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2.
J Clin Epidemiol ; 143: 159-168, 2021 Dec 15.
Artigo em Inglês | MEDLINE | ID: mdl-34920113

RESUMO

OBJECTIVES: To create estimates for clinically meaningful changes and differences in pain and joint function for the Oxford Hip and Knee Scores (OHS/OKS) in primary and revision joint replacement. STUDY DESIGN AND SETTING: 694,487 primary and revision joint replacement procedures were analyzed from the NHS PROMs dataset between 2012-2020. Minimal important changes (MIC) and differences (MID) were calculated using distribution and anchor-based methods (including receiver-operating characteristic (ROC) curve and predictive-modelling techniques). RESULTS: For comparison of two or more groups (such as in a clinic trial), MID estimates were ∼5 points. For cohort studies investigating changes over time in a single group of patients, MICgroup estimates were 12.4 points (primary hip replacement), 8.6 points (revision hip replacement), 10.5 points (primary knee replacement) and 9.4 points (revision knee replacement). For studies investigating changes over time at the individual patient level, MICadjusted estimates were ∼8 points, ∼6 points, ∼7 points and ∼6 points respectively. CONCLUSION: This study has calculated contemporary estimates of clinically important changes and differences for the OHS/OKS for primary and revision hip and knee replacement. These estimates can be used to inform sample size calculations and to interpret changes in joint function over time and differences between groups.

3.
Health Technol Assess ; 25(66): 1-126, 2021 11.
Artigo em Inglês | MEDLINE | ID: mdl-34812138

RESUMO

BACKGROUND: Although routine NHS data potentially include all patients, confounding limits their use for causal inference. Methods to minimise confounding in observational studies of implantable devices are required to enable the evaluation of patients with severe systemic morbidity who are excluded from many randomised controlled trials. OBJECTIVES: Stage 1 - replicate the Total or Partial Knee Arthroplasty Trial (TOPKAT), a surgical randomised controlled trial comparing unicompartmental knee replacement with total knee replacement using propensity score and instrumental variable methods. Stage 2 - compare the risk benefits and cost-effectiveness of unicompartmental knee replacement with total knee replacement surgery in patients with severe systemic morbidity who would have been ineligible for TOPKAT using the validated methods from stage 1. DESIGN: This was a cohort study. SETTING: Data were obtained from the National Joint Registry database and linked to hospital inpatient (Hospital Episode Statistics) and patient-reported outcome data. PARTICIPANTS: Stage 1 - people undergoing unicompartmental knee replacement surgery or total knee replacement surgery who met the TOPKAT eligibility criteria. Stage 2 - participants with an American Society of Anesthesiologists grade of ≥ 3. INTERVENTION: The patients were exposed to either unicompartmental knee replacement surgery or total knee replacement surgery. MAIN OUTCOME MEASURES: The primary outcome measure was the postoperative Oxford Knee Score. The secondary outcome measures were 90-day postoperative complications (venous thromboembolism, myocardial infarction and prosthetic joint infection) and 5-year revision risk and mortality. The main outcome measures for the health economic analysis were health-related quality of life (EuroQol-5 Dimensions) and NHS hospital costs. RESULTS: In stage 1, propensity score stratification and inverse probability weighting replicated the results of TOPKAT. Propensity score adjustment, propensity score matching and instrumental variables did not. Stage 2 included 2256 unicompartmental knee replacement patients and 57,682 total knee replacement patients who had severe comorbidities, of whom 145 and 23,344 had linked Oxford Knee Scores, respectively. A statistically significant but clinically irrelevant difference favouring unicompartmental knee replacement was observed, with a mean postoperative Oxford Knee Score difference of < 2 points using propensity score stratification; no significant difference was observed using inverse probability weighting. Unicompartmental knee replacement more than halved the risk of venous thromboembolism [relative risk 0.33 (95% confidence interval 0.15 to 0.74) using propensity score stratification; relative risk 0.39 (95% confidence interval 0.16 to 0.96) using inverse probability weighting]. Unicompartmental knee replacement was not associated with myocardial infarction or prosthetic joint infection using either method. In the long term, unicompartmental knee replacement had double the revision risk of total knee replacement [hazard ratio 2.70 (95% confidence interval 2.15 to 3.38) using propensity score stratification; hazard ratio 2.60 (95% confidence interval 1.94 to 3.47) using inverse probability weighting], but half of the mortality [hazard ratio 0.52 (95% confidence interval 0.36 to 0.74) using propensity score stratification; insignificant effect using inverse probability weighting]. Unicompartmental knee replacement had lower costs and higher quality-adjusted life-year gains than total knee replacement for stage 2 participants. LIMITATIONS: Although some propensity score methods successfully replicated TOPKAT, unresolved confounding may have affected stage 2. Missing Oxford Knee Scores may have led to information bias. CONCLUSIONS: Propensity score stratification and inverse probability weighting successfully replicated TOPKAT, implying that some (but not all) propensity score methods can be used to evaluate surgical innovations and implantable medical devices using routine NHS data. Unicompartmental knee replacement was safer and more cost-effective than total knee replacement for patients with severe comorbidity and should be considered the first option for suitable patients. FUTURE WORK: Further research is required to understand the performance of propensity score methods for evaluating surgical innovations and implantable devices. TRIAL REGISTRATION: This trial is registered as EUPAS17435. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 25, No. 66. See the NIHR Journals Library website for further project information.


Assuntos
Artroplastia do Joelho , Estudos de Coortes , Análise Custo-Benefício , Humanos , Pontuação de Propensão , Qualidade de Vida , Anos de Vida Ajustados por Qualidade de Vida
4.
Health Technol Assess ; 25(53): 1-52, 2021 09.
Artigo em Inglês | MEDLINE | ID: mdl-34505829

RESUMO

BACKGROUND: The use of placebo comparisons for randomised trials assessing the efficacy of surgical interventions is increasingly being considered. However, a placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. OBJECTIVES: To provide a summary of knowledge on placebo controls in surgical trials and to summarise any recommendations for designers, evaluators and funders of placebo-controlled surgical trials. DESIGN: To carry out a state-of-the-art workshop and produce a corresponding report involving key stakeholders throughout. SETTING: A workshop to discuss and summarise the existing knowledge and to develop the new guidelines. RESULTS: To assess what a placebo control entails and to assess the understanding of this tool in the context of surgery is considered, along with when placebo controls in surgery are acceptable (and when they are desirable). We have considered ethics arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be carried out and interpreted. The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with a high risk of bias, particularly because of the placebo effect. CONCLUSIONS: The use of placebo controls is justified in randomised controlled trials of surgical interventions provided that there is a strong scientific and ethics rationale. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. An outline for best practice was produced in the form of the Applying Surgical Placebo in Randomised Evaluations (ASPIRE) guidelines for those considering the use of a placebo control in a surgical randomised controlled trial. LIMITATIONS: Although the workshop participants involved international members, the majority of participants were from the UK. Therefore, although every attempt was made to make the recommendations applicable to all health systems, the guidelines may, unconsciously, be particularly applicable to clinical practice in the UK NHS. FUTURE WORK: Future work should evaluate the use of the ASPIRE guidelines in making decisions about the use of a placebo-controlled surgical trial. In addition, further work is required on the appropriate nomenclature to adopt in this space. FUNDING: Funded by the Medical Research Council UK and the National Institute for Health Research as part of the Medical Research Council-National Institute for Health Research Methodology Research programme.


Assuntos
Efeito Placebo , Humanos , Projetos de Pesquisa
5.
Pain ; 2021 Aug 02.
Artigo em Inglês | MEDLINE | ID: mdl-34382608

RESUMO

ABSTRACT: The number of placebo surgical trials on musculoskeletal conditions is increasing, but little is known about the quality of their design and methods. This review aimed to (1) assess the level of placebo fidelity (ie, degree to which the placebo control mimicked the index procedure) in placebo trials of musculoskeletal surgery, (2) describe the trials' methodological features using the adapted Applying Surgical Placebo in Randomised Evaluations (ASPIRE) checklist, and (3) describe each trial's characteristics. We searched 4 electronic databases from inception until February 18, 2021, for randomised trials of surgery that included a placebo control for any musculoskeletal condition. Protocols and full text were used to assess placebo fidelity (categorised as minimal, low, or high fidelity). The adapted 26-item ASPIRE checklist was also completed on each trial. PROSPERO registration number: CRD42021202131. A total of 30,697 studies were identified in the search, and 22 placebo-controlled surgical trials of 2045 patients included. Thirteen trials (59%) included a high-fidelity placebo control, 7 (32%) used low fidelity, and 2 (9%) minimal fidelity. According to the ASPIRE checklist, included trials had good reporting of the "rationale and ethics" (68% overall) and "design" sections (42%), but few provided enough information on the "conduct" (13%) and "interpretation and translation" (11%) of the placebo trials. Most trials sufficiently reported their rationale and ethics, but interpretation and translation are areas for improvement, including greater stakeholder involvement. Most trials used a high-fidelity placebo procedure suggesting an emphasis on blinding and controlling for nonspecific effects.

6.
Phys Ther ; 101(11)2021 Nov 01.
Artigo em Inglês | MEDLINE | ID: mdl-34331766

RESUMO

Physical therapy is routinely delivered to patients after discharge from the hospital following knee arthroplasty. Posthospitalization physical therapy is thought to be beneficial, particularly for those patients most at risk of poor outcome, the subgroup with persistent function-limiting pain, despite an apparently successful surgery. Research teams have undertaken 3 large-scale multicenter Phase 3 randomized clinical trials designed specifically for patients at risk of poor outcome following knee arthroplasty. All 3 trials screened for poor outcome risk using different methods and investigated different physical therapist interventions delivered in different ways. Despite the variety of types of physical therapy and mode of delivery, all trials found no effects of the enhanced treatment compared with usual care. In all cases, usual care required a lower dosage of physical therapy compared with the enhanced interventions. This Perspective compares and contrasts the 3 trials, speculates on factors that could explain the no-effect findings, and proposes areas for future study designed to benefit the poor outcome phenotype.

7.
Bone Joint J ; 103-B(4): 627-634, 2021 Apr.
Artigo em Inglês | MEDLINE | ID: mdl-33789485

RESUMO

AIMS: To estimate the measurement properties for the Oxford Knee Score (OKS) in patients undergoing revision knee arthroplasty (responsiveness, minimal detectable change (MDC-90), minimal important change (MIC), minimal important difference (MID), internal consistency, construct validity, and interpretability). METHODS: Secondary data analysis was performed for 10,727 patients undergoing revision knee arthroplasty between 2013 to 2019 using a UK national patient-reported outcome measure (PROM) dataset. Outcome data were collected before revision and at six months postoperatively, using the OKS and EuroQol five-dimension score (EQ-5D). Measurement properties were assessed according to COnsensus-based Standards for the selection of health status Measurement Instruments (COSMIN) guidelines. RESULTS: A total of 9,219 patients had complete outcome data. Mean preoperative OKS was 16.7 points (SD 8.1), mean postoperative OKS 29.1 (SD 11.4), and mean change in OKS + 12.5 (SD 10.7). Median preoperative EQ-5D index was 0.260 (interquartile range (IQR) 0.055 to 0.691), median postoperative EQ-5D index 0.691 (IQR 0.516 to 0.796), and median change in EQ-5D index + 0.240 (IQR 0.000 to 0.567). Internal consistency was good with Cronbach's α 0.88 (baseline) and 0.94 (post-revision). Construct validity found a high correlation of OKS total score with EQ-5D index (r = 0.76 (baseline), r = 0.83 (post-revision), p < 0.001). The OKS was responsive with standardized effect size (SES) 1.54 (95% confidence interval (CI) 1.51 to 1.57), compared to SES 0.83 (0.81 to 0.86) for the EQ-5D index. The MIC for the OKS was 7.5 points (95% CI 5.5 to 8.5) based on the optimal cut-off with specificity 0.72, sensitivity 0.60, and area under the curve 0.66. The MID for the OKS was 5.2 points. The MDC-90 was 3.9 points. The OKS did not demonstrate significant floor or ceiling effects. CONCLUSION: This study found that the OKS was a useful and valid instrument for assessment of outcome following revision knee arthroplasty. The OKS was responsive to change and demonstrated good measurement properties. Cite this article: Bone Joint J 2021;103-B(4):627-634.


Assuntos
Artroplastia do Joelho , Osteoartrite do Joelho/cirurgia , Medidas de Resultados Relatados pelo Paciente , Reoperação , Idoso , Feminino , Humanos , Masculino , Qualidade de Vida , Reino Unido
8.
J Arthroplasty ; 36(8): 2887-2895.e7, 2021 08.
Artigo em Inglês | MEDLINE | ID: mdl-33840536

RESUMO

BACKGROUND: The aim of the study was to investigate changes in patient-reported outcome measures (PROMs) after revision total knee arthroplasty (rTKA). METHODS: A total of 10,727 patients undergoing elective rTKA were recruited from the UK National Health Service PROMs data set from 2013 to 2019. PROMs were collected at baseline and six months to assess joint function (Oxford Knee Score, OKS) and quality of life (EQ-5D). Associations with a change in the OKS (COKS) were investigated through multiple linear regression. RESULTS: The mean COKS was 12.4 (standard deviation 10.7) points. A total of 6776 of 10,329 (65.6%) patients demonstrated increase in the OKS above the minimal important change of 7.5 points. The median change in the EQ-5D utility was 0.227 (interquartile range 0.000 to 0.554). A total of 4917 of 9279 (53.0%) patients achieved a composite endpoint of improvement greater than the minimal important change for joint function and 'better' QoL as per the Paretian analysis. A total of 7477 of 10,727 (69.7%) patients reported satisfaction with rTKA. A total of 7947 of 10,727 (74.1%) patients felt surgery was a success. A total of 4888 of 10,632 (46.0%) patients reported one or more adverse events. A higher preoperative OKS was associated with a lower COKS (coefficient -0.63 [95% confidence interval -0.67 to -0.60]). Other factors associated with a lower COKS were postoperative complication(s), age under 60 years, longer duration of knee problems, patients who identified as disabled, problems in EQ-5D dimensions of anxiety/depression and self-care, comorbid conditions (circulatory problems, diabetes, and depression), and earlier year of procedure in the data set. CONCLUSION: Two-thirds of patients experienced a meaningful improvement in joint function after rTKA. However, there was a high frequency of patient-reported complications. These findings may enable better informed discussion of the risks and benefits of discretionary rTKA.


Assuntos
Artroplastia do Joelho , Qualidade de Vida , Artroplastia do Joelho/efeitos adversos , Humanos , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Satisfação Pessoal , Medicina Estatal
9.
Health Technol Assess ; 24(65): 1-116, 2020 11.
Artigo em Inglês | MEDLINE | ID: mdl-33250068

RESUMO

BACKGROUND: Over 100,000 primary knee arthroplasty operations are undertaken annually in the UK. Around 15-30% of patients do not report a good outcome. Better rehabilitation strategies may improve patient-reported outcomes. OBJECTIVES: To compare the outcomes from a traditional outpatient physiotherapy model with those from a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty. DESIGN: An individually randomised, two-arm controlled trial with a blinded outcome assessment, a parallel health economic evaluation and a nested qualitative study. SETTING: The trial took place in 14 NHS physiotherapy departments. PARTICIPANTS: People identified as being at high risk of a poor outcome after knee arthroplasty. INTERVENTIONS: A multicomponent home-based rehabilitation package delivered by rehabilitation assistants with supervision from qualified therapists compared with usual-care outpatient physiotherapy. MAIN OUTCOME MEASURES: The primary outcome was the Late Life Function and Disability Instrument at 12 months. Secondary outcomes were the Oxford Knee Score (a disease-specific measure of function); Knee injury and Osteoarthritis Outcome Score; Quality of Life subscale; Physical Activity Scale for the Elderly; EuroQol-5 Dimensions, five-level version; and physical function assessed using the Figure-of-8 Walk Test, 30-Second Chair Stand Test and Single Leg Stance. Data on the use of health-care services, time off work and informal care were collected using participant diaries. RESULTS: In total, 621 participants were randomised. A total of 309 participants were assigned to the COmmunity based Rehabilitation after Knee Arthroplasty (CORKA) home-based rehabilitation programme, receiving a median of five treatment sessions (interquartile range 4-7 sessions). A total of 312 participants were assigned to usual care, receiving a median of four sessions (interquartile range 2-6 sessions). The primary outcome, Late Life Function and Disability Instrument function total score at 12 months, was collected for 279 participants (89%) in the home-based CORKA group and 287 participants (92%) in the usual-care group. No clinically or statistically significant difference was found between the groups (intention-to-treat adjusted difference 0.49 points, 95% confidence interval -0.89 to 1.88 points; p = 0.48). There were no statistically significant differences between the groups in any of the patient-reported or physical secondary outcome measures at 6 or 12 months post randomisation. The health economic analysis found that the CORKA intervention was cheaper to provide than usual care (£66 less per participant). Total societal costs (combining health-care costs and other costs) were lower for the CORKA intervention than usual care (£316 less per participant). Adopting a societal perspective, CORKA had a 75% probability of being cost-effective at a threshold of £30,000 per quality-adjusted life-year. Adopting the narrower health and social care perspective, CORKA had a 43% probability of being cost-effective at the same threshold. LIMITATIONS: The interventions were of short duration and were set within current commissioning guidance for UK physiotherapy. Participants and treating therapists could not be blinded. CONCLUSIONS: This randomised controlled trial found no important differences in outcomes when post-arthroplasty rehabilitation was delivered using a home-based, rehabilitation assistant-delivered rehabilitation package or a traditional outpatient model. However, the health economic evaluation found that when adopting a societal perspective, the CORKA home-based intervention was cost-saving and more effective than, and thus dominant over, usual care, owing to reduced time away from paid employment for this group. Further research could look at identifying the risk of poor outcome and further evaluation of a cost-effective treatment, including the workforce model to deliver it. TRIAL REGISTRATION: Current Controlled Trials ISRCTN13517704. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 65. See the NIHR Journals Library website for further project information.


Assuntos
Artroplastia do Joelho/reabilitação , Análise Custo-Benefício/economia , Serviços de Assistência Domiciliar/economia , Pacientes Ambulatoriais/estatística & dados numéricos , Medidas de Resultados Relatados pelo Paciente , Idoso , Artroplastia do Joelho/economia , Feminino , Humanos , Masculino , Modalidades de Fisioterapia , Inquéritos e Questionários , Reino Unido
10.
BMJ ; 371: m3576, 2020 10 13.
Artigo em Inglês | MEDLINE | ID: mdl-33051212

RESUMO

OBJECTIVE: To evaluate whether a progressive course of outpatient physiotherapy offers superior outcomes to a single physiotherapy review and home exercise based intervention when targeted at patients with a predicted poor outcome after total knee arthroplasty. DESIGN: Parallel group randomised controlled trial. SETTING: 13 secondary and tertiary care centres in the UK providing postoperative physiotherapy. PARTICIPANTS: 334 participants with knee osteoarthritis who were defined as at risk of a poor outcome after total knee arthroplasty, based on the Oxford knee score, at six weeks postoperatively. 163 were allocated to therapist led outpatient rehabilitation and 171 to a home exercise based protocol. INTERVENTIONS: All participants were reviewed by a physiotherapist and commenced 18 sessions of rehabilitation over six weeks, either as therapist led outpatient rehabilitation (progressive goal oriented functional rehabilitation protocol, modified weekly in one-one contact sessions) or as physiotherapy review followed by a home exercise based regimen (without progressive input from a physiotherapist). MAIN OUTCOME MEASURES: Primary outcome was Oxford knee score at 52 weeks, with a 4 point difference between groups considered to be clinically meaningful. Secondary outcomes included additional patient reported outcome measures of pain and function at 14, 26, and 52 weeks post-surgery. RESULTS: 334 patients were randomised. Eight were lost to follow-up. Intervention compliance was more than 85%. The between group difference in Oxford knee score at 52 weeks was 1.91 (95% confidence interval -0.18 to 3.99) points, favouring the outpatient rehabilitation arm (P=0.07). When all time point data were analysed, the between group difference in Oxford knee score was a non-clinically meaningful 2.25 points (0.61 to 3.90, P=0.01). No between group differences were found for secondary outcomes of average pain (0.25 points, -0.78 to 0.28, P=0.36) or worst pain (0.22 points, -0.71 to 0.41, P=0.50) at 52 weeks or earlier time points, or of satisfaction with outcome (odds ratio 1.07, 95% confidence interval 0.71 to 1.62, P=0.75) or post-intervention function (4.64 seconds, 95% confidence interval -14.25 to 4.96, P=0.34). CONCLUSIONS: Outpatient therapist led rehabilitation was not superior to a single physiotherapist review and home exercise based regimen in patients at risk of poor outcomes after total knee arthroplasty. No clinically relevant differences were observed across primary or secondary outcome measures. TRIALS REGISTRATION: Current Controlled Trials ISRCTN23357609 and ClinicalTrials.gov NCT01849445.


Assuntos
Artroplastia do Joelho/reabilitação , Terapia por Exercício/métodos , Osteoartrite do Joelho/reabilitação , Dor Pós-Operatória/reabilitação , Modalidades de Fisioterapia , Idoso , Artroplastia do Joelho/efeitos adversos , Protocolos Clínicos , Feminino , Humanos , Articulação do Joelho/patologia , Articulação do Joelho/cirurgia , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/cirurgia , Medição da Dor , Dor Pós-Operatória/etiologia , Cooperação do Paciente , Medidas de Resultados Relatados pelo Paciente , Resultado do Tratamento
11.
Bone Joint J ; 102-B(7): 941-949, 2020 Jul.
Artigo em Inglês | MEDLINE | ID: mdl-32600142

RESUMO

AIMS: To calculate how the likelihood of obtaining measurable benefit from hip or knee arthroplasty varies with preoperative patient-reported scores. METHODS: Existing UK data from 222,933 knee and 209,760 hip arthroplasty patients were used to model an individual's probability of gaining meaningful improvement after surgery based on their preoperative Oxford Knee or Hip Score (OKS/OHS). A clinically meaningful improvement after arthroplasty was defined as ≥ 8 point improvement in OHS, and ≥ 7 in OKS. RESULTS: The upper preoperative score threshold, above which patients are unlikely to achieve any meaningful improvement from surgery, is 41 for knees and 40 for hips. At lower scores, the probability of improvement increased towards a maximum of 88% (knee) and 95% for (hips). CONCLUSION: By our definition of meaningful improvement, patients with preoperative scores above 41 (OKS) and 40 (OHS) should not be routinely referred to secondary care for possible arthroplasty. Using lower thresholds would incrementally increase the probability of meaningful benefit for those referred but will exclude some patients with potential to benefit. The findings are useful to support the complex shared decision-making process in primary care for referral to secondary care; and in secondary care for experienced clinicians counselling patients considering knee or hip arthroplasty, but should not be used in isolation. Cite this article: Bone Joint J 2020;102-B(7):941-949.


Assuntos
Artroplastia de Quadril , Artroplastia do Joelho , Osteoartrite do Quadril/cirurgia , Osteoartrite do Joelho/cirurgia , Medidas de Resultados Relatados pelo Paciente , Anos de Vida Ajustados por Qualidade de Vida , Encaminhamento e Consulta , Idoso , Avaliação da Deficiência , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Probabilidade , Reino Unido
13.
J Arthroplasty ; 35(9): 2640-2645.e2, 2020 09.
Artigo em Inglês | MEDLINE | ID: mdl-32475786

RESUMO

AIM: To determine the association between manipulation under anesthetic (MUA) after primary knee arthroplasty and subsequent revision surgery. METHODS: Patients undergoing primary knee arthroplasty from April 2011 to April 2016 with minimum 1-year follow-up to April 2017 were identified from the national hospital episode statistics for England. The first arthroplasty per patient, per side, was included; cases with a record of subsequent infection or periprosthetic fracture were excluded. Patients undergoing MUA within 1 year to the same knee were identified, defining the populations for the MUA and non-MUA cohorts. Mortality-adjusted Kaplan-Meier survival analysis (revision arthroplasty) was performed to a maximum of 6 years. A Cox proportional hazards model was used to determine the hazard for revision, adjusting for type of primary arthroplasty, gender, age group, year, comorbidity index, obesity, regional deprivation, rurality, and ethnicity. RESULTS: A total of 309,650 primary arthroplasty cases (309,650 patients) were included. MUA within 1 year was recorded in 6882 patients (2.22%; 95% confidence interval [95% CI], 2.17-2.28) defining the MUA cohort; all others were included in the parallel non-MUA cohort. At 6 years, the mortality-adjusted estimated implant survival rate in the MUA cohort was 91.2% (95% CI, 90.0-92.2) in comparison to 98.1% (95% CI, 98.0-98.2) in the non-MUA cohort. In the fully adjusted model, this corresponded to an adjusted hazard for revision of 5.03 (hazard ratio; 95% CI, 4.55-5.57). CONCLUSION: Patients who underwent MUA within 1 year of primary arthroplasty were at a 5-fold increased risk of subsequent revision even after excluding cases of infection or fracture. Further investigation of the etiology of stiffness after primary knee arthroplasty and the optimal treatment options to improve outcomes is justified.


Assuntos
Anestésicos , Artroplastia do Joelho , Artroplastia do Joelho/efeitos adversos , Inglaterra , Humanos , Amplitude de Movimento Articular , Reoperação , Resultado do Tratamento
14.
Health Technol Assess ; 24(20): 1-98, 2020 04.
Artigo em Inglês | MEDLINE | ID: mdl-32369436

RESUMO

BACKGROUND: Late-stage medial compartment knee osteoarthritis can be treated using total knee replacement or partial (unicompartmental) knee replacement. There is high variation in treatment choice and insufficient evidence to guide selection. OBJECTIVE: To assess the clinical effectiveness and cost-effectiveness of partial knee replacement compared with total knee replacement in patients with medial compartment knee osteoarthritis. The findings are intended to guide surgical decision-making for patients, surgeons and health-care providers. DESIGN: This was a randomised, multicentre, pragmatic comparative effectiveness trial that included an expertise component. The target sample size was 500 patients. A web-based randomisation system was used to allocate treatments. SETTING: Twenty-seven NHS hospitals (68 surgeons). PARTICIPANTS: Patients with medial compartment knee osteoarthritis. INTERVENTIONS: The trial compared the overall management strategy of partial knee replacement treatment with total knee replacement treatment. No specified brand or subtype of implant was investigated. MAIN OUTCOME MEASURES: The Oxford Knee Score at 5 years was the primary end point. Secondary outcomes included activity scores, global health measures, transition items, patient satisfaction (Lund Score) and complications (including reoperation, revision and composite 'failure' - defined by minimal Oxford Knee Score improvement and/or reoperation). Cost-effectiveness was also assessed. RESULTS: A total of 528 patients were randomised (partial knee replacement, n = 264; total knee replacement, n = 264). The follow-up primary outcome response rate at 5 years was 88% and both operations had good outcomes. There was no significant difference between groups in mean Oxford Knee Score at 5 years (difference 1.04, 95% confidence interval -0.42 to 2.50). An area under the curve analysis of the Oxford Knee Score at 5 years showed benefit in favour of partial knee replacement over total knee replacement, but the difference was within the minimal clinically important difference [mean 36.6 (standard deviation 8.3) (n = 233), mean 35.1 (standard deviation 9.1) (n = 231), respectively]. Secondary outcome measures showed consistent patterns of benefit in the direction of partial knee replacement compared with total knee replacement although most differences were small and non-significant. Patient-reported improvement (transition) and reflection (would you have the operation again?) showed statistically significant superiority for partial knee replacement only, but both of these variables could be influenced by the lack of blinding. The frequency of reoperation (including revision) by treatment received was similar for both groups: 22 out of 245 for partial knee replacement and 28 out of 269 for total knee replacement patients. Revision rates at 5 years were 10 out of 245 for partial knee replacement and 8 out of 269 for total knee replacement. There were 28 'failures' of partial knee replacement and 38 'failures' of total knee replacement (as defined by composite outcome). Beyond 1 year, partial knee replacement was cost-effective compared with total knee replacement, being associated with greater health benefits (measured using quality-adjusted life-years) and lower health-care costs, reflecting lower costs of the index surgery and subsequent health-care use. LIMITATIONS: It was not possible to blind patients in this study and there was some non-compliance with the allocated treatment interventions. Surgeons providing partial knee replacement were relatively experienced with the procedure. CONCLUSIONS: Both total knee replacement and partial knee replacement are effective, offer similar clinical outcomes and have similar reoperation and complication rates. Some patient-reported measures of treatment approval were significantly higher for partial knee replacement than for total knee replacement. Partial knee replacement was more cost-effective (more effective and cost saving) than total knee replacement at 5 years. FUTURE WORK: Further (10-year) follow-up is in progress to assess the longer-term stability of these findings. TRIAL REGISTRATION: Current Controlled Trials ISRCTN03013488 and ClinicalTrials.gov NCT01352247. FUNDING: This project was funded by the National Institute for Health Research (NIHR) Health Technology Assessment programme and will be published in full in Health Technology Assessment; Vol. 24, No. 20. See the NIHR Journals Library website for further project information.


Assuntos
Artroplastia do Joelho/economia , Protocolos Clínicos , Análise Custo-Benefício/estatística & dados numéricos , Osteoartrite do Joelho/cirurgia , Resultado do Tratamento , Idoso , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Anos de Vida Ajustados por Qualidade de Vida , Reoperação/estatística & dados numéricos , Inquéritos e Questionários , Reino Unido
15.
BMJ Open ; 10(4): e030609, 2020 04 16.
Artigo em Inglês | MEDLINE | ID: mdl-32303510

RESUMO

OBJECTIVE: The purpose of this study was to analyse the rate of knee arthroplasty in the population of patients with a history of arthroscopic chondroplasty of the knee, in England, over 10 years, with comparison to general population data for patients without a history of chondroplasty. DESIGN: Retrospective cohort study. SETTING: English Hospital Episode Statistics (HES) data. PARTICIPANTS AND INTERVENTIONS: Patients undergoing arthroscopic chondroplasty in England between 2007/2008 and 2016/2017 were identified. Patients undergoing previous arthroscopic knee surgery or simultaneous cruciate ligament reconstruction or microfracture in the same knee were excluded. OUTCOMES: Patients subsequently undergoing a knee arthroplasty in the same knee were identified and mortality-adjusted survival analysis was performed (survival without undergoing knee arthroplasty). A Cox proportional hazards model was used to identify factors associated with knee arthroplasty. Relative risk of knee arthroplasty (total or partial) in comparison to the general population was determined. RESULTS: Through 2007 to 2017, 157 730 eligible chondroplasty patients were identified. Within 1 year, 5.91% (7984/135 197; 95% CI 5.78 to 6.03) underwent knee arthroplasty and 14.22% (8145/57 267; 95% CI 13.94 to 14.51) within 5 years. Patients aged over 30 years with a history of chondroplasty were 17.32 times (risk ratio; 95% CI 16.81 to 17.84) more likely to undergo arthroplasty than the general population without a history of chondroplasty. CONCLUSIONS: Patients with cartilage lesions of the knee, treated with arthroscopic chondroplasty, are at greater risk of subsequent knee arthroplasty than the general population and for a proportion of patients, there is insufficient benefit to prevent the need for knee arthroplasty within 1 to 5 years. These important new data will inform patients of the anticipated outcomes following this procedure. The risk in comparison to non-operative treatment remains unknown and there is an urgent need for a randomised clinical trial in this population.


Assuntos
Artroplastia/estatística & dados numéricos , Artroscopia/estatística & dados numéricos , Cartilagem/cirurgia , Articulação do Joelho/cirurgia , Adulto , Fatores Etários , Idoso , Idoso de 80 Anos ou mais , Inglaterra , Feminino , Humanos , Estimativa de Kaplan-Meier , Masculino , Pessoa de Meia-Idade , Modelos de Riscos Proporcionais , Estudos Retrospectivos , Risco , Fatores Sexuais , Fatores de Tempo , Adulto Jovem
16.
Lancet ; 395(10226): 828-838, 2020 03 07.
Artigo em Inglês | MEDLINE | ID: mdl-32145797

RESUMO

Placebo comparisons are increasingly being considered for randomised trials assessing the efficacy of surgical interventions. The aim of this Review is to provide a summary of knowledge on placebo controls in surgical trials. A placebo control is a complex type of comparison group in the surgical setting and, although powerful, presents many challenges. This Review outlines what a placebo control entails and present understanding of this tool in the context of surgery. We consider when placebo controls in surgery are acceptable (and when they are desirable) in terms of ethical arguments and regulatory requirements, how a placebo control should be designed, how to identify and mitigate risk for participants in these trials, and how such trials should be done and interpreted. Use of placebo controls is justified in randomised controlled trials of surgical interventions provided there is a strong scientific and ethical rationale. Surgical placebos might be most appropriate when there is poor evidence for the efficacy of the procedure and a justified concern that results of a trial would be associated with high risk of bias, particularly because of the placebo effect. Feasibility work is recommended to optimise the design and implementation of randomised controlled trials. This Review forms an outline for best practice and provides guidance, in the form of the Applying Surgical Placebo in Randomised Evaluations (known as ASPIRE) checklist, for those considering the use of a placebo control in a surgical randomised controlled trial.


Assuntos
Placebos , Ensaios Clínicos Controlados Aleatórios como Assunto , Procedimentos Cirúrgicos Operatórios , Guias como Assunto , Humanos , Ensaios Clínicos Controlados Aleatórios como Assunto/ética , Ensaios Clínicos Controlados Aleatórios como Assunto/normas , Projetos de Pesquisa
17.
Knee Surg Sports Traumatol Arthrosc ; 28(10): 3279-3286, 2020 Oct.
Artigo em Inglês | MEDLINE | ID: mdl-31965215

RESUMO

PURPOSE: Lower limb malalignment is a strong predictor of progression in knee osteoarthritis. The purpose of this study is to identify the individual alignment variables that predict progression in early to moderate osteoarthritis of the knee. METHOD: A longitudinal cohort study using data from the Osteoarthritis Initiative. In total, 955 individuals (1329 knees) with early to moderate osteoarthritis (Kellgren-Lawrence grade 1, 2 or 3) were identified. All subjects had full-limb radiographs analysed using the Osteotomy module within Medicad® Classic (Hectec GMBH) to give a series of individual alignment variables relevant to the coronal alignment of the lower limb. Logistic regression models, with generalised estimating equations were used to identify which of these individual alignment variables predict symptom worsening (WOMAC score > 9 points) and or structural progression (joint space narrowing progression in the medial compartment > 0.7mm) over 24 months. RESULTS: Individual alignment variable were associated with both valgus and varus alignment (mechanical Lateral Distal Femoral Angle, Medial Proximal Tibial Angle and mechanical Lateral Distal Tibial Angle). Only the Medial Proximal Tibial Angle was significantly associated with structural progression and none of the variables was associated with symptom progression. The odds of joint space narrowing progression in the medial compartment occurring at 24 months increased by 21% for every one degree decrease (more varus) in Medial Proximal Tibial Angle (p < 0.001) CONCLUSIONS: Our results suggest that the risk of structural progression in the medial compartment is associated with greater varus alignment of the proximal tibia. LEVEL OF EVIDENCE: Level III, retrospective cohort study.


Assuntos
Extremidade Inferior/fisiopatologia , Osteoartrite do Joelho/fisiopatologia , Tíbia/fisiopatologia , Idoso , Progressão da Doença , Feminino , Fêmur/fisiopatologia , Humanos , Articulação do Joelho/fisiopatologia , Articulação do Joelho/cirurgia , Estudos Longitudinais , Extremidade Inferior/diagnóstico por imagem , Masculino , Pessoa de Meia-Idade , Osteoartrite do Joelho/diagnóstico por imagem , Osteoartrite do Joelho/cirurgia , Osteotomia , Radiografia , Estudos Retrospectivos , Tíbia/diagnóstico por imagem , Tíbia/cirurgia
18.
Lancet Infect Dis ; 20(3): 341-349, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31862240

RESUMO

BACKGROUND: The short-term and long-term consequences of septic arthritis are uncertain. We aimed to determine risk of mortality and adverse joint outcomes following septic arthritis of the native knee. METHODS: We did a retrospective cohort study in patients who received arthroscopic knee washout for septic arthritis in England between April 1, 1997, and March 31, 2017, using data in the national Hospital Episode Statistics database. Patients with previous knee surgery to the same knee were excluded. Mortality within 90 days, adverse joint outcomes (arthrodesis, amputation, arthroplasty) within 1 year, and arthroplasty within 15 years were determined. Mortality in patients with a primary admitting diagnosis of septic arthritis (ICD-10) was compared with that in patients in whom septic arthritis was a secondary diagnosis. FINDINGS: 12 132 patients were included (mean age 56·6 years [SD 24·9]) of whom 4307 (36%) were female. In 10 195 (84%) patients with septic arthritis as the primary admitting diagnosis, 90-day mortality was 7·05% (95% CI 6·56-7·57; 719 patients), rising to 22·69% (20·80-24·68; 418 patients) in 1842 patients older than 79 years. Secondary septic arthritis diagnosis versus primary diagnosis was associated with an adjusted odds ratio for mortality of 2·10 (95% CI 1·79-2·46; p<0·0001). In 11 393 patients with at least 1 year follow-up, the 1 year rates were 0·13% (95% CI 0·07-0·22; 15 patients) for arthrodesis, 0·40% (0·30-0·54; 46 patients) for amputation, and 1·33%; (1·13-1·56; 152 patients) for arthroplasty. Within 15 years, 159 (8·76%; 95% CI 7·50-10·15) of 1816 patients had received arthroplasty, corresponding to an annual risk of arthroplasty that was about six times that of the general population (risk ratio 6·14, 95% CI 4·95-7·62; p<0·0001). INTERPRETATION: The consequences of septic knee arthritis in patients undergoing arthroscopic knee washout are serious. These findings highlight the potentially devastating outcomes associated with sepsis from musculoskeletal joint infection. FUNDING: National Institute for Health Research.


Assuntos
Artrite Infecciosa/mortalidade , Artrite Infecciosa/cirurgia , Artroscopia/métodos , Articulação do Joelho/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Inglaterra/epidemiologia , Feminino , Hospitais , Humanos , Estudos Longitudinais , Masculino , Pessoa de Meia-Idade , Estudos Retrospectivos , Medição de Risco , Análise de Sobrevida , Resultado do Tratamento , Adulto Jovem
19.
Br J Sports Med ; 54(5): 286-291, 2020 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30661013

RESUMO

OBJECTIVES: We investigated the temporal trend and the geographical variation in the rate of an anterior cruciate ligament (ACL) reconstruction and meniscal repair (MR) performed in England during a 20-year window. METHODS: All hospital episodes for patients undergoing ACL reconstruction or MR between 1 April 1997 and 31 March 2017 were extracted by procedure code from the national hospital episode statistics. Age-standardised and sex-standardised rates of surgery were calculated using Office for National Statistics population data as the denominator and analysed over time both nationally and regionally by National Health Service clinical commissioning group (CCG). RESULTS: Between 1997-1998 and 2016-2017, there were 133 270 cases of ACL reconstruction (124 489 patients) and 42 651 cases of MR (41 120 patients) (isolated or simultaneous). Nationally, the rate of ACL reconstruction increased 12-fold from 2.0/100K population (95% CI 1.9 to 2.1) in 1997-1998 to 24.2/100K (95% CI 23.8 to 24.6) in 2016-2017. The rate of MR increased more than twofold from 3.0/100K (95% CI 2.8 to 3.1) in 1997-1998 to 7.3/100K (95% CI 7.1 to 7.5) in 2016-2017. Of these cases, the rate of simultaneous ACL reconstruction and MR was 2.6/100K (95% CI 2.5 to 2.8) in 2016/2017. In 2016-2017, for patients aged 20-29, the sex-standardised rate of ACL reconstruction was 76.9/100K (95% CI 74.9 to 78.9) and for MR was 19.8/100K (95% CI 18.8 to 20.9). Practice varied by region-in 2016-2017, 14.5% (30/207) of the CCGs performed more than twice the national average rate of ACL reconstruction and 15.0% (31/207) performed more than twice the national average rate of MR. CONCLUSIONS: The rate of ACL reconstruction (12-fold) and MR (2.4-fold) has increased in England over the last two decades. There is variation in these rates across geographical regions and further work is required to deliver standardised treatment guidance for appropriate use.


Assuntos
Lesões do Ligamento Cruzado Anterior/cirurgia , Reconstrução do Ligamento Cruzado Anterior/estatística & dados numéricos , Artroplastia/estatística & dados numéricos , Lesões do Menisco Tibial/cirurgia , Adulto , Inglaterra/epidemiologia , Feminino , Hospitais/estatística & dados numéricos , Humanos , Masculino , Utilização de Procedimentos e Técnicas/tendências , Adulto Jovem
20.
J Clin Epidemiol ; 119: 109-116, 2020 03.
Artigo em Inglês | MEDLINE | ID: mdl-31786153

RESUMO

OBJECTIVES: To examine key methodological considerations for using a placebo intervention in randomized controlled trials (RCTs) evaluating invasive procedures, including surgery. STUDY DESIGN AND SETTING: RCTs comparing an invasive procedure with a placebo were included in this systematic review. Articles published from database inception to December 31, 2017, were retrieved from Ovid MEDLINE, Ovid EMBASE and CENTRAL electronic databases, by handsearching references and expert knowledge. Data on trial characteristics (clinical area, nature of invasive procedure, number of patients and centers) and key methodological (rationale for using placebos, minimization of risk, information provision, offering the treatment intervention to patients randomized to placebo, delivery of cointerventions, and intervention standardization and fidelity) were extracted and summarized descriptively. RESULTS: One hundred thirteen articles reporting 96 RCTs were identified. Most were conducted in gastrointestinal surgery (n = 40, 42%) and evaluated minimally invasive procedures (n = 44, 46%). Over two-thirds randomized fewer than 100 patients (n = 65, 68%) and a third were single center (n = 31, 32%). A third (n = 33, 34%) did not report a rationale for using a placebo. Most common strategies to minimize patient risk were operator skill (n = 22, 23%) and independent data monitoring (n = 28, 29%). Provision of patient information regarding placebo use was infrequently reported (n = 11, 11%). Treatment interventions were offered to patients randomized to placebo in 43 trials (45%). Cointerventions were inconsistently reported, but 64 trials (67%) stated that anesthesia was matched between groups. Attempts to standardize interventions and monitor their delivery were reported in n = 7, (7%) and n = 4, (4%) trials, respectively. CONCLUSION: Most placebo-controlled trials in surgery evaluate minor surgical procedures and currently there is inconsistent reporting of key trial methods. There is a need for guidance to optimize the transparency of trial reporting in this area.


Assuntos
Coleta de Dados/métodos , Melhoria de Qualidade , Ensaios Clínicos Controlados Aleatórios como Assunto/métodos , Projetos de Pesquisa , Procedimentos Cirúrgicos Operatórios/métodos , Humanos , Placebos
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