RESUMEN
INTRODUCTION: Pain and disability after meniscectomy can be a substantial lifelong problem. There are few treatment options, especially for young people. Non-surgical management (rehabilitation) is an option but increasingly surgeons are performing meniscal allograft transplants (MATs) for these individuals. However, this is still an uncommon procedure, and availability and usage of MAT vary widely both in the UK and internationally. It is not known which treatment option is the most effective and cost-effective. METHODS AND ANALYSIS: The Meniscal Transplant surgery or Optimised Rehabilitation trial is an international, multicentre, randomised controlled trial. The aim is to compare the clinical and cost effectiveness of MAT versus an optimised package of individualised, progressive, rehabilitation that we have called personalised knee therapy (PKT).Participants will be recruited from sites across the UK, Australia, Canada and Belgium. The planned 144 participants provide at least 90% power to detect a 10-point difference in the Knee injury and Osteoarthritis Outcome Score (KOOS4) at 24-months post randomisation (primary outcome). A prospectively planned economic evaluation will be conducted from a healthcare system and personal social services perspective. Secondary outcome data including health utility, occupational status, sports participation, mental well-being, further treatment, and adverse events will be collected at 3, 6, 12, 18, and 24 months. Analysis will be on an intention-to-treat basis and reported in-line with the Consolidated Standards of Reporting Trials statement. ETHICS AND DISSEMINATION: The trial was approved by the London-Bloomsbury Research Ethics Committee on 19 August 2022 (22/LO/0327) and Northern Sydney Local Health District Human Research Ethics Committee, NSW, Australia on the 13 March 2023 (2022/ETH01890).Trial results will be disseminated via peer-reviewed publications, presentations at international conferences, in lay summaries and using social media as appropriate.This protocol adheres to the recommended Standard Protocol Items: Recommendations for Interventional Trials (SPIRIT) checklist. TRIAL REGISTRATION NUMBER: ISRCTN87336549.
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Ensayos Clínicos Controlados Aleatorios como Asunto , Humanos , Análisis Costo-Beneficio , Estudios Multicéntricos como Asunto , Meniscectomía , Meniscos Tibiales/cirugía , Meniscos Tibiales/trasplante , Lesiones de Menisco Tibial/cirugía , Lesiones de Menisco Tibial/terapia , Lesiones de Menisco Tibial/rehabilitaciónRESUMEN
OBJECTIVES: To evaluate whether a home-based rehabilitation programme for people assessed as being at risk of a poor outcome after knee arthroplasty offers superior outcomes to traditional outpatient physiotherapy. DESIGN: A prospective, single-blind, two-arm randomised controlled superiority trial. SETTING: 14 National Health Service physiotherapy departments in the UK. PARTICIPANTS: 621 participants identified at high risk of a poor outcome after knee arthroplasty using a bespoke screening tool. INTERVENTIONS: A multicomponent home-based rehabilitation programme delivered by rehabilitation assistants with supervision from qualified therapists versus usual care outpatient physiotherapy. MAIN OUTCOME MEASURES: The primary outcome was the Late-Life Function and Disability Instrument (LLFDI) 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, 5 dimension, 5 level version of Euroqol (EQ-5D-5L) and physical function assessed using the Figure of 8 Walk test, 30 s Chair Stand Test and Single Leg Stance. RESULTS: 621 participants were randomised between March 2015 and January 2018. 309 were assigned to CORKA (Community Rehabilitation after Knee Arthroplasty) home-based rehabilitation, receiving a median five treatment sessions (IQR 4-7). 312 were assigned to usual care, receiving a median 4 sessions (IQR 2-6). The primary outcome, LLFDI 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% CI -0.89 to 1.88; p=0.48). There were no statistically significant differences between the groups on any of the patient-reported or physical secondary outcome measures at 6 or 12 months.There were 18 participants in the intervention group reporting a serious adverse event (5.8%), only one directly related to the intervention, all other adverse events recorded throughout the trial related to underlying chronic medical conditions. CONCLUSIONS: The CORKA intervention was not superior to usual care. The trial detected no significant differences, clinical or statistical, between the two groups on either primary or secondary outcomes. CORKA offers an evaluation of an intervention utilising a different service delivery model for this patient group. TRIAL REGISTRATION NUMBER: ISRCTN13517704.
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Artroplastia de Reemplazo de Rodilla , Anciano , Análisis Costo-Beneficio , Humanos , Modalidades de Fisioterapia , Estudios Prospectivos , Calidad de Vida , Método Simple Ciego , Medicina EstatalRESUMEN
OBJECTIVE: Tourniquet use in total knee replacement (TKR) is believed to improve the bone-cement interface by reducing bleeding, potentially prolonging implant survival. This study aimed to compare the risk of revision for primary cemented TKR performed with or without a tourniquet. DESIGN: We analysed data from the National Joint Registry (NJR) for all primary cemented TKRs performed in England and Wales between April 2003 and December 2003. Kaplan-Meier plots and Cox regression were used to assess the influence of tourniquet use, age at time of surgery, sex and American Society of Anaesthesiologists (ASA) classification on risk of revision for all-causes. RESULTS: Data were available for 16 974 cases of primary cemented TKR, of which 16 132 had surgery with a tourniquet and 842 had surgery without a tourniquet. At 10 years, 3.8% had undergone revision (95% CI 2.6% to 5.5%) in the no-tourniquet group and 3.1% in the tourniquet group (95% CI 2.8% to 3.4%). After adjusting for age at primary surgery, gender and primary ASA score, the HR for all-cause revision for cemented TKR without a tourniquet was 0.82 (95% CI 0.57 to 1.18). CONCLUSIONS: We did not find evidence that using a tourniquet for primary cemented TKR offers a clinically important or statistically significant reduction in the risk of all-cause revision up to 13 years after surgery. Surgeons should consider this evidence when deciding whether to use a tourniquet for cemented TKR.
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Artroplastia de Reemplazo de Rodilla , Prótesis de la Rodilla , Artroplastia de Reemplazo de Rodilla/efectos adversos , Inglaterra , Humanos , Falla de Prótesis , Sistema de Registros , Reoperación , Torniquetes , GalesRESUMEN
INTRODUCTION: Tourniquets are routinely used during total knee replacement (TKR) surgery. They could increase the risk of thromboembolic events including cerebral emboli, cognitive decline, pain and other adverse events (AEs). A randomised controlled trial to assess whether tourniquet use might safely be avoided is therefore warranted but it is unclear whether such a trial would be feasible. METHODS: In a single-site feasibility study and pilot randomised controlled trial, adults having a TKR were randomised to surgery with an inflated tourniquet versus a non-inflated tourniquet. Participants underwent brain MRI preoperatively and within 2 days postoperatively. We assessed cognition using the Mini-Mental State Examination (MMSE), Montreal Cognitive Assessment (MoCA) and Oxford Cognitive Screen (OCS) and thigh pain using a Visual Analogue Scale at baseline and days 1 and 2, and 1 week postsurgery. AEs related to surgery were recorded up to 12 months. RESULTS: We randomised 53 participants (27 tourniquet inflated and 26 tourniquet not inflated). Fifty-one participants received care per-protocol (96%) and 48 (91%) were followed up at 12 months. One new ischaemic brain lesion was detected. Of the cognitive tests, MoCA was easy to summarise, sensitive to change with lower ceiling effects compared with OCS and MMSE. There was a trend towards more thigh pain (mean 49.6 SD 30.4 vs 36.2 SD 28 at day 1) and more AEs related to surgery (21 vs 9) in participants with an inflated tourniquet compared with those with a tourniquet not inflated. CONCLUSION: A full trial is feasible, but using MRI as a primary outcome is unlikely to be appropriate or feasible. Suitable primary outcomes would be cognition measured using MoCA, pain and AEs, all of which warrant investigation in a large multicentre trial. TRIAL REGISTRATION NUMBER: ISRCTN20873088.
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Artroplastia de Reemplazo de Rodilla , Torniquetes , Adulto , Artroplastia de Reemplazo de Rodilla/efectos adversos , Estudios de Factibilidad , Femenino , Humanos , Proyectos Piloto , Resultado del TratamientoRESUMEN
INTRODUCTION: Meniscal tears are a common knee injury with an incidence of 60 per 100 000. Management of meniscal tears can include either non-operative measures or operative procedures such as arthroscopic partial meniscectomy (APM). Despite substantial research evaluating the effectiveness of APM in the recent past, little is known about the clinical course or the experiences of patients with a meniscal tear. AIM: To summarise the short to long-term patterns of variability in outcome in patients with a meniscal tear.To summarise the evidence on patient experiences of meniscal tears. In particular, we will focus on patient experiences of treatment options, treatment pathways and their views of the outcomes used in meniscal tear research. METHODS AND ANALYSIS: Two search strategies will be developed to identify citations from EMBASE, MEDLINE, AMED, CENTRAL, Web of Science and Sociofile. The date of our planned search is 14 August 2020. For the quantitative review we will identify studies reporting patient-reported outcome measures in patients after a meniscal tear. The standardised mean change will be used to assess the variation in size of response and summarise the overall response to each treatment option. All studies will undergo quality assessment using either the Cochrane risk of bias or the Newcastle-Ottawa tool.A qualitative systematic review will be used to identify studies reporting views and experiences of patients with a meniscal tear. All studies will be assessed using the Critical Appraisal Skills Programme tool and if sufficient data are present a meta-synthesis will be performed to identify first, second and third-order constructs. ETHICS AND DISSEMINATION: Given the nature of this study, no formal ethical approval will be sought. Results from the review will be disseminated at national conferences and will be submitted to a peer-reviewed journal for publication. Lay summaries will be freely available via the study Twitter page. PROSPERO REGISTRATION NUMBER: CRD42019122179.
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Traumatismos de la Rodilla , Lesiones de Menisco Tibial , Artroscopía , Humanos , Traumatismos de la Rodilla/cirugía , Meniscectomía , Medición de Resultados Informados por el Paciente , Lesiones de Menisco Tibial/cirugíaRESUMEN
INTRODUCTION: This study is designed to explore the baseline characteristics of patients under 55 years of age with a meniscal tear, and to describe the relationship between the baseline characteristics and patient-reported outcome measures (PROMs) over 12 months. Research has highlighted the need for a trial to investigate the effectiveness of arthroscopic meniscectomy in younger patients. Before this trial, we need to understand the patient population in greater detail. METHODS AND ANALYSIS: This is a multicentre prospective cohort study. Participants aged between 18 and 55 years with an MRI confirmed meniscal tear are eligible for inclusion. Baseline characteristics including age, body mass index, gender, PROMs duration of symptoms and MRI will be collected. The primary outcome measure is the Western Ontario Meniscal Evaluation Tool at 12 months. Secondary outcome measures will include PROMs such as EQ5D, Knee Injury and Osteoarthritis Outcome Score and patient global impression of change score at 3, 6 and 12 months. ETHICS AND DISSEMINATION: The study obtained approval from the National Research Ethics Committee West Midlands-Black Country research ethics committee (19/WM/0079) on 12 April 2019. The study is sponsored by the University of Warwick. The results will be disseminated via peer-reviewed publication. TRIAL REGISTRATION NUMBER: UHCW R&D Reference: IA428119. University of Warwick Sponsor ID: SC.08/18-19.
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Traumatismos de la Rodilla , Lesiones de Menisco Tibial , Adolescente , Adulto , Humanos , Lactante , Traumatismos de la Rodilla/cirugía , Persona de Mediana Edad , Estudios Multicéntricos como Asunto , Ontario , Evaluación de Resultado en la Atención de Salud , Estudios Prospectivos , Lesiones de Menisco Tibial/diagnóstico por imagen , Lesiones de Menisco Tibial/cirugía , Adulto JovenRESUMEN
OBJECTIVES: Effects of the UK Department of Health's national Enhanced Recovery After Surgery (ERAS) Programme on outcomes after primary hip replacement. DESIGN: Natural experimental study using interrupted time series to assess the changes in trends before, during and after ERAS implementation (April 2009 to March 2011). SETTING: Surgeries in the UK National Joint Registry were linked with Hospital Episode Statistics containing inpatient episodes from National Health Service trusts in England and patient reported outcome measures. PARTICIPANTS: Patients aged ≥18 years from 2008 to 2016. MAIN OUTCOME MEASURES: Regression coefficients of monthly means of length of hospital stay, bed day cost, change in Oxford Hip Scores (OHS) 6 months post-surgery, complications 6 months post-surgery and revision rates 5 years post-surgery. RESULTS: 438 921 primary hip replacements were identified. Hospital stays shortened from 5.6 days in April 2008 to 3.6 in December 2016. There were also improvements in bed day costs (£7573 in April 2008 to £5239 in December 2016), positive change in self-reported OHS from baseline to 6 months post-surgery (17.7 points in April 2008 to 22.9 points in December 2016), complication rates (4.1% in April 2008 to 1.7% March 2016) and 5 year revision rates (5.9 per 1000 implant-years (95% CI 4.8 to 7.2) in April 2008 to 2.9 (95% CI 2.2 to 3.9) in December 2011). The positive trends in all outcomes started before ERAS was implemented and continued during and after the programme. CONCLUSIONS: Patient outcomes after hip replacement have improved over the last decade. A national ERAS programme maintained this improvement but did not alter the existing rate of change.
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Artroplastia de Reemplazo de Cadera , Recuperación Mejorada Después de la Cirugía , Análisis de Series de Tiempo Interrumpido , Medición de Resultados Informados por el Paciente , Anciano , Anciano de 80 o más Años , Estudios de Cohortes , Inglaterra , Femenino , Humanos , Masculino , Persona de Mediana Edad , Sistema de Registros , GalesRESUMEN
OBJECTIVES: We have previously developed and validated the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways, showing encouraging psychometric test results. The objective of this study was to determine the responsiveness of MSK-HQ following MSK treatments and to determine the minimally important change (MIC). SETTING: We collected data in four cohorts from community physiotherapy and secondary-care orthopaedic hip, knee and shoulder clinics. PARTICIPANTS: 592 individuals were recruited; 210 patients treated with physiotherapy for a range of MSK conditions in primary care; 150 patients undergoing hip replacement, 150 patients undergoing knee replacement and 82 undergoing shoulder surgery in secondary care. OUTCOME MEASURES: Preoperative data were collected including the MSK-HQ, European Quality of Life-5D (EQ-5D) and the OHS, OKS or OSS in each joint-specific group. The same scores, together with anchor questions, were collected postintervention at 3 months for the physiotherapy group and 6 months for all others. Following COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) guidelines, responsiveness was assessed using correlation between scores and the MIC was calculated for the entire cohort using receiver operating characteristic curve analysis. RESULTS: The MSK-HQ demonstrated strong correlation (R=0.73) with EQ-5D across the entire cohort and with each of the joint-specific Oxford scores (hip R=0.87, knee R=0.92 and shoulder R=0.77). Moderate correlation was seen between MSK-HQ and EQ-5D across each individual group (R value range 0.60-0.68), apart from the hip group where correlation was strong (R=0.77). The effect size with MSK-HQ was 0.93, in the entire cohort, double that measured with EQ-5D (0.43). In all subgroups, MSK-HQ measured a greater treatment effect compared with EQ-5D. The MIC is 5.5 (95% CI 2.7 to 8.3). CONCLUSION: Our study demonstrates that the MSK-HQ questionnaire is responsive to change across a range of musculoskeletal conditions, supporting its use as a generic MSK measurement instrument.
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Enfermedades Musculoesqueléticas/terapia , Encuestas y Cuestionarios/estadística & datos numéricos , Adulto , Anciano , Artroplastia de Reemplazo de Cadera , Artroplastia de Reemplazo de Rodilla , Femenino , Humanos , Estudios Longitudinales , Masculino , Persona de Mediana Edad , Modalidades de Fisioterapia , Periodo Posoperatorio , Periodo Preoperatorio , Curva ROC , Articulación del Hombro/cirugía , Resultado del TratamientoRESUMEN
OBJECTIVES: The aim of this study was to investigate whether ACL injury (ACLi) or meniscal injury increases the risk of end-stage osteoarthritis (OA) resulting in total knee replacement (TKR). METHODS: A matched case-control study of all TKRs performed in the UK between January 1990 and July 2011 and recorded in the Clinical Practice Research Datalink (CPRD) was undertaken. The CPRD contains longitudinal data on approximately 3.6 million patients. Two controls were selected for each case of TKR, matched on age, sex and general practitioner location as a proxy for socioeconomic status. Individuals with inflammatory arthritis were excluded. The odds of having TKR for individuals with a CPRD-recorded ACLi were compared with those without ACLi using conditional logistic regression, after adjustment for body mass index, previous knee fracture and meniscal injury. The adjusted odds of TKR in individuals with a recorded meniscal injury compared with those without were calculated. RESULTS: After exclusion of individuals with inflammatory arthritis, there were 49 723 in the case group and 104 353 controls. 153 (0.31%) cases had a history of ACLi compared with 41 (0.04%) controls. The adjusted OR of TKR after ACLi was 6.96 (95% CI 4.73 to 10.31). 4217 (8.48%) individuals in the TKR group had a recorded meniscal injury compared with 669 (0.64%) controls. The adjusted OR of TKR after meniscal injury was 15.24 (95% CI 13.88 to 16.69). CONCLUSION: This study demonstrates that ACLi is associated with a sevenfold increased odds of TKR resulting from OA. Meniscal injury is associated with a 15-fold increase odds of TKR for OA.
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Lesiones del Ligamento Cruzado Anterior/complicaciones , Artroplastia de Reemplazo de Rodilla , Osteoartritis de la Rodilla/etiología , Osteoartritis de la Rodilla/cirugía , Lesiones de Menisco Tibial/complicaciones , Anciano , Estudios de Casos y Controles , Femenino , Humanos , Masculino , Persona de Mediana Edad , Factores de RiesgoRESUMEN
OBJECTIVES: Wearable motion sensors are used with increasing frequency in the evaluation of gait, function and physical activity within orthopaedics and sports medicine. The integration of wearable technology into the clinical pathway offers the ability to improve post-operative patient assessment beyond the scope of current, questionnaire-based patient-reported outcome measures. This scoping review assesses the current methodology and clinical application of accelerometers and inertial measurement units for the evaluation of patient activity and functional recovery following knee arthroplasty. DESIGN: This is a systematically conducted scoping review following Joanna Briggs Institute methodology for scoping reviews and reported consulting the Preferred Reporting Items for Systematic Review and Meta-Analyses extension for scoping reviews. A protocol for this review is registered with the Open Science Framework (https://osf.io/rzg9q). DATA SOURCES: CINAHL, EMBASE, MEDLINE and Web of Science databases were searched for manuscripts published between 2008 and 2019. ELIGIBILITY CRITERIA: We included clinical studies reporting the use of any combination of accelerometers, pedometers or inertial measurement units for patient assessment at any time point following knee arthroplasty. DATA EXTRACTION AND SYNTHESIS: Data extracted from manuscripts included patient demographics, sensor technology, testing protocol and sensor-based outcome variables. RESULTS: 45 studies were identified, including 2076 knee arthroplasty patients, 620 patients with end-stage osteoarthritis and 449 healthy controls. Primary aims of the identified studies included functional assessment, physical activity monitoring and evaluation of knee instability. Methodology varied widely between studies, with inconsistency in reported sensor configuration, testing protocol and output variables. CONCLUSIONS: The use of wearable sensors in evaluation of knee arthroplasty procedures is becoming increasingly common and offers the potential to improve clinical understanding of recovery and rehabilitation. While current studies lack consistency, significant opportunity exists for the development of standardised measures and protocols for function and physical activity evaluation.
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Artroplastia de Reemplazo de Rodilla , Dispositivos Electrónicos Vestibles , Acelerometría , Ejercicio Físico , Marcha/fisiología , Humanos , Resultado del TratamientoRESUMEN
OBJECTIVES: To assess how costs and quality of life (measured by EuroQoL-5 Dimensions (EQ-5D)) before and after total hip replacement (THR) and total knee replacement (TKR) vary with age, gender and preoperative Oxford hip score (OHS) and Oxford knee score (OKS). DESIGN: Regression analyses using prospectively collected data from clinical trials, cohort studies and administrative data bases. SETTING: UK secondary care. PARTICIPANTS: Men and women undergoing primary THR or TKR. The Hospital Episode Statistics data linked to patient-reported outcome measures included 602 176 patients undergoing hip or knee replacement who were followed up for up to 6 years. The Knee Arthroplasty Trial included 2217 patients undergoing TKR who were followed up for 12 years. The Clinical Outcomes in Arthroplasty Study cohort included 806 patients undergoing THR and 484 patients undergoing TKR who were observed for 1 year. OUTCOME MEASURES: EQ-5D-3L quality of life before and after surgery, costs of primary arthroplasty, costs of revision arthroplasty and the costs of hospital readmissions and ambulatory costs in the year before and up to 12 years after joint replacement. RESULTS: Average postoperative utility for patients at the 5th percentile of the OHS/OKS distribution was 0.61/0.5 for THR/TKR and 0.89/0.85 for patients at the 95th percentile. The difference between postoperative and preoperative EQ-5D utility was highest for patients with preoperative OHS/OKS lower than 10. However, postoperative EQ-5D utility was higher than preoperative utility for all patients with OHS≤46 and those with OKS≤44. In contrast, costs were generally higher for patients with low preoperative OHS/OKS than those with high OHS/OKS. For example, costs of hospital readmissions within 12 months after primary THR/TKR were £740/£888 for patients at the 5th percentile compared with £314/£404 at the 95th percentile of the OHS/OKS distribution. CONCLUSIONS: Our findings suggest that costs and quality of life associated with total joint replacement vary systematically with preoperative symptoms measured by OHS/OKS.