Posterior cervical foraminotomy is non-inferior to anterior cervical discectomy with fusion for patients with cervical radiculopathy in relation to procedural success rate and reduction in arm pain at one year. This is according to the latest results from the FACET randomised controlled trial, which were published by Anne Broekema (University of Groningen, Groningen, The Netherlands) et al in JAMA Neurology.
The researchers believe that the results, which also showed that decreases in arm pain and secondary outcomes had small between-group differences “may be used to enhance shared decision-making”.
This multicentre investigator-blinded non-inferiority randomised clinical trial was conducted from January 2016 to May 2020 with a total follow-up of two years. Patients were included from nine hospitals in the Netherlands.
Of 389 adult patients with one-sided single-level cervical foraminal radiculopathy screened for eligibility, 124 declined to participate or did not meet eligibility criteria. Patients with pure axial neck pain without radicular pain were not eligible. Of 265 patients randomised), 11 had spontaneous improvement of symptoms, 15 were lost to follow-up and 228 were included in the one-year analysis (110 in posterior and 118 in anterior).
Patients were randomly assigned 1:1 to posterior foraminotomy (132) or anterior cervical discectomy with fusion (133).
The primary outcomes were proportion of success using Odom criteria and decrease in arm pain using a visual analogue scale from 0 to 100 with a noninferiority margin of 10% (assuming advantages with posterior surgery over anterior surgery that would justify a tolerable loss of efficacy of 10%).
Secondary outcomes were neck pain, disability, quality of life, work status, treatment satisfaction, reoperations, and complications. Analyses were performed with two-proportion z tests at one-sided 0.05 significance levels with Bonferroni corrections.
Among the 265 included patients, the mean (standard deviation [SD]) age was 51.2 (8.3) years; 133 patients were female and 132 were male.
The proportion of success was 0.88 (86 of 98) in the posterior surgery group and 0.76 (81 of 106) in the anterior surgery group (difference, −0.11 percentage points; one-sided 95% confidence interval [CI], −0.01) and the between-group difference in arm pain was −2.8 (one-sided 95% CI, −9.4) at one-year follow-up, indicating noninferiority of posterior surgery.
Decrease in arm pain had a between-group difference of 3.4 (one-sided 95% CI, 11.8), crossing the noninferiority margin with 1.8 points. All secondary outcomes had two-sided 95% CIs clustered around 0 with small between-group differences, note the researchers.
Speaking to Spinal News International, Broekema said: “Our trial demonstrates that posterior foraminotomy is a valid alternative to anterior cervical discectomy with fusion. A current preference for anterior surgery is observed, although posterior surgery has some important advantages. There are less vital structures at risk, there is no need to use implants and no fusion, with in theory less chance on adjacent segment disease. Our opinion is that patients presenting with cervical radiculopathy due to nerve root compression should always be counselled for both treatments and a shared decision should be made on the approach.
“Our future research will focus on the clinical outcome after two years of follow-up and cost-effectiveness of posterior foraminotomy. Previous retrospective studies demonstrated less costs associated with posterior foraminotomy, which may be another benefit of the posterior approach.”