Trial Outcomes & Findings for Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF) (NCT NCT02577991)
NCT ID: NCT02577991
Last Updated: 2019-05-30
Results Overview
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
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
80 participants
Primary outcome timeframe
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.
Results posted on
2019-05-30
Participant Flow
Participant milestones
| Measure |
Control Group
No steroid
|
IV Steroid
10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
|
Local Steroid
40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
|
|---|---|---|---|
|
Overall Study
STARTED
|
24
|
27
|
29
|
|
Overall Study
COMPLETED
|
21
|
25
|
29
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF)
Baseline characteristics by cohort
| Measure |
Control Group
n=21 Participants
No steroid
|
IV Steroid
n=25 Participants
10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
|
Local Steroid
n=29 Participants
40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
|
Total
n=75 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
15 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
58 Participants
n=4 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
17 Participants
n=4 Participants
|
|
Age, Continuous
|
54 years
n=5 Participants
|
51.6 years
n=7 Participants
|
55.6 years
n=5 Participants
|
53.7 years
n=4 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
40 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
75 Participants
n=4 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=5 Participants
|
25 participants
n=7 Participants
|
29 participants
n=5 Participants
|
75 participants
n=4 Participants
|
PRIMARY outcome
Timeframe: 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.Population: 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
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
Outcome measures
| Measure |
Control Group
n=21 Participants
No steroid
|
IV Steroid
n=25 Participants
10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
|
Local Steroid
n=29 Participants
40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
|
|---|---|---|---|
|
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
Baseline Dysphagia
|
9.52 percentage
|
16.00 percentage
|
10.34 percentage
|
|
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
Baseline Severe Dysphagia
|
0 percentage
|
0 percentage
|
0 percentage
|
|
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
1 Day Post Op Dysphagia
|
76.19 percentage
|
68.00 percentage
|
61.90 percentage
|
|
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
1 Day Post Op Severe Dysphagia
|
38.09 percentage
|
32.00 percentage
|
17.85 percentage
|
|
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
2 wk. Post Op Dysphagia
|
50.00 percentage
|
48.00 percentage
|
27.58 percentage
|
|
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
2 wk. Post Op Severe Dysphagia
|
20.00 percentage
|
16.00 percentage
|
0.00 percentage
|
|
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
6 wk. Post Op Dysphagia
|
38.09 percentage
|
34.78 percentage
|
17.24 percentage
|
|
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
6 wk. Post Op Severe Dysphagia
|
28.57 percentage
|
0.00 percentage
|
0.00 percentage
|
|
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
3 mo. Post Op Dysphagia
|
20.00 percentage
|
8.69 percentage
|
6.89 percentage
|
|
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
3 mo. Post Op Severe Dysphagia
|
10.00 percentage
|
0.00 percentage
|
0.00 percentage
|
|
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
6 mo. Post Op Dysphagia
|
21.05 percentage
|
8.33 percentage
|
13.79 percentage
|
|
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
6 mo. Post Op Severe Dysphagia
|
0.00 percentage
|
0.00 percentage
|
0.00 percentage
|
|
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
1 yr. Post Op Dysphagia
|
21.05 percentage
|
0.00 percentage
|
6.89 percentage
|
|
Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op
1 yr. Post Op Severe Dysphagia
|
10.52 percentage
|
0.00 percentage
|
0.00 percentage
|
PRIMARY outcome
Timeframe: 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.Population: 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
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
Outcome measures
| Measure |
Control Group
n=21 Participants
No steroid
|
IV Steroid
n=25 Participants
10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
|
Local Steroid
n=29 Participants
40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
|
|---|---|---|---|
|
Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op
3 mo. Post Op Abnormal VHI-10
|
10.00 percentage of patients
|
4.34 percentage of patients
|
0.00 percentage of patients
|
|
Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op
6 mo. Post Op Abnormal VHI-10
|
10.53 percentage of patients
|
8.33 percentage of patients
|
3.44 percentage of patients
|
|
Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op
1 yr. Post Op Abnormal VHI-10
|
10.53 percentage of patients
|
8.33 percentage of patients
|
0.00 percentage of patients
|
|
Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op
Baseline Abnormal VHI-10
|
9.52 percentage of patients
|
8.00 percentage of patients
|
3.44 percentage of patients
|
|
Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op
1 Day Post Op Abnormal VHI-10
|
4.76 percentage of patients
|
4.00 percentage of patients
|
3.57 percentage of patients
|
|
Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op
2 wk. Post Op Abnormal VHI-10
|
10.00 percentage of patients
|
20.00 percentage of patients
|
0.00 percentage of patients
|
|
Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op
6 wk. Post Op Abnormal VHI-10
|
9.52 percentage of patients
|
8.69 percentage of patients
|
3.44 percentage of patients
|
PRIMARY outcome
Timeframe: 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 yearPopulation: 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
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.
Outcome measures
| Measure |
Control Group
n=21 Participants
No steroid
|
IV Steroid
n=25 Participants
10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
|
Local Steroid
n=29 Participants
40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
|
|---|---|---|---|
|
Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op
Baseline NDI
|
40 percentage of disability/difficulty
Standard Deviation 19
|
34 percentage of disability/difficulty
Standard Deviation 18
|
35 percentage of disability/difficulty
Standard Deviation 19
|
|
Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op
1 Day Post Op NDI
|
27 percentage of disability/difficulty
Standard Deviation 14
|
28 percentage of disability/difficulty
Standard Deviation 16
|
27 percentage of disability/difficulty
Standard Deviation 18
|
|
Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op
2 wk. Post Op NDI
|
31 percentage of disability/difficulty
Standard Deviation 20
|
24 percentage of disability/difficulty
Standard Deviation 15
|
20 percentage of disability/difficulty
Standard Deviation 16
|
|
Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op
6 wk. Post Op NDI
|
23 percentage of disability/difficulty
Standard Deviation 19
|
21 percentage of disability/difficulty
Standard Deviation 15
|
24 percentage of disability/difficulty
Standard Deviation 19
|
|
Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op
3 mo. Post Op NDI
|
14.6 percentage of disability/difficulty
Standard Deviation 40
|
11.1 percentage of disability/difficulty
Standard Deviation 23.3
|
10 percentage of disability/difficulty
Standard Deviation 23.5
|
|
Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op
6 mo. Post Op NDI
|
23 percentage of disability/difficulty
Standard Deviation 19
|
21 percentage of disability/difficulty
Standard Deviation 15
|
24 percentage of disability/difficulty
Standard Deviation 19
|
|
Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op
1 yr. Post Op NDI
|
22.2 percentage of disability/difficulty
Standard Deviation 33.6
|
4.0 percentage of disability/difficulty
Standard Deviation 18
|
6.0 percentage of disability/difficulty
Standard Deviation 26
|
PRIMARY outcome
Timeframe: 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 opPopulation: 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
Most commonly utilized pain scale; scored 0-10 with higher values indicating increased severity of pain experienced by the patient
Outcome measures
| Measure |
Control Group
n=21 Participants
No steroid
|
IV Steroid
n=25 Participants
10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
|
Local Steroid
n=29 Participants
40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
|
|---|---|---|---|
|
Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op
VAS Pain Score (Baseline)
|
8.0 Score on a scale
Interval 6.0 to 9.0
|
8.0 Score on a scale
Interval 6.0 to 9.0
|
7.0 Score on a scale
Interval 4.0 to 9.0
|
|
Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op
VAS Pain Score (1 Day Post Op)
|
7.00 Score on a scale
Interval 6.5 to 9.0
|
6.00 Score on a scale
Interval 3.0 to 9.0
|
6.00 Score on a scale
Interval 3.0 to 7.0
|
|
Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op
VAS Pain Score (2 wk. Post Op)
|
6.00 Score on a scale
Interval 5.0 to 8.0
|
4.00 Score on a scale
Interval 3.0 to 6.0
|
4.00 Score on a scale
Interval 3.0 to 6.0
|
|
Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op
VAS Pain Score (6 wk. Post Op)
|
5.00 Score on a scale
Interval 3.0 to 8.0
|
4.00 Score on a scale
Interval 2.0 to 5.5
|
5.00 Score on a scale
Interval 3.0 to 7.0
|
|
Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op
VAS Pain Score (3 mo. Post Op)
|
4.5 Score on a scale
Interval 1.75 to 7.0
|
3.0 Score on a scale
Interval 1.0 to 4.0
|
3.00 Score on a scale
Interval 2.0 to 5.0
|
|
Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op
VAS Pain Score (6 mo. Post Op)
|
5.0 Score on a scale
Interval 3.0 to 8.0
|
4.0 Score on a scale
Interval 2.0 to 5.5
|
5.00 Score on a scale
Interval 3.0 to 7.0
|
|
Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op
VAS Pain Score (1 yr. Post Op)
|
4.0 Score on a scale
Interval 1.0 to 6.0
|
2.0 Score on a scale
Interval 1.0 to 4.0
|
1.0 Score on a scale
Interval 1.0 to 5.0
|
PRIMARY outcome
Timeframe: 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 yearPopulation: 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
Outcome measure used to measure the incidence and severity of postoperative trouble swallowing
Outcome measures
| Measure |
Control Group
n=21 Participants
No steroid
|
IV Steroid
n=25 Participants
10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
Decadron: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
|
Local Steroid
n=29 Participants
40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
Triamcinolone: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
|
|---|---|---|---|
|
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
Baseline Bazaz Score (Mild or Greater)
|
4.76 percentage of patients
|
0.00 percentage of patients
|
6.89 percentage of patients
|
|
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
Baseline Bazaz Score (Moderate-Severe)
|
0.00 percentage of patients
|
0.00 percentage of patients
|
0.00 percentage of patients
|
|
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
1 Day Post Op Bazaz Score (Mild or Greater)
|
61.90 percentage of patients
|
44.00 percentage of patients
|
50.00 percentage of patients
|
|
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
1 Day Post Op Bazaz Score (Moderate-Severe)
|
33.33 percentage of patients
|
24.00 percentage of patients
|
7.14 percentage of patients
|
|
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
2 wk. Post Op Bazaz Score (Mild or Greater)
|
30.00 percentage of patients
|
16.00 percentage of patients
|
13.79 percentage of patients
|
|
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
2 wk. Post Op Bazaz Score (Moderate-Severe)
|
15.00 percentage of patients
|
16.00 percentage of patients
|
0.00 percentage of patients
|
|
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
6 wk. Post Op Bazaz Score (Mild or Greater)
|
28.57 percentage of patients
|
17.39 percentage of patients
|
6.89 percentage of patients
|
|
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
6 wk. Post Op Bazaz Score (Moderate-Severe)
|
23.80 percentage of patients
|
8.69 percentage of patients
|
0.00 percentage of patients
|
|
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
3 mo. Post Op Bazaz Score (Mild or Greater)
|
15.00 percentage of patients
|
13.04 percentage of patients
|
13.79 percentage of patients
|
|
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
3 mo. Post Op Bazaz Score (Moderate-Severe)
|
15.00 percentage of patients
|
0.00 percentage of patients
|
0.00 percentage of patients
|
|
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
6 mo. Post Op Bazaz Score (Mild or Greater)
|
15.78 percentage of patients
|
8.33 percentage of patients
|
13.79 percentage of patients
|
|
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
6 mo. Post Op Bazaz Score (Moderate-Severe)
|
5.26 percentage of patients
|
0.00 percentage of patients
|
0.00 percentage of patients
|
|
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
1 yr. Post Op Bazaz Score (Mild or Greater)
|
15.78 percentage of patients
|
0.00 percentage of patients
|
3.44 percentage of patients
|
|
Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score
1 yr. Post Op Bazaz Score (Moderate-Severe)
|
5.26 percentage of patients
|
0.00 percentage of patients
|
3.44 percentage of patients
|
Adverse Events
IV Steroid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Local Steroid
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Surabhi Bhatt
Northwestern University Department of Orthopaedic Surgery
Phone: 312-472-6024
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place