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

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Abstract

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.

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Holy, M., MacDowall, A., Sigmundsson, F. G., & Olerud, C. (2021). Operative treatment of cervical radiculopathy: anterior cervical decompression and fusion compared with posterior foraminotomy: study protocol for a randomized controlled trial. Trials, 22(1). https://doi.org/10.1186/s13063-021-05492-2

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