N/A
N=80
Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF)
Cervical Spine
Bottom Line
View on ClinicalTrials.gov: NCT02577991 ↗Enrolled (actual)
80
Serious AEs
—
Results posted
May 2019
Primary outcome: Primary: Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op — 9.52; 16.00; 10.34; 0 percentage
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Decadron (Drug); Triamcinolone (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Northwestern University
- Primary completion
- Jun 2017
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op |
9.52; 16.00; 10.34; 0; 0; 0 | — |
| PRIMARY Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op |
9.52; 8.00; 3.44; 4.76; 4.00; 3.57 | — |
| PRIMARY Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op |
40; 34; 35; 27; 28; 27 | — |
| PRIMARY Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op |
8.0; 8.0; 7.0; 7.00; 6.00; 6.00 | — |
| PRIMARY Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score |
4.76; 0.00; 6.89; 0.00; 0.00; 0.00 | — |
Summary
Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia compared to intravenous steroids or a control group
Eligibility Criteria
Inclusion Criteria
- All patients undergoing ACDF (single or multi-level) for the treatment of cervical radiculopathy or myelopathy
- All subjects must have given signed, informed consent prior to registration on study.
Exclusion Criteria
- Patients undergoing revision surgery, any operations for trauma, infection, tumor
- Patients with general metabolic diseases such as rheumatoid arthritis, diabetes, chronic heart and renal diseases.
Data sourced from ClinicalTrials.gov (NCT02577991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.