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INTRODUCTION: Low back pain (LBP) is the leading global cause of disability. Patients with moderate to severe LBP who respond positively to a diagnostic medial nerve branch block can be offered radiofrequency denervation (RFD). However, high-quality evidence on the effectiveness of RFD is lacking. METHODS AND ANALYSIS: RADICAL (RADIofrequenCy denervAtion for Low back pain) is a double-blind, parallel-group, superiority randomised controlled trial. A total of 250 adults listed for RFD will be recruited from approximately 20 National Health Service (NHS) pain and spinal clinics. Recruitment processes will be optimised through qualitative research during a 12-month internal pilot phase. Participants will be randomised in theatre using a 1:1 allocation ratio to RFD or placebo. RFD technique will follow best practice guidelines developed for the trial. Placebo RFD will follow the same protocol, but the electrode tip temperature will not be raised. Participants who do not experience a clinically meaningful improvement in pain 3 months after randomisation will be offered the alternative intervention to the one provided at the outset without disclosing the original allocation. The primary clinical outcome will be pain severity, measured using a pain Numeric Rating Scale, at 3 months after randomisation. Secondary outcomes will be assessed up to 2 years after randomisation and include disability, health-related quality of life, psychological distress, time to pain recovery, satisfaction, adverse events, work outcomes and healthcare utilisation. The primary statistical analyses will be by intention to treat and will follow a prespecified analysis plan. The primary economic evaluation will take an NHS and social services perspective and estimate the discounted cost per quality-adjusted life-year and incremental net benefit of RFD over the 2-year follow-up period. ETHICS AND DISSEMINATION: Ethics approval was obtained from the London-Fulham Research Ethics Committee (21/LO/0471). Results will be disseminated in open-access publications and plain language summaries. TRIAL REGISTRATION NUMBER: ISRCTN16473239.
Subject(s)
Cost-Benefit Analysis , Denervation , Low Back Pain , Humans , Low Back Pain/therapy , Low Back Pain/surgery , Low Back Pain/economics , Double-Blind Method , Denervation/methods , Denervation/economics , Pain Measurement , Chronic Pain/therapy , Chronic Pain/surgery , Quality of Life , Treatment Outcome , AdultABSTRACT
Aims: During total knee replacement (TKR), surgeons can choose whether or not to resurface the patella, with advantages and disadvantages of each approach. Recently, the National Institute for Health and Care Excellence (NICE) recommended always resurfacing the patella, rather than never doing so. NICE found insufficient evidence on selective resurfacing (surgeon's decision based on intraoperative findings and symptoms) to make recommendations. If effective, selective resurfacing could result in optimal individualized patient care. This protocol describes a randomized controlled trial to evaluate the clinical and cost-effectiveness of primary TKR with always patellar resurfacing compared to selective patellar resurfacing. Methods: The PAtellar Resurfacing Trial (PART) is a patient- and assessor-blinded multicentre, pragmatic parallel two-arm randomized superiority trial of adults undergoing elective primary TKR for primary osteoarthritis at NHS hospitals in England, with an embedded internal pilot phase (ISRCTN 33276681). Participants will be randomly allocated intraoperatively on a 1:1 basis (stratified by centre and implant type (cruciate-retaining vs cruciate-sacrificing)) to always resurface or selectively resurface the patella, once the surgeon has confirmed sufficient patellar thickness for resurfacing and that constrained implants are not required. The primary analysis will compare the Oxford Knee Score (OKS) one year after surgery. Secondary outcomes include patient-reported outcome measures at three months, six months, and one year (Knee injury and Osteoarthritis Outcome Score, OKS, EuroQol five-dimension five-level questionnaire, patient satisfaction, postoperative complications, need for further surgery, resource use, and costs). Cost-effectiveness will be measured for the lifetime of the patient. Overall, 530 patients will be recruited to obtain 90% power to detect a four-point difference in OKS between the groups one year after surgery, assuming up to 40% resurfacing in the selective group. Conclusion: The trial findings will provide evidence about the clinical and cost-effectiveness of always patellar resurfacing compared to selective patellar resurfacing. This will inform future NICE guidelines on primary TKR and the role of selective patellar resurfacing.
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AIMS: Elective hip and knee replacement operations were suspended in April 2020 due to the COVID-19 pandemic. The impact of this suspension and continued disruption to the delivery of joint replacement surgery is still emerging. We describe the impact of the pandemic on the provision of publicly funded elective hip and knee replacement surgery at one teaching hospital in England and on which patients had surgery. METHODS: We included all elective primary and revision hip and knee replacements performed at one hospital between January 2016 and June 2021. Using data for the years 2016-2019, we estimated the expected number of operations and beds occupied per month in January 2020 to June 2021 using time series linear models (adjusting for season and trend). We compared the predictions with the real data for January 2020 to June 2021 to assess the impact of the pandemic on the provision of elective hip and knee replacements. We compared the length of stay and characteristics (age, gender, number of comorbidities, index of multiple deprivation) of patients who had surgery before the pandemic with those who had surgery during the pandemic. RESULTS: We included 6,964 elective primary and revision hip and knee replacements between January 2016 and June 2021. Between January 2020 and June 2021 primary hip replacement volume was 59% of predicted, and 47% for primary knee replacements. Revision hip replacement volume was 77% of predicted, and 42% for revision knee replacement. Median length of stay was one day shorter for primary (4 vs 3 days) and revision (6 vs 5 days) operations during the pandemic compared with before. Patients operated on during the pandemic were younger and had slightly more comorbidities than those operated on before the pandemic. CONCLUSIONS: The restricted provision of elective hip and knee replacements during the COVID-19 pandemic changed the patient casemix, but did not introduce new inequalities in access to these operations. Patients were younger, had more comorbidities, and stayed in hospital for less time than those treated before the pandemic. Approximately half the number of operations were performed during the pandemic than would have been expected and the effect was greatest for revision knee replacements.
Subject(s)
Arthroplasty, Replacement, Hip , COVID-19 , Humans , Pandemics , COVID-19/epidemiology , England/epidemiology , Knee JointABSTRACT
We compared the risks of re-revision and mortality between two-stage and single-stage revision surgeries among patients with infected primary hip arthroplasty. Patients with a periprosthetic joint infection (PJI) of their primary arthroplasty revised with single-stage or two-stage procedure in England and Wales between 2003 and 2014 were identified from the National Joint Registry. We used Poisson regression with restricted cubic splines to compute hazard ratios (HRs) at different postoperative periods. The total number of revisions and re-revisions undergone by patients was compared between the two strategies. In total, 535 primary hip arthroplasties were revised with single-stage procedure (1,525 person-years) and 1,605 with two-stage procedure (5,885 person-years). All-cause re-revision was higher following single-stage revision, especially in the first three months (HR at 3 months = 1.98 (95% confidence interval (CI) 1.14 to 3.43), p = 0.009). The risks were comparable thereafter. Re-revision for PJI was higher in the first three postoperative months for single-stage revision and waned with time (HR at 3 months = 1.81 (95% CI 1.22 to 2.68), p = 0.003; HR at 6 months = 1.25 (95% CI 0.71 to 2.21), p = 0.441; HR at 12 months = 0.94 (95% CI 0.54 to 1.63), p = 0.819). Patients initially managed with a single-stage revision received fewer revision operations (mean 1.3 (SD 0.7) vs 2.2 (SD 0.6), p < 0.001). Mortality rates were comparable between these two procedures (29/10,000 person-years vs 33/10,000). The risk of unplanned re-revision was lower following two-stage revision, but only in the early postoperative period. The lower overall number of revision procedures associated with a single-stage revision strategy and the equivalent mortality rates to two-stage revision are reassuring. With appropriate counselling, single-stage revision is a viable option for the treatment of hip PJI.
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OBJECTIVES: To explore the impact of a temporary cancellation of elective surgery in winter 2017 on trends in primary hip and knee replacement at a major National Health Service (NHS) Trust, and whether lessons can be learnt about efficient surgery provision. DESIGN AND SETTING: Observational descriptive study using interrupted time series analysis of hospital records to explore trends in primary hip and knee replacement surgery at a major NHS Trust, as well as patient characteristics, 2016-2019. INTERVENTION: A temporary cancellation of elective services for 2 months in winter 2017. OUTCOMES: NHS-funded hospital admissions for primary hip or knee replacement, length of stay and bed occupancy. Additionally, we explored the ratio of elective to emergency admissions at the Trust as a measure of elective capacity, and the ratio of public to private provision of NHS-funded hip and knee surgery. RESULTS: After winter 2017, there was a sustained reduction in the number of knee replacements, a decrease in the proportion of most deprived people having knee replacements and an increase in average age for knee replacement and comorbidity for both types of surgery. The ratio of public to private provision dropped after winter 2017, and elective capacity generally has reduced over time. There was clear seasonality in provision of elective surgery, with less complex patients admitted during winter. CONCLUSIONS: Declining elective capacity and seasonality has a marked effect on the provision of joint replacement, despite efficiency improvements in hospital treatment. The Trust has outsourced less complex patients to independent providers, and/or treated them during winter when capacity is most limited. There is a need to explore whether these are strategies that could be used explicitly to maximise the use of limited elective capacity, provide benefit to patients and value for money for taxpayers.
Subject(s)
Arthroplasty, Replacement, Hip , Arthroplasty, Replacement, Knee , Humans , State Medicine , Interrupted Time Series Analysis , Arthroplasty, Replacement, Hip/adverse effects , Arthroplasty, Replacement, Knee/adverse effects , HospitalizationABSTRACT
Periprosthetic hip-joint infection is a multifaceted and highly detrimental outcome for patients and clinicians. The incidence of prosthetic joint infection reported within two years of primary hip arthroplasty ranges from 0.8% to 2.1%. Costs of treatment are over five-times greater in people with periprosthetic hip joint infection than in those with no infection. Currently, there are no national evidence-based guidelines for treatment and management of this condition to guide clinical practice or to inform clinical study design. The aim of this study is to develop guidelines based on evidence from the six-year INFection and ORthopaedic Management (INFORM) research programme. We used a consensus process consisting of an evidence review to generate items for the guidelines and online consensus questionnaire and virtual face-to-face consensus meeting to draft the guidelines. The consensus panel comprised 21 clinical experts in orthopaedics, primary care, rehabilitation, and healthcare commissioning. The final output from the consensus process was a 14-item guideline. The guidelines make recommendations regarding increased vigilance and monitoring of those at increased risk of infection; diagnosis including strategies to ensure the early recognition of prosthetic infection and referral to orthopaedic teams; treatment, including early use of DAIR and revision strategies; and postoperative management including appropriate physical and psychological support and antibiotic strategies. We believe the implementation of the INFORM guidelines will inform treatment protocols and clinical pathways to improve the treatment and management of periprosthetic hip infection.
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BACKGROUND: While the United Kingdom National Health Service aimed to reduce social inequalities in the provision of joint replacement, it is unclear whether these gaps have reduced. We describe secular trends in the provision of primary hip and knee replacement surgery between social deprivation groups. METHODS AND FINDINGS: We used the National Joint Registry to identify all hip and knee replacements performed for osteoarthritis from 2007 to 2017 in England. The Index of Multiple Deprivation (IMD) 2015 was used to identify the relative level of deprivation of the patient living area. Multilevel negative binomial regression models were used to model the differences in rates of joint replacement. Choropleth maps of hip and knee replacement provision were produced to identify the geographical variation in provision by Clinical Commissioning Groups (CCGs). A total of 675,342 primary hip and 834,146 primary knee replacements were studied. The mean age was 70 years old (standard deviation: 9) with 60% and 56% of women undergoing hip and knee replacements, respectively. The overall rate of hip replacement increased from 27 to 36 per 10,000 person-years and knee replacement from 33 to 46. Inequalities of provision between the most (reference) and least affluent areas have remained constant for both joints (hip: rate ratio (RR) = 0.58, 95% confidence interval [0.56, 0.60] in 2007, RR = 0.59 [0.58, 0.61] in 2017; knee: RR = 0.82 [0.80, 0.85] in 2007, RR = 0.81 [0.80, 0.83] in 2017). For hip replacement, CCGs with the highest concentration of deprived areas had lower overall provision rates, and CCGs with very few deprived areas had higher provision rates. There was no clear pattern of provision inequalities between CCGs and deprivation concentration for knee replacement. Study limitations include the lack of publicly available information to explore these inequalities beyond age, sex, and geographical area. Information on clinical need for surgery or patient willingness to access care were unavailable. CONCLUSIONS: In this study, we found that there were inequalities, which remained constant over time, especially in the provision of hip replacement, by degree of social deprivation. Providers of healthcare need to take action to reduce this unwarranted variation in provision of surgery.
Subject(s)
Osteoarthritis , State Medicine , Humans , Female , Aged , Cohort Studies , England/epidemiology , Social Deprivation , RegistriesABSTRACT
BACKGROUND: Revision total knee replacement (TKR) is a major operation with a long recovery period and many patients report suboptimal outcomes. Rehabilitation has the potential to improve outcomes. The aim of this study was to understand current provision of rehabilitation for revision TKR in England and evaluate the existing evidence. METHODS: Phase 1: An online national survey of education and rehabilitation provision for patients receiving revision TKR was completed by physiotherapy staff at 22 hospitals across England that were high volume for revision TKR (response rate of 34%). Phase 2: Systematic review to identify studies evaluating rehabilitation programmes for revision joint replacement. Searches were conducted in MEDLINE, EMBASE, PsycINFO, CINAHL, and Cochrane databases from inception to 15th June 2022. Randomised controlled trials (RCTs) and observational studies that evaluated post-operative rehabilitation for adults undergoing revision joint replacement were included. Screening, data extraction and quality assessment was undertaken by two reviewers. RESULTS: Phase 1: Pre-operative education which aimed to prepare patients for surgery and recovery was provided in most hospitals, predominately involving a single session delivered by a multidisciplinary team. Inpatient physiotherapy commonly commenced on post-operative day 1 and was provided twice daily, with most hospitals also providing occupational therapy. Rehabilitation was often provided in the first four weeks after hospital discharge, either in an outpatient, community or home setting. In most hospitals, the education and rehabilitation provided to patients receiving revision TKR was the same as that provided to patients undergoing primary TKR. Phase 2: Of the 1,445 articles identified, three retrospective cohort studies based on hospital records review were included. The studies evaluated intensive inpatient rehabilitation programmes, consisting of 2-3 h of daily group or individual physiotherapy, with additional occupational therapy in one study. All three studies reported improvement in functional outcomes for patients undergoing rehabilitation after revision TKR. All studies were limited by their retrospective design, short duration of follow-up and lack of sample size calculation. No RCTs evaluating effectiveness of rehabilitation for revision TKR were identified. CONCLUSION: This study identified the need for future research to develop and evaluate tailored rehabilitation to optimise patient outcomes following revision TKR.
Subject(s)
Arthroplasty, Replacement, Knee , Adult , Humans , Arthroplasty, Replacement, Knee/rehabilitation , England , Physical Therapy ModalitiesABSTRACT
BACKGROUND: The incidence of dislocation after revision total hip arthroplasty (rTHA) is reported to be up to 25% and remains a common source of failure. Constrained acetabular components and dual mobility implants are two implant classes being utilized to alleviate this burden in patients who have recurrent instability or major intraoperative instability. This meta-analysis evaluated the incidence and temporal trends of dislocation after implantation with constrained acetabular components and dual mobility implants in rTHA. METHODS: Longitudinal studies reporting dislocation after the use of constrained acetabular components or dual mobility implants in rTHA were sought from Medline and Embase to October 2022. Secondary outcomes included re-revision surgery for dislocation and all causes. A total of 75 relevant citations were identified comprising 36 datasets of 3,784 constrained acetabular components and 47 datasets of 10,216 dual mobility implants. RESULTS: For constrained acetabular components, the pooled incidence of dislocation was 9% (95% confidence interval: 7.2, 11.7) (range 0.0%-35.3%) over a weighted mean follow-up of 6 years, in contrast to 3% (95% confidence interval: 2.2, 4.4) (range 0.0%-21.4%) over 5 years for dual mobility implants. Re-revision rates for dislocation after using constrained acetabular components were around 9%, in contrast to 2% for dual mobility implants. Re-revision rates for all causes after using constrained acetabular components were around 19%, in contrast to 8% for dual mobility implants. CONCLUSION: Dual mobility implants in the context of rTHA demonstrate lower incidences of dislocation (3% versus 9%), re-revision for dislocation (2% versus 9%), and rer-evision for any cause (8% versus 19%) in contrast to constrained acetabular components. This must be considered by surgeons when implanting such devices, often selected to treat instability.
Subject(s)
Arthroplasty, Replacement, Hip , Hip Dislocation , Hip Prosthesis , Joint Dislocations , Humans , Arthroplasty, Replacement, Hip/adverse effects , Hip Prosthesis/adverse effects , Incidence , Reoperation/adverse effects , Hip Dislocation/epidemiology , Hip Dislocation/etiology , Hip Dislocation/surgery , Prosthesis Failure , Prosthesis Design , Retrospective StudiesABSTRACT
Background: Hip replacements are common and effective operations but patients that undergo this intervention are at risk of the replacements failing, requiring costly and often complex revision surgery with poorer outcomes than primary surgery. There is paucity of reliable data examining the treatment pathway for hip replacements over the life of the patient in terms of risk of revision and re-revisions. We aim to provide detailed information on the longevity of hip revision surgery. Methods: We did a retrospective observational registry-based study of the National Joint Registry, using data on hip replacements from all participating hospitals in England and Wales, UK. We included data on all first revisions, with an identifiable primary procedure, with osteoarthritis as the sole indication for the original primary procedure. Kaplan-Meier estimates were used to determine the cumulative probability of revision and subsequent re-revision after primary hip replacement. Analyses were stratified by age and gender, and the influence of time from first to second revision on the risk of further revision was explored. Findings: Between April 1, 2003, and Dec 31, 2019, there were 29â010 revision hip replacements with a linked primary episode. Revision rates of revision hip replacements were higher in patients younger than 55 years than in older age groups. After revision of primary total hip replacement, 21·3% (95% CI 18·6-24·4) of first revisions were revised again within 15 years, 22·3% (20·3-24·4) of second revisions were revised again within 7 years, and 22·3% (18·3-27·0) of third revisions were revised again within 3 years. After revision of hip resurfacing, 23·7% (95% CI 19·6-28·5) of these revisions were revised again within 15 years, 21·0% (17·0-25·8) of second revisions were revised again within 7 years, and 19·3% (11·9-30·4) of third revisions were revised again within 3 years. A shorter time between revision episodes was associated with earlier subsequent revision. Interpretation: Younger patients are at an increased risk of multiple revisions. Patients who undergo a revision have a steadily increasing risk of further revision the more procedures they undergo, and each subsequent revision lasts for approximately half the time of the previous one. Although hip replacements are effective for improving pain and function and usually last a remarkably long time, if they are revised, successive revisions are progressively and markedly less successful. Funding: NIHR Biomedical Research Centre at the University Hospitals Bristol and Weston NHS Foundation Trust and the University of Bristol, Healthcare Quality Improvement Partnership; and the National Joint Registry.
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OBJECTIVES: To determine whether patient reported outcomes improve after single stage versus two stage revision surgery for prosthetic joint infection of the hip, and to determine the cost effectiveness of these procedures. DESIGN: Pragmatic, parallel group, open label, randomised controlled trial. SETTING: High volume tertiary referral centres or orthopaedic units in the UK (n=12) and in Sweden (n=3), recruiting from 1 March 2015 to 19 December 2018. PARTICIPANTS: 140 adults (aged ≥18 years) with a prosthetic joint infection of the hip who required revision (65 randomly assigned to single stage and 75 to two stage revision). INTERVENTIONS: A computer generated 1:1 randomisation list stratified by hospital was used to allocate participants with prosthetic joint infection of the hip to a single stage or a two stage revision procedure. MAIN OUTCOME MEASURES: The primary intention-to-treat outcome was pain, stiffness, and functional limitations 18 months after randomisation, measured by the Western Ontario and McMasters Universities Osteoarthritis Index (WOMAC) score. Secondary outcomes included surgical complications and joint infection. The economic evaluation (only assessed in UK participants) compared quality adjusted life years and costs between the randomised groups. RESULTS: The mean age of participants was 71 years (standard deviation 9) and 51 (36%) were women. WOMAC scores did not differ between groups at 18 months (mean difference 0.13 (95% confidence interval -8.20 to 8.46), P=0.98); however, the single stage procedure was better at three months (11.53 (3.89 to 19.17), P=0.003), but not from six months onwards. Intraoperative events occurred in five (8%) participants in the single stage group and 20 (27%) in the two stage group (P=0.01). At 18 months, nine (14%) participants in the single stage group and eight (11%) in the two stage group had at least one marker of possible ongoing infection (P=0.62). From the perspective of healthcare providers and personal social services, single stage revision was cost effective with an incremental net monetary benefit of £11 167 (95% confidence interval £638 to £21 696) at a £20 000 per quality adjusted life years threshold (£1.0; $1.1; 1.4). CONCLUSIONS: At 18 months, single stage revision compared with two stage revision for prosthetic joint infection of the hip showed no superiority by patient reported outcome. Single stage revision had a better outcome at three months, fewer intraoperative complications, and was cost effective. Patients prefer early restoration of function, therefore, when deciding treatment, surgeons should consider patient preferences and the cost effectiveness of single stage surgery. TRIAL REGISTRATION: ISRCTN registry ISRCTN10956306.
Subject(s)
Quality of Life , Adolescent , Adult , Aged , Female , Humans , Male , Cost-Benefit Analysis , Ontario , Quality-Adjusted Life Years , SwedenABSTRACT
BACKGROUND: Patellar resurfacing is optional during total knee replacement (TKR). Some surgeons always resurface the patella, some never resurface, and others selectively resurface. Which resurfacing strategy provides optimal outcomes is unclear. We assessed the effectiveness of patellar resurfacing, no resurfacing, and selective resurfacing in primary TKR. METHODS: A systematic review and meta-analysis was performed. MEDLINE, Embase, Web of Science, The Cochrane Library, and bibliographies were searched to November 2021 for randomised-control trials (RCTs) comparing outcomes for two or more resurfacing strategies (resurfacing, no resurfacing, or selective resurfacing) in primary TKR. Observational studies were included if limited or no RCTs existed for resurfacing comparisons. Outcomes assessed were patient reported outcome measures (PROMs), complications, and further surgery. Study-specific relative risks [RR] were aggregated using random-effects models. Quality of the evidence was assessed using GRADE. RESULTS: We identified 33 RCTs involving 5,540 TKRs (2,727 = resurfacing, 2,772 = no resurfacing, 41 = selective resurfacing). One trial reported on selective resurfacing. Patellar resurfacing reduced anterior knee pain compared with no resurfacing (RR = 0.65 (95% CI = 0.44-0.96)); there were no significant differences in PROMs. Resurfacing reduced the risk of revision surgery (RR = 0.63, CI = 0.42-0.94) and other complications (RR = 0.54, CI = 0.39-0.74) compared with no resurfacing. Quality of evidence ranged from high to very low. Limited observational evidence (5 studies, TKRs = 215,419) suggested selective resurfacing increased the revision risk (RR = 1.14, CI = 1.05-1.22) compared with resurfacing. Compared with no resurfacing, selective resurfacing had a higher risk of pain (RR = 1.25, CI = 1.04-1.50) and lower risk of revision (RR = 0.92, CI = 0.85-0.99). CONCLUSIONS: Level 1 evidence supports TKR with patellar resurfacing over no resurfacing. Resurfacing has a reduced risk of anterior knee pain, revision surgery, and complications, despite PROMs being comparable. High-quality RCTs involving selective resurfacing, the most common strategy in the UK and other countries, are needed given the limited observational data suggests selective resurfacing may not be effective over other strategies.
Subject(s)
Arthroplasty, Replacement, Knee , Patella , Humans , Patella/surgery , Arthroplasty, Replacement, Knee/adverse effects , Knee Joint/surgery , Treatment Outcome , Pain/surgeryABSTRACT
Objective: To identify research priorities for intra-articular corticosteroid injections for osteoarthritis using a Delphi study. Design: In the Round 1 questionnaire, participants generated up to five potential research topics related to corticosteroid injections for osteoarthritis. These responses were collated and grouped to develop candidate research questions. Literature searches were conducted and questions with a lack of evidence were included in the next round. In Round 2, importance ratings (1-9; not important to very important) were assigned to each question. Those questions given an importance rating of 7-9 by ≥ 70% of participants were carried forward. In Round 3, participants were provided with the group ratings and the rating process was repeated to develop the final research priority list. Results: All three Delphi rounds were completed by 75 participants (82%; 34 patients, 21 healthcare professionals and 20 academics). A total of 310 research topics were generated in Round 1, from which 26 research questions were developed. None had been robustly answered by research and therefore all were included in the Round 2 questionnaire. In Round 2, 14 research questions were retained; all 14 were prioritised in Round 3 and included in the final research priority list. The questions covered long-term effects, clinical and cost-effectiveness, measurement of outcomes, comparison to other treatments, provision, safety, identifying responders, maximising benefits, patient experience, delaying the need for joint replacement, and dosage. Conclusion: Using a robust consensus technique with key stakeholders, we have developed a research priority list to guide future research into corticosteroid injections for osteoarthritis.
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AIMS: We compared the risks of re-revision and mortality between two-stage revision surgery and single-stage revision surgery among patients with infected primary knee arthroplasty. METHODS: Patients with a periprosthetic joint infection (PJI) of their primary knee arthroplasty, initially revised with a single-stage or a two-stage procedure in England and Wales between 2003 and 2014, were identified from the National Joint Registry. We used Poisson regression with restricted cubic splines to compute hazard ratios (HR) at different postoperative periods. The total number of revisions and re-revisions undergone by patients was compared between the two strategies. RESULTS: A total of 489 primary knee arthroplasties were revised with single-stage procedure (1,390 person-years) and 2,377 with two-stage procedure (8,349 person-years). The adjusted incidence rates of all-cause re-revision and for infection were comparable between these strategies (HR overall five years, 1.15 (95% confidence interval (CI) 0.87 to 1.52), p = 0.308; HR overall five years, 0.99 (95% CI 0.70 to 1.39), p = 0.949, respectively). Patients initially managed with single-stage revision received fewer revision procedures overall than after two-stage revision (1.2 vs 2.2, p < 0.001). Mortality was lower for single-stage revision between six and 18 months postoperative (HR at six months, 0.51 (95% CI 0.25 to 1.00), p = 0.049 HR at 18 months, 0.33 (95% CI 0.12 to 0.99), p = 0.048) and comparable at other timepoints. CONCLUSION: The risk of re-revision was similar between single- and two-stage revision for infected primary knee arthroplasty. Single-stage group required fewer revisions overall, with lower or comparable mortality at specific postoperative periods. The single-stage revision is a safe and effective strategy to treat infected knee arthroplasties. There is potential for increased use to reduce the burden of knee PJI for patients, and for the healthcare system.Cite this article: Bone Joint Res 2022;11(10):690-699.
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AIMS: Our main aim was to describe the trend in the comorbidities of patients undergoing elective total hip arthroplasties (THAs) and knee arthroplasties (KAs) between 1 January 2005 and 31 December 2018 in England. METHODS: We combined data from the National Joint Registry (NJR) on primary elective hip and knee arthroplasties performed between 2005 and 2018 with pre-existing conditions recorded at the time of their primary operation from Hospital Episodes Statistics. We described the temporal trend in the number of comorbidities identified using the Charlson Comorbidity Index, and how this varied by age, sex, American Society of Anesthesiologists (ASA) grade, index of multiple deprivation, and type of KA. RESULTS: We included 696,504 and 833,745 elective primary THAs and KAs respectively, performed for any indication. Between 2005 and 2018, the proportion of elective THA and KA patients with one or more comorbidity at the time of their operation increased substantially (THA: 20% to 38%, KA: 22% to 41%). This was driven by increases in four conditions: chronic obstructive pulmonary disease (COPD) (2018: ~17%), diabetes without complications (2018: THA 10%, KA 14%), myocardial infarction (2018: 4%), and renal disease (2018: ~8%). Notably, renal disease prevalence increased from < 1% in 2005 to ~8% in 2018. CONCLUSION: Between 2005 and 2018 there were significant changes in the number of comorbidities recorded in patients having elective primary THAs and KAs. Renal disease is now one of the most prevalent comorbidities in this patient population. Future research should explore whether this comorbidity trend has increased the burden on other medical specialities to optimize these patients before surgery and to provide additional postoperative care.Cite this article: Bone Joint J 2022;104-B(9):1052-1059.
Subject(s)
Arthroplasty, Replacement, Hip , Arthroplasty, Replacement, Knee , Adult , Cohort Studies , Comorbidity , England/epidemiology , Humans , RegistriesABSTRACT
BACKGROUND AND PURPOSE: This study aims to determine, for the first time, generalizable data on the longevity and long-term function of elbow replacements. METHODS: In this systematic review and meta-analysis, we searched MEDLINE and Embase for articles reporting 10-year or greater survival of total elbow replacements (TERs) and distal humeral hemiarthroplasty. Implant survival and patient reported outcome measures (PROMs) data were extracted. National joint replacement registries were also analyzed. We weighted each series and calculated a pooled survival estimate at 10, 15, and 20 years. For PROMs we pooled the standardized mean difference (SMD) at 10 years. FINDINGS: Despite its widespread use, we identified only 9 series reporting all-cause survival of 628 linked TERs and 610 unlinked TERs and no series for distal humeral hemiarthroplasty. The studied population was treated for rheumatoid arthritis in over 90% of cases. The estimated 10-year survival for linked TERs was 92% (95% CI 90-95) and unlinked TERs 84% (CI 81-88). 2 independent registries contributed 32 linked TERs and 530 unlinked TERs. The pooled registry 10-year survival for unlinked TERs was 86% (CI 83-89). Pooled 10-year PROMs from 164 TERs (33 linked and 131 unlinked), revealed a substantial improvement from baseline scores (SMD 2.7 [CI 1.6-3.8]). INTERPRETATION: Over 80% of all elbow replacements and over 90% of linked elbow replacements can last more than 10 years with sustained patient-reported benefits. This information is long overdue and will be particularly useful to patients as well as healthcare providers.
Subject(s)
Arthroplasty, Replacement , Elbow , Follow-Up Studies , Humans , RegistriesABSTRACT
OBJECTIVE: To assess the cost-utility and cost-effectiveness of a group-based outpatient physical therapy intervention delivered 6 weeks after primary total knee replacement (TKR) compared with usual care, alongside the Activity-Orientated Rehabilitation Following Knee Arthroplasty (ARENA) multicenter, randomized, controlled trial. METHODS: The economic analyses were performed from the perspective of the health and social care payer. We collected resource use for health and social care and productivity losses and patient outcomes for 12 months after surgery to derive costs and quality-adjusted life years (QALYs). Results were expressed in incremental cost-effectiveness ratios (ICERs), and incremental net monetary benefit statistics (INMBs) for a society willingness-to-pay (WTP) threshold of £20,000 per QALY gained, with sensitivity analyses to model specification and perspective. RESULTS: The cost of the ARENA physical therapy classes was mean ± SD £179 ± 39 per patient. Treatment in the year following surgery cost was, on average, £1,739 (95% confidence interval [95% CI] -£742, £4,221) per patient in the intervention group (n = 89), which was an additional £346 (95% CI £38, £653) per patient compared with usual care (n = 91) (£1,393 [95% CI -£780, £3,568]). QALY benefits were 0.0506 higher (95% CI 0.009, 0.09) in the intervention group, corresponding to an additional 19 days in "perfect health." The ICER for the intervention group was £6,842 per QALY gained, and the INMB was £665 (95% CI £139, £1,191), with a 92% probability of being cost-effective, and no less than 73% in all sensitivity analysis scenarios. CONCLUSION: The addition of group-based outpatient physical therapy classes to usual care improves quality of life and is a cost-effective treatment option following TKR for a society WTP threshold of £20,000 per QALY gained.
Subject(s)
Arthroplasty, Replacement, Knee , Humans , Cost-Benefit Analysis , Quality of Life , Outpatients , Quality-Adjusted Life Years , Physical Therapy ModalitiesABSTRACT
AIMS: A recent report from France suggested an association between the use of cobalt-chrome (CoCr) femoral heads in total hip arthroplasties (THAs) and an increased risk of dilated cardiomyopathy and heart failure. CoCr is a commonly used material in orthopaedic implants. If the reported association is causal, the consequences would be significant given the millions of joint arthroplasties and other orthopaedic procedures in which CoCr is used annually. We examined whether CoCr-containing THAs were associated with an increased risk of all-cause mortality, heart outcomes, cancer, and neurodegenerative disorders in a large national database. METHODS: Data from the National Joint Registry was linked to NHS English hospital inpatient episodes for 374,359 primary THAs with up to 14.5 years' follow-up. We excluded any patients with bilateral THAs, knee arthroplasties, indications other than osteoarthritis, aged under 55 years, and diagnosis of one or more outcome of interest before THA. Implants were grouped as either containing CoCr or not containing CoCr. The association between implant construct and the risk of all-cause mortality and incident heart failure, cancer, and neurodegenerative disorders was examined. RESULTS: There were 158,677 individuals (42.4%) with an implant containing CoCr. There were 47,963 deaths, 27,332 heart outcomes, 35,720 cancers, and 22,025 neurodegenerative disorders. There was no evidence of an association between patients with CoCr implants and higher rates of any of the outcomes. CONCLUSION: CoCr-containing THAs did not have an increased risk of all-cause mortality, or clinically meaningful heart outcomes, cancer, or neurodegenerative disorders into the second decade post-implantation. Our findings will help reassure clinicians and the increasing number of patients receiving primary THA worldwide that the use of CoCr-containing implants is not associated with significant adverse systemic effects. Cite this article: Bone Joint J 2022;104-B(3):359-367.
Subject(s)
Chromium Alloys/adverse effects , Heart Diseases/etiology , Heart Diseases/mortality , Hip Prosthesis/adverse effects , Neoplasms/etiology , Neoplasms/mortality , Neurodegenerative Diseases/etiology , Neurodegenerative Diseases/mortality , Postoperative Complications/etiology , Postoperative Complications/mortality , Aged , Aged, 80 and over , Cause of Death , Cohort Studies , Female , Humans , Male , Middle Aged , Prosthesis Design , Registries , Retrospective Studies , Risk Assessment , United KingdomABSTRACT
AIMS: Total hip arthroplasties (THAs) are performed by surgeons at various stages in training with varying levels of supervision, but we do not know if this is safe practice with comparable outcomes to consultant-performed THA. Our aim was to examine the association between surgeon grade, the senior supervision of trainees, and the risk of revision following THA. METHODS: We performed an observational study using National Joint Registry (NJR) data. We included adult patients who underwent primary THA for osteoarthritis, recorded in the NJR between 2003 and 2016. Exposures were operating surgeon grade (consultant or trainee) and whether or not trainees were directly supervised by a scrubbed consultant. Outcomes were all-cause revision and the indication for revision up to ten years. We used methods of survival analysis, adjusted for patient, operation, and healthcare setting factors. RESULTS: We included 603,474 THAs, of which 58,137 (9.6%) procedures were performed by a trainee. There was no association between surgeon grade and all-cause revision up to ten years (crude hazard ratio (HR) 1.00 (95% confidence interval (CI) 0.94 to 1.07); p = 0.966), a finding which persisted with adjusted analysis. Fully adjusted analysis demonstrated an association between trainees operating without scrubbed consultant supervision and an increased risk of all-cause revision (HR 1.10 (95% CI 1.00 to 1.21); p = 0.045). There was an association between trainee-performed THA and revision for instability (HR 1.14 (95% CI 1.01 to 1.30); p = 0.039). However, this was not observed in adjusted models, or when trainees were supervised by a scrubbed consultant. CONCLUSION: Within the current training system in England and Wales, appropriately supervised trainees achieve comparable THA survival to consultants. Trainees who are supervised by a scrubbed consultant achieve superior outcomes compared to trainees who are not supervised by a scrubbed consultant, particularly in terms of revision for instability. Cite this article: Bone Joint J 2022;104-B(3):341-351.
Subject(s)
Arthroplasty, Replacement, Hip/standards , Clinical Competence , Reoperation/statistics & numerical data , Aged , Aged, 80 and over , Female , Humans , Male , Middle Aged , Prospective Studies , Registries , Risk AssessmentABSTRACT
BACKGROUND: Approximately 20% of people experience chronic pain after total knee replacement, but effective treatments are not available. We aimed to evaluate the clinical effectiveness and cost-effectiveness of a new care pathway for chronic pain after total knee replacement. METHODS: We did an unmasked, parallel group, pragmatic, superiority, randomised, controlled trial at eight UK National Health Service (NHS) hospitals. People with chronic pain at 3 months after total knee replacement surgery were randomly assigned (2:1) to the Support and Treatment After Replacement (STAR) care pathway plus usual care, or to usual care alone. The STAR intervention aimed to identify underlying causes of chronic pain and enable onward referrals for targeted treatment through a 3-month post-surgery assessment with an extended scope practitioner and telephone follow-up over 12 months. Co-primary outcomes were self-reported pain severity and pain interference in the replaced knee, assessed with the Brief Pain Inventory (BPI) pain severity and interference scales at 12 months (scored 0-10, best to worst) and analysed on an as-randomised basis. Resource use, collected from electronic hospital records and participants, was valued with UK reference costs. Quality-adjusted life-years (QALYs) were calculated from EQ-5D-5L responses. This trial is registered with ISRCTN, ISRCTN92545361. FINDINGS: Between Sept 6, 2016, and May 31, 2019, 363 participants were randomly assigned to receive the intervention plus usual care (n=242) or to receive usual care alone (n=121). Participants had a median age of 67 years (IQR 61 to 73), 217 (60%) of 363 were female, and 335 (92%) were White. 313 (86%) patients provided follow-up data at 12 months after randomisation (213 assigned to the intervention plus usual care and 100 assigned to usual care alone). At 12 months, the mean between-group difference in the BPI severity score was -0·65 (95% CI -1·17 to -0·13; p=0·014) and the mean between-group difference in the BPI interference score was -0·68 (-1·29 to -0·08; p=0·026), both favouring the intervention. From an NHS and personal social services perspective, the intervention was cost-effective (greater improvement with lower cost), with an incremental net monetary benefit of £1256 (95% CI 164 to 2348) at £20 000 per QALY threshold. One adverse reaction of participant distress was reported in the intervention group. INTERPRETATION: STAR is a clinically effective and cost-effective intervention to improve pain outcomes over 1 year for people with chronic pain at 3 months after total knee replacement surgery. FUNDING: National Institute for Health Research.