Operative treatment of cervical radiculopathy: anterior cervical decompression and fusion compared with posterior foraminotomy: study protocol for a randomized controlled trial.

BACKGROUND

Cervical radiculopathy is the most common disease in the cervical spine, affecting patients around 50-55 year of age. An operative treatment is common clinical praxis when non-operative treatment fails. The controversy is in the choice of operative treatment, conducting either anterior cervical decompression and fusion or posterior foraminotomy. The study objective is to evaluate short- and long-term outcome of anterior cervical decompression and fusion (ACDF) and posterior foraminotomy (PF)

METHODS

A multicenter prospective randomized controlled trial with 1:1 randomization, ACDF vs. PF including 110 patients. The primary aim is to evaluate if PF is non-inferior to ACDF using a non-inferiority design with ACDF as "active control." The neck disability index (NDI) is the primary outcome measure, and duration of follow-up is 2 years.

DISCUSSION: Due to absence of high level of evidence, the authors believe that a RCT will improve the evidence for using the different surgical treatments for cervical radiculopathy and strengthen current surgical treatment recommendation.

TRIAL REGISTRATION: ClinicalTrials.gov NCT04177849. Registered on November 26, 2019.