Author(s): Thomson S.; Selvanathan S.; Stoken D.; Hutchinson P.; Wilby M.; Croft J.; Hukins D.; Brown S.; Ainsworth G.; Collier H.; Sutton A.
Source: British Journal of Neurosurgery; 2018; vol. 32 (no. 2); p. 220-221
Publication Date: 2018
Publication Type(s): Conference Abstract
Abstract:Aim: Optimal surgical management of cervical brachialgia is unclear. Currently patients either have Posterior Cervical Foraminotomy (PCF) or Anterior Cervical Discectomy (ACD) and there is no level 1 evidence to guide practice. The FORVAD trial will be a two-arm, multi-centre, randomised controlled trial comparing PCF to ACD for surgical management of brachialgia. 1. Compare clinical effectiveness of PCF and ACD for cervical brachialgia. 2. Compare the cost effectiveness of PCF and ACD. 3. Assess whether PCF results in fewer complications than ACD. Method: Design: We will perform a multi-centre, Phase III, pragmatic, open-label, parallel group, individually randomised controlled trial. Subjects: Patients with brachialgia of at least 6 weeks with no symptoms, signs and/or imaging consistent with cord compression will be eligible for recruitment. To detect a difference between the two groups of 10% on the Neck Disability Index Score (NDI) at a 5% significance level with 90% power, a total of 252 participants are required. Methods: This is a superiority trial, the primary outcome is NDI at 12 months. Secondary outcomes include NDI scores at 1 day, 6 weeks, 3,6 and 9 months, Visual analogue scores for arm and neck pain and health economic analysis (incremental cost per QALY gained). Incidence of complications up to 12 months post-surgery (dysphagia, hoarse voice, arm and leg function, revision surgery, other adverse events) will be recorded. Results: This trial has been funded by the NIHR HTA programme (HTA-16/31/53). The trial will start recruitment in summer 2018 and report in 2021. We are keen to update the research community on this trial and to invite centres to participate. Conclusion: Multi-site recruitment will begin in September 2018 and the trial is now open for expression of interest. Email [email protected] Website www.forvad.uk.
Database: EMBASE