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

Paul D Lane; Jacob L Cox; Roger B Gaskins 3rd; Brandon G Santoni; James B Billys; Antonio E Castellvi

doi:10.14444/2039

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

Int J Spine Surg. 2015 Jul 17:9:39. doi: 10.14444/2039. eCollection 2015.

Authors

Paul D Lane¹, Jacob L Cox², Roger B Gaskins 3rd², Brandon G Santoni³, James B Billys¹, Antonio E Castellvi¹

Affiliations

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

PMID: 26273557
PMCID: PMC4528503
DOI: 10.14444/2039

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. Patientreported 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; clinical outcomes; integrated interbody spacer; radiographic fusion.