Aims. Periprosthetic proximal femoral fractures (PFFs) are a major complication after total hip arthroplasty (THA). Health status after PFF is not specifically investigated. The aim of this study is to evaluate the health status pattern over two years after sustaining a PFF. Methods. A cohort of patients with PFF after THA was derived from the Brabant Injury Outcomes Surveillance (BIOS) study. The BIOS study, a prospective, observational, multicentre follow-up cohort study, was conducted to obtain data by questionnaires pre-injury and at one week, and one, three, six, 12, and 24 months after trauma. Primary outcome measures were the EuroQol five-dimension three-level questionnaire (EQ-5D-3L), the Health Utility Index 2 (HUI2), and the Health Utility Index 3 (HUI3). Secondary outcome measures were general measurements such as duration of hospital stay and mortality. Results. A total of 70 patients with a PFF were included. EQ-5D utility scores were significantly lower on all timepoints except at six months’ follow-up compared to pre-injury. EuroQol visual analogue scale (EQ-VAS) scores at one month's follow-up were significantly lower compared to pre-injury. The percentage of reported problems at two years was higher for all dimensions except anxiety/depression when compared to pre-injury. The mean EQ-5D utility score was 0.26 higher in males compared to females (95% confidence interval (CI) 0.01 to 0.42; p = 0.003). The mean EQ-VAS score for males was 8.9 points higher when compared to females over all timepoints (95% CI 1.2 to 16.7; p = 0.027). Mortality was 10% after two years’ follow-up. Conclusion. PFF patients are a frail population with substantial functional impairment at baseline. Post-injury, they have a significant and clinically relevant lower health status two years after trauma when compared to pre-injury. Health status improves the most between one and three months after injury. Two years after PFF, more patients experience problems in mobility, self-care, usual activities, and pain/discomfort than pre-injury. Cite this article: Bone Joint J 2024;106-B(5):442–449

Aims. This study uses prospective registry data to compare early patient outcomes following arthroscopic repair or debridement of the acetabular labrum. Methods. Data on adult patients who underwent arthroscopic labral debridement or repair between 1 January 2012 and 31 July 2019 were extracted from the UK Non-Arthroplasty Hip Registry. Patients who underwent microfracture, osteophyte excision, or a concurrent extra-articular procedure were excluded. The EuroQol five-dimension (EQ-5D) and International Hip Outcome Tool 12 (iHOT-12) questionnaires were collected preoperatively and at six and 12 months post-operatively. Due to concerns over differential questionnaire non-response between the two groups, a combination of random sampling, propensity score matching, and pooled multivariable linear regression models were employed to compare iHOT-12 improvement. Results. A total of 2,025 labral debridements (55%) and 1,659 labral repairs (45%) were identified. Both groups saw significant (p < 0.001) EQ-5D and iHOT-12 gain compared to preoperative scores at 12 months (iHOT-12 improvement: labral repair = +28.7 (95% confidence interval (CI) 26.4 to 30.9), labral debridement = +24.7 (95% CI 22.5 to 27.0)), however there was no significant difference between procedures after multivariable modelling. Overall, 66% of cases achieved the minimum clinically important difference (MCID) and 48% achieved substantial clinical benefit at 12 months. Conclusion. Both labral procedures were successful in significantly improving early functional outcome following hip arthroscopy, regardless of age or sex. Labral repair was associated with superior outcomes in univariable analysis, however there was no significant superiority demonstrated in the multivariable model. Level of evidence: III. Cite this article: Bone Jt Open 2022;3(4):291–301

Aims. Hip fracture patients have high morbidity and mortality. Patient-reported outcome measures (PROMs) assess the quality of care of patients with hip fracture, including those with chronic cognitive impairment (CCI). Our aim was to compare PROMs from hip fracture patients with and without CCI, using the Norwegian Hip Fracture Register (NHFR). Methods. PROM questionnaires at four months (n = 34,675) and 12 months (n = 24,510) after a hip fracture reported from 2005 to 2018 were analyzed. Pre-injury score was reported in the four-month questionnaire. The questionnaires included the EuroQol five-dimension three-level (EQ-5D-3L) questionnaire, and information about who completed the questionnaire. Results. Of the 34,675 included patients, 5,643 (16%) had CCI. Patients with CCI were older (85 years vs 81 years) (p < 0.001), and had a higher American Society of Anesthesiologists (ASA) classification compared to patients without CCI. CCI was unrelated to fracture type and treatment method. EQ-5D index scores were lower in patients with CCI after four months (0.37 vs 0.60; p < 0.001) and 12 months (0.39 vs 0.64; p < 0.001). Patients with CCI had lower scores for all dimensions of the EQ-5D-3L pre-fracture and at four and 12 months. Conclusion. Patients with CCI reported lower health-related quality of life pre-fracture, at four and 12 months after the hip fracture. PROM data from hip fracture patients with CCI are valuable in the assessment of treatment. Patients with CCI should be included in future studies. Cite this article: Bone Jt Open 2021;2(7):454–465

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.

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

Aims

The primary aim of our study was to assess the influence of age on hip-specific outcome following total hip arthroplasty (THA). Secondary aims were to assess health-related quality of life (HRQoL) and level of activity according to age.

Objectives

This study investigates the reporting of health-related quality of life (HRQoL) in patients following hip fracture. We compare the relative merits and make recommendations for the use for two methods of measuring HRQoL; (i) including patients who died during follow-up and (ii) including survivors only.

Aims. This study investigates the use of the metabolic equivalent of task (MET) score in a young hip arthroplasty population, and its ability to capture additional benefit beyond the ceiling effect of conventional patient-reported outcome measures. Methods. From our electronic database of 751 hip arthroplasty procedures, 221 patients were included. Patients were excluded if they had revision surgery, an alternative hip procedure, or incomplete data either preoperatively or at one-year follow-up. Included patients had a mean age of 59.4 years (SD 11.3) and 54.3% were male, incorporating 117 primary total hip and 104 hip resurfacing arthroplasty operations. Oxford Hip Score (OHS), EuroQol five-dimension questionnaire (EQ-5D), and the MET were recorded preoperatively and at one-year follow-up. The distribution was examined reporting the presence of ceiling and floor effects. Validity was assessed correlating the MET with the other scores using Spearman’s rank correlation coefficient and determining responsiveness. A subgroup of 93 patients scoring 48/48 on the OHS were analyzed by age, sex, BMI, and preoperative MET using the other metrics to determine if differences could be established despite scoring identically on the OHS. Results. Postoperatively the OHS and EQ-5D demonstrate considerable negatively skewed distributions with ceiling effects of 41.6% and 53.8%, respectively. The MET was normally distributed postoperatively with no relevant ceiling effect. Weak-to-moderate significant correlations were found between the MET and the other two metrics. In the 48/48 subgroup, no differences were found comparing groups with the EQ-5D, however significantly higher mean MET scores were demonstrated for patients aged < 60 years (12.7 (SD 4.7) vs 10.6 (SD 2.4), p = 0.008), male patients (12.5 (SD 4.5) vs 10.8 (SD 2.8), p = 0.024), and those with preoperative MET scores > 6 (12.6 (SD 4.2) vs 11.0 (SD 3.3), p = 0.040). Conclusion. The MET is normally distributed in patients following hip arthroplasty, recording levels of activity which are undetectable using the OHS. Cite this article: Bone Joint Res 2022;11(5):317–326

Aims. To assess the variation in pre-fracture quality of life (QoL) within the UK hip fracture population, and quantify the nature and strength of associations between QoL and other routinely collected patient characteristics and treatment choices. Methods. The World Hip Trauma Evaluation (WHiTE) study, an observational cohort study of UK hip fracture patients, collects a range of routine data and a health-related QoL score (EuroQol five-dimension questionnaire (EQ-5D)). Pre-fracture QoL data are summarized and statistical models fitted to understand associations between QoL, patient characteristics, fracture types, and operations. Results. Fitting a multiple linear regression model indicated that 36.5% of the variance in pre-fracture EQ-5D scores was explained by routinely collected patient characteristics: sex (0.14%), age (0.17%), American Society of Anesthesiologists (ASA) score (0.73%), Abbreviated Mental Test Score (AMTS; 1.3%), pre-fracture mobility (11.2%), and EQ-5D respondent (participant, relative, or carer; 23.0%). There was considerable variation in pre-fracture EQ-5D scores between operations within fracture types. Participants with trochanteric fractures reported statistically significant but not clinically relevant lower pre-fracture QoL than those with intracapsular fractures. Participants with intracapsular fractures treated with internal fixation or total hip arthroplasty (THA) reported better QoL than those treated with hemiarthroplasty with the overall fittest group receiving THA. Conclusion. Pre-fracture QoL varies considerably between hip fracture patients; it is generally higher in younger than older patients, patients with better mobility, and those patients who live more independently. Pre-fracture QoL is significantly associated with a range of patient characteristics (e.g. age, mobility, residency). These data explain ~35% of the variation in QoL. Cite this article: Bone Joint Res 2020;9(8):468–476

Aims. The primary aim of this study was to quantify the improvement in patient-reported outcome measures (PROMs) following total hip arthroplasty (THA), as well as the extent of any deterioration through the seven-year follow-up. The secondary aim was to identify predictors of PROM improvement and deterioration. Patients and Methods. A total of 976 patients were enrolled into a prospective, international, multicentre study. Patients completed a battery of PROMs prior to THA, at three months post-THA, and at one, three, five, and seven-years post-THA. The Harris Hip Score (HHS), the 36-Item Short-Form Health Survey (SF-36) Physical Component Summary (PCS), the SF-36 Mental Component Summary (MCS), and the EuroQol five-dimension three-level (EQ-5D) index were the primary outcomes. Longitudinal changes in each PROM were investigated by piece-wise linear mixed effects models. Clinically significant deterioration was defined for each patient as a decrease of one half of a standard deviation (group baseline). Results. Improvements were noted in each PROM between the preoperative and one-year visits, with one-year values exceeding age-matched population norms. Patients with difficulty in self-care experienced less improvement in HHS (odds ratio (OR) 2.2; p = 0.003). Those with anxiety/depression experienced less improvement in PCS (OR -3.3; p = 0.002) and EQ-5D (OR -0.07; p = 0.005). Between one and seven years, obesity was associated with deterioration in HHS (1.5 points/year; p = 0.006), PCS (0.8 points/year; p < 0.001), and EQ-5D (0.02 points/year; p < 0.001). Preoperative difficulty in self-care was associated with deterioration in HHS (2.2 points/year; p < 0.001). Preoperative pain from other joints was associated with deterioration in MCS (0.8 points/year; p < 0.001). All aforementioned factors were associated with clinically significant deterioration in PROMs (p < 0.035), except anxiety/depression with regard to PCS (p = 0.060). Conclusion. The present study finds that patient factors affect the improvement and deterioration in PROMs over the medium term following THA. Special attention should be given to patients with risk factors for decreased PROMs, both preoperatively and during follow-up. Cite this article: Bone Joint J 2019;101-B:768–778

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

Aims. The primary aim of this study was to compare the hip-specific functional outcome of robotic assisted total hip arthroplasty (rTHA) with manual total hip arthroplasty (mTHA) in patients with osteoarthritis (OA). Secondary aims were to compare general health improvement, patient satisfaction, and radiological component position and restoration of leg length between rTHA and mTHA. Methods. A total of 40 patients undergoing rTHA were propensity score matched to 80 patients undergoing mTHA for OA. Patients were matched for age, sex, and preoperative function. The Oxford Hip Score (OHS), Forgotten Joint Score (FJS), and EuroQol five-dimension questionnaire (EQ-5D) were collected pre- and postoperatively (mean 10 months (SD 2.2) in rTHA group and 12 months (SD 0.3) in mTHA group). In addition, patient satisfaction was collected postoperatively. Component accuracy was assessed using Lewinnek and Callanan safe zones, and restoration of leg length were assessed radiologically. Results. There were no significant differences in the preoperative demographics (p ≥ 0.781) or function (p ≥ 0.383) between the groups. The postoperative OHS (difference 2.5, 95% confidence interval (CI) 0.1 to 4.8; p = 0.038) and FJS (difference 21.1, 95% CI 10.7 to 31.5; p < 0.001) were significantly greater in the rTHA group when compared with the mTHA group. However, only the FJS was clinically significantly greater. There was no difference in the postoperative EQ-5D (difference 0.017, 95% CI -0.042 to 0.077; p = 0.562) between the two groups. No patients were dissatisfied in the rTHA group whereas six were dissatisfied in the mTHA group, but this was not significant (p = 0.176). rTHA was associated with an overall greater rate of component positioning in a safe zone (p ≤ 0.003) and restoration of leg length (p < 0.001). Conclusion. Patients undergoing rTHA had a greater hip-specific functional outcome when compared to mTHA, which may be related to improved component positioning and restoration of leg length. However, there was no difference in their postoperative generic health or rate of satisfaction. Cite this article: Bone Joint Res 2021;10(1):22–30

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

Aims. The aim of this study was to compare early functional and health related quality of life outcomes (HRQoL) in patients who have undergone total hip arthroplasty (THA) using a bone conserving short stem femoral component and those in whom a conventional length uncemented component was used. Outcome was assessed using a validated performance based outcome instrument as well as patient reported outcome measures (PROMs). Patients and Methods. We prospectively analysed 33 patients whose THA involved a contemporary proximally porous coated tapered short stem femoral component and 53 patients with a standard conventional femoral component, at a minimum follow-up of two years. The mean follow-up was 31.4 months (24 to 39). Patients with poor proximal femoral bone quality were excluded. The mean age of the patients was 66.6 years (59 to 77) and the mean body mass index was 30.2 kg/m. 2. (24.1 to 41.0). Outcome was assessed using the Oxford Hip Score (OHS) and the University College Hospital (UCH) hip score which is a validated performance based instrument. HRQoL was assessed using the EuroQol 5D (EQ-5D). Results. There were no major peri-operative complications. There was no difference in the mean post-operative OHS, EQ-5D or function subscale of the UCH hip scores between the two groups. The mean pre-operative OHS and EQ-5D scores improved significantly (all p <  0.001). The mean functional component of the UCH hip score at final follow-up was 42.5 and 40.6 in the short stem and conventional stem groups, respectively. There was no statistically significant difference between the groups (p = 0.42). A total of seven patients (21.2%) in the short stem group and nine (16.98%) in the conventional group achieved a ceiling effect using the OHS; none did using the function subscale of the UCH hip score. Conclusion. The proximally porous coated tapered short stem femoral component achieves comparable short-term functional outcomes when compared with a conventional longer stem uncemented femoral component when THA is undertaken in patients with good bone quality. Cite this article: Bone Joint J 2017;99-B(4 Supple B):49–55

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

Our aim was to define the minimum set of patient-reported outcome measures which are required to assess health status after total hip replacement (THR). In 114 patients, we compared the pre-operative characteristics and sensitivity to change of the Oxford hip score (OHS), the Western Ontario and McMaster Universities osteoarthritis index (WOMAC), the SF-36, the SF-12 (derived from the SF-36), and the Euroqol questionnaire (EQ-5D). At one year after operation, very large effect sizes were found for the disease-specific measures, the physical domains of the SF-12, SF-36 and the EQ-5D. index. (1.3 to 3.0). Patients in Charnley class A showed more change in the OHS, WOMAC pain and function, the physical domains of the SF-36 and the EQ-5D. vas. (p < 0.05) compared with those in the Charnley B and C group. In this group, the effect size for the OHS more than doubled the effect sizes of WOMAC pain and physical function. We found high correlations and correlations of change between the OHS, the WOMAC, the physical domains of the SF-12 and the SF-36 and EQ-5D. index. The SF-36 and EQ-5D scores at one year after operation approached those of the general population. Furthermore, we found a binomial distribution of the pre-operative EQ-5D. index. score and a pre-operative discrepancy and post-operative agreement between the EQ-5D. vas. and EQ-5D. index. . We recommend the use of the OHS and SF-12 in the assessment of THR. The SF-36 may be used in circumstances when smaller changes in health status are investigated, for example in the follow-up of THR. The EQ-5D is useful in situations in which utility values are needed in order to calculate cost-effectiveness or quality-adjusted life years (QALYs), such as in the assessment of new techniques in THR

Objectives. Our primary aim was to describe migration of the Exeter stem with a 32 mm head on highly crosslinked polyethylene and whether this is influenced by age. Our secondary aims were to assess functional outcome, satisfaction, activity, and bone mineral density (BMD) according to age. Patients and Methods. A prospective cohort study was conducted. Patients were recruited into three age groups: less than 65 years (n = 65), 65 to 74 years (n = 68), and 75 years and older (n = 67). There were 200 patients enrolled in the study, of whom 115 were female and 85 were male, with a mean age of 69.9 years (sd 9.5, 42 to 92). They were assessed preoperatively, and at three, 12 and, 24 months postoperatively. Stem migration was assessed using Einzel-Bild-Röntgen-Analyse (EBRA). Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Harris Hip Score (HHS), Hip Disability and Osteoarthritis Outcome Score (HOOS), EuroQol-5 domains questionnaire (EQ-5D), short form-36 questionnaire (SF-36,) and patient satisfaction were used to assess outcome. The Lower Extremity Activity Scale (LEAS), Timed Up and Go (TUG) test, and activPAL monitor (energy expelled, time lying/standing/walking and step count) were used to assess activity. The BMD was assessed in Gruen and Charnley zones. Results. Mean varus/valgus tilt was -0.77⁰ and axial subsidence was -1.20 mm. No significant difference was observed between age groups (p ⩾ 0.07). There was no difference according to age group for postoperative WOMAC (p ⩾ 0.11), HHS (p ⩾ 0.06), HOOS (p ⩾ 0.46), EQ-5D (p ⩾ 0.38), patient satisfaction (p ⩾ 0.05), or activPAL (p ⩾ 0.06). Patients 75 years and older had a worse SF-36 physical function (p = 0.01) and physical role (p = 0.03), LEAS score (p < 0.001), a shorter TUG (p = 0.01), and a lower BMD in Charnley zone 1 (p = 0.02). Conclusion. Exeter stem migration is within normal limits and is not influenced by age group. Functional outcome, patient satisfaction, activity level, and periprosthetic BMD are similar across all age groups. Cite this article: N. D. Clement, M. Bardgett, K. Merrie, S. Furtado, R. Bowman, D. J. Langton, D. J. Deehan, J. Holland. Cemented Exeter total hip arthroplasty with a 32 mm head on highly crosslinked polyethylene: Does age influence functional outcome, satisfaction, activity, stem migration, and periprosthetic bone mineral density? Bone Joint Res 2019;8:275–287. DOI: 10.1302/2046-3758.86.BJR-2018-0300.R1

Aims

The aim of this study was to explore the functional results in a fitter subgroup of participants in the Hip Fracture Evaluation with Alternatives of Total Hip Arthroplasty versus Hemiarthroplasty (HEALTH) trial to determine whether there was an advantage of total hip arthroplasty (THA) versus hemiarthroplasty (HA) in this population.

Aims

We assessed the long-term outcomes of a large cohort of patients who have undergone a periacetabular osteotomy (PAO), and sought to validate a patient satisfaction questionnaire for use in a PAO cohort.

Aims

The primary outcome was investigating differences in wear, as measured by femoral head penetration, between cross-linked vitamin E-diffused polyethylene (vE-PE) and cross-linked polyethylene (XLPE) acetabular component liners and between 32 and 36 mm head sizes at the ten-year follow-up. Secondary outcomes included acetabular component migration and patient-reported outcome measures (PROMs) such as the EuroQol five-dimension questionnaire, 36-Item Short-Form Health Survey, Harris Hip Score, and University of California, Los Angeles Activity Scale (UCLA).

Aims

Achieving accurate implant positioning and restoring native hip biomechanics are key surgeon-controlled technical objectives in total hip arthroplasty (THA). The primary objective of this study was to compare the reproducibility of the planned preoperative centre of hip rotation (COR) in patients undergoing robotic arm-assisted THA versus conventional THA.

Aims

Head-taper corrosion is a cause of failure in total hip arthroplasty (THA). Recent reports have described an increasing number of V40 taper failures with adverse local tissue reaction (ALTR). However, the real incidence of V40 taper damage and its cause remain unknown. The aim of this study was to evaluate the long-term incidence of ALTR in a consecutive series of THAs using a V40 taper and identify potentially related factors.

Aims

The aim of this study was to estimate the clinical and economic burden of dislocation following primary total hip arthroplasty (THA) in England.

Aims

Instability is a common cause of failure after total hip arthroplasty. A novel reverse total hip has been developed, with a femoral cup and acetabular ball, creating enhanced mechanical stability. The purpose of this study was to assess the implant fixation using radiostereometric analysis (RSA), and the clinical safety and efficacy of this novel design.

Aims

Although the Fitmore Hip Stem has been on the market for almost 15 years, it is still not well documented in randomized controlled trials. This study compares the Fitmore stem with the CementLeSs (CLS) in several different clinical and radiological aspects. The hypothesis is that there will be no difference in outcome between stems.

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.

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.

The aim of this randomised controlled study was to compare functional and radiological outcomes between modern cemented and uncemented hydroxyapatite coated stems after one year in patients treated surgically for a fracture of the femoral neck. A total of 141 patients aged > 65 years were included. Patients were randomised to be treated with a cemented Exeter stem or an uncemented Bimetric stem. The patients were reviewed at four and 12 months. The cemented group performed better than the uncemented group for the Harris hip score (78 vs 70.7, p = 0.004) at four months and for the Short Musculoskeletal Function Assesment Questionnaire dysfunction score at four (29.8 vs 39.2, p = 0.007) and 12 months (22.3 vs 34.9, p = 0.001). The mean EQ-5D index score was better in the cemented group at four (0.68 vs 0.53, p = 0.001) and 12 months (0.75 vs 0.58, p = < 0.001) follow-up. There were nine intra-operative fractures in the uncemented group and none in the cemented group. . In conclusion, our data do not support the use of an uncemented hydroxyapatite coated stem for the treatment of displaced fractures of the femoral neck in the elderly. Cite this article: Bone Joint J 2015;97-B:1475–80

Aims

Golf is a popular pursuit among those requiring total hip arthroplasty (THA). The aim of this study was to determine if participating in golf is associated with greater functional outcomes, satisfaction, or improvement in quality of life (QoL) compared to non-golfers.

Aims

The aim of this study was to compare the mid-term patient-reported outcome, bone remodelling, and migration of a short stem (Collum Femoris Preserving; CFP) with a conventional uncemented stem (Corail).

Aims

The aim of this study was to identify the minimal clinically important difference (MCID), minimal important change (MIC), minimal detectable change (MDC), and patient-acceptable symptom state (PASS) in the Forgotten Joint Score (FJS) according to patient satisfaction six months following total hip arthroplasty (THA) in a UK population.

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.

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.

Aims

Periacetabular osteotomy (PAO) is an established treatment for acetabular dysplasia. It has also been proposed as a treatment for patients with acetabular retroversion. By reviewing a large cohort, we aimed to test whether outcome is equivalent for both types of morphology and identify factors that influenced outcome.

We report the clinical and radiological outcome of 86 revisions of cemented hip arthroplasties using JRI-Furlong hydroxyapatite-ceramic-coated acetabular and femoral components. The acetabular component was revised in 62 hips and the femoral component in all hips. The mean follow-up was 12.6 years and no patient was lost to follow-up. The mean age of the patients was 71.2 years. The mean Harris hip and Oxford scores were 82 (59 to 96) and 23.4 (14 to 40), respectively. The mean Charnley modification of the Merle d’Aubigné and Postel score was 5 (3 to 6) for pain, 4.9 (3 to 6) for movement and 4.4 (3 to 6) for mobility. Migration of the acetabular component was seen in two hips and the mean acetabular inclination was 42.6°. The mean linear polyethylene wear was 0.05 mm/year. The mean subsidence of the femoral component was 1.9 mm and stress shielding was seen in 23 (28%) with bony ingrowth in 76 (94%). Heterotopic ossification was seen in 12 hips (15%). There were three re-revisions, two for deep sepsis and one for recurrent dislocation and there were no re-revisions for aseptic loosening. The mean EuroQol EQ-5D description scores and health thermometer scores were 0.69 (0.51 to 0.89) and 79 (54 to 95), respectively. With an end-point of definite or probable loosening, the probability of survival at 12 years was 93.9% and 95.6% for the acetabular and femoral components, respectively. Overall survival at 12 years, with removal or further revision of either component for any reason as the end-point, was 92.3%. Our study supports the continued use of this arthroplasty and documents the durability of hydroxyapatite-ceramic-coated components

Aims

Vitamin E-infused highly crosslinked polyethylene (VEPE) has been introduced into total hip arthroplasty (THA) with the aim of further improving the wear characteristics of moderately and highly crosslinked polyethylenes (ModXLPE and HXLPE). There are few studies analyzing the outcomes of vitamin E-infused components in cemented arthroplasty, though early acetabular component migration has been reported. The aim of this study was to measure five-year polyethylene wear and acetabular component stability of a cemented VEPE acetabular component compared with a ModXLPE cemented acetabular component.

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.

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).

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.

Aims

Responsiveness and ceiling effects are key properties of an outcome score. No such data have been reported for the original English version of the International Hip Outcome Tool 12 (iHOT-12) at a follow-up of more than four months. The aim of this study was to identify the responsiveness and ceiling effects of the English version iHOT-12 in a series of patients undergoing hip arthroscopy for intra-articular hip pathology at a minimum of one year postoperatively.

Aims

Vitamin E-diffused, highly crosslinked polyethylene (VEPE) and porous titanium-coated (PTC) shells were introduced in total hip arthroplasty (THA) to reduce the risk of aseptic loosening. The purpose of this study was: 1) to compare the wear properties of VEPE to moderately crosslinked polyethylene; 2) to assess the stability of PTC shells; and 3) to report their clinical outcomes at seven years.

Aims

The aim of this study was to report our experience at 3.5 years with outpatient total hip arthroplasty (THA).

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.

Aim

This paper describes the methods applied to assess the cost-effectiveness of cemented versus uncemented hemiarthroplasty among hip fracture patients in the World Hip Trauma Evaluation Five (WHiTE5) trial.

Aims

The purpose of this study was to compare two different types of metal-on-metal (MoM) bearing for total hip arthroplasty (THA): one with a large femoral head (38 mm to 52 mm) and the other with a conventional femoral head (28 mm or 32 mm). We compared clinical outcome, blood metal ion levels, and the incidence of pseudotumour in the two groups.

Aims

Psychological factors play a critical role in patient presentation, satisfaction, and outcomes. Pain catastrophizing, anxiety, and depression are important to consider, as they are associated with poorer outcomes and are potentially modifiable. The aim of this study was to assess the level of pain catastrophizing, anxiety, and depression in patients with a range of hip pathology and to evaluate their relationship with patient-reported psychosocial and functional outcome measures.

Aims

The routine use of dual-mobility (DM) acetabular components in total hip arthroplasty (THA) may not be cost-effective, but an increasing number of patients undergoing THA have a coexisting spinal disorder, which increases the risk of postoperative instability, and these patients may benefit from DM articulations. This study seeks to examine the cost-effectiveness of DM components as an alternative to standard articulations in these patients.

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.

Aims

The aim of this study was to compare the incidence of aseptic loosening after the use of a cemented acetabular component and a Trabecular Metal (TM) acetabular component (Zimmer Inc., Warsaw, Indiana) at acetabular revision with bone impaction grafting.

Aims

The purpose of our study is to summarise the current scientific findings regarding the impact of obesity on total hip arthroplasty (THA); specifically the influence of obesity on the timing of THA, incidence of complications, and effect on clinical and functional outcomes.

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.

Aims

The optimal management of intracapsular fractures of the femoral neck in independently mobile patients remains open to debate. Successful fixation obviates the limitations of arthroplasty for this group of patients. However, with fixation failure rates as high as 30%, the outcome of revision surgery to salvage total hip arthroplasty (THA) must be considered. We carried out a systematic review to compare the outcomes of salvage THA and primary THA for intracapsular fractures of the femoral neck.

We report the kinematic and early clinical results of a patient- and observer-blinded randomised controlled trial in which CT scans were used to compare potential impingement-free range of movement (ROM) and acetabular component cover between patients treated with either the navigated ‘femur-first’ total hip arthroplasty (THA) method (n = 66; male/female 29/37, mean age 62.5 years; 50 to 74) or conventional THA (n = 69; male/female 35/34, mean age 62.9 years; 50 to 75). The Hip Osteoarthritis Outcome Score, the Harris hip score, the Euro-Qol-5D and the Mancuso THA patient expectations score were assessed at six weeks, six months and one year after surgery. A total of 48 of the patients (84%) in the navigated ‘femur-first’ group and 43 (65%) in the conventional group reached all the desirable potential ROM boundaries without prosthetic impingement for activities of daily living (ADL) in flexion, extension, abduction, adduction and rotation (p = 0.016). Acetabular component cover and surface contact with the host bone were > 87% in both groups. There was a significant difference between the navigated and the conventional groups’ Harris hip scores six weeks after surgery (p = 0.010). There were no significant differences with respect to any clinical outcome at six months and one year of follow-up. The navigated ‘femur-first’ technique improves the potential ROM for ADL without prosthetic impingement, although there was no observed clinical difference between the two treatment groups.

Cite this article: Bone Joint J 2015; 97-B:890–8.

Aims

We present a minimum 20-year follow-up study of 382 cemented Exeter Universal total hip arthroplasties (350 patients) operated on at a mean age of 66.3 years (17 to 94).

Objectives

The Oxford hip score (OHS) is a 12-item questionnaire designed and developed to assess function and pain from the perspective of patients who are undergoing total hip replacement (THR). The OHS has been shown to be consistent, reliable, valid and sensitive to clinical change following THR. It has been translated into different languages, but no adequately translated, adapted and validated Danish language version exists.

The aim of this study was to evaluate the ten-year clinical and functional outcome of hip resurfacing and to compare it with that of cementless hip arthroplasty in patients under the age of 55 years.

Between 1999 and 2002, 80 patients were enrolled into the study: 24 were randomised (11 to hip resurfacing, 13 to total hip arthroplasty), 18 refused hip resurfacing and chose cementless total hip arthroplasty with a 32 mm bearing, and 38 insisted on resurfacing. The mean follow-up for all patients was 12.1 years (10 to 14).

Patients were assessed clinically and radiologically at one year, five years and ten years. Outcome measures included EuroQol EQ5D, Oxford, Harris hip, University of California Los Angeles and University College Hospital functional scores.

No differences were seen between the two groups in the Oxford or Harris hip scores or in the quality of life scores. Despite a similar aspiration to activity pre-operatively, a higher proportion of patients with a hip resurfacing were running and involved in sport and heavy manual labour after ten years.

We found significantly higher function scores in patients who had undergone hip resurfacing than in those with a cementless hip arthroplasty at ten years. This suggests a functional advantage for hip resurfacing. There were no other attendant problems.

Cite this article: Bone Joint J 2015; 97-B:617–22.

Aims

We report on the outcome of the Exeter Contemporary flanged cemented all-polyethylene acetabular component with a mean follow-up of 12 years (10 to 13.9). This study reviewed 203 hips in 194 patients. 129 hips in 122 patients are still in situ; 66 hips in 64 patients were in patients who died before ten years, and eight hips (eight patients) were revised. Clinical outcome scores were available for 108 hips (104 patients) and radiographs for 103 hips (100 patients).

The reported prevalence of an asymptomatic slip of the contralateral hip in patients operated on for unilateral slipped capital femoral epiphysis (SCFE) is as high as 40%. Based on a population-based cohort of 2072 healthy adolescents (58% women) we report on radiological and clinical findings suggestive of a possible previous SCFE. Common threshold values for Southwick’s lateral head–shaft angle (≥ 13°) and Murray’s tilt index (≥ 1.35) were used. New reference intervals for these measurements at skeletal maturity are also presented.

At follow-up the mean age of the patients was 18.6 years (17.2 to 20.1). All answered two questionnaires, had a clinical examination and two hip radiographs.

There was an association between a high head–shaft angle and clinical findings associated with SCFE, such as reduced internal rotation and increased external rotation. Also, 6.6% of the cohort had Southwick’s lateral head–shaft angle ≥ 13°, suggestive of a possible slip. Murray’s tilt index ≥ 1.35 was demonstrated in 13.1% of the cohort, predominantly in men, in whom this finding was associated with other radiological findings such as pistol-grip deformity or focal prominence of the femoral neck, but no clinical findings suggestive of SCFE.

This study indicates that 6.6% of young adults have radiological findings consistent with a prior SCFE, which seems to be more common than previously reported.

Cite this article: Bone Joint J 2013;95-B:452–8.

We have studied the natural history of a first episode of dislocation after primary total hip replacement (THR) to clarify the incidence of recurrent dislocation, the need for subsequent revision and the quality of life of these patients.

Over a six-year period, 99 patients (101 hips) presented with a first dislocation of a primary THR. A total of 61 hips (60.4%) had dislocated more than once. After a minimum follow-up of one year, seven patients had died. Of the remaining 94 hips (92 patients), 47 underwent a revision for instability and one awaits operation (51% in total). Of these, seven re-dislocated and four needed further surgery. The quality of life of the patients was studied using the Oxford Hip Score and the EuroQol-5 Dimension (EQ-5D) questionnaire. A control group of patients who had not dislocated was also studied. At a mean follow-up of 4.5 years (1 to 20), the mean Oxford Hip Score was 26.7 (15 to 47) after one episode of dislocation, 27.2 (12 to 45) after recurrent dislocation, 34.5 (12 to 54) after successful revision surgery, 42 (29 to 55) after failed revision surgery and 17.4 (12 to 32) in the control group. The EuroQol-5 dimension questionnaire revealed more health problems in patients undergoing revision surgery.

Many different designs of total hip arthroplasty (THA) with varying performance and cost are available. The identification of those which are the most cost-effective could allow significant cost-savings. We used an established Markov model to examine the cost effectiveness of five frequently used categories of THA which differed according to bearing surface and mode of fixation, using data from the National Joint Registry for England and Wales. Kaplan–Meier analyses of rates of revision for men and women were modelled with parametric distributions. Costs of devices were provided by the NHS Supply Chain and associated costs were taken from existing studies. Lifetime costs, lifetime quality-adjusted-life-years (QALYs) and the probability of a device being cost effective at a willingness to pay £20 000/QALY were included in the models.

The differences in QALYs between different categories of implant were extremely small (<  0.0039 QALYs for men or women over the patient’s lifetime) and differences in cost were also marginal (£2500 to £3000 in the same time period). As a result, the probability of any particular device being the most cost effective was very sensitive to small, plausible changes in quality of life estimates and cost.

Our results suggest that available evidence does not support recommending a particular device on cost effectiveness grounds alone. We would recommend that the choice of prosthesis should be determined by the rate of revision, local costs and the preferences of the surgeon and patient.

Cite this article: Bone Joint J 2015;97-B:449–57.

Objective

The objective of this study was to explore dimensionality of the Oxford Hip Score (OHS) and examine whether self-reported pain and functioning can be distinguished in the form of subscales.

Aims

Femoroacetabular Junction Impingement (FAI) describes abnormalities in the shape of the femoral head–neck junction, or abnormalities in the orientation of the acetabulum. In the short term, FAI can give rise to pain and disability, and in the long-term it significantly increases the risk of developing osteoarthritis. The Femoroacetabular Impingement Trial (FAIT) aims to determine whether operative or non-operative intervention is more effective at improving symptoms and preventing the development and progression of osteoarthritis.

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.

We compared the medium-term clinical and radiological results of hybrid total hip replacement (THR) with metal-on-metal Birmingham hip resurfacing (BHR) in two groups of 54 young patients matched for age, gender, body mass index and pre-operative levels of activity.

The clinical outcome was assessed by the University of California, Los Angeles (UCLA) activity score, the Oxford Hip Score (OHS) and the EuroQol scores. Radiologically, all hips were assessed for migration and osteolysis, the hybrid THRs for polyethylene wear and the BHRs for a pedestal sign. The mean follow-up of the patients with a hybrid THR was ten years and for those with a BHR, nine years. Four patients with a hybrid THR and one with a BHR had died. In each group five were lost to follow-up. The revision rate of the hybrid THRs was 16.7% (9 of 54) and of the BHRs 9.3% (5 of 54) (p = 0.195). Radiographs of a further eight hybrid THRs demonstrated wear and osteolysis, and they await revision (p = 0.008). Of the unrevised BHRs 90% had radiological changes, of which approximately 50% had progressed over the previous four years. All hybrid THRs demonstrated linear polyethylene wear with a mean of 1.24 mm (0.06 to 3.03). The BHRs recorded superior OHS (p = 0.013), UCLA (p = 0.008), and EuroQol visual analogue scores (p = 0.009).

After nine years, patients with BHRs remained more active and had a lower rate of revision than those with hybrid THRs. Both groups demonstrated progressive radiological changes at medium-term follow-up.

We compared the five- to seven-year clinical and radiological results of the metal-on-metal Birmingham hip resurfacing with a hybrid total hip arthroplasty in two groups of 54 hips, matched for gender, age, body mass index and activity level.

Function was excellent in both groups, as measured by the Oxford hip score, but the Birmingham hip resurfacings had higher University of California at Los Angeles activity scores and better EuroQol quality of life scores. The total hip arthroplasties had a revision or intention-to-revise rate of 8%, and the Birmingham hip resurfacings of 6%. Both groups demonstrated impending failure on surrogate end-points. Of the total hip arthroplasties, 12% had polyethylene wear and osteolysis under observation, and 8% of Birmingham hip resurfacings showed migration of the femoral component. Polyethylene wear was present in 48% of the hybrid hips without osteolysis. Of the femoral components in the Birmingham hip resurfacing group which had not migrated, 66% had radiological changes of unknown significance.

Muscle atrophy has been demonstrated in patients suffering from osteoarthritis of the hip, but little is known about muscular recovery after total hip replacement (THR). A total of 20 patients with unilateral osteoarthritis of the hip were assessed before, six months and two years after THR. The cross-sectional area and radiological density of the muscles of the hip, thigh, calf and back were measured using CT. We hypothesised that the muscles would not recover fully after operation.

After two years comparison of the limb with the THR with the healthy limb showed that there was such a reduction in the cross-sectional area in iliopsoas (7.0%; p = 0.006) and the hip adductors (8.4%, p = 0.003) and in the radiological density in gluteus maximus (10.1 Hounsfield units; p < 0.001), gluteus medius/minimus (5.6 Hounsfield units; p = 0.011), iliopsoas (3.9 Hounsfield units; p < 0.001) and the adductors (2.4 Hounsfield units; p = 0.022).

Thus, there was persistent muscle atrophy in muscles acting about the hip two years after THR. We suggest that an earlier operation or a more intensive rehabilitation may reverse these changes.

Little is known about the efficacy of graduated compression stockings in preventing venous thromboembolism after hip surgery. We conducted a prospective, randomised single-blind study to determine whether the addition of compression stockings to fondaparinux conferred any additional benefit.

The study included 874 patients, of whom 795 could be evaluated (400 in the fondaparinux group and 395 in the fondaparinux plus compression stocking group). Fondaparinux was given post-operatively for five to nine days, either alone or combined with wearing stockings, which were worn for a mean 42 days (35 to 49).

The study outcomes were venous thromboembolism, or sudden death before day 42. Duplex ultrasonography was scheduled within a week of day 42. Safety outcomes were bleeding and death from venous thromboembolism.

The prevalence of deep-vein thrombosis was similar in the two groups 5.5% (22 of 400) in the fondaparinux group and 4.8 (19 of 395) in the fondaparinux plus stocking group (odds ratio 0.88, 95% confidence interval 0.46 to 1.65, p = 0.69). Major bleeding occurred in only one patient.

The addition of graduated compression stockings to fondaparinux appears to offer no additional benefit over the use of fondaparinux alone.