Clinical and cost-effectiveness of PCF versus ACD in the treatment of cervical brachialgia (FORVAD trial)

Abstract

Background

Cervical radiculopathy occurs when a nerve root is compressed in the spine, if symptoms fail to resolve after 6 weeks surgery may be indicated. Anterior Cervical Discectomy (ACD) is the commonest procedure, Posterior Cervical Foraminotomy (PCF) is an alternative that avoids the risk of damage to anterior neck structures. This prospective, Phase III, UK multicentre, open, individually randomised controlled trial was performed to determine whether PCF is superior to ACD in terms of improving clinical outcome as measured by the Neck Disability Index (NDI) 52 weeks post–surgery.

Method

Following consent to participate and collection of baseline data, subjects with cervical brachialgia were randomised to ACD or PCF in a 1:1 ratio on the day of surgery. Clinical outcomes were assessed on day 1 and patient reported outcomes on day 1 and weeks 6, 12, 26, 39 and 52 post-operation. A total of 252 participants were planned to be randomised. Statistical analysis was limited to descriptive statistics. Health economic outcomes were also described.

Results

The trial was closed early (n = 23). Compared to baseline, the median (interquartile range (IQR)) NDI score at 52 weeks reduced from 44.0 (36.0, 62.0) to 25.3 (20.0, 42.0) in the PCF group and increased from 35.6 (34.0, 44.0) to 45.0 (20.0, 57.0) in the ACD group. ACD may be associated with more swallowing, voice and other complications and was more expensive; neck and arm pain scores were similar.

Conclusions

The trial was closed early, therefore no definitive conclusions on clinical or cost-effectiveness could be made.

Keywords:

• Cervical
• radiculopathy
• randomised controlled clinical trial
• posterior cervical foraminotomy
• anterior cervical Discectomy

Ethical approval

Regional Ethics Committee approval (REC): 18/NW/0682

Disclosure statement

No potential conflict of interest was reported by the author(s).

Copyright materials

Copyright release permission for all copyrighted materials have been obtained and will be provided to the publisher.

International standard randomised controlled trial number

ISRCTN reference: 10133661

Level of Evidence

Level 2 using OCEBM Levels of Evidence Working Group*. The Oxford 2011 Levels of Evidence. Oxford Centre for Evidence-Based Medicine. http://www.cebm.net/index.aspx?o=5653

Data availability statement

Data supporting this study are available from the Clinical Trials Unit of the University of Leeds. Access to the data is subject to approval and a data-sharing agreement due to patient confidentiality.

Additional information

Funding

This study has been supported by the National Institute for Health and Care Research, Health Technology Fund. Ref 16/31/53. https://fundingawards.nihr.ac.uk/award/16/31/53