Alison J Smith

Failure rates of stemmed metal-on-metal hip replacements: analysis of data from the National Joint Registry of England and Wales

BACKGROUND Total hip replacement (THR) is extremely common. Some prostheses fail, particularly in younger patients, and need to be revised, most commonly for loosening secondary to wear or dislocation. Surgeons have tried to address these problems by implanting large diameter metal-on-metal bearing surfaces. Our aim was to assess if metal-on-metal bearing surfaces lead to increased implant survival compared with other bearing surfaces in stemmed THR and, additionally, if larger head sizes result in improved implant survival. METHODS We analysed the National Joint Registry of England and Wales for primary hip replacements (402,051, of which 31,171 were stemmed metal-on-metal) undertaken between 2003 and 2011. Our analysis was with a multivariable flexible parametric survival model to estimate the covariate-adjusted cumulative incidence of revision adjusting for the competing risk of death. FINDINGS Metal-on-metal THR failed at high rates. Failure was related to head size, with larger heads failing earlier (3·2% cumulative incidence of revision [95% CI 2·5-4·1] for 28 mm and 5·1% [4·2-6·2] for 52 mm head at 5 years in men aged 60 years). 5 year revision rates in younger women were 6·1% (5·2-7·2) for 46 mm metal-on-metal compared with 1·6% (1·3-2·1) for 28 mm metal-on-polyethylene. By contrast, for ceramic-on-ceramic articulations larger head sizes were associated with improved survival (5 year revision rate of 3·3% [2·6-4·1] with 28 mm and 2·0% [1·5-2·7] with 40 mm for men aged 60 years). INTERPRETATION Metal-on-metal stemmed articulations give poor implant survival compared with other options and should not be implanted. All patients with these bearings should be carefully monitored, particularly young women implanted with large diameter heads. Since large diameter ceramic-on-ceramic bearings seem to do well we support their continued use. FUNDING National Joint Registry of England and Wales.

Failure rates of metal-on-metal hip resurfacings: analysis of data from the National Joint Registry for England and Wales

BACKGROUND Implant survival after conventional total hip replacement (THR) is often poor in younger patients, so alternatives such as hip resurfacing, with various sizes to fit over the femoral head, have been explored. We assessed the survival of different sizes of metal-on-metal resurfacing in men and women, and compared this survival with those for conventional stemmed THRs. METHODS We analysed the National Joint Registry for England and Wales (NJR) for primary THRs undertaken between 2003 and 2011. Our analysis involved multivariable flexible parametric survival models to estimate the covariate-adjusted cumulative incidence of revision adjusting for the competing risk of death. FINDINGS The registry included 434,560 primary THRs, of which 31,932 were resurfacings. In women, resurfacing resulted in worse implant survival than did conventional THR irrespective of head size. Predicted 5-year revision rates in 55-year-old women were 8·3% (95% CI 7·2-9·7) with a 42 mm resurfacing head, 6·1% (5·3-7·0) with a 46 mm resurfacing head, and 1·5% (0·8-2·6) with a 28 mm cemented metal-on-polyethylene stemmed THR. In men with smaller femoral heads, resurfacing resulted in poor implant survival. Predicted 5-year revision rates in 55-year-old men were 4·1% (3·3-4·9) with a 46 mm resurfacing head, 2·6% (2·2-3·1) with a 54 mm resurfacing head, and 1·9% (1·5-2·4) with a 28 mm cemented metal-on-polyethylene stemmed THR. Of male resurfacing patients, only 23% (5085 of 22076) had head sizes of 54 mm or above. INTERPRETATION Hip resurfacing only resulted in similar implant survivorship to other surgical options in men with large femoral heads, and inferior implant survivorship in other patients, particularly women. We recommend that resurfacing is not undertaken in women and that preoperative measurement is used to assess suitability in men. Before further new implant technology is introduced we need to learn the lessons from resurfacing and metal-on-metal bearings. FUNDING National Joint Registry for England and Wales.

Risk of cancer in first seven years after metal-on-metal hip replacement compared with other bearings and general population: linkage study between the National Joint Registry of England and Wales and hospital episode statistics

Objective To determine whether use of metal-on-metal bearing surfaces is associated with an increased risk of a diagnosis of cancer in the early years after total hip replacement and specifically with an increase in malignant melanoma and haematological, prostate, and renal tract cancers. Design Linkage study with multivariable competing risks flexible parametric survival model to examine the incidence of new diagnoses of cancer in patients with metal-on-metal hip replacement compared with those with alternative bearings and to compare the observed incidence of diagnoses in patients undergoing hip replacement with that predicted by national incidence rates in the general population. Setting National Joint Registry of England and Wales (NJR) linked to NHS hospital episode statistics data. Participants 40 576 patients with hip replacement with metal-on-metal bearing surfaces and 248 995 with alternative bearings. Main outcome measures Incidence of all cancers and incidence of malignant melanoma and prostate, renal tract, and haematological cancers. Results The incidence of new diagnoses of cancer was low after hip replacement (1.25% at one year, 95% confidence interval 1.21% to 1.30%) and lower than that predicted from the age and sex matched normal population (1.65%, 1.60% to 1.70%). Compared with alternative bearings, there was no evidence that metal-on-metal bearing surfaces were associated with an increased risk of any cancer diagnosis in the seven years after surgery (mean follow-up of three years, 23% (n=67 361) of patients observed for five years or more). Similarly, there was no increase in the risk of malignant melanoma or haematological, prostate, and renal tract cancers. The adjusted five year incidence of all cancers for men aged 60 was 4.8% (4.4% to 5.3%) with resurfacing, 6.2% (5.7% to 6.7%) with stemmed metal-on-metal, and 6.7% (6.5% to 7.0%) for other bearing surfaces. Equivalent rates for women aged 60 were lower: 3.1% (2.8% to 3.4%) with resurfacing, 4.0% (3.7% to 4.3%) with stemmed metal-on-metal, and 4.4% (4.2% to 4.5%) with other bearings. Conclusions These data are reassuring, but the findings are observational with short follow-up. The use of hospital episode statistics data might underestimate cancer diagnoses, and there is the possibility of confounding by indication. Furthermore, as some cancers have a long latency period it is important that we study the longer term outcomes and continue to investigate the effects of exposure to orthopaedic metals.

What is the evidence base to guide surgical treatment of infected hip prostheses? systematic review of longitudinal studies in unselected patients

BackgroundProsthetic joint infection is an uncommon but serious complication of hip replacement. There are two main surgical treatment options, with the choice largely based on the preference of the surgeon. Evidence is required regarding the comparative effectiveness of one-stage and two-stage revision to prevent reinfection after prosthetic joint infection.MethodsWe conducted a systematic review to identify randomised controlled trials, systematic reviews and longitudinal studies in unselected patients with infection treated exclusively by one- or two-stage methods or by any method. The Embase, MEDLINE and Cochrane databases were searched up to March 2011. Reference lists were checked, and citations of key articles were identified by using the ISI Web of Science portal. Classification of studies and data extraction were performed independently by two reviewers. The outcome measure studied was reinfection within 2 years. Data were combined to produce pooled random-effects estimates using the Freeman-Tukey arc-sine transformation.ResultsWe identified 62 relevant studies comprising 4,197 patients. Regardless of treatment, the overall rate of reinfection after any treatment was 10.1% (95% CI = 8.2 to 12.0). In 11 studies comprising 1,225 patients with infected hip prostheses who underwent exclusively one-stage revision, the rate of reinfection was 8.6% (95% CI = 4.5 to 13.9). After two-stage revision exclusively in 28 studies comprising 1,188 patients, the rate of reinfection was 10.2% (95% CI = 7.7 to 12.9).ConclusionEvidence of the relative effectiveness of one- and two-stage revision in preventing reinfection of hip prostheses is largely based on interpretation of longitudinal studies. There is no suggestion in the published studies that one- or two stage methods have different reinfection outcomes. Randomised trials are needed to establish optimum management strategies.

Maintaining independence in older people

Summary Appropriate social and medical interventions may help maintain independence in older people. Determinants of functional decline, disability and reduced independence are recognized and specific interventions target the treatment of clinical conditions, multiple health problems and geriatric conditions, prevention of falls and fractures, and maintenance of physical and cognitive function and social engagement. Preventive strategies to identify and treat diverse unmet needs of older people have been researched extensively. We reviewed systematically recent randomized controlled trials evaluating these ‘complex’ interventions and incorporated the findings of 21 studies into an established meta-analysis that included 108,838 people in 110 trials. There was an overall benefit of complex interventions in helping older people to live at home, explained by reduced nursing home admissions rather than death rates. Hospital admissions and falls were also reduced in intervention groups. Benefits were largely restricted to earlier studies, perhaps reflecting general improvements in health and social care for older people. The wealth of high-quality trial evidence endorses the value of preventive strategies to help maintain independence in older people.

Early death following primary total knee arthroplasty.

BACKGROUND Total knee arthroplasty carries major risks, including death. Conventional studies have compared the mortality rate following total knee arthroplasty with standardized mortality ratios or age and sex-matched populations. The purpose of the present study was to compare the mortality rate in a population of patients who were managed with total knee arthroplasty with that in patients who were awaiting surgery. METHODS All patients undergoing primary total knee arthroplasty from 2000 to 2007 at a single institution were recorded. In the same period, all patients who were added to the waiting list for total knee arthroplasty were recorded. The mortality rate and time to death were calculated, and death certificates were retrieved for those who died within thirty or ninety days after the index event. RESULTS Two thousand, six hundred and ninety-five patients undergoing primary total knee arthroplasty were used for the thirty-day mortality calculation, and 2527 were used for the ninety-day mortality calculation. These patients were compared with 5857 and 5689 patients who were added to the waiting list for the thirty-day and ninety-day mortality calculations, respectively. There was no difference between the populations in terms of age or sex (p > 0.05). The thirty-day mortality following surgery was significantly greater for the surgery group (0.371%; 95% confidence interval, 0.202% to 0.682%) than for the waiting list group (0.0683%; 95% confidence interval, 0.0266% to 0.1755%) (odds ratio, 5.45; 95% confidence interval, 1.81 to 16.43). The ninety-day mortality was also significantly greater for the surgery group (0.792%; 95% confidence interval, 0.513% to 1.219%) than for the waiting list group (0.387%; 95% confidence interval, 0.256% to 0.585%) (odds ratio, 2.05; 95% confidence interval, 1.13 to 3.74). CONCLUSIONS Primary total knee arthroplasty is associated with an increased risk of death at thirty and ninety days after the operation when compared with a population awaiting the same procedure. Increasing age was a risk factor for death following total knee arthroplasty.

The effect of local anaesthetic wound infiltration on chronic pain after lower limb joint replacement: A protocol for a double-blind randomised controlled trial

BackgroundFor the majority of patients with osteoarthritis (OA), joint replacement is a successful intervention for relieving chronic joint pain. However, between 10-30% of patients continue to experience chronic pain after joint replacement. Evidence suggests that a risk factor for chronic pain after joint replacement is the severity of acute post-operative pain. The aim of this randomised controlled trial (RCT) is to determine if intra-operative local anaesthethic wound infiltration additional to a standard anaethesia regimen can reduce the severity of joint pain at 12-months after total knee replacement (TKR) and total hip replacement (THR) for OA.Methods300 TKR patients and 300 THR patients are being recruited into this single-centre double-blind RCT. Participants are recruited before surgery and randomised to either the standard care group or the intervention group. Participants and outcome assessors are blind to treatment allocation throughout the study. The intervention consists of an intra-operative local anaesthetic wound infiltration, consisting of 60 mls of 0.25% bupivacaine with 1 in 200,000 adrenaline. Participants are assessed on the first 5 days post-operative, and then at 3-months, 6-months and 12-months. The primary outcome is the WOMAC Pain Scale, a validated measure of joint pain at 12-months. Secondary outcomes include pain severity during the in-patient stay, post-operative nausea and vomiting, satisfaction with pain relief, length of hospital stay, joint pain and disability, pain sensitivity, complications and cost-effectiveness. A nested qualitative study within the RCT will examine the acceptability and feasibility of the intervention for both patients and healthcare professionals.DiscussionLarge-scale RCTs assessing the effectiveness of a surgical intervention are uncommon, particulary in orthopaedics. The results from this trial will inform evidence-based recommendations for both short-term and long-term pain management after lower limb joint replacement. If a local anaesthetic wound infiltration is found to be an effective and cost-effective intervention, implementation into clinical practice could improve long-term pain outcomes for patients undergoing lower limb joint replacement.Trial registrationCurrent Controlled Trials ISRCTN96095682

Surgical approach and patient-reported outcomes after total hip replacement.

Background Previous research has mainly focused on how factors such as surgical approach might affect implant survivorship and the incidence of complications. Given the increasing interest in patient-reported outcomes, the purpose of this study is to explore whether surgical approach is associated with patient-reported pain, function, and satisfaction at 1–3 years after primary total hip replacement (THR). Methods Details of surgical factors were collated from operation notes for all consecutive patients at our centre from 2004–2006. All patients were mailed a questionnaire 1–3 years following surgery that collected WOMAC pain and function scores and the Self-Administered Patient Satisfaction Scale for Primary Hip and Knee Arthroplasty. Of the eligible 1,315 patients, 911 patients returned a completed questionnaire (69% response rate). Multivariable fractional logit models were used to identify whether surgical approach was associated with outcome scores. Results Surgical approach was found to be a significant predictor of patient-reported outcomes at 1–3 years after surgery, even after controlling for patient-specific factors. A posterior approach was associated with better scores on all three outcome measures. On average, predicted outcome scores for a typical patient with a posterior approach were between 3.5 and 7.2 percentage points higher than an equivalent patient with an anterolateral approach. Interpretation These findings suggest that clinical decisions concerning surgical approach may have an observable impact on patient-reported levels of pain, function, and satisfaction following THR.

Patient-reported history of leg ulceration 12-16 years after total primary knee or hip replacement

Background and purpose Deep vein thrombosis is common after total joint replacement. It is frequently asymptomatic, and it is unclear whether this leads to longer-term problems such as post-thrombotic syndrome and leg ulceration. We investigated whether the postoperative prevalence of ulceration in patients who had undergone primary total hip replacement (THR) or total knee replacement (TKR) was higher than that found in a control group who had not undergone total joint replacement. Methods The study group consisted of patients who had undergone THR or TKR at one orthopedic center 12–16 years previously without routine chemothromboprophylaxis, and who had not undergone revision surgery. The control group was recruited via primary care. All participants were recruited by post and asked to complete a questionnaire. Age- and sex-adjusted prevalence of self-reported leg ulceration was calculated, and logistic regression was used to determine whether there were any associations between THR or TKR and leg ulceration. Results Completed questionnaires were received from 441 THR patients (54% response rate), 196 TKR patients (48%) and 967 control participants (36%). No statistically significant differences in age- and sex-adjusted prevalence of ulceration were found between the groups, for either lifetime prevalence or prevalence over the previous 15 years. Interpretation Patients who undergo THR and TKR without chemothromboprophylaxis are unlikely to be at a higher risk of long-term venous ulceration than the normal population.