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Two-level ACDF with a zero-profile stand-alone spacer compared to conventional plating: a prospective randomized
M Scholz1, B Onal2, P Schleicher3
1Center for Spinal Surgery and Neurotraumatology, BG Unfallklinik Frankfurt am Main gGmbH, Friedberger Landstraße 430, 60389, Frankfurt am Main, Germany. matti.scholz@bgu-frankfurt.de.
This study found that zero-profile devices and cage+plate constructs are safe for two-level anterior cervical discectomy and fusion (ACDF). While zero-profile devices showed a trend towards less dysphagia, the difference was not statistically significant compared to cage+plate.
Area of Science:
- Neurosurgery
- Spinal Surgery
- Orthopedic Surgery
Background:
- Zero-profile devices are increasingly used in spinal fusion procedures.
- Previous studies suggested reduced dysphagia with zero-profile implants.
- Level-one evidence for zero-profile implants in multilevel procedures was lacking.
Purpose of the Study:
- To compare the clinical and radiological outcomes of zero-profile spacers versus cage + plate constructs in two-level anterior cervical discectomy and fusion (ACDF).
- To evaluate the prevalence of dysphagia as the primary endpoint at 24 months post-surgery.
Main Methods:
- A randomized controlled trial (RCT) involving patients with contiguous two-level cervical degenerative disc disease (cDD).
- Patients were randomized to receive either a zero-profile device (interventional group) or a cage + plate construct (control group).
- Secondary outcomes included disability, adjacent segment degeneration, fusion status, and loss of correction.
Main Results:
- Forty-one patients were included in the study.
- Dysphagia was more frequent in both groups at 3 months, with a trend favoring the interventional group (p=0.078).
- At 24 months, dysphagia rates were lower in the zero-profile group but not statistically significant; no significant differences were found in other secondary outcomes. Fusion rates were slightly lower with zero-profile devices.
Conclusions:
- Both zero-profile spacers and cage + plate constructs are safe for two-level ACDF.
- The study did not achieve statistical significance in demonstrating the superiority of zero-profile devices for reducing dysphagia rates at 24 months.
- Further research may be needed to confirm the long-term clinical benefits of zero-profile implants in multilevel spinal procedures.
