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Anterior Cervical Discectomy and Fusion in the Ovine Model
Published on: October 5, 2009
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Study protocol for a randomised controlled multicentre study: the Foraminotomy ACDF Cost-Effectiveness Trial (FACET)
A E H Broekema1, J M A Kuijlen1,2, G A T Lesman-Leegte3
1Department of Neurosurgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands.
BMJ Open
|January 7, 2017
Summary
This study compares anterior cervical discectomy with fusion (ACDF) to posterior foraminotomy (FOR) for cervical radiculopathy. It aims to determine if FOR is non-inferior to ACDF in clinical outcomes, complications, and cost-effectiveness.
Area of Science:
- Neurosurgery
- Orthopedics
- Health Economics
Background:
- Cervical radiculopathy often results from neuroforaminal stenosis.
- Anterior cervical discectomy with fusion (ACDF) and posterior foraminotomy (FOR) are surgical options.
- ACDF is preferred, but FOR may offer comparable effectiveness with fewer complications and lower costs.
Purpose of the Study:
- To compare the clinical outcomes of FOR versus ACDF for cervical radiculopathy.
- To evaluate complication rates associated with each surgical technique.
- To assess the cost-effectiveness of FOR compared to ACDF.
Main Methods:
- Prospective randomized controlled trial (FACET study) across 7 Dutch medical centers.
- Inclusion of patients with single-level cervical foraminal stenosis requiring decompression.
- Primary outcomes: operative success (visual analogue scale) and patient success (modified Odom's criteria); secondary outcomes: WAI, EQ-5D-5L, NDI, complications.
Main Results:
- The study is registered (NTR5536) and is in the pre-results phase.
- A sample size of 308 patients is required to demonstrate non-inferiority.
- Follow-up is planned for 2 years, with an economic evaluation of cost-effectiveness.
Conclusions:
- This trial is crucial for evidence-based decision-making in cervical radiculopathy surgery.
- Findings will inform surgical technique selection based on efficacy, safety, and economic factors.
- Results will be disseminated through publications and to patient groups.