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.
Asunto(s)
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
In the period 1 January 2012 to 30 June 2020, 76 doctors whose names/entries had been erased from the UK Medical Register by a disciplinary tribunal applied for restoration, and 23 out of 76 (30.3%) applications granted. In 5 of the 53 of those refused restoration, the tribunal suspended indefinitely the right to make further applications. The most frequent reasons for refusal were failure to demonstrate insight (seen in 96%), failure to demonstrate remediation (seen in 79%), and failure to demonstrate that knowledge and skills were up to date (24.5%). Success was more common in UK graduate applications (14/29 - 48.3%) than non-UK graduate applications (9/37 - 24.3%), and in those legally represented (16/29 - 55.2%) than in those without legal representation (7/29 - 24.1%), but the data does not indicate the reasons for these differences. Disciplinary erasure need not necessarily be for life as doctors who learn from their experience, change their ways, and provide evidence of genuine insight and remediation along with up to date knowledge and skills can successfully be reinstated on the register.