Posterior Cervical Foraminotomy Compared with Anterior Cervical Discectomy with Fusion for Cervical Radiculopathy: Two-Year Results of the FACET Randomized Noninferiority Study

Abstract

Background: Posterior cervical foraminotomy (posterior surgery) is a valid alternative to anterior discectomy with fusion (anterior surgery) as a surgical treatment of cervical radiculopathy, but the quality of evidence has been limited. The purpose of this study was to compare the clinical outcome of these treatments after 2 years of follow-up. We hypothesized that posterior surgery would be noninferior to anterior surgery.

Methods: This multicenter, randomized, noninferiority trial assessed patients with single-level cervical radiculopathy in 9 Dutch hospitals with a follow-up duration of 2 years. The primary outcomes measured reduction of cervical radicular pain and were the success ratio based on the Odom criteria, and arm pain and decrease in arm pain, evaluated with the visual analog scale, with a 10% noninferiority margin, which represents the maximum acceptable difference between the new treatment (posterior surgery) and the standard treatment (anterior surgery), beyond which the new treatment would be considered clinically unacceptable. The secondary outcomes were neck pain, Neck Disability Index, Work Ability Index, quality of life, complications (including reoperations), and treatment satisfaction. Generalized linear mixed effects modeling was used for analyses. The study was registered at the Overview of Medical Research in the Netherlands (OMON), formerly the Netherlands Trial Register (NTR5536).

Results: From January 2016 to May 2020, 265 patients were randomized (132 to the posterior surgery group and 133 to the anterior surgery group). Among these, 25 did not have the allocated intervention; 11 of these 25 patients had symptom improvement, and the rest of the patients did not have the intervention due to various reasons. At the 2-year follow-up, of 243 patients, primary outcome data were available for 236 patients (97%). Predicted proportions of a successful outcome were 0.81 after posterior surgery and 0.74 after anterior surgery (difference in rate, -0.06 [1-sided 95% confidence interval (CI), -0.02]), indicating the noninferiority of posterior surgery. The between-group difference in arm pain was -2.7 (1-sided 95% CI, 7.4) and the between-group difference in the decrease in arm pain was 1.5 (1-sided 95% CI, 8.2), both confirming the noninferiority of posterior surgery. The secondary outcomes demonstrated small between-group differences. Serious surgery-related adverse events occurred in 9 patients (8%) who underwent posterior surgery, including 9 reoperations, and 11 patients (9%) who underwent anterior surgery, including 7 reoperations (difference in reoperation rate, -0.02 [2-sided 95% CI, -0.09 to 0.05]).

Conclusions: This trial demonstrated that, after a 2-year follow-up, posterior surgery was noninferior to anterior surgery with regard to the success rate and arm pain reduction in patients with cervical radiculopathy.

Level of evidence: Therapeutic Level I . See Instructions for Authors for a complete description of levels of evidence.

Fig. 1

Flowchart of patient randomization, primary treatment, and follow-up status. Participants who were included in the 2-year analyses of the primary outcomes had available data for the Odom score and/or the VAS for arm pain, as prespecified in the study protocol. (Reproduced, with permission from JAMA Neurology. Noninferiority of Posterior Cervical Foraminotomy vs Anterior Cervical Discectomy With Fusion for Procedural Success and Reduction in Arm Pain Among Patients With Cervical Radiculopathy at 1 Year: The FACET Randomized Clinical Trial. 2023. 80[1]:40-8. Copyright © 2022 American Medical Association. All rights reserved, including those for text and data mining, AI training, and similar technologies.)

Fig. 2

Results for the primary outcomes. The error bars in the top left, middle left, and bottom left indicate the 2-sided 95% CI. Top left: The model-based estimated proportions of patients with a successful outcome (per the Odom criteria) are depicted for the posterior and anterior surgery groups. The Odom score was not measured at baseline. Middle left: The observed baseline scores and subsequent model-based estimated mean VAS arm pain scores are given for the posterior and anterior surgery groups. Bottom left: The model-based estimated changes in VAS arm pain from baseline to the follow-up time points are given for posterior and anterior surgery. No baseline score is given for the VAS arm pain score, as the VAS arm pain change score is calculated by subtracting follow-up scores from baseline. Top right: The model-based point estimates, with accompanying 1-sided 95% CIs, for the difference between anterior surgery and posterior surgery are given. Noninferiority was established at each follow-up time point. The red dotted line denotes the noninferiority margin of 0.1. Middle right: The model-based point estimates, with accompanying 95% CIs, are given for the between-group difference in mean VAS arm pain and for the decrease in mean VAS arm pain from baseline. The red dotted line denotes the noninferiority margin of 0.1.