Cervical Spine Degeneration, Degenerative Disc Disease
Conditions
Keywords
Anterior Cervical Discectomy and Fusion, Stand-Alone Cage, Anterior Plating
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.
Interventions
DEVICEInterbody Cage
Anterior cervical discectomy and fusion with interbody cage placement
DEVICEInterbody Cage and Anterior Plating
Anterior cervical discectomy and fusion with interbody cage placement and anterior plating
Sponsors
Rush University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention 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.
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events | 1 year | (a) Intra-operative - Information will be obtained from the operative note. (i) Blood loss, length of surgery, procedural details, complications (b) Post-operative - Information will be obtained from the clinic notes |
| Narcotics Consumption | 3 days | The total amount of narcotic use for each subject will be recorded. Dosages of narcotics will be converted to morphine equivalents. This information will be measured during the hospitalization. |
Countries
United States
Outcome results
None listed