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

Not Applicable

Withdrawn

• Conditions: Cervical Spine Degeneration; Degenerative Disc Disease
• Interventions: Device: Interbody Cage and Anterior Plating; Device: Interbody Cage

• Registration Number: NCT03312192
• Lead Sponsor: Rush University Medical Center

Brief 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.

Study Timeline

• Study Start: 2017-07-17
• Study First Submitted: 2017-08-08
• Study First Submitted QC: 2017-10-11
• Study First Posted: 2017-10-17
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-08
• Last Update Posted: 2021-09-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients undergoing a primary 1- to 2-level ACDF

  (a) Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis

• Patients able to provide informed consent

Exclusion Criteria

• Cervical spine trauma

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Plate and Cage	Interbody Cage and Anterior Plating	ACDF with interbody cage and anterior plating.
Stand Alone Cage	Interbody Cage	ACDF with stand alone interbody cage without anterior plating

Primary Outcome Measures

Name	Time	Method
Clinical Improvement - Change in Baseline Visual analogue Score (VAS) for Pain	6 months	Patients will be asked to complete the VAS to measure their pain prior to surgery and at their preoperative office visit(s) or just prior to surgery in the preoperative waiting area. Scores at the 6 month follow up office visit will be compared to baseline

Secondary Outcome Measures

Name	Time	Method
Dysphagia	6 months	6 month postoperative followup SWAL-QOL score will be compared to baseline
Fusion Rates	6 months	Postoperative radiographic studies will be performed at 6 month follow up visit to assess for arthrodesis (fusion) and pseudarthrosis (non-fusion).
Clinical Improvement - Change in baseline 12-item Short Form (SF-12) Health Survey at 6 months	6 months	SF-12 survey scores at 6 month follow up will be compared to baseline
Clinical Improvement - Change in baseline Oswestry Disability Index (ODI) at 6 months	6 months	ODI survey scores at 6 month follow up will be compared to baseline

Trial Locations

Locations (1)

Rush University Medical Center; 🇺🇸 Chicago, Illinois, United States