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Early Radiographic and Clinical Outcomes Study Evaluating an Integrated Screw and Interbody Spacer for One- and Two-Level ACDF

Paul D. Lane, MD,1 Jacob L. Cox, MD,2 Roger B. Gaskins III, MD,2 Brandon G. Santoni, PhD,3 James B. Billys, MD,1 Antonio E. Castellvi, MD1

1Florida Orthopaedic Institute, Tampa, FL, 2University of South Florida, Department of Orthopaedics and Sports Medicine, Tampa, FL,3Foundation for Orthopaedic Research and Education, Tampa, FL

Abstract

Background

Multiple techniques and implants can be used in ACDF, the newest of which are integrated cage and screw constructs. These devices may be beneficial over anterior plate constructs due to a negligible anterior profile that may reduce dysphagia. The goal of this study is to review the early radiographical and clinical results associated with a low profile integrated intervertebral cage in one- and two-level anterior column fusions.

Methods

Fusion rates, incidence of hardware failure and deformity correction were assessed through 1 year. Patient-reported scores, including VAS for neck pain, and improvements in axial neck pain and neurologic deficit from the preoperative baseline were quantified at 3, 6 and 12 months post-operatively. The incidence of dysphagia was recorded.

Results

Lordosis and disc space height at the operated levels increased an average of 4.5° and 3.3mm after device placement (p<0.001). Sagittal plane correction was maintained at 1 year. VAS improved from an average of 5.1 preoperatively to 3.1 immediately postoperatively and was maintained at 12 months. At 3 months, patient-reported improvements in axial neck pain and neurologic deficit were 85% and 93%, respectively. Reported improvements were sustained for both parameters at 12 months (77% and 86%, respectively). Fusion was noted in 93% of the operated levels. There were two documented cases of dysphagia that lasted more than 5 weeks, both following two level ACDFs with the test device (3.5% rate of chronic dysphagia).

Conclusions

The low profile integrated device improved lordosis at the operated level that was maintained at 1 year. Fusion rates with the new device are consistent with ACDF using anterior plating. In combination with improvements in pain and a minimal rate of dysphagia, study findings support the use of integrated interbody spacers for use in one- and two-level ACDF procedures.

Level of Evidence

Level IV, Case Series.

keywords: 
Anterior cervical discectomy and fusion, integrated interbody spacer, radiographic fusion, clinical outcomes
Volume 9 Article 39 - Biomechanics Special Issue
doi: 
10.14444/2039