Arthroscopic hip surgery compared with personalised hip therapy in people over 16 years old with femoroacetabular impingement syndrome: UK FASHIoN RCT.

BACKGROUND: Femoroacetabular impingement syndrome is an important cause of hip pain in young adults. It can be treated by arthroscopic hip surgery or with physiotherapist-led conservative care. OBJECTIVE: To compare the clinical effectiveness and cost-effectiveness of hip arthroscopy with best conservative care. DESIGN: The UK FASHIoN (full trial of arthroscopic surgery for hip impingement compared with non-operative care) trial was a pragmatic, multicentre, randomised controlled trial that was carried out at 23 NHS hospitals. PARTICIPANTS: Participants were included if they had femoroacetabular impingement, were aged ≥ 16 years old, had hip pain with radiographic features of cam or pincer morphology (but no osteoarthritis) and were believed to be likely to benefit from hip arthroscopy. INTERVENTION: Participants were randomly allocated (1 : 1) to receive hip arthroscopy followed by postoperative physiotherapy, or personalised hip therapy (i.e. an individualised physiotherapist-led programme of conservative care). Randomisation was stratified by impingement type and recruiting centre using a central telephone randomisation service. Outcome assessment and analysis were masked. MAIN OUTCOME MEASURE: The primary outcome was hip-related quality of life, measured by the patient-reported International Hip Outcome Tool (iHOT-33) 12 months after randomisation, and analysed by intention to treat. RESULTS: Between July 2012 and July 2016, 648 eligible patients were identified and 348 participants were recruited. In total, 171 participants were allocated to receive hip arthroscopy and 177 participants were allocated to receive personalised hip therapy. Three further patients were excluded from the trial after randomisation because they did not meet the eligibility criteria. Follow-up at the primary outcome assessment was 92% (N = 319; hip arthroscopy, n = 157; personalised hip therapy, n = 162). At 12 months, mean International Hip Outcome Tool (iHOT-33) score had improved from 39.2 (standard deviation 20.9) points to 58.8 (standard deviation 27.2) points for participants in the hip arthroscopy group, and from 35.6 (standard deviation 18.2) points to 49.7 (standard deviation 25.5) points for participants in personalised hip therapy group. In the primary analysis, the mean difference in International Hip Outcome Tool scores, adjusted for impingement type, sex, baseline International Hip Outcome Tool score and centre, was 6.8 (95% confidence interval 1.7 to 12.0) points in favour of hip arthroscopy (p = 0.0093). This estimate of treatment effect exceeded the minimum clinically important difference (6.1 points). Five (83%) of six serious adverse events in the hip arthroscopy group were related to treatment and one serious adverse event in the personalised hip therapy group was not. Thirty-eight (24%) personalised hip therapy patients chose to have hip arthroscopy between 1 and 3 years after randomisation. Nineteen (12%) hip arthroscopy patients had a revision arthroscopy. Eleven (7%) personalised hip therapy patients and three (2%) hip arthroscopy patients had a hip replacement within 3 years. LIMITATIONS: Study participants and treating clinicians were not blinded to the intervention arm. Delays were encountered in participants accessing treatment, particularly surgery. Follow-up lasted for 3 years. CONCLUSION: Hip arthroscopy and personalised hip therapy both improved hip-related quality of life for patients with femoroacetabular impingement syndrome. Hip arthroscopy led to a greater improvement in quality of life than personalised hip therapy, and this difference was clinically significant at 12 months. This study does not demonstrate cost-effectiveness of hip arthroscopy compared with personalised hip therapy within the first 12 months. Further follow-up will reveal whether or not the clinical benefits of hip arthroscopy are maintained and whether or not it is cost-effective in the long term. TRIAL REGISTRATION: Current Controlled Trials ISRCTN64081839. 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. 26, No. 16. See the NIHR Journals Library website for further project information.

In some people, the ball and the socket of the hip joint develop so that they do not fit together properly. This is called hip impingement, and is an important cause of hip and groin pain in young and middle-aged adults. Treatments include physiotherapy and surgery. Physiotherapy typically involves a programme of 6­10 outpatient consultations that aim to strengthen the muscles around the hip: we called this personalised hip therapy. Surgery can be carried out by a keyhole operation, called a hip arthroscopy, which aims to reshape the hip to prevent impingement. Surgery is normally followed by some physiotherapy. We performed a research study to compare the results of hip arthroscopy and personalised hip therapy in people with hip impingement. A total of 348 people with painful hip impingement in 23 hospitals in the UK agreed to take part. About half were treated with hip arthroscopy and half with personalised hip therapy. We used questionnaires to ask participants about pain in the hip and their ability to do everyday things at 6 months and 1 year after entering the study. At 2 and 3 years, we asked if patients required any additional treatments. We found that both groups improved, but those treated with hip arthroscopy improved a moderate amount more than those treated with personalised hip therapy. However, these improvements were not cost-effective compared with personalised hip therapy at 1 year. We need to see whether or not this difference continues after several years, but the results, so far, suggest that if a person has painful hip impingement, then hip arthroscopy offers greater improvements than personalised hip therapy.

Tourniquet use for knee replacement surgery.

BACKGROUND: Many surgeons prefer to perform total knee replacement surgery with the aid of a tourniquet. A tourniquet is an occlusive device that restricts distal blood flow to help create a bloodless field during the procedure. A tourniquet may be associated with increased risk of pain and complications. OBJECTIVES: To determine the benefits and harms of tourniquet use in knee replacement surgery. SEARCH METHODS: We searched MEDLINE, Embase, and Cochrane Central Register of Controlled Trials (CENTRAL) up to 26 March 2020. We searched clinicaltrials.gov, the World Health Organization trials portal, and several international registries and joint registries up to March 2020. SELECTION CRITERIA: We included randomised controlled trials (RCTs) comparing knee replacement with use of a tourniquet versus without use of a tourniquet and non-randomised studies with more than 1000 participants. Major outcomes included pain, function, global assessment of success, health-related quality of life, serious adverse events (including venous thromboembolism, infection, re-operation, and mortality), cognitive function, and survival of the implant. Minor outcomes included blood loss, economic outcomes, implant stability, and adverse events. DATA COLLECTION AND ANALYSIS: Two review authors screened abstracts and full texts, extracted data, performed risk of bias assessments, and assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: We included 41 RCTs with 2819 participants. Trials included from 20 to 199 participants. Mean age ranged between 58 and 84 years. More than half of the RCTs had unclear risk of selection bias and unclear risk of performance and detection bias due to absence of blinding of participants and surgeons. Major outcomes Pain: at postoperative day 1, pain (on a scale from zero to 10, with higher scores indicating worse pain) was ranked at 4.56 points after surgery without a tourniquet and at 1.25 points (MD) higher (95% CI 0.32 higher to 2.19 higher) with a tourniquet (8 studies; 577 participants), for an absolute difference of 12.5% higher pain scores (95% CI 3.2% higher to 21.9% higher) and a relative difference of 19% higher pain scores (95% CI 3.4% higher to 49% higher) with a tourniquet. Evidence for these findings was of moderate certainty, downgraded due to risk of bias. Knee replacement with a tourniquet probably led to higher postoperative pain scores at day 1, although this difference may or may not be noticeable to patients (based on a minimal clinically important difference (MCID) of 1.0). Function: at 12 months, tourniquet use probably makes little or no difference to function, based on an MCID of 5.3 for Knee Society Score (KSS) and 5.0 for Oxford Knee Score (OKS). Mean function (on a scale from 0 to 100, with higher scores indicating better outcomes) was 90.03 points after surgery without a tourniquet and was 0.29 points worse (95% CI 1.06 worse to 0.48 better) on a 0 to 100 scale, absolute difference was 0.29% worse (1.06% worse to 0.48% better), with a tourniquet (5 studies; 611 participants). This evidence was downgraded to moderate certainty due to risk of bias. Global assessment of success: low-certainty evidence (downgraded due to bias and imprecision) indicates that tourniquet use may have little or no effect on success. At six months, 47 of 50 (or 940 per 1000) reported overall successful treatment after surgery without a tourniquet and 47 of 50 (or 940 per 1000) with a tourniquet (risk ratio (RR) 1.0, 95% CI 0.91 to 1.10) based on one study with 100 participants. Health-related quality of life: at six months, tourniquet may have little or no effect on quality of life. The 12-Item Short Form Survey (SF-12) score (mental component from zero to 100 (100 is best)) was 54.64 after surgery without a tourniquet and 1.53 (MD) better (95% CI 0.85 worse to 3.91 better) with a tourniquet (1 study; 199 participants); absolute difference was 1.53% better (0.85% worse to 3.91% better). Evidence was of low certainty, downgraded due to risk of bias and small number of participants. Serious adverse events: the risk of serious adverse events was probably higher with tourniquet; 26 of 898 (29 per 1000) reported events following surgery without a tourniquet compared to 53 of 901 (59 per 1000) with a tourniquet (RR 1.73, 95% CI 1.10 to 2.73) in 21 studies (1799 participants). Twenty-nine more per 1000 patients (95% CI 3 to 50 more per 1000 patients) had a serious adverse event with a tourniquet. Forty-eight (95% CI 20 to 345) participants would need to have surgery without a tourniquet to avoid one serious adverse event. This evidence was downgraded to moderate certainty due to risk of bias. Cognitive function: one study reported cognitive function as an outcome; however the data were incompletely reported and could not be extracted for analysis. Survival of implant: it is uncertain if tourniquet has an effect on implant survival due to very low certainty evidence (downgraded for bias, and twice due to very low event rates); 2 of 107 (19 per 1000) required revision surgery in the surgery with a tourniquet group compared to 1 of 107 (9 per 1000) without a tourniquet group at up to two years' follow-up (RR 1.44, 95% CI 0.23 to 8.92). This equates to a 0.4% (0.7% lower to 7% more) increased absolute risk in surgery with a tourniquet. AUTHORS' CONCLUSIONS: Moderate certainty evidence shows that knee replacement surgery with a tourniquet is probably associated with an increased risk of serious adverse events. Surgery with a tourniquet is also probably associated with higher postoperative pain, although this difference may or may not be noticeable to patients. Surgery with a tourniquet does not appear to confer any clinically meaningful benefit on function, treatment success or quality of life. Further research is required to explore the effects of tourniquet use on cognitive function and implant survival, to identify any additional harms or benefits. If a tourniquet continues to be used in knee replacement surgery, patients should be informed about the potential increased risk of serious adverse events and postoperative pain.

ANTECEDENTES: Muchos cirujanos prefieren realizar una cirugía de reemplazo total de rodilla con la ayuda de un torniquete. Un torniquete es un dispositivo oclusivo que restringe el flujo sanguíneo distal para ayudar a crear un campo sin sangre durante el procedimiento. El torniquete se puede asociar con un mayor riesgo de dolor y complicaciones. OBJETIVOS: Determinar los efectos beneficiosos y perjudiciales del uso de torniquetes en la cirugía de reemplazo de rodilla. MÉTODOS DE BÚSQUEDA: Se hicieron búsquedas en MEDLINE, Embase y en el Registro Cochrane central de ensayos controlados (CENTRAL) hasta el 26 de marzo de 2020. Se realizaron búsquedas en clinicaltrials.gov, el portal de ensayos de la Organización Mundial de la Salud, y en varios registros internacionales y registros conjuntos hasta marzo de 2020. CRITERIOS DE SELECCIÓN: Se incluyeron los ensayos controlados aleatorizados (ECA) que compararon el reemplazo de rodilla con el uso de un torniquete versus sin el uso de un torniquete y los estudios no aleatorizados con más de 1000 participantes. Los desenlaces principales fueron el dolor, la funcionalidad, la evaluación general del éxito, la calidad de vida relacionada con la salud, los eventos adversos graves (incluido el tromboembolismo venoso, la infección, la reintervención y la mortalidad), la función cognitiva y la supervivencia del implante. Los desenlaces secundarios incluyeron la pérdida de sangre, los desenlaces económicos, la estabilidad del implante y los eventos adversos. OBTENCIÓN Y ANÁLISIS DE LOS DATOS: Dos autores de la revisión examinaron los resúmenes y los textos completos, extrajeron los datos, realizaron las evaluaciones del riesgo de sesgo y evaluaron la certeza de la evidencia utilizando el enfoque GRADE. RESULTADOS PRINCIPALES: Se incluyeron 41 ECA con 2819 participantes. Los ensayos incluyeron de 20 a 199 participantes. La media de edad varió entre 58 y 84 años. Más de la mitad de los ECA tenían riesgo incierto de sesgo de selección y riesgo incierto de sesgo de realización y detección debido a la falta de cegamiento de los participantes y los cirujanos. Desenlaces principales Dolor: en el primer día después de la cirugía, el dolor (en una escala de 0 a 10, con puntuaciones mayores que indican un peor dolor) se clasificó en 4,56 puntos después de la cirugía sin torniquete y en 1,25 puntos (DM) mayor (IC del 95%: 0,32 mayor a 2,19 mayor) con un torniquete (ocho estudios; 577 participantes), para una diferencia absoluta de 12,5% de puntuaciones mayores de dolor (IC del 95%: 3,2% mayor a 21,9% mayor) y una diferencia relativa de 19% de puntuaciones mayores de dolor (IC del 95%: 3,4% mayor a 49% mayor) con un torniquete. La evidencia de estos hallazgos fue de certeza moderada, disminuida debido al riesgo de sesgo. El reemplazo de rodilla con un torniquete probablemente dio lugar a mayores puntuaciones de dolor en el primer día después de la cirugía, aunque esta diferencia puede o no ser perceptible para los pacientes (sobre la base de una diferencia mínima clínicamente importante [DMCI] de 1,0). Funcionalidad: a los 12 meses el uso de torniquetes probablemente da lugar a poca o ninguna diferencia en la funcionalidad, según una DMCI de 5,3 en la Knee Society Score (KSS) y de 5,0 en la Oxford Knee Score (OKS). La funcionalidad media (en una escala de 0 a 100, con puntuaciones más altas que indican mejores desenlaces) fue de 90,03 puntos después de la cirugía sin torniquete y fue 0,29 puntos peor (IC del 95%: 1,06 peor a 0,48 mejor) en una escala de 0 a 100, la diferencia absoluta fue 0,29% peor (1,06% peor a 0,48% mejor), con un torniquete (cinco estudios; 611 participantes). Esta evidencia se disminuyó a certeza moderada debido al riesgo de sesgo. Evaluación general del éxito: evidencia de certeza baja (disminuida debido al sesgo y la imprecisión) indica que el uso de torniquetes puede tener poco o ningún efecto en el éxito. A los seis meses, 47 de 50 (o 940 por 1000) informaron de un tratamiento general exitoso después de la cirugía sin torniquete y 47 de 50 (o 940 por 1000) con torniquete (razón de riesgos [RR] 1,0; IC del 95%: 0,91 a 1,10), según un estudio con 100 participantes. Calidad de vida relacionada con la salud: a los seis meses, el torniquete puede tener poco o ningún efecto en la calidad de vida. La puntuación de la 12­Item Short Form Survey (SF­12) (componente mental de 0 a 100 [100 es mejor]) fue de 54,64 después de la cirugía sin torniquete y 1,53 (DM) mejor (IC del 95%: 0,85 peor a 3,91 mejor) con torniquete (un estudio; 199 participantes); la diferencia absoluta fue 1,53% mejor (0,85% peor a 3,91% mejor). La evidencia fue de certeza baja, y se disminuyó debido al riesgo de sesgo y al escaso número de participantes. Eventos adversos graves: el riesgo de eventos adversos graves probablemente fue mayor con el uso de un torniquete; 26 de 898 (29 por 1000) notificaron eventos después de la cirugía sin torniquete en comparación con 53 de 901 (59 por 1000) con un torniquete (RR 1,73; IC del 95%: 1,10 a 2,73) en 21 estudios (1799 participantes). Veintinueve más por cada 1000 pacientes (95% CI 3 a 50 más por 1000 pacientes) presentaron un evento adverso grave con un torniquete. Cuarenta y ocho (IC del 95%: 20 a 345) participantes tendrían que ser operados sin torniquete para evitar un evento adverso grave. Esta evidencia se disminuyó a certeza moderada debido al riesgo de sesgo. Función cognitiva: un estudio informó de la función cognitiva como un desenlace; sin embargo, los datos se informaron de manera incompleta y no se pudieron extraer para el análisis. Supervivencia del implante: no está claro si el torniquete tiene un efecto sobre la supervivencia del implante debido a evidencia de certeza muy baja (disminuida por el sesgo, y dos veces debido a las tasas de eventos muy bajas); dos de 107 (19 por 1000) requirieron cirugía de revisión en el grupo de cirugía con torniquete en comparación con uno de 107 (nueve por 1000) en el grupo sin torniquete hasta los dos años de seguimiento (RR 1,44; IC del 95%: 0,23 a 8,92). Esto equivale a un 0,4% (0,7% menos a 7% más) de aumento del riesgo absoluto en la cirugía con torniquete. CONCLUSIONES DE LOS AUTORES: Evidencia de certeza moderada muestra que la cirugía de reemplazo de rodilla con torniquete probablemente se asocia con un mayor riesgo de eventos adversos graves. La cirugía con torniquete también se asocia probablemente con un mayor dolor posoperatorio, aunque esta diferencia puede o no ser perceptible para los pacientes. La cirugía con torniquete no parece conferir efectos beneficiosos clínicamente significativos en la funcionalidad, el éxito del tratamiento o la calidad de vida. Se necesitan estudios de investigación adicionales para explorar los efectos del uso de torniquetes en la función cognitiva y la supervivencia del implante, para identificar cualquier efecto perjudicial o beneficioso adicional. Si se sigue utilizando un torniquete en la cirugía de reemplazo de rodilla, se debe informar a los pacientes sobre el posible aumento del riesgo de que se produzcan efectos adversos graves y dolor posoperatorio.

Safety and feasibility evaluation of tourniquets for total knee replacement (SAFE-TKR): study protocol.

INTRODUCTION: This study is designed to determine whether a full randomised controlled trial (RCT) examining the clinical effectiveness and safety of total knee replacement surgery with or without a tourniquet is warranted and feasible. METHOD AND ANALYSIS: Single centre, patient-blinded and assessor-blinded RCT. A computer-generated randomisation service will allocate 50 participants into one of two trial treatments, surgery with or without a tourniquet. The primary objective is to estimate recruitment, crossovers and follow-up of patients. All patients will have an MRI scan of their brain preoperatively and day 1 or 2 postoperatively to identify ischaemic cerebral emboli (primary clinical outcome). Oxford Cognitive Screen, Montreal Cognitive Assessment and Mini-Mental State Examination will be evaluated as outcome tools for measuring cognitive impairment at days 1, 2 and 7 postoperatively. Thigh pain, blood transfusion requirements, venous thromboembolism, revision surgery, surgical complications, mortality and Oxford knee and five-level EuroQol-5D scores will be collected over 12 months. Integrated qualitative research study: 30 trial patients and 20 knee surgeons will take part in semistructured interviews. Interviews will capture views regarding the pilot trial and explore barriers and potential solutions to a full trial. Multicentre cohort study: UK National Joint Registry data will be linked to Hospital Episode Statistics to estimate the relationship between tourniquet use and venous thromboembolic event, length of hospital stay, risk of revision surgery and death. The study will conclude with a multidisciplinary workshop to reach a consensus on whether a full trial is warranted and feasible. ETHICS AND DISSEMINATION: National Research Ethics Committee (West Midlands-Edgbaston) approved this study on 27 January 2016 (15/WM/0455). The study is sponsored by University of Warwick and University Hospitals Coventry and Warwickshire. The results will be disseminated via high-impact peer-reviewed publication. TRIAL REGISTRATION NUMBER: ISRCTN20873088; Pre-results.

Personalised Hip Therapy: development of a non-operative protocol to treat femoroacetabular impingement syndrome in the FASHIoN randomised controlled trial.

INTRODUCTION: Femoroacetabular impingement (FAI) syndrome is increasingly recognised as a cause of hip pain. As part of the design of a randomised controlled trial (RCT) of arthroscopic surgery for FAI syndrome, we developed a protocol for non-operative care and evaluated its feasibility. METHODS: In phase one, we developed a protocol for non-operative care for FAI in the UK National Health Service (NHS), through a process of systematic review and consensus gathering. In phase two, the protocol was tested in an internal pilot RCT for protocol adherence and adverse events. RESULTS: The final protocol, called Personalised Hip Therapy (PHT), consists of four core components led by physiotherapists: detailed patient assessment, education and advice, help with pain relief and an exercise-based programme that is individualised, supervised and progressed over time. PHT is delivered over 12-26 weeks in 6-10 physiotherapist-patient contacts, supplemented by a home exercise programme. In the pilot RCT, 42 patients were recruited and 21 randomised to PHT. Review of treatment case report forms, completed by physiotherapists, showed that 13 patients (62%) received treatment that had closely followed the PHT protocol. 13 patients reported some muscle soreness at 6 weeks, but there were no serious adverse events. CONCLUSION: PHT provides a structure for the non-operative care of FAI and offers guidance to clinicians and researchers in an evolving area with limited evidence. PHT was deliverable within the National Health Service, is safe, and now forms the comparator to arthroscopic surgery in the UK FASHIoN trial (ISRCTN64081839). TRIAL REGISTRATION NUMBER: ISRCTN 09754699.