Study protocol for a randomised controlled multicentre study: the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) in patients with cervical radiculopathy

Abstract

IntroductionCervical radiculopathy due to discogenic or spondylotic stenosis of the neuroforamen can be surgically treated by an anterior discectomy with fusion (ACDF) or a posterior foraminotomy (FOR). Most surgeons prefer ACDF, although there are indications that FOR is as effective as ACDF, has a lower complication rate and is less expensive. A head-to-head comparison of the 2 surgical techniques in a randomised controlled trial has not yet been performed. The study objectives of the Foraminotomy ACDF Cost-Effectiveness Trial (FACET) study are to compare clinical outcomes, complication rates and cost-effectiveness of FOR to ACDF.Methods and analysisThe FACET study is a prospective randomised controlled trial conducted in 7 medical centres in the Netherlands. The follow-up period is 2 years. The main inclusion criterion is a radiculopathy of the C4, C5, C6 or C7 nerve root, due to a single-level isolated cervical foraminal stenosis caused by a soft disc and/or osteophytic component, requiring operative decompression. A sample size of 308 patients is required to test the hypothesis of clinical non-inferiority of FOR versus ACDF. Primary outcomes are: ‘operative success’, the measured decrease in radiculopathy assessed by the visual analogue scale and ‘patient success’, assessed by the modified Odom's criteria. Secondary outcomes are: Work Ability Index (single-item WAI), quality of life (EuroQol 5 Dimensions 5 level Survey, EQ-5D-5L), Neck Disability Index (NDI) and complications. An economic evaluation will assess cost-effectiveness. In addition, a budget impact analysis will be performed.Ethics and disseminationEthical approval was obtained from the Institutional Ethics Committee of the University Medical Center Groningen. Results of this study will be disseminated through national and international papers. The participants and relevant patient support groups will be informed about the results of the study.Trial registration numberNTR5536, pre-results.

Transtubular Anterior Cervical Foraminotomy for the Treatment of Compressive Cervical Radiculopathy: Surgical Results and Complications in a Consecutive Series of Cases

“…The overall rate of complications for ACF in our series was low (4.4%), which was comparable with other ACF and PCF series (Table 3) [5,8,[11][12][13]15,16,21,22,24].…”

“…One study that compared ACF and ADR reported similar clinical results but different biomechanical outcomes. Range of motion was preserved for patients who underwent arthroplasty, whereas those who underwent foraminotomies exhibited reduced motion [9,24]. The conclusions of this study were limited by the small number of patients included; thus, a larger series with longer-term outcomes is required to compare ACF with ADR.…”

“…lateral mobilization of the loose fascia where the cervical sympathetic trunk runs (10-15 mm lateral to the medial edge of the longus colli muscle). Despite the occurrence of Horner's syndrome, which was more frequent than reported in literature for ACDF [27], all patients experienced complete resolution of symptoms within 6 months to 1 year after surgery (Table 3) [5,8,[11][12][13]15,16,21,22,24]. Only two studies in the literature reported a complication rate of >5% for ACF [8,12].…”

Surgical Interventions for Cervical Radiculopathy without Myelopathy

“…To begin with, more studies should focus on the cost-effectiveness of the procedures. Two RCTs 63,64 comparing economic outcomes of ACDF and PCF are already being conducted, but for other comparisons such as CDR versus ACDF, there are no RCTs that focus on patients with pure cervical radiculopathy, to our knowledge.…”

Clinical efficacy of autogenous vertebrae-filled polyetheretherketone cage in anterior cervical discectomy and fusion with instrumentation

“…However, clinical e cacy is closely related to the e cacy of intraoperative decompression and postoperative intervertebral fusion. [7] To achieve satisfying intervertebral fusion, it is crucial to select a suitable interbody fusion material. The commonly used materials mainly include autologous iliac bone, allogeneic bone, and synthetic materials.…”