 1992 and 1998. Radiographic analysis revealed high rates of wear of the polyethylene liner with marked periacetabular osteolysis. Clinical examination indicated that many of these patients were initially asymptomatic. Wear-related problems have required ten hips to be revised and a furher 13 are awaiting revision. This gives a failure rate of 24% at a mean follow-up of 69 months. Contributing factors are likely to include poor wear characteristics of the polyethylene liners which were gamma irradiated in air, and increased wear debris caused by a poor fit of the polyethylene liner within the shell. We believe that all ABG I implants should be immediately reviewed and remain under careful, long-term follow-up


The Journal of Bone & Joint Surgery British Volume
Vol. 86-B, Issue 2 | Pages 190 - 194
1 Mar 2004
Bizot P Hannouche D Nizard R Witvoet J Sedel L

Between 1990 and 1992, we implanted 71 hybrid alumina-on-alumina hip arthroplasties in 62 consecutive patients under the age of 55 years, with a mean age of 46 years at surgery. There were 56 primary and 15 secondary procedures. The prostheses involved a cemented titanium alloy stem, a 32 mm alumina head, and a press-fit metal-backed socket with an alumina insert. Three patients (four hips) died from unrelated causes. Four hips had revision surgery for either deep infection, unexplained persistent pain, fracture of the alumina head, or aseptic loosening of the socket. The nine-year survival rate was 93.7% with revision for any cause as the end-point and 98.4% with revision for aseptic loosening as the end-point. The outcome in the surviving patients (50 patients, 57 hips) with a minimum five-year follow-up (mean eight years) was excellent in 47 hips (82.5%), very good in eight (14%), good in one and fair in one. A thin, partial, lucent line, mainly in zone III was present in 38% of the sockets and one socket had a complete lucency less than 1 mm thick. One stem had isolated femoral osteolysis. There was no detectable component migration nor acetabular osteolysis. This hybrid arthroplasty gave satisfactory medium-term results in active patients. The press-fit metal-backed socket appeared to have reliable fixation in alumina-on-alumina hip arthroplasty. The excellent results using cemented fixation of the stem may be related to the low production of wear debris


The Journal of Bone & Joint Surgery British Volume
Vol. 82-B, Issue 7 | Pages 952 - 958
1 Sep 2000
Morrey BF Adams RA Kessler M

Between 1985 and 1993, 146 patients (162 hips) had total hip replacement (THR) using a conservative uncemented femoral component. The mean age of the patients was 50.8 years and the mean follow-up was 6.2 years (2 to 13). One patient was lost to follow-up, one died within two years of surgery and one had a revision procedure after a fracture sustained in a road-traffic accident. For the remaining 159, Kaplan-Meier survival analysis was calculated for the incidence of revision because of mechanical loosening or osteolysis. Survival without mechanical loosening at both five and ten years was 98.2%. Survival without osteolysis was 99% at five and 91% at ten years. The Harris hip score improved from a mean of 66.3 before to 90.4 at follow-up. Of particular note is the lack of thigh pain in this group. Radiological analysis showed that 139 stems (88%) had no measurable subsidence, 8 (5%) had less than 2 mm and 12 (7%) had more than 2 mm. Two of the eight and one of the 12 were revised for mechanical loosening. Nine hips were revised for late loosening associated with osteolysis. No reaming of the femoral canal was associated with statistically significant less blood loss compared with a comparable control group of uncemented implants (p < 0.0001). Our study suggests that using a conservative femoral implant does not protect against wear debris but the reliable mechanical stability (98.2%) makes this an attractive design of implant particularly for young patients


The Bone & Joint Journal
Vol. 103-B, Issue 10 | Pages 1604 - 1610
1 Oct 2021
Takaoka Y Goto K Tamura J Okuzu Y Kawai T Kuroda Y Orita K Matsuda S

Aims

We aimed to evaluate the long-term outcome of highly cross-linked polyethylene (HXLPE) cemented acetabular components and assess whether any radiolucent lines (RLLs) which arose were progressive.

Methods

We retrospectively reviewed 170 patients who underwent 187 total hip arthroplasties at two hospitals with a minimum follow-up of ten years. All interventions were performed using the same combination of HXLPE cemented acetabular components with femoral stems made of titanium alloy. Kaplan-Meier survival analysis was performed for the primary endpoint of acetabular component revision surgery for any reason and secondary endpoint of the appearance of RLLs. RLLs that had appeared once were observed over time. We statistically assessed potential relationships between RLLs and a number of factors, including the technique of femoral head autografting and the Japanese Orthopaedic Association score.


The Bone & Joint Journal
Vol. 102-B, Issue 7 | Pages 832 - 837
1 Jul 2020
Dover C Kuiper JH Craig P Shaylor P

Aims

We have previously demonstrated raised cobalt and chromium levels in patients with larger diameter femoral heads, following metal-on-polyethylene uncemented total hip arthroplasty. Further data have been collected, to see whether these associations have altered with time and to determine the long-term implications for these patients and our practice.

Methods

Patients from our previous study who underwent Trident-Accolade primary total hip arthroplasties using a metal-on-polyethylene bearing in 2009 were reviewed. Patients were invited to have their cobalt and chromium levels retested, and were provided an Oxford Hip Score. Serum ion levels were then compared between groups (28 mm, 36 mm, and 40 mm heads) and over time.


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1231 - 1237
1 Jul 2021
Manninen E Lainiala O Karsikas M Reito A Jämsä P Eskelinen A

Aims

To find out if there is an inverse association between estimated glomerular filtration rate (eGFR) and whole blood cobalt (Co) and chromium (Cr) levels in patients with metal-on-metal (MoM) hip arthroplasties and renal insufficiency, suggesting that renal insufficiency could cause accumulation of Co and Cr in blood.

Methods

Out of 2,520 patients with 3,013 MoM hip arthroplasties, we identified 1,244 patients with whole blood Co, Cr, and creatinine measured within no more than a one-year interval. We analyzed the correlation of blood metal ion levels and eGFR to identify a potential trend of accumulating Co or Cr with decreasing eGFR.


The Bone & Joint Journal
Vol. 102-B, Issue 11 | Pages 1491 - 1496
1 Nov 2020
Buddhdev PK Vanhegan IS Khan T Hashemi-Nejad A

Aims

Despite advances in the treatment of paediatric hip disease, adolescent and young adult patients can develop early onset end-stage osteoarthritis. The aims of this study were to address the indications and medium-term outcomes for total hip arthroplasty (THA) with ceramic bearings for teenage patients.

Methods

Surgery was performed by a single surgeon working in the paediatric orthopaedic unit of a tertiary referral hospital. Databases were interrogated from 2003 to 2017 for all teenage patients undergoing THA with a minimum 2.3 year follow-up. Data capture included patient demographics, the underlying hip pathology, number of previous surgeries, and THA prostheses used. Institutional ethical approval was granted to contact patients for prospective clinical outcomes and obtain up-to-date radiographs. In total, 60 primary hips were implanted in 51 patients (35 female, 16 male) with nine bilateral cases. The mean age was 16.7 years (12 to 19) and mean follow-up was 9.3 years (2.3 to 16.8).


The Bone & Joint Journal
Vol. 102-B, Issue 10 | Pages 1303 - 1310
3 Oct 2020
Kjærgaard K Ding M Jensen C Bragdon C Malchau H Andreasen CM Ovesen O Hofbauer C Overgaard S

Aims

The most frequent indication for revision surgery in total hip arthroplasty (THA) is aseptic loosening. Aseptic loosening is associated with polyethylene liner wear, and wear may be reduced by using vitamin E-doped liners. The primary objective of this study was to compare proximal femoral head penetration into the liner between a) two cross-linked polyethylene (XLPE) liners (vitamin E-doped (vE-PE)) versus standard XLPE liners, and b) two modular femoral head diameters (32 mm and 36 mm).

Methods

Patients scheduled for a THA were randomized to receive a vE-PE or XLPE liner with a 32 mm or 36 mm metal head (four intervention groups in a 2 × 2 factorial design). Head penetration and acetabular component migration were measured using radiostereometric analysis at baseline, three, 12, 24, and 60 months postoperatively. The Harris Hip Score, University of California, Los Angeles (UCLA) Activity Score, EuroQol five-dimension questionnaire (EQ-5D), and 36-Item Short-Form Health Survey questionnaire (SF-36) were assessed at baseline, three, 12, 36, and 60 months.