NCT03312192

Stand-Alone Cage Verus Anterior Plating for Anterior Cervical Discectomy and Fusion.

Stand-Alone Cage Versus Anterior Plating for 1-2 Level Anterior Cervical Discectomy and Fusion. A Clinical and Radiographic Analysis

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Rush University Medical Center · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to compare the clinical results between two different techniques for ACDF: 1. Stand-alone ACDF, which means the placement of an interbody device (cage) without anterior fixation or plating; 2. ACDF with and interbody cage and anterior plating for fixation. Both of these procedures are commonly performed at Rush with unclear advantage of one procedure over the other. Both have been associated with good to excellent clinical outcomes. The devices used in this study are approved by the Food and Drug Administration (FDA).

Detailed description

Anterior cervical discectomy and fusion (ACDF) is one the most common procedures performed by spine surgeons. Although ACDF with autologous bone graft and anterior plating is commonly performed, this procedure may be associated with postoperative dysphagia, significant costs and adjacent segment pathology. To address these concerns, a number of surgeons have opted to utilize an interbody cage in a stand-alone fashion with good to excellent results. However, the published data is limited and currently there in no consensus among spine surgeons regarding the best technique to achieve fusion and improve clinical outcomes in patients with degenerative disc disease in the cervical spine.

Conditions

• Degenerative Disc Disease
• Cervical Spine Degeneration

Interventions

Type	Name	Description
DEVICE	Interbody Cage	Anterior cervical discectomy and fusion with interbody cage placement
DEVICE	Interbody Cage and Anterior Plating	Anterior cervical discectomy and fusion with interbody cage placement and anterior plating

Timeline

• Start date: 2017-07-17
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2017-10-17
• Last updated: 2021-09-16

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study