Objectives. High failure rates of metal-on-metal hip arthroplasty implants have highlighted the need for more careful introduction and monitoring of new implants and for the evaluation of the safety of medical devices. The National Joint Registry and other regulatory services are unable to detect failing implants at an early enough stage. We aimed to identify validated surrogate markers of long-term outcome in patients undergoing primary total hip arthroplasty (THA). Methods. We conducted a systematic review of studies evaluating surrogate markers for predicting long-term outcome in primary THA. Long-term outcome was defined as revision rate of an implant at ten years according to National Institute of Health and Care Excellence guidelines. We conducted a search of Medline and Embase (OVID) databases. Separate search strategies were devised for the Cochrane database and Google Scholar. Each search was performed to include articles from the date of their inception to June 8, 2015. Results. Our search strategy identified 1082 studies of which 115 studies were included for full article review. Following review, 17 articles were found that investigated surrogate markers of long-term outcome. These included one systematic review, one randomised control trial (RCT), one case control study and 13 case series. Validated surrogate markers included Radiostereometric Analysis (RSA) and Einzel-Bild-Röntgen-Analyse (EBRA), each measuring implant migration and wear. We identified five RSA studies (one systematic review and four case series) and four EBRA studies (one RCT and three case series). Patient Reported Outcome Measures (PROMs) at six months have been investigated but have not been validated against long-term outcomes. Conclusions. This systematic review identified two validated surrogate markers of long-term primary THA outcome: RSA and EBRA, each measuring implant migration and wear. We recommend the consideration of RSA in the pre-market testing of new implants. EBRA can be used to investigate acetabular wear but not femoral migration. Further studies are needed to validate the use of PROMs for post-market surveillance. Cite this article: T. T. Malak, J. A. J. Broomfield, A. J. R. Palmer, S. Hopewell, A. Carr, C. Brown, D. Prieto-Alhambra, S. Glyn-Jones. Surrogate markers of long-term outcome in primary total hip arthroplasty: A systematic review. Bone Joint Res 2016;5:206–214. DOI: 10.1302/2046-3758.56.2000568

Aims

The primary objective of this study was to develop a validated classification system for assessing iatrogenic bone trauma and soft-tissue injury during total hip arthroplasty (THA). The secondary objective was to compare macroscopic bone trauma and soft-tissues injury in conventional THA (CO THA) versus robotic arm-assisted THA (RO THA) using this classification system.

Aims

Uncemented metal acetabular components show good osseointegration, but material stiffness causes stress shielding and retroacetabular bone loss. Cemented monoblock polyethylene components load more physiologically; however, the cement bone interface can suffer fibrous encapsulation and loosening. It was hypothesized that an uncemented titanium-sintered monoblock polyethylene component may offer the optimum combination of osseointegration and anatomical loading.

Aims

Postoperative delirium (POD) and postoperative cognitive decline (POCD) are common surgical complications. In the UK, the Best Practice Tariff incentivizes the screening of delirium in patients with hip fracture. Further, a National Hip Fracture Database (NHFD) performance indicator is the reduction in the incidence of POD. To aid in its recognition, we sought to determine factors associated with POD and POCD in patients with hip fractures.

Aims

Patients with abnormal spinopelvic mobility are at increased risk for instability. Measuring the change in sacral slope (ΔSS) can help determine spinopelvic mobility preoperatively. Sacral slope (SS) should decrease at least 10° to demonstrate adequate posterior pelvic tilt. There is potential for different ΔSS measurements in the same patient based on sitting posture. The purpose of this study was to determine the effect of sitting posture on the ΔSS in patients undergoing total hip arthroplasty (THA).

Aims

Arthroplasty skills need to be acquired safely during training, yet operative experience is increasingly hard to acquire by trainees. Virtual reality (VR) training using headsets and motion-tracked controllers can simulate complex open procedures in a fully immersive operating theatre. The present study aimed to determine if trainees trained using VR perform better than those using conventional preparation for performing total hip arthroplasty (THA).

There is a high rate of mortality in elderly patients who sustain a fracture of the hip. We aimed to determine the rate of preventable mortality and errors during the management of these patients. A 12 month prospective study was performed on patients aged > 65 years who had sustained a fracture of the hip. This was conducted at a Level 1 Trauma Centre with no orthogeriatric service. A multidisciplinary review of the medical records by four specialists was performed to analyse errors of management and elements of preventable mortality. During 2011, there were 437 patients aged > 65 years admitted with a fracture of the hip (85 years (66 to 99)) and 20 died while in hospital (86.3 years (67 to 96)). A total of 152 errors were identified in the 80 individual reviews of the 20 deaths. A total of 99 errors (65%) were thought to have at least a moderate effect on death; 45 reviews considering death (57%) were thought to have potentially been preventable. Agreement between the panel of reviewers on the preventability of death was fair. A larger-scale assessment of preventable mortality in elderly patients who sustain a fracture of the hip is required. Multidisciplinary review panels could be considered as part of the quality assurance process in the management of these patients.

Cite this article: Bone Joint J 2014;96-B:1178–84.

Objectives

The spinopelvic relationship (including pelvic incidence) has been shown to influence pelvic orientation, but its potential association with femoroacetabular impingement has not been thoroughly explored. The purpose of this study was to prove the hypothesis that decreasing pelvic incidence is associated with increased risk of cam morphology.

Aims

Periprosthetic fracture (PF) after primary total hip arthroplasty (THA) is an uncommon but potentially devastating complication. This study aims to investigate the influence of cemented stem designs on the risk of needing a revision for a PF.

Concerns have been raised that deformation of acetabular shells may disrupt the assembly process of modular prostheses. In this study we aimed to examine the effect that the strength of bone has on the amount of deformation of the acetabular shell. The hypothesis was that stronger bone would result in greater deformation. A total of 17 acetabular shells were inserted into the acetabula of eight cadavers, and deformation was measured using an optical measuring system. Cores of bone from the femoral head were taken from each cadaver and compressed using a materials testing machine. The highest peak modulus and yield stress for each cadaver were used to represent the strength of the bone and compared with the values for the deformation and the surgeon’s subjective assessment of the hardness of the bone. The mean deformation of the shell was 129 µm (3 to 340). No correlation was found between deformation and either the maximum peak modulus (r² = 0.011, t = 0.426, p = 0.676) or the yield stress (r² = 0.024, t = 0.614, p = 0.549) of the bone. Although no correlation was found between the strength of the bone and deformation, the values for the deformation observed could be sufficient to disrupt the assembly process of modular acetabular components.

Cite this article: Bone Joint J 2015; 97-B:473–7.

We aimed to determine whether cemented hemiarthroplasty is associated with a higher post-operative mortality and rate of re-operation when compared with uncemented hemiarthroplasty. Data on 19 669 patients, who were treated with a hemiarthroplasty following a fracture of the hip in a nine-year period from 2002 to 2011, were extracted from NHS Scotland’s acute admission database (Scottish Morbidity Record, SMR01). We investigated the rate of mortality at day 0, 1, 7, 30, 120 and one-year post-operatively using 12 case-mix variables to determine the independent effect of the method of fixation. At day 0, those with a cemented hemiarthroplasty had a higher rate of mortality (p < 0.001) compared with those with an uncemented hemiarthroplasty, equivalent to one extra death per 424 procedures. By day one this had become one extra death per 338 procedures. Increasing age and the five-year co-morbidity score were noted as independent risk factors. By day seven, the cumulative rate of mortality was less for cemented hemiarthroplasty though this did not reach significance until day 120. The rate of re-operation was significantly higher for uncemented hemiarthroplasty. Despite adjusting for 12 confounding variables, these only accounted for 15% of the observed variability.

The debate about the choice of the method of fixation for a hemiarthroplasty with respect to the rate of mortality or the risk of re-operation may be largely superfluous. Our results suggest that uncemented hemiarthroplasties may have a role to play in elderly patients with significant co-morbid disease.

Cite this article: Bone Joint J 2014;96-B:1185–91.

Version of the femoral stem is an important factor influencing the risk of dislocation after total hip replacement (THR) as well as the position of the acetabular component. However, there is no radiological method of measuring stem anteversion described in the literature. We propose a radiological method to measure stem version and have assessed its reliability and validity. In 36 patients who underwent THR, a hip radiograph and CT scan were taken to measure stem anteversion. The radiograph was a modified Budin view. This is taken as a posteroanterior radiograph in the sitting position with 90° hip flexion and 90° knee flexion and 30° hip abduction. The angle between the stem-neck axis and the posterior intercondylar line was measured by three independent examiners. The intra- and interobserver reliabilities of each measurement were examined. The radiological measurements were compared with the CT measurements to evaluate their validity. The mean radiological measurement was 13.36° (sd 6.46) and the mean CT measurement was 12.35° (sd 6.39) (p = 0.096). The intra- and interobserver reliabilities were excellent for both measurements. The radiological measurements correlated well with the CT measurements (p = 0.001, r = 0.877). The modified Budin method appears reliable and valid for the measurement of femoral stem anteversion.

Cite this article: Bone Joint J 2013;95-B:877–80.

A retrospective study was conducted to investigate the changes in metal ion levels in a consecutive series of Birmingham Hip Resurfacings (BHRs) at a minimum ten-year follow-up. We reviewed 250 BHRs implanted in 232 patients between 1998 and 2001. Implant survival, clinical outcome (Harris hip score), radiographs and serum chromium (Cr) and cobalt (Co) ion levels were assessed.

Of 232 patients, 18 were dead (five bilateral BHRs), 15 lost to follow-up and ten had been revised. The remaining 202 BHRs in 190 patients (136 men and 54 women; mean age at surgery 50.5 years (17 to 76)) were evaluated at a minimum follow-up of ten years (mean 10.8 years (10 to 13.6)). The overall implant survival at 13.2 years was 92.4% (95% confidence interval 90.8 to 94.0). The mean Harris hip score was 97.7 (median 100; 65 to 100). Median and mean ion levels were low for unilateral resurfacings (Cr: median 1.3 µg/l, mean 1.95 µg/l (< 0.5 to 16.2); Co: median 1.0 µg/l, mean 1.62 µg/l (< 0.5 to 17.3)) and bilateral resurfacings (Cr: median 3.2 µg/l, mean 3.46 µg/l (< 0.5 to 10.0); Co: median 2.3 µg/l, mean 2.66 µg/l (< 0.5 to 9.5)). In 80 unilateral BHRs with sequential ion measurements, Cr and Co levels were found to decrease significantly (p < 0.001) from the initial assessment at a median of six years (4 to 8) to the last assessment at a median of 11 years (9 to 13), with a mean reduction of 1.24 µg/l for Cr and 0.88 µg/l for Co. Three female patients had a > 2.5 µg/l increase of Co ions, associated with head sizes ≤ 50 mm, clinical symptoms and osteolysis. Overall, there was no significant difference in change of ion levels between genders (Cr, p = 0.845; Co, p = 0.310) or component sizes (Cr, p = 0.505; Co, p = 0.370). Higher acetabular component inclination angles correlated with greater change in ion levels (Cr, p = 0.013; Co, p = 0.002). Patients with increased ion levels had lower Harris hip scores (p = 0.038).

In conclusion, in well-functioning BHRs the metal ion levels decreased significantly at ten years. An increase > 2.5 µg/l was associated with poor function.

Cite this article: Bone Joint J 2013;95-B:1332–8.

Objectives

The number of surgical procedures performed each year to treat femoroacetabular impingement (FAI) continues to rise. Although there is evidence that surgery can improve symptoms in the short-term, there is no evidence that it slows the development of osteoarthritis (OA). We performed a feasibility study to determine whether patient and surgeon opinion was permissive for a Randomised Controlled Trial (RCT) comparing operative with non-operative treatment for FAI.

Despite excellent results, the use of cemented total hip replacement (THR) is declining. This retrospective cohort study records survival time to revision following primary cemented THR using the most common combination of components that accounted for almost a quarter of all cemented THRs, exploring risk factors independently associated with failure. All patients with osteoarthritis who had an Exeter V40/Contemporary THR (Stryker) implanted before 31 December 2010 and recorded in the National Joint Registry for England and Wales were included in the analysis. Cox’s proportional hazard models were used to analyse the extent to which risk of revision was related to patient, surgeon and implant covariates, with a significance threshold of p < 0.01. A total of 34 721 THRs were included in the study. The overall seven-year rate of revision for any reason was 1.70% (99% confidence interval (CI) 1.28 to 2.12). In the final adjusted model the risk of revision was significantly higher in THRs with the Contemporary hooded component (hazard ratio (HR) 1.88, p < 0.001) than with the flanged version, and in smaller head sizes (< 28 mm) compared with 28 mm diameter heads (HR 1.50, p = 0.005). The seven-year revision rate was 1.16% (99% CI 0.69 to 1.63) with a 28 mm diameter head and flanged component. The overall risk of revision was independent of age, gender, American Society of Anesthesiologists grade, body mass index, surgeon volume, surgical approach, brand of cement/presence of antibiotic, femoral head material (stainless steel/alumina) and stem taper size/offset. However, the risk of revision for dislocation was significantly higher with a ‘plus’ offset head (HR 2.05, p = 0.003) and a hooded acetabular component (HR 2.34, p < 0.001).

In summary, we found that there were significant differences in failure between different designs of acetabular component and sizes of femoral head after adjustment for a range of covariates.

The popularity of cementless total hip replacement (THR) has surpassed cemented THR in England and Wales. This retrospective cohort study records survival time to revision following primary cementless THR with the most common combination (accounting for almost a third of all cementless THRs), and explores risk factors independently associated with failure, using data from the National Joint Registry for England and Wales. Patients with osteoarthritis who had a DePuy Corail/Pinnacle THR implanted between the establishment of the registry in 2003 and 31 December 2010 were included within analyses. There were 35 386 procedures. Cox proportional hazard models were used to analyse the extent to which the risk of revision was related to patient, surgeon and implant covariates. The overall rate of revision at five years was 2.4% (99% confidence interval 2.02 to 2.79). In the final adjusted model, we found that the risk of revision was significantly higher in patients receiving metal-on-metal (MoM: hazard ratio (HR) 1.93, p < 0.001) and ceramic-on-ceramic bearings (CoC: HR 1.55, p = 0.003) compared with the best performing bearing (metal-on-polyethylene). The risk of revision was also greater for smaller femoral stems (sizes 8 to 10: HR 1.82, p < 0.001) compared with mid-range sizes. In a secondary analysis of only patients where body mass index (BMI) data were available (n = 17 166), BMI ≥ 30 kg/m² significantly increased the risk of revision (HR 1.55, p = 0.002). The influence of the bearing on the risk of revision remained significant (MoM: HR 2.19, p < 0.001; CoC: HR 2.09, p = 0.001). The risk of revision was independent of age, gender, head size and offset, shell, liner and stem type, and surgeon characteristics.

We found significant differences in failure between bearing surfaces and femoral stem size after adjustment for a range of covariates in a large cohort of single-brand cementless THRs. In this study of procedures performed since 2003, hard bearings had significantly higher rates of revision, but we found no evidence that head size had an effect. Patient characteristics, such as BMI and American Society of Anesthesiologists grade, also influence the survival of cementless components.

Cite this article: Bone Joint J 2013;95-B:747–57.

The purpose of this study was to define immediate post-operative ‘quality’ in total hip replacements and to study prospectively the occurrence of failure based on these definitions of quality. The evaluation and assessment of failure were based on ten radiological and clinical criteria. The cumulative summation (CUSUM) test was used to study 200 procedures over a one-year period. Technical criteria defined failure in 17 cases (8.5%), those related to the femoral component in nine (4.5%), the acetabular component in 32 (16%) and those relating to discharge from hospital in five (2.5%). Overall, the procedure was considered to have failed in 57 of the 200 total hip replacements (28.5%). The use of a new design of acetabular component was associated with more failures. For the CUSUM test, the level of adequate performance was set at a rate of failure of 20% and the level of inadequate performance set at a failure rate of 40%; no alarm was raised by the test, indicating that there was no evidence of inadequate performance.

The use of a continuous monitoring statistical method is useful to ensure that the quality of total hip replacement is maintained, especially as newer implants are introduced.

Modern metal-on-metal hip resurfacing has been widely performed in the United Kingdom for over a decade. However, the literature reports conflicting views of the benefits: excellent medium- to long-term results with some brands in specific subgroups, but high failure rates and local soft-tissue reactions in others. The National Joint Registry for England and Wales (NJR) has collected data on all hip resurfacings performed since 2003. This retrospective cohort study recorded survival time to revision from a resurfacing procedure, exploring risk factors independently associated with failure. All patients with a primary diagnosis of osteoarthritis who underwent resurfacing between 2003 and 2010 were included in the analyses. Cox’s proportional hazard models were used to analyse the extent to which the risk of revision was related to patient, surgeon and implant covariates.

A total of 27 971 hip resurfacings were performed during the study period, of which 1003 (3.59%) underwent revision surgery. In the final adjusted model, we found that women were at greater risk of revision than men (hazard ratio (HR) = 1.30, p = 0.007), but the risk of revision was independent of age. Of the implant-specific predictors, five brands had a significantly greater risk of revision than the Birmingham Hip Resurfacing (BHR) (ASR: HR = 2.82, p < 0.001, Conserve: HR = 2.03, p < 0.001, Cormet: HR = 1.43, p = 0.001, Durom: HR = 1.67, p < 0.001, Recap: HR = 1.58, p = 0.007). Smaller femoral head components were also significantly more likely to require revision (≤ 44 mm: HR = 2.14, p < 0.001, 45 to 47 mm: HR = 1.48, p = 0.001) than medium or large heads, as were operations performed by low-volume surgeons (HR = 1.36, p <  0.001). Once these influences had been removed, in 4873 male patients < 60 years old undergoing resurfacing with a BHR, the five-year estimated risk of revision was 1.59%.

In summary, after adjustment for a range of covariates we found that there were significant differences in the rate of failure between brands and component sizes. Younger male patients had good five-year implant survival when the BHR was used.

We retrospectively analysed concentrations of chromium and cobalt ions in samples of synovial fluid and whole blood taken from a group of 92 patients with failed current-generation metal-on-metal hip replacements. We applied acid oxidative digestion to our trace metal analysis protocol, which found significantly higher levels of metal ion concentrations in blood and synovial fluid than a non-digestive method. Patients were subcategorised by mode of failure as either ‘unexplained pain’ or ‘defined causes’. Using this classification, chromium and cobalt ion levels were present over a wider range in synovial fluid and not as strongly correlated with blood ion levels as previously reported. There was no significant difference between metal ion concentrations and manufacturer of the implant, nor femoral head size below or above 50 mm. There was a moderately positive correlation between metal ion levels and acetabular component inclination angle as measured on three-dimensional CT imaging.

Our results suggest that acid digestion of samples of synovial fluid samples is necessary to determine metal ion concentrations accurately so that meaningful comparisons can be made between studies.

The presence of pseudotumours, which are soft-tissue masses relating to the hip, after metal-on-metal hip resurfacing arthroplasty has been associated with elevated levels of metal ions in serum, suggesting that pseudotumours occur when there is increased wear. We aimed to quantify the wear in vivo of implants revised for pseudotumours (eight) and of a control group of implants (22) revised for other reasons of failure.

We found that the implant group with pseudotumours had a significantly higher rate of median linear wear of the femoral component at 8.1 μm/year (2.75 to 25.4) than the 1.79 μm/year (0.82 to 4.15; p = 0.002) of the non-pseudotumour group. For the acetabular component a significantly higher rate of median linear wear of 7.36 μm/year (1.61 to 24.9) was observed in the pseudotumour group compared with 1.28 μm/year (0.81 to 3.33, p = 0.001) in the other group. Wear of the acetabular component in the pseudotumour group always involved the edge of the implant, indicating that edge-loading had occurred.

Our findings are the first direct evidence that pseudotumour is associated with increased wear at the metal-on-metal articulation. Furthermore, edge-loading with the loss of fluid-film lubrication may be an important mechanism of generation of wear in patients with a pseudotumour.