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The Journal of Bone & Joint Surgery British Volume
Vol. 91-B, Issue 6 | Pages 720 - 724
1 Jun 2009
Ollivere B Darrah C Brankin RC Donnell ST Walton NP

We report the follow-up at 12 years of the use of the Elite Plus total hip replacement (THR). We have previously reported the results at a mean of 6.4 years. Of the 217 patients (234 THRs), 83 had died and nine had been lost to follow-up. The patients were reviewed radiologically and clinically using the Oxford hip score. Of the 234 THRs, 19 (8.1%) had required a revision by the final follow-up in all but one for aseptic loosening. Survivorship analysis for revision showed a survival of 93.9% (95% confidence interval (CI) 89.2 to 96.5) at ten years, and of 88.0% (95% CI 81.8 to 92.3) at 12 years. At the final follow-up survival analysis showed that 37% (95% CI 37.3 to 44.7) of the prostheses had either failed radiologically or had been revised. Patients with a radiologically loose femoral component had a significantly poorer Oxford hip score than those with a well-fixed component (p = 0.03). Radiological loosening at 6.4 years was predictive of failure at 12 years. Medium-term radiographs and clinical scores should be included in the surveillance of THR to give an early indication of the performance of specific implants


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

Aims

Cardiac magnetic resonance (CMR) was used to assess whether cardiac function or tissue composition was affected in patients with well-functioning metal-on-metal hip resurfacing arthroplasties (MoMHRA) when compared with a group of controls, and to assess if metal ion levels correlated with any of the functional or structural parameters studied.

Patients and Methods

In all, 30 participants with no significant cardiac history were enrolled: 20 patients with well-functioning MoMHRA at mean follow-up of 8.3 years post-procedure (ten unilateral, ten bilateral; 17 men, three women) and a case-matched control group of ten non-MoM total hip arthroplasty patients (six men, four women). The mean age of the whole cohort (study group and controls) at the time of surgery was 50.6 years (41.0 to 64.0). Serum levels of cobalt and chromium were measured, and all patients underwent CMR imaging, including cine, T2* measurements, T1 and T2 mapping, late gadolinium enhancement, and strain measurements.


The Bone & Joint Journal
Vol. 97-B, Issue 3 | Pages 300 - 305
1 Mar 2015
Hill JC Diamond OJ O’Brien S Boldt JG Stevenson M Beverland DE

Ceramic-on-metal (CoM) is a relatively new bearing combination for total hip arthroplasty (THA) with few reported outcomes. A total of 287 CoM THAs were carried out in 271 patients (mean age 55.6 years (20 to 77), 150 THAs in female patients, 137 in male) under the care of a single surgeon between October 2007 and October 2009. With the issues surrounding metal-on-metal bearings the decision was taken to review these patients between March and November 2011, at a mean follow-up of 34 months (23 to 45) and to record pain, outcome scores, radiological analysis and blood ion levels. The mean Oxford Hip Score was 19.2 (12 to 53), 254 patients with 268 hips (95%) had mild/very mild/no pain, the mean angle of inclination of the acetabular component was 44.8o (28o to 63o), 82 stems (29%) had evidence of radiolucent lines of > 1 mm in at least one Gruen zone and the median levels of cobalt and chromium ions in the blood were 0.83 μg/L (0.24 μg/L to 27.56 μg/L) and 0.78 μg/L (0.21 μg/L to 8.84 μg/L), respectively. The five-year survival rate is 96.9% (95% confidence interval 94.7% to 99%).

Due to the presence of radiolucent lines and the higher than expected levels of metal ions in the blood, we would not recommend the use of CoM THA without further long-term follow-up. We plan to monitor all these patients regularly.

Cite this article: Bone Joint J 2015;97-B:300–5.


Bone & Joint Open
Vol. 3, Issue 1 | Pages 61 - 67
18 Jan 2022
van Lingen CP Ettema HB Bosker BH Verheyen CCPM

Aims

Large-diameter metal-on-metal (MoM) total hip arthroplasty (THA) has demonstrated unexpected high failure rates and pseudotumour formation. The purpose of this prospective cohort study is to report ten-year results in order to establish revision rate, prevalence of pseudotumour formation, and relation with whole blood cobalt levels.

Methods

All patients were recalled according to the guidelines of the Dutch Orthopaedic Association. They underwent clinical and radiographical assessments (radiograph and CT scan) of the hip prosthesis and whole blood cobalt ion measurements. Overall, 94 patients (95 hips) fulfilled our requirements for a minimum ten-year follow-up.


Orthopaedic Proceedings
Vol. 102-B, Issue SUPP_5 | Pages 21 - 21
1 Jul 2020
Nandra R Ahmed U Berryman F Brash L Dunlop D Matharu G
Full Access

Introduction. Many worldwide regulatory authorities recommend regular surveillance of metal-on-metal hip arthroplasty patients given high failure rates. However concerns have been raised about whether such regular surveillance, which includes asymptomatic patients, is evidence-based and cost-effective. We determined: (1) the cost of implementing the 2015 MHRA surveillance in “at-risk” Birmingham Hip Resurfacing (BHR) patients, and (2) how many asymptomatic hips with adverse reactions to metal debris (ARMD) would have been missed if patients were not recalled. Methods. All BHR patients subject to the 2015 MHRA recall (all females, and males with head sizes 46mm or below, regardless of symptoms) at one specialist centre were invited for review (707 hips). All patients were investigated (Oxford Hip Score, radiographs, blood metal ions, and targeted cross-sectional imaging) and managed accordingly. Surveillance costs were calculated using finance department data, as was the number needed to treat (NNT) to avoid missing one case of asymptomatic ARMD. Results. The overall institutional surveillance cost to investigate all patients once was £105,922 (range £148 to £258 per patient). The most expensive aspects of surveillance were radiographs (£39,598), advanced nurse practitioner assistance (£23,618), cross-sectional imaging (£14,828), and blood metal ions (£14,825). 31 hips had imaging evidence of ARMD (12 revised, with 19 under surveillance). Seven hips were asymptomatic, however all revisions were symptomatic. The NNT to avoid missing one case of asymptomatic ARMD (on imaging and/or requiring revision) was 101 patients, equating to a screening cost of £18,041 to avoid one case of asymptomatic ARMD. Conclusions. Implementing MHRA surveillance for “at-risk” BHR patients was extremely costly, both financially and logistically. As the risk of asymptomatic ARMD was low, our data suggests the 2015 MHRA surveillance is not cost-effective. We therefore have concerns about the increasingly intensive surveillance recommended in the 2017 MHRA guidance for all metal-on-metal hip arthroplasty patients


The Bone & Joint Journal
Vol. 102-B, Issue 7 Supple B | Pages 85 - 89
1 Jul 2020
Barrack TN Abu-Amer W Schwabe MT Adelani MA Clohisy JC Nunley RM Lawrie CM

Aims. Routine surveillance of primary hip and knee arthroplasties has traditionally been performed with office follow-up visits at one year postoperatively. The value of these visits is unclear. The present study aims to determine the utility and burden of routine clinical follow-up at one year after primary arthroplasty to patients and providers. Methods. All patients (473) who underwent primary total hip (280), hip resurfacing (eight), total knee (179), and unicompartmental knee arthroplasty (six) over a nine-month period at a single institution were identified from an institutional registry. Patients were prompted to attend their routine one-year postoperative visit by a single telephone reminder. Patients and surgeons were given questionnaires at the one-year postoperative visit, defined as a clinical encounter occurring at nine to 15 months from the date of surgery, regarding value of the visit. Results. Compliance with routine follow-up at one year was 35%. The response rate was over 80% for all questions in the patient and clinician surveys. Overall, 75% of the visits were for routine surveillance. Patients reported high satisfaction with their visits despite the general time for attendance, including travel, being over four hours. Surgeons found the visits more worthwhile when issues were identified or problems were addressed. Conclusion. Patient compliance with follow-up at one year postoperatively after primary hip and knee is low. Routine visits of asymptomatic patients deliver little practical value and represent a large time and cost burden for patients and surgeons. Remote strategies should be considered for routine postoperative surveillance primary hip and knee arthroplasties beyond the acute postoperative period. Cite this article: Bone Joint J 2020;102-B(7 Supple B):85–89


The Bone & Joint Journal
Vol. 106-B, Issue 5 | Pages 442 - 449
1 May 2024
Nieboer MF van der Jagt OP de Munter L de Jongh MAC van de Ree CLP

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


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_12 | Pages 18 - 18
23 Jun 2023
Morlock M Melsheimer O
Full Access

The early revision rate in elective Total Hip Arthroplasty (THA) three years after surgery in elderly patients over 80 years is significantly lower for cemented stems in the German Arthroplasty Register (EPRD): cemented 3,1% (3.0 – 3.2) vs. uncemented 4.2% (4.1 – 4.3; p < 0.001). However, the mortality rate in elderly patients is elevated for cemented fixation. This study presents a detailed analysis of the influence of stem type and fixation on revision and mortality rate in this patient cohort. Elective primary THA cases for primary Coxarthrosis using uncemented cups from the EPRD data base were analysed (n. 0. = 37,183). Four stem type groups were compared: cementless, cementless with collar, cementless short, and cemented. Stems with at least 300 cases at risk three years after surgery were analysed individually. The reference stem was determined as the stem with the lowest revision rate and at least 1000 cases under surveillance 3 years after surgery (n. 3. = 28,637). The revision rate for cemented stems (2.5% [2.2–1.81] was lower than for uncemented (4.5% [4.2–4.9]; p<0.001) and uncemented short stems (4.2% [3.1–5.7]; p=0.002). The revision rate of uncemented collared stems (2.3% [1.5–3.6]) was similar to cemented stems (p=0.89) and lower than for uncemented stems (p=0.02). One year mortality showed no sig. differences between the groups (p>0.17): cemented 3.2% [2.9–3.6], uncemented 3.4% [3.1–3.7], uncemented short 3.5% [2.5–4.9], uncemented collar 2.0% [1.2–3.2]. “Cementless” and “cementless short” stems should not be used in patients over 80 years due to the higher revision risk. If cementing should be avoided, “cementless collared” stems seem to be a good alternative combined with a tendency for a lower one year mortality rate


The Posterior and Lateral approaches are most commonly used for Total Hip Arthroplasty (THA) in the United Kingdom (UK). Fewer than 5% of UK surgeons routinely use the Direct Anterior Approach (DAA). DAA THA is increasing, particularly among surgeons who have learned the technique during overseas fellowships. Whether DAA offers long-term clinical benefit is unclear. We undertook a retrospective analysis of prospectively collected 10-year, multi-surgeon, multi-centre implant surveillance study data for matched cohorts of patients whose operations were undertaken by either the DAA or posterior approach. All operations were undertaken using uncemented femoral and acetabular components. The implants were different for the two surgical approaches. We report the pre-operative, and post operative six-month, two-year, five-year and 10-year Oxford Hip Score (OHS) and 10-year revision rates. 125 patients underwent DAA THA; these patients were matched against those undergoing the posterior approach through propensity score matching for age, gender and body mass index. The 10-year revision rate for DAA THA was 3.2% (4/125) and 2.4% (3/125) for posterior THA. The difference in revision rate was not statistically significant. Both DAA and Posterior THA pre-operative OHS were comparable at 19.85 and 19.12 respectively. At the six-month time point, there was an OHS improvement of 20.89 points for DAA and 18.82 points for Posterior THA and this was statistically significant (P-Value <0.001). At the two, five and 10-year time-points the OHS and OHS improvement from the pre-operative review were comparable. At the 10-year time point post-op the OHS for DAA THA was 42.63, 42.10 for posterior THA and the mean improvement from pre-op to 10-years post op was 22.78 and 22.98 respectively. There was no statistical difference when comparing the OHS or the OHS mean improvements at the two, five and 10-year point. Whilst there was greater improvement and statistical significance during the initial six month time period, as time went on there was no statistically significant difference between the outcome measures or revision rates for the two approaches


Total hip arthroplasty has been constantly evolving with technological improvements to achieve the best survival rates. Although the new implants are under closer surveillance through processes such as Beyond Compliance, orthopaedic surgeons generally tend to look out for the latest implants with good short-term results and hope for better long-term results for these. We questioned whether such an assumption or bias is valid. We analysed the data of Kaplan-Meier estimates of cumulative revisions of primary hip replacement by fixation, stem/cup brand and bearing combinations from the NJR 19th Annual Report published in September 2022. We performed a univariate linear regression analysis to predict the 10- and 15-year revision rates for these different hip implant combinations from the 3- and 5-year revision rates. Thirty-seven implant combinations had their 15-year revision rates reported and 67 had the 10-year revision rates. The correlation co-efficients were 0.43 and 0.58 for the 3-year and 5-year revision rates against 15-year revision rates. Only 17% of the variance in 15-year revision rates could be predicted by a linear regression model from the 3-year revision rate and 32% from the 5-year revision rate. Corresponding values for the 10-year revision rates were 46% and 67%. 95% prediction intervals for the 15-year revision rate were +/− 3.1% from the 3-year revision rate and +/− 2.8% from the 5-year revision rate. Corresponding values for the 10-year revision rates were +/− 1.3% and +/− 1%. 19 of 37 implant combinations showed 15-year revision rate of more than 4%. Average 3-year and 5-year revision rates for this cohort was 1.0% and 1.42% compared to 1.4% and 1.9% for the rest and the difference was statistically significant. Although average early revision rates showed small but significant difference between the groups with lower and higher 15-year revision rates, the prediction intervals for 15-year revision rates for individual hips based on their 3-year and 5-year revision rates are very wide. Three- and 5-year revision rates for primary total hip replacements are poor predictors of 15-year revision rates


Orthopaedic Proceedings
Vol. 105-B, Issue SUPP_11 | Pages 31 - 31
7 Jun 2023
Asopa V Womersley A Wehbe J Spence C Harris P Sochart D Tucker K Field R
Full Access

Over 8000 total hip arthroplasties (THA) in the UK were revised in 2019, half for aseptic loosening. It is believed that Artificial Intelligence (AI) could identify or predict failing THA and result in early recognition of poorly performing implants and reduce patient suffering. The aim of this study is to investigate whether Artificial Intelligence based machine learning (ML) / Deep Learning (DL) techniques can train an algorithm to identify and/or predict failing uncemented THA. Consent was sought from patients followed up in a single design, uncemented THA implant surveillance study (2010–2021). Oxford hip scores and radiographs were collected at yearly intervals. Radiographs were analysed by 3 observers for presence of markers of implant loosening/failure: periprosthetic lucency, cortical hypertrophy, and pedestal formation. DL using the RGB ResNet 18 model, with images entered chronologically, was trained according to revision status and radiographic features. Data augmentation and cross validation were used to increase the available training data, reduce bias, and improve verification of results. 184 patients consented to inclusion. 6 (3.2%) patients were revised for aseptic loosening. 2097 radiographs were analysed: 21 (11.4%) patients had three radiographic features of failure. 166 patients were used for ML algorithm testing of 3 scenarios to detect those who were revised. 1) The use of revision as an end point was associated with increased variability in accuracy. The area under the curve (AUC) was 23–97%. 2) Using 2/3 radiographic features associated with failure was associated with improved results, AUC: 75–100%. 3) Using 3/3 radiographic features, had less variability, reduced AUC of 73%, but 5/6 patients who had been revised were identified (total 66 identified). The best algorithm identified the greatest number of revised hips (5/6), predicting failure 2–8 years before revision, before all radiographic features were visible and before a significant fall in the Oxford Hip score. True-Positive: 0.77, False Positive: 0.29. ML algorithms can identify failing THA before visible features on radiographs or before PROM scores deteriorate. This is an important finding that could identify failing THA early


Bone & Joint Research
Vol. 7, Issue 11 | Pages 595 - 600
1 Nov 2018
Bergiers S Hothi HS Henckel J Eskelinen A Skinner J Hart A

Objectives. Previous studies have suggested that metal-on-metal (MoM) Pinnacle (DePuy Synthes, Warsaw, Indiana) hip arthroplasties implanted after 2006 exhibit higher failure rates. This was attributed to the production of implants with reduced diametrical clearances between their bearing surfaces, which, it was speculated, were outside manufacturing tolerances. This study aimed to better understand the performance of Pinnacle Systems manufactured before and after this event. Methods. A total of 92 retrieved MoM Pinnacle hips were analyzed, of which 45 were implanted before 2007, and 47 from 2007 onwards. The ‘pre-2007’ group contained 45 implants retrieved from 21 male and 24 female patients, with a median age of 61.3 years (interquartile range (IQR) 57.1 to 65.5); the ‘2007 onwards’ group contained 47 implants retrieved from 19 male and 28 female patients, with a median age of 61.8 years (IQR 58.5 to 67.8). The volume of material lost from their bearing and taper surfaces was measured using coordinate and roundness measuring machines. These outcomes were then compared statistically using linear regression models, adjusting for potentially confounding factors. Results. There was no significant difference between the taper and bearing wear rates of the ‘pre-2007’ and ‘2007 onwards’ groups (p = 0.67 and p = 0.39, respectively). Pinnacles implanted from 2007 onwards were revised after a mean time of 50 months, which was significantly earlier than the ‘pre-2007’ hips (96 months) (p < 0.001). A reduction in the time to revision was present year on year from 2003 to 2011. Conclusion. We found no difference in the wear rate of these implants based on the year of implantation. The ‘pre-2007’ hips had a two-fold greater time to revision than those implanted after 2007; this may be due to the increased surveillance of MoM hips following UK regulatory advice and several high-profile failures. Interestingly, we observed a decreasing trend in the mean time to revision every year from 2003 onwards. Cite this article: S. Bergiers, H. S. Hothi, J. Henckel, A. Eskelinen, J. Skinner, A. Hart. Wear performance of retrieved metal-on-metal Pinnacle hip arthroplasties implanted before and after 2007. Bone Joint Res 2018;7:595–600. DOI: 10.1302/2046-3758.711.BJR-2018-0143.R1


Orthopaedic Proceedings
Vol. 97-B, Issue SUPP_12 | Pages 24 - 24
1 Nov 2015
Matharu G Mellon S Murray D Pandit H
Full Access

Introduction. This study aimed to: (1) compare published follow-up guidelines for metal-on-metal (MoM) hip patients and analyse protocols in relation to current evidence, and (2) assess the financial implications of these guidelines. Methods. Follow-up guidance for MoM hips from five national authorities (MHRA in the UK; EFORT; United States FDA; Therapeutic Goods Administration of Australia; Health Canada) were contrasted and critically appraised. Using National Joint Registry (NJR) data (67,363 MoM hips implanted) the cost of annual surveillance for all MoM hips recorded in the NJR was calculated for each protocol. Results. Significant differences existed between recommended guidance, with protocols not reflecting the best available evidence. These include not stratifying patients according to implant type (total hip replacement (THR) or hip resurfacing (HR)) or adverse reaction to metal debris (ARMD) risk factors, using symptoms to decide patient follow-up, and using suboptimal blood metal ion thresholds to identify poorly performing hips. Patients with asymptomatic ARMD lesions, especially HR patients with no ARMD risk factors, would not be identified by most protocols. Vast cost differences exist between protocols when considering annual surveillance of the NJR population. The MHRA guidance was cheapest for annual follow-up (£8,264,064/10,423,296 Euro/$13,717,440). The most expensive protocols were those recommended by the FDA (£22,321,020/28,134,526 Euro/$37,029,889) and EFORT (£22,708,226/28,590,554 Euro/$37,671,431), both approaching three-times the MHRA costs. The FDA protocol was most costly for surveillance of all symptomatic patients (£18,210,816/22,947,840 Euro/$30,228,480), and EFORTs was most costly for asymptomatic HR patients (£8,283,010 / 10,428,250 Euro / $13,735,495). Discussion. Current MoM hip follow-up guidance is not evidence-based. Most protocols lack the sensitivity to detect asymptomatic ARMD lesions. It is also clear that these protocols are not financially sustainable in the long-term. Conclusions. Further work is required to ensure future guidance published by authorities is more unified as well as both clinically and cost effective


The Bone & Joint Journal
Vol. 101-B, Issue 4 | Pages 365 - 371
1 Apr 2019
Nam D Salih R Nahhas CR Barrack RL Nunley RM

Aims. Modular dual mobility (DM) prostheses in which a cobalt-chromium liner is inserted into a titanium acetabular shell (vs a monoblock acetabular component) have the advantage of allowing supplementary screw fixation, but the potential for corrosion between the liner and acetabulum has raised concerns. While DM prostheses have shown improved stability in patients deemed ‘high-risk’ for dislocation undergoing total hip arthroplasty (THA), their performance in young, active patients has not been reported. This study’s purpose was to assess clinical outcomes, metal ion levels, and periprosthetic femoral bone mineral density (BMD) in young, active patients receiving a modular DM acetabulum and recently introduced titanium, proximally coated, tapered femoral stem design. Patients and Methods. This was a prospective study of patients between 18 and 65 years of age, with a body mass index (BMI) < 35 kg/m. 2. and University of California at Los Angeles (UCLA) activity score > 6, who received a modular cobalt-chromium acetabular liner, highly crosslinked polyethylene mobile bearing, and cementless titanium femoral stem for their primary THA. Patients with a history of renal disease and metal hardware elsewhere in the body were excluded. A total of 43 patients (30 male, 13 female; mean age 52.6 years (. sd. 6.5)) were enrolled. All patients had a minimum of two years’ clinical follow-up. Patient-reported outcome measures, whole blood metal ion levels (ug/l), and periprosthetic femoral BMD were measured at baseline, as well as at one and two years postoperatively. Power analysis indicated 40 patients necessary to demonstrate a five-fold increase in cobalt levels from baseline (alpha = 0.05, beta = 0.80). A mixed model with repeated measures was used for statistical analysis. Results. Mean Harris Hip Scores improved from 54.1 (. sd. 20.5) to 91.2 (. sd. 10.8) at two years postoperatively (p < 0.001). All patients had radiologically well-fixed components, no patients experienced any instability, and no patients required any further intervention. Mean cobalt levels increased from 0.065 ug/l (. sd. 0.03) preoperatively to 0.30 ug/l (. sd. 0.51) at one year postoperatively (p = 0.01) but decreased at two years postoperatively to 0.16 ug/l (. sd. 0.23; p = 0.2). Four patients (9.3%) had a cobalt level outside the reference range (0.03 ug/l to 0.29 ug/l) at two years postoperatively, with values from 0.32 ug/l to 0.94 ug/l. The mean femoral BMD ratio was maintained in Gruen zones 2 to 7 at both one and two years postoperatively using this stem design. At two years postoperatively, mean BMD in the medial calcar was 101.5% of the baseline value. Conclusion. Use of a modular DM prosthesis and cementless, tapered femoral stem has shown encouraging results in young, active patients undergoing primary THA. Elevation in mean cobalt levels and the presence of four patients outside the reference range at two years postoperatively demonstrates the necessity of continued surveillance in this cohort. Cite this article: Bone Joint J 2019;101-B:365–371


Orthopaedic Proceedings
Vol. 98-B, Issue SUPP_11 | Pages 22 - 22
1 Jun 2016
Davidson J Sabah S Berber R Hothi H Miles J Carrington R Power A Skinner J Hart A
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Introduction. The Birmingham Hip Resurfacing (Smith & Nephew London, UK) is the most popular hip resurfacing (HR) in the UK. However, it is now subject to two Medical Device Alerts (MDA) from the Medicines and Healthcare products Regulatory Agency (MHRA). Patients/Materials & Methods. A cross-sectional survey of primary metal-on-metal hip procedures recorded on the National Joint Registry for England, Wales and Northern Ireland (NJR) until 5. th. November 2013 was performed. Cost-analysis was based on an algorithm for surveillance of HR at a tertiary referral centre and followed previous MHRA guidance. NIHR NHS Treatment costs were used. The local protocol encompassed: patient outcome scoring (Oxford hip score), blood metal ion measurement (cobalt, chromium), cross-sectional imaging (MRI) and discussion at an internet-enabled multidisciplinary team meeting (iMDT) in addition to routine hip surveillance. Results. A total of 33996 patients have Hip Resurfacings in the UK. 18478 have BHR and 9457 are female or small men. Costs:. Cobalt and Chromium levels £34.64. Single site MRI scan £438.91. Review of medical notes is £97.98. New Patient Appointment £137. Every patient requires at least 1 set of blood tests, an MRI and discussion in iMDT in our unit at a minimum cost of £571.53. This excludes clinic appointments; repeat testing, or costs of revision surgery and litigation. Total minimum cost to NHS £5.4 million. Discussion. It is important to not ignore nationally delivered guidance and therefore this patient group now requires comprehensive follow up as described by the MHRA. Other HR devices may now need to be considered to require further follow-up with inherently increased costs to the NHS. Conclusion. We recommend a streamlining of review via regional iMDTs in order to effectively manage MDA's and minimise potential costs


The Bone & Joint Journal
Vol. 106-B, Issue 6 | Pages 540 - 547
1 Jun 2024
Nandra RS Elnahal WA Mayne A Brash L McBryde CW Treacy RBC

Aims

The Birmingham Hip Resurfacing (BHR) was introduced in 1997 to address the needs of young active patients using a historically proven large-diameter metal-on-metal (MoM) bearing. A single designer surgeon’s consecutive series of 130 patients (144 hips) was previously reported at five and ten years, reporting three and ten failures, respectively. The aim of this study was to extend the follow-up of this original cohort at 25 years.

Methods

The study extends the reporting on the first consecutive 144 resurfacing procedures in 130 patients for all indications. All operations were undertaken between August 1997 and May 1998. The mean age at operation was 52.1 years (SD 9.93; 17 to 76), and included 37 female patients (28.5%). Failure was defined as revision of either component for any reason. Kaplan-Meier survival analysis was performed. Routine follow-up with serum metal ion levels, radiographs, and Oxford Hip Scores (OHSs) was undertaken.


Bone & Joint Research
Vol. 5, Issue 6 | Pages 206 - 214
1 Jun 2016
Malak TT Broomfield JAJ Palmer AJR Hopewell S Carr A Brown C Prieto-Alhambra D Glyn-Jones S

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


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_6 | Pages 41 - 41
1 May 2019
Afzal I Radha S Stafford G Smoljanović T Field R
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Patients need to know the benefits, risks and alternatives to any proposed treatment. Surgeons discussing the risk of a revision procedure becoming necessary, after a hip replacement can draw upon the orthopaedic literature and arthroplasty registries for long-term implant survival. However, early revision is required in a minority of cases. We have investigated the probability for revision hip replacement patients in terms of time-point and indication for revision. Of the 9,411 Primary Total Hip Replacements (THR), undertaken by 22 surgeons, over an eleven-year period, between January 2004 and March 2015, 1.70% (160) were subsequently reported to the National Joint Registry (NJR) as revised. Each revision case was reviewed under the supervision of senior hip specialist consultants. The modes of failure of were identified through clinical, laboratory and imaging (x-rays, CT, MRI and Isotope scans) studies. The revision rate for THRs was 0.58% in the first year. This was statistically higher than all subsequent years, P-Value <0.001. There was no statistical difference between any pair of subsequent years. Thereafter, the average revision rate was 0.30% per annum. The odds ratio for revision during the first post–operative year against the subsequent year average was 1.67. The indications for the early hip revisions in the first three years were infection, dislocation and peri-prosthetic fracture. The data from this study can help better inform patients of the revision rates after a primary THR and allow surgeons to develop implant surveillance strategies among high-risk patients


Orthopaedic Proceedings
Vol. 101-B, Issue SUPP_6 | Pages 38 - 38
1 May 2019
Viner J Sochart D
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Introduction. The Opera acetabular component (Smith & Nephew Ltd) shares many same design features with the Ogee (Depuy Int.). Differences are a malleable flange, instrumentation designed to improve cement pressurisation and the specifics of the UHMW-poly used. Methods. Data was collected prospectively on 419 consecutive replacements (390 patients), performed between March 2000 and February 2005. A posterior approach was used, and the acetabulum was prepared with multiple key holes. Palacos-R bone cement containing Gentamicin was used with a cement pressuriser. Results. There were 243 Operas (221 patients) and 176 Ogees (169 patients). There were 262 in female patients (62.5%) and age at surgery averaged 68.3yrs (25–92). Average follow-up of surviving patients was 185 months (165 – 225). Acetabular abduction angle in both groups averaged 46° (25–65). Opera group: 27 (11.1%) acetabular components loosened aseptically, all associated with rapid wear. 16 (6.6%) acetabular components were revised (15 (6.2%) - aseptic loosening and 1 late infection. At 10 years 85% were graded Hodgkinson 0 or 1. Six femoral implants loosened (2.5%), 2 of which have been revised. Ogee group: 3 acetabular components (1.7%) were revised (2 - aseptic loosening (1.1%) and 1 for recurrent dislocation). None are currently loose. At 10 years 99% were graded Hodgkinson 0 or 1. There was no femoral loosening. Conclusions. In the Opera group aseptic acetabular loosening (11.1% v 1.1%), acetabular revision for aseptic loosening (6.2 v 1.1%), aseptic femoral loosening (2.5% v 0) and Hodgkinson grading > 1 at 10 years (15% v 1%) were more common and associated with rapid wear. This must be attributable to poorer wear properties of the UHMW-poly of the Opera implant and patients with these components require regular surveillance to detect loosening


Bone & Joint Open
Vol. 5, Issue 11 | Pages 971 - 976
5 Nov 2024
Baker G Hill J O'Neill F McChesney J Stevenson M Beverland D

Aims

In 2015, we published the results of our ceramic-on-metal (CoM) total hip arthroplasties (THAs) performed between October 2007 and July 2009 with a mean follow-up of 34 months (23 to 45) and a revision rate of 3.1%. The aim of this paper is to present the longer-term outcomes.

Methods

A total of 264 patients were reviewed at a mean of 5.8 years (4.6 to 7.2) and 10.1 years (9.2 to 10.6) to determine revision rate, pain, outcome scores, radiological analysis, and blood ion levels. Those who were unwilling or unable to travel were contacted by telephone.