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

Study Overview
=================
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.

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

Conditions
-----------------
Degenerative Disc Disease, Cervical Spine Degeneration

Intervention / Treatment
-----------------
* Device: Interbody Cage
* Device: Interbody Cage and Anterior Plating


Participation Criteria
=================
Eligibility Criteria
-----------------
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
Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Plate and Cage<br>ACDF with interbody cage and anterior plating. | Device: Interbody Cage and Anterior Plating<br>* Anterior cervical discectomy and fusion with interbody cage placement and anterior plating<br>|
| Active Comparator: Stand Alone Cage<br>ACDF with stand alone interbody cage without anterior plating | Device: Interbody Cage<br>* Anterior cervical discectomy and fusion with interbody cage placement<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Improvement - Change in Baseline Visual analogue Score (VAS) for Pain | 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 | 6 months | 

Secondary Outcome Measures

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anterior Cervical Discectomy and Fusion, Stand-Alone Cage, Anterior Plating