Author(s): Selvanathan S.; Pal D.; Brown S.; Sutton A.; Collier H.; Croft J.; Ainsworth G.; Hukins D.; Stocken D.; Thomson S.; Wilby M.; Hutchinson P.
Source: British Journal of Neurosurgery; 2018; vol. 32 (no. 3); p. 324
Publication Date: 2018
Publication Type(s): Conference Abstract
Abstract:Objectives: Surgical management of brachialgia is unclear. Patients either have Posterior Cervical Foraminotomy (PCF) or Anterior Cervical Discectomy (ACD). FORVAD trial will be a two-arm, multicentre, randomised trial comparing PCF to ACD. Obejctives. Compare effectiveness of PCF and ACD for brachialgia. 2. Compare the cost effectiveness of PCF and ACD. 3. Whether PCF results in fewer complications than ACD. Design: We aim to perform a multi-centre, Phase III, 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: The primary outcome is NDI at 12 months. Secondary outcomes include health economic analysis. Incidence of complications (dysphagia, hoarse voice and neurological deficit) will be recorded. Results: This study has been granted funding from the NIHR. Multi-site recruitment will begin in September 2018 and trial is now open for expression of interest. Conclusions: The results of the FORVAD study will provide surgical treatment recommendations for the management of brachialgia.