Degenerative Disc Disease Clinical Trial
Official title:
Stand-Alone Cage Versus Anterior Plating for 1-2 Level Anterior Cervical Discectomy and Fusion. A Clinical and Radiographic Analysis
Verified date | September 2021 |
Source | Rush University Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 31, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Rush University Medical Center | Chicago | Illinois |
Lead Sponsor | Collaborator |
---|---|
Rush University Medical Center |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Adverse Events | (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 | 1 year | |
Other | Narcotics Consumption | 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. | 3 days | |
Primary | 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 | Dysphagia | 6 month postoperative followup SWAL-QOL score will be compared to baseline | 6 months | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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