Trial · NCT02577991
Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF)
NCT02577991, Not applicable, Completed, Northwestern University; results first posted 2019-05-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF). Trials, record NCT02577991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02577991
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF)
- NCT number
- NCT02577991
- Status
- Completed
- Phases
- Not applicable
- Enrollment
- 80 participants, actual
- Lead sponsor
- Northwestern University
- Conditions
- Cervical Spine
- Interventions
- Decadron, Triamcinolone
- First posted
- 2015-10-16
- Last updated
- 2019-05-30
- Results first posted
- 2019-05-30
Source ClinicalTrials.gov
Registered outcomes5
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year. | Outcome measure used to measure the incidence and severity of postoperative trouble swallowing. Summative score of 10 questions (range 0-40) with each question scored 0-4 with higher scores indicating greater severity/frequency of difficulty or disability reported by the patient for the indicated activity; EAT-10 \>3 = dysphagia \& EAT-10 \>15 = severe dysphagia |
| Primary | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year. | Outcome measure used to measure the incidence and severity of postoperative trouble with hoarseness of voice; summative score of 10 questions (range 0-40) with each question scored 0-4 with higher scores indicating greater severity/frequency of disability or handicap reported by the patient. Reported as a percentage of patients in each group reporting an 'abnormal' VHI-10 score defined as a summative score \>11 |
| Primary | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year | Outcome measure used to measure for neck pain that includes personal care, lifting, reading, headaches, concentration, work, driving, sleeping and recreation. Summative scores for 10 questions (range 0-50) with each question scored 0-5 where higher scores for each question indicates greater extent of disability/difficulty for the associated activity. Reported as a mean percentage + standard deviation of difficulty/disability experienced by the patient. |
| Primary | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year; analyzed for all time points through 6 months post op | Most commonly utilized pain scale; scored 0-10 with higher values indicating increased severity of pain experienced by the patient |
| Primary | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | Evaluated at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year | Outcome measure used to measure the incidence and severity of postoperative trouble swallowing |
Source ClinicalTrials.gov
Outcomes5
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year. | All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team | percentage | NUMBER |
| PRIMARY | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year. | All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team | percentage of patients | NUMBER |
| PRIMARY | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year | All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team | percentage of disability/difficulty | MEAN |
| PRIMARY | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | Obtained at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year; analyzed for all time points through 6 months post op | All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team | Score on a scale | MEDIAN |
| PRIMARY | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | Evaluated at baseline, post op day 1, post op 2 weeks, post op 6 weeks, post op 3 months, post op 6 months, and post op 1 year | All discrepancies between analyzed group participant totals and individual time point participant totals are due lack of patient response for follow-up data for the given time point despite multiple contact attempts by the research team | percentage of patients | NUMBER |
Source ClinicalTrials.gov
Results by group147
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | Control Group | Baseline Dysphagia | 9.52 | percentage | |
| Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | IV Steroid | Baseline Dysphagia | 16.00 | percentage | |
| Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | Local Steroid | Baseline Dysphagia | 10.34 | percentage | |
| Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | Control Group | Baseline Severe Dysphagia | 0 | percentage | |
| Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | IV Steroid | Baseline Severe Dysphagia | 0 | percentage | |
| Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | Local Steroid | Baseline Severe Dysphagia | 0 | percentage | |
| Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | Control Group | 1 Day Post Op Dysphagia | 76.19 | percentage | |
| Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | IV Steroid | 1 Day Post Op Dysphagia | 68.00 | percentage | |
| Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | Local Steroid | 1 Day Post Op Dysphagia | 61.90 | percentage | |
| Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | Control Group | 1 Day Post Op Severe Dysphagia | 38.09 | percentage |
1 to 10 of 147Source ClinicalTrials.gov
See all 147 results by groupParticipant flow9
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Control Group | 24 | |
| Overall Study | STARTED | IV Steroid | 27 | |
| Overall Study | STARTED | Local Steroid | 29 | |
| Overall Study | COMPLETED | Control Group | 21 | |
| Overall Study | COMPLETED | IV Steroid | 25 | |
| Overall Study | COMPLETED | Local Steroid | 29 | |
| Overall Study | NOT COMPLETED | Control Group | 3 | |
| Overall Study | NOT COMPLETED | IV Steroid | 2 | |
| Overall Study | NOT COMPLETED | Local Steroid | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Control Group | 0 | 0 |
| Total, all-cause mortality | IV Steroid | 0 | 0 |
| Total, all-cause mortality | Local Steroid | 0 | 0 |
| Total, other adverse events | Control Group | 0 | 0 |
| Total, other adverse events | IV Steroid | 0 | 0 |
| Total, other adverse events | Local Steroid | 0 | 0 |
| Total, serious adverse events | Control Group | 0 | 0 |
| Total, serious adverse events | IV Steroid | 0 | 0 |
| Total, serious adverse events | Local Steroid | 0 | 0 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02577991
GET https://conductscience.org/api/trials/v1/NCT02577991/results?page=2