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Aims. Surgical treatment of hip fracture is challenging; the bone is porotic and fixation failure can be catastrophic. Novel implants are available which may yield superior clinical outcomes. This study compared the clinical effectiveness of the novel X-Bolt Hip System (XHS) with the sliding hip screw (SHS) for the treatment of fragility hip fractures. Methods. We conducted a multicentre, superiority, randomized controlled trial. Patients aged 60 years and older with a trochanteric hip fracture were recruited in ten acute UK NHS hospitals. Participants were randomly allocated to fixation of their fracture with XHS or SHS. A total of 1,128 participants were randomized with 564 participants allocated to each group. Participants and outcome assessors were blind to treatment allocation. The primary outcome was the EuroQol five-dimension five-level health status (EQ-5D-5L) utility at four months. The minimum clinically important difference in utility was pre-specified at 0.075. Secondary outcomes were EQ-5D-5L utility at 12 months, mortality, residential status, mobility, revision surgery, and radiological measures. Results. Overall, 437 and 443 participants were analyzed in the primary intention-to-treat analysis in XHS and SHS treatment groups respectively. There was a mean difference of 0.029 in adjusted utility index in favour of XHS with no evidence of a difference between treatment groups (95% confidence interval -0.013 to 0.070; p = 0.175). There was no evidence of any differences between treatment groups in any of the secondary outcomes. The pattern and overall risk of adverse events associated with both treatments was similar. Conclusion. Any difference in four-month health-related quality of life between the XHS and SHS is small and not clinically important. There was no evidence of a difference in the safety profile of the two treatments; both were associated with lower risks of revision surgery than previously reported. Cite this article: Bone Joint J 2021;103-B(2):256–263


The Bone & Joint Journal
Vol. 103-B, Issue 5 | Pages 881 - 887
1 May 2021
Griffin XL Achten J Parsons N Costa ML

Aims. The aim of this study was to determine whether national standards of best practice are associated with improved health-related quality of life (HRQoL) outcomes in hip fracture patients. Methods. This was a multicentre cohort study conducted in 20 acute UK NHS hospitals treating hip fracture patients. Patients aged ≥ 60 years treated operatively for a hip fracture were eligible for inclusion. Regression models were fitted to each of the “Best Practice Tariff” indicators and overall attainment. The impact of attainment on HRQoL was assessed by quantifying improvement in EuroQol five-dimension five-level questionnaire (EQ-5D-5L) from estimated regression model coefficients. Results. A total of 6,532 patients provided both baseline and four-month EQ-5D-5L, of whom 1,060 participants had died at follow-up. Best practice was achieved in the care of 57% of participants; there was no difference in age, cognitive ability, and mobility at baseline for the overall attainment and non-attainment groups. Attaining at least ‘joint care by surgeon and orthogeriatrician’, ‘delirium assessment’, and ‘falls assessment’ was associated with a large, clinically relevant increase in four months EQ-5D-5L of 0.094 (bootstrapped 95% confidence interval (CI) 0.046 to 0.146). Conclusion. National standards with enhanced remuneration in hip fracture care results in improvement in individual patients’ HRQoL. Cite this article: Bone Joint J 2021;103-B(5):881–887


The Bone & Joint Journal
Vol. 102-B, Issue 12 | Pages 1662 - 1669
1 Dec 2020
Pollmann CT Gjertsen J Dale H Straume-Næsheim TM Dybvik E Hallan G

Aims. To compare the functional outcome, health-related quality of life (HRQoL), and satisfaction of patients who underwent primary total hip arthroplasty (THA) and a single debridement, antibiotics and implant retention (DAIR) procedure for deep infection, using either the transgluteal or the posterior surgical approach for both procedures. Methods. The study was registered at clinicaltrials.gov (ID: NCT03161990) on 15 May 2017. Patients treated with a single DAIR procedure for deep infection through the same operative approach as their primary THA (either the transgluteal or the posterior approach) were identified in the Norwegian Arthroplasty Register and given a questionnaire. Median follow-up after DAIR by questionnaire was 5.5 years in the transgluteal group (n = 87) and 2.5 years in the posterior approach group (n = 102). Results. Patients in the posterior approach group were less likely to limp after the DAIR procedure (17% vs 36% limped all the time; p = 0.005), had a higher mean Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) function score (80 vs 71; p = 0.013), and were more likely to achieve a patient acceptable symptom state for the WOMAC function score (76% vs 55%; p = 0.002). In a multivariable analysis, the point estimate for the increase in WOMAC function score using the posterior approach was 10.2 (95% CI 3.1 to 17.2; p = 0.005), which is above the minimal clinically important improvement. The patients in the posterior approach group also reported better mean HRQoL scores and were more likely to be satisfied with their hip arthroplasty (77% vs 55%; p = 0.001). Conclusion. In patients treated with a single, successful DAIR procedure for deep infection of a primary THA, the use of the posterior approach in both primary surgery and DAIR was associated with less limping, better functional outcome, better HRQoL, and higher patient satisfaction compared with cases where both were performed using the transgluteal approach. The observed differences in functional outcome and patient satisfaction were clinically relevant. Cite this article: Bone Joint J 2020;102-B(12):1662–1669


The Bone & Joint Journal
Vol. 106-B, Issue 7 | Pages 656 - 661
1 Jul 2024
Bolbocean C Hattab Z O'Neill S Costa ML

Aims. Cemented hemiarthroplasty is an effective form of treatment for most patients with an intracapsular fracture of the hip. However, it remains unclear whether there are subgroups of patients who may benefit from the alternative operation of a modern uncemented hemiarthroplasty – the aim of this study was to investigate this issue. Knowledge about the heterogeneity of treatment effects is important for surgeons in order to target operations towards specific subgroups who would benefit the most. Methods. We used causal forest analysis to compare subgroup- and individual-level treatment effects between cemented and modern uncemented hemiarthroplasty in patients aged > 60 years with an intracapsular fracture of the hip, using data from the World Hip Trauma Evaluation 5 (WHiTE 5) multicentre randomized clinical trial. EuroQol five-dimension index scores were used to measure health-related quality of life at one, four, and 12 months postoperatively. Results. Our analysis revealed a complex landscape of responses to the use of a cemented hemiarthroplasty in the 12 months after surgery. There was heterogeneity of effects with regard to baseline characteristics, including age, pre-injury health status, and lifestyle factors such as alcohol consumption. This heterogeneity was greater at the one-month mark than at subsequent follow-up timepoints, with particular regard to subgroups based on age. However, for all subgroups, the effect estimates for quality of life lay within the confidence intervals derived from the analysis of all patients. Conclusion. The use of a cemented hemiarthroplasty is expected to increase health-related quality of life compared with modern uncemented hemiarthroplasty for all subgroups of patients aged > 60 years with a displaced intracapsular fracture of the hip. Cite this article: Bone Joint J 2024;106-B(7):656–661


The Bone & Joint Journal
Vol. 104-B, Issue 12 | Pages 1304 - 1312
1 Dec 2022
Kim HKW Almakias R Millis MB Vakulenko-Lagun B

Aims

Perthes’ disease (PD) is a childhood hip disorder that can affect the quality of life in adulthood due to femoral head deformity and osteoarthritis. There is very little data on how PD patients function as adults, especially from the patients’ perspective. The purpose of this study was to collect treatment history, demographic details, the University of California, Los Angeles activity score (UCLA), the 36-Item Short Form survey (SF-36) score, and the Hip disability and Osteoarthritis Outcome score (HOOS) of adults who had PD using a web-based survey method and to compare their outcomes to the outcomes from an age- and sex-matched normative population.

Methods

The English REDCap-based survey was made available on a PD study group website. The survey included childhood and adult PD history, UCLA, SF-36, and HOOS. Of the 1,182 participants who completed the survey, the 921 participants who did not have a total hip arthroplasty are the focus of this study. The mean age at survey was 38 years (SD 12) and the mean duration from age at PD onset to survey participation was 30.8 years (SD 12.6).


The Journal of Bone & Joint Surgery British Volume
Vol. 89-B, Issue 2 | Pages 160 - 165
1 Feb 2007
Blomfeldt R Törnkvist H Eriksson K Söderqvist A Ponzer S Tidermark J

The best treatment for the active and lucid elderly patient with a displaced intracapsular fracture of the femoral neck is still controversial. Randomised controlled trials have shown that a primary total hip replacement is superior to internal fixation as regards the need for secondary surgery, hip function and health-related quality of life. Despite good results achieved with total hip replacement in this group, most orthopaedic surgeons still advocate hemiarthroplasty for this injury. We studied 120 patients with a mean age of 81 years (70 to 90) with an acute displaced intracapsular fracture of the femoral neck. They were randomly allocated to be treated with either a bipolar hemiarthroplasty or total hip replacement. Outcome measurements included peri-operative data, general and hip-specific complications, hip function and health-related quality of life. The patients were reviewed at four and 12 months. The duration of surgery was longer in the total hip replacement group (102 minutes (70 to 151)) versus 78 minutes (43 to 131) (p < 0.001), and the intra-operative blood loss was increased 460 ml (100 to 1100) versus 320 ml (50 to 850) (p < 0.001), but there were no differences between the groups regarding any complications or mortality. There were no dislocations in either group. Hip function measured by the Harris hip score was significantly better in the total hip replacement group at both follow-up periods (p = 0.011 and p < 0.001, respectively). The health-related quality of life measure was in favour of the total hip replacement group but did not reach statistical significance (p = 0.818 at four months and p = 0.636 at 12 months). These results indicate that a total hip replacement provides better function than a bipolar hemiarthroplasty as soon as one year post-operatively, without increasing the complication rate. We recommend total hip replacement as the primary treatment for this group of patients


The Journal of Bone & Joint Surgery British Volume
Vol. 93-B, Issue 7 | Pages 867 - 875
1 Jul 2011
Rolfson O Kärrholm J Dahlberg LE Garellick G

We present the development and results of a nationwide, prospective, observational follow-up programme including patient-reported outcome measures (PROMs) for the Swedish Hip Arthroplasty Register. The programme started in 2002 and has gradually expanded to include all units performing total hip replacement in Sweden. The self-administered PROMs protocol comprises the EQ-5D instrument, the Charnley class categorisation and visual analogue scales for pain and satisfaction. These current analyses include 34 960 total hip replacements with complete pre- and one-year post-operative questionnaires. Patients eligible for total hip replacement generally report low health-related quality of life and suffer from pain. One year post-operatively the mean EQ-5D index increased to above the level of an age- and gender-matched population, with a considerable reduction of pain (p < 0.001). Females, younger patients and those with Charnley category C reported a lower EQ-5D index pre-operatively than males, older patients and Charnley category A or B, respectively (all p < 0.001). In a multivariable regression analysis Charnley category C, male gender and higher age were associated with less improvement in health-related quality of life (p < 0.001). Nationwide implementation of a PROMs programme requires a structured organisation and effective data capture. Patients’ response rates to the Registry are good. The continuous collection of PROMs permits local and national improvement work and allows for further health-economic evaluation


The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 2 | Pages 157 - 161
1 Feb 2009
Rolfson O Dahlberg LE Nilsson J Malchau H Garellick G

In this study we hypothesised that anxiety/depression, one of five dimensions in the health-related quality of life (HRQoL) measurement tool EQ-5D, could predict outcome after total hip replacement surgery. Pre-operative and one-year post-operative data from the Swedish Hip Arthroplasty Register, including 6158 patients with primary osteoarthritis of the hip, were analysed. In order to examine the association between anxiety and outcome with respect to pain and satisfaction an analysis of covariance was used. The pre-operative EQ-5D anxiety/depression dimension was a strong predictor for pain relief and patient satisfaction (p < 0.001). Orthopaedic surgeons involved in the care of patients eligible for total hip replacement surgery should be aware that mental health may influence post-operative pain and HRQoL. An appropriate assessment of mental health may enable a modification in the way these patients are managed in order to optimise the outcome after joint replacement surgery


The Bone & Joint Journal
Vol. 99-B, Issue 6 | Pages 759 - 765
1 Jun 2017
Eneqvist T Nemes S Brisby H Fritzell P Garellick G Rolfson O

Aims. The aims of this study were to describe the prevalence of previous lumbar surgery in patients who undergo total hip arthroplasty (THA) and to investigate their patient-reported outcomes (PROMs) one year post-operatively. Patients and Methods. Data from the Swedish Hip Arthroplasty Register and the Swedish Spine Register gathered from 2002 to 2013 were merged to identify a group of patients who had undergone lumbar surgery before THA (n = 997) and a carefully matched one-to-one control group. We investigated differences in the one-year post-operative PROMs between the groups. Linear regression analyses were used to explore the associations between previous lumbar surgery and these PROMs following THA. The prevalence of prior lumbar surgery was calculated as the ratio of patients identified with previous lumbar surgery between 2002 and 2012, and divided by the total number of patients who underwent a THA in 2012. Results. The prevalence of lumbar surgery prior to THA in 2012 was 3.5% (351 of 10 082). Linear regression analyses showed an association with more pain (B = 4.35, 95% confidence interval (CI) 2.57 to 6.12), worse EuroQol (EQ)-5D index, (B = -0.089, 95% CI -0.112 to -0.066), worse EQ VAS (B = -6.75, 95% CI -8.58 to -4.92), and less satisfaction (B = 6.04, 95% CI 4.05 to 8.02). Conclusion. Lumbar spinal surgery prior to THA is associated with less reduction of pain, worse health-related quality of life, and less satisfaction one year after THA. This is useful information to share in the decision-making process and may help establish realistic expectations of the outcomes of THA in patients who also have previously undergone lumbar spinal surgery. Cite this article: Bone Joint J 2017;99-B:759–65


The Bone & Joint Journal
Vol. 96-B, Issue 8 | Pages 1016 - 1023
1 Aug 2014
Haywood KL Griffin XL Achten J Costa ML

The lack of a consensus for core health outcomes that should be reported in clinical research has hampered study design and evidence synthesis. We report a United Kingdom consensus for a core outcome set (COS) for clinical trials of patients with a hip fracture. We adopted a modified nominal group technique to derive consensus on 1) which outcome domains should be measured, and 2) methods of assessment. Participants reflected a diversity of perspectives and experience. They received an evidence synthesis and postal questionnaire in advance of the consensus meeting, and ranked the importance of candidate domains and the relevance and suitability of short-listed measures. During the meeting, pre-meeting source data and questionnaire responses were summarised, followed by facilitated discussion and a final plenary session. A COS was determined using a closed voting system: a 70% consensus was required. Consensus supported a five-domain COS: mortality, pain, activities of daily living, mobility, and health-related quality of life (HRQL). Single-item measures of mortality and mobility (indoor/outdoor walking status) and a generic multi-item measure of HRQL - the EuroQoL EQ-5D - were recommended. These measures should be included as a minimum in all hip fracture trials. Other outcome measures should be added depending on the particular interventions being studied. Cite this article: Bone Joint J 2014; 96-B:1016–23


The Bone & Joint Journal
Vol. 96-B, Issue 5 | Pages 590 - 596
1 May 2014
Lindgren JV Wretenberg P Kärrholm J Garellick G Rolfson O

The effects of surgical approach in total hip replacement on health-related quality of life and long-term pain and satisfaction are unknown. From the Swedish Hip Arthroplasty Register, we extracted data on all patients that had received a total hip replacement for osteoarthritis through either the posterior or the direct lateral approach, with complete pre- and one-year post-operative Patient Reported Outcome Measures (PROMs). A total of 42 233 patients met the inclusion criteria and of these 4962 also had complete six-year PROM data. The posterior approach resulted in an increased mean satisfaction score of 15 (. sd 19. ) vs 18 (. sd. 22) (p <  0.001) compared with the direct lateral approach. The mean pain score was 13 (. sd 17). vs 15 (. sd. 19) (p < 0.001) and the proportion of patients with no or minimal pain was 78% vs 74% (p < 0.001) favouring the posterior approach. The patients in the posterior approach group reported a superior mean EQ-5D index of 0.79 (. sd 0.23) . vs 0.77 (. sd. 0.24) (p < 0.001) and mean EQ score of 76 (. sd. 20) vs 75 (. sd 20). (p < 0.001). All observed differences between the groups persisted after six years follow-up. Although PROMs after THR in general are very good regardless of surgical approach, the results indicate that some patients operated by the direct lateral approach report an inferior outcome compared with the posterior approach. The large number of procedures and the seemingly sustained differences make it likely these findings are clinically relevant. Cite this article: Bone Joint J 2014;96-B:590–6


The Journal of Bone & Joint Surgery British Volume
Vol. 85-B, Issue 3 | Pages 380 - 388
1 Apr 2003
Tidermark J Ponzer S Svensson O Söderqvist A Törnkvist H

The treatment algorithms for displaced fractures of the femoral neck need to be improved if we are to reduce the need for secondary surgery. We have studied 102 patients of mean age 80 years, with an acute displaced fracture of the femoral neck. They were randomly placed into two groups, treated either by internal fixation (IF) with two cannulated screws or total hip replacement (THR). None showed severe cognitive dysfunction, all were able to walk independently, and all lived in their own home. They were reviewed at four, 12 and 24 months after surgery. Outcome measurements included hip complications, revision surgery, hip function according to Charnley and the health-related quality of life (HRQoL) according to EuroQol (EQ-5D). The failure rate after 24 months was higher in the IF group than in the THR group with regard to hip complications (36% and 4%, respectively; p < 0.001), and the number of revision procedures (42% and 4%, p < 0.001). Hip function was significantly better in the THR group at all follow-up reviews regarding pain (p < 0.005), movement (p < 0.05 except at 4 months) and walking (p < 0.05). The reduction in HRQoL (EQ-5D . index. score) was also significantly lower in the THR group than in the IF group, comparing the pre-fracture situation with that at all follow-up reviews (p < 0.05). The results of our study strongly suggest that THR provides a better outcome than IF for elderly, relatively healthy, lucid patients with a displaced fracture of the femoral neck


The Bone & Joint Journal
Vol. 106-B, Issue 2 | Pages 136 - 143
1 Feb 2024
van der Lelij TJN Marang-van de Mheen PJ Kaptein BL Koster LA Ljung P Nelissen RGHH Toksvig-Larsen S

Aims

The objective of this study was to compare the two-year migration and clinical outcomes of a new cementless hydroxyapatite (HA)-coated titanium acetabular shell with its previous version, which shared the same geometrical design but a different manufacturing process for applying the titanium surface.

Methods

Overall, 87 patients undergoing total hip arthroplasty (THA) were randomized to either a Trident II HA or Trident HA shell, each cementless with clusterholes and HA-coating. All components were used in combination with a cemented Exeter V40 femoral stem. Implant migration was measured using radiostereometric analysis (RSA), with radiographs taken within two days of surgery (baseline), and at three, 12, and 24 months postoperatively. Proximal acetabular component migration was the primary outcome measure. Clinical scores and patient-reported outcome measures (PROMs) were collected at each follow-up.


The Bone & Joint Journal
Vol. 104-B, Issue 8 | Pages 922 - 928
1 Aug 2022
Png ME Petrou S Fernandez MA Achten J Parsons N McGibbon A Gould J Griffin XL Costa ML

Aims

The aim of this study was to compare the cost-effectiveness of cemented hemiarthroplasty (HA) versus hydroxyapatite-coated uncemented HA for the treatment of displaced intracapsular hip fractures in older adults.

Methods

A within-trial economic evaluation was conducted based on data collected from the World Hip Trauma Evaluation 5 (WHiTE 5) multicentre randomized controlled trial in the UK. Resource use was measured over 12 months post-randomization using trial case report forms and participant-completed questionnaires. Cost-effectiveness was reported in terms of incremental cost per quality-adjusted life year (QALY) gained from the NHS and personal social service perspective. Methodological uncertainty was addressed using sensitivity analysis, while decision uncertainty was represented graphically using confidence ellipses and cost-effectiveness acceptability curves.


The Bone & Joint Journal
Vol. 104-B, Issue 7 | Pages 844 - 851
1 Jul 2022
Rogmark C Nåtman J Jobory A Hailer NP Cnudde P

Aims

Patients with femoral neck fractures (FNFs) treated with total hip arthroplasty (THA) have an almost ten-fold increased risk of dislocation compared to patients undergoing elective THA. The surgical approach influences the risk of dislocation. To date, the influence of differing head sizes and dual-mobility components (DMCs) on the risk of dislocation has not been well studied.

Methods

In an observational cohort study on 8,031 FNF patients with THA between January 2005 and December 2014, Swedish Arthroplasty Register data were linked with the National Patient Register, recording the total dislocation rates at one year and revision rates at three years after surgery. The cumulative incidence of events was estimated using the Kaplan-Meier method. Cox multivariable regression models were fitted to calculate adjusted hazard ratios (HRs) with 95% confidence intervals (CIs) for the risk of dislocation, revision, or mortality, stratified by surgical approach.


The Bone & Joint Journal
Vol. 104-B, Issue 7 | Pages 792 - 800
1 Jul 2022
Gustafsson K Kvist J Zhou C Eriksson M Rolfson O

Aims

The aim of this study was to estimate time to arthroplasty among patients with hip and knee osteoarthritis (OA), and to identify factors at enrolment to first-line intervention that are prognostic for progression to surgery.

Methods

In this longitudinal register-based observational study, we identified 72,069 patients with hip and knee OA in the Better Management of Patients with Osteoarthritis Register (BOA), who were referred for first-line OA intervention, between May 2008 and December 2016. Patients were followed until the first primary arthroplasty surgery before 31 December 2016, stratified into a hip and a knee OA cohort. Data were analyzed with Kaplan-Meier and multivariable-adjusted Cox regression.


The Bone & Joint Journal
Vol. 103-B, Issue 12 | Pages 1783 - 1790
1 Dec 2021
Montgomery S Bourget-Murray J You DZ Nherera L Khoshbin A Atrey A Powell JN

Aims

Total hip arthroplasty (THA) with dual-mobility components (DM-THA) has been shown to decrease the risk of dislocation in the setting of a displaced neck of femur fracture compared to conventional single-bearing THA (SB-THA). This study assesses if the clinical benefit of a reduced dislocation rate can justify the incremental cost increase of DM-THA compared to SB-THA.

Methods

Costs and benefits were established for patients aged 75 to 79 years over a five-year time period in the base case from the Canadian Health Payer’s perspective. One-way and probabilistic sensitivity analysis assessed the robustness of the base case model conclusions.


The Bone & Joint Journal
Vol. 103-B, Issue 7 | Pages 1206 - 1214
1 Jul 2021
Tsikandylakis G Mortensen KRL Gromov K Mohaddes M Malchau H Troelsen A

Aims

We aimed to investigate if the use of the largest possible cobalt-chromium head articulating with polyethylene acetabular inserts would increase the in vivo wear rate in total hip arthroplasty.

Methods

In a single-blinded randomized controlled trial, 96 patients (43 females), at a median age of 63 years (interquartile range (IQR) 57 to 69), were allocated to receive either the largest possible modular femoral head (36 mm to 44 mm) in the thinnest possible insert or a standard 32 mm head. All patients received a vitamin E-doped cross-linked polyethylene insert and a cobalt-chromium head. The primary outcome was proximal head penetration measured with radiostereometric analysis (RSA) at two years. Secondary outcomes were volumetric wear, periacetabular radiolucencies, and patient-reported outcomes.


The Bone & Joint Journal
Vol. 102-B, Issue 9 | Pages 1128 - 1135
14 Sep 2020
Khoshbin A Haddad FS Ward S O hEireamhoin S Wu J Nherera L Atrey A

Aims

The rate of dislocation when traditional single bearing implants are used in revision total hip arthroplasty (THA) has been reported to be between 8% and 10%. The use of dual mobility bearings can reduce this risk to between 0.5% and 2%. Dual mobility bearings are more expensive, and it is not clear if the additional clinical benefits constitute value for money for the payers. We aimed to estimate the cost-effectiveness of dual mobility compared with single bearings for patients undergoing revision THA.

Methods

We developed a Markov model to estimate the expected cost and benefits of dual mobility compared with single bearing implants in patients undergoing revision THA. The rates of revision and further revision were calculated from the National Joint Registry of England and Wales, while rates of transition from one health state to another were estimated from the literature, and the data were stratified by sex and age. Implant and healthcare costs were estimated from local procurement prices and national tariffs. Quality-adjusted life-years (QALYs) were calculated using published utility estimates for patients undergoing THA.


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.