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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Anterior cervical discectomy and fusion with interbody cage placement
Anterior cervical discectomy and fusion with interbody cage placement and anterior plating
Rush University Medical Center
Chicago, Illinois, United States
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
Time frame: 6 months
Dysphagia
6 month postoperative followup SWAL-QOL score will be compared to baseline
Time frame: 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).
Time frame: 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
Time frame: 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
Time frame: 6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.