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Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia compared to intravenous steroids or a control group
Dysphagia is a common complication after ACDF. PSTS is also a natural sequela of ACDF and can lead to airway compromise among other complications. Previous studies have demonstrated that administration of intravenous methylprednisolone (1mg/kg) after anterior cervical spine surgery reduced the incidence of pharyngolaryngeal lesions as identified by nasofibroscopic examination. Lee et al. prospectively evaluated 50 patients and determined that local application of steroids in the retropharyngeal area following ACDF reduced PSTS and odynophagia as measured by the Visual Analogue Scale (VAS) and the Neck Disability Index (NDI) compared to a control group. Furthermore, there were no adverse events/reactions from local application of steroid on a gel foam sponge in the setting of anterior spinal surgery. There are no studies in the current literature that investigate the incidence of dysphagia with application of local steroids after ACDF, nor are there any studies that stratify the efficacy of local steroids compared to intravenous steroids. There is also no current spine literature that directly compares the efficacy of intravenous steroids versus local steroids in the incidence of dysphagia or dysphonia. Our study will be the first in the literature to assess the efficacy of local steroids in reducing the incidence of dysphagia after anterior cervical spine surgery, and as a result, may improve patient outcomes after ACDF.
Dysphagia and dysphonia are common complications after anterior cervical spine surgery. Despite their clinical importance, studies on the treatment and/or prevention of these complications are limited due to the lack of valid and reliable outcome measures. The majority of research is found in the otolaryngology literature and has focused on disease pathophysiology, diagnosis, and therapy.
The Bazaz score has been used in the spine literature to evaluate dysphagia after anterior cervical discectomy and fusion (ACDF). This is a subjective questionnaire that has not been validated in the literature. Additionally, new patient-centered outcome measures, the Eating Assessment Tool (EAT-10) and Voice Handicap Index (VHI-10) have recently been developed, and in addition to the Bazaz score, have been shown to have excellent validity and reliability in the ENT patient population. These instruments can be used to document the initial dysphagia or dysphonia severity and monitor the treatment response in people with a wide array of swallowing and voice disorders.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control group | No Intervention | No steroid | |
| IV steroid | Experimental | 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate |
|
| Local steroid | Experimental | 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Decadron | Drug | 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 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 | 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. |
| Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 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 | 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. |
| Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 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. | 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 |
| Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern Medicine Department of Orthopaedic Surgery | Chicago | Illinois | 60611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 17906571 | Background | Fountas KN, Kapsalaki EZ, Nikolakakos LG, Smisson HF, Johnston KW, Grigorian AA, Lee GP, Robinson JS Jr. Anterior cervical discectomy and fusion associated complications. Spine (Phila Pa 1976). 2007 Oct 1;32(21):2310-7. doi: 10.1097/BRS.0b013e318154c57e. | |
| 16891973 | Background | Sanfilippo JA Jr, Lim MR, Jacoby SM, Laterra R, Harrop JS, Vaccaro AR, Hilibrand AS, Anderson DG, Albert TJ. "Normal" prevertebral soft tissue swelling following elective anterior cervical decompression and fusion. J Spinal Disord Tech. 2006 Aug;19(6):399-401. doi: 10.1097/00024720-200608000-00004. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Control Group | No steroid |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Dec 14, 2015 |
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| Triamcinolone | Drug | 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate |
|
Most commonly utilized pain scale; scored 0-10 with higher values indicating increased severity of pain experienced by the patient
| 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 |
| Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | Outcome measure used to measure the incidence and severity of postoperative trouble swallowing | 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 |
| 12592551 | Background | Pedram M, Castagnera L, Carat X, Macouillard G, Vital JM. Pharyngolaryngeal lesions in patients undergoing cervical spine surgery through the anterior approach: contribution of methylprednisolone. Eur Spine J. 2003 Feb;12(1):84-90. doi: 10.1007/s00586-002-0495-6. Epub 2002 Dec 4. |
| 22020609 | Background | Lee SH, Kim KT, Suk KS, Park KJ, Oh KI. Effect of retropharyngeal steroid on prevertebral soft tissue swelling following anterior cervical discectomy and fusion: a prospective, randomized study. Spine (Phila Pa 1976). 2011 Dec 15;36(26):2286-92. doi: 10.1097/BRS.0b013e318237e5d0. |
| 20051917 | Background | McAfee PC, Cappuccino A, Cunningham BW, Devine JG, Phillips FM, Regan JJ, Albert TJ, Ahrens JE. Lower incidence of dysphagia with cervical arthroplasty compared with ACDF in a prospective randomized clinical trial. J Spinal Disord Tech. 2010 Feb;23(1):1-8. doi: 10.1097/BSD.0b013e31819e2ab8. |
| 19140539 | Background | Belafsky PC, Mouadeb DA, Rees CJ, Pryor JC, Postma GN, Allen J, Leonard RJ. Validity and reliability of the Eating Assessment Tool (EAT-10). Ann Otol Rhinol Laryngol. 2008 Dec;117(12):919-24. doi: 10.1177/000348940811701210. |
| FG002 | 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 |
| COMPLETED |
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| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control Group | No steroid |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||
| Age, Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op | 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 | 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 | Posted | Number | percentage | 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. |
|
|
| ||||||||||||||||||||||||||||||||
| Primary | Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op | 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 | 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 | Posted | Number | percentage of patients | 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. |
| ||||||||||||||||||||||||||||||||||
| Primary | Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op | 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. | 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 | Posted | Mean | Standard Deviation | percentage of disability/difficulty | 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 |
| |||||||||||||||||||||||||||||||||
| Primary | Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op | Most commonly utilized pain scale; scored 0-10 with higher values indicating increased severity of pain experienced by the patient | 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 | Posted | Median | Inter-Quartile Range | Score on a scale | 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 |
| |||||||||||||||||||||||||||||||||
| Primary | Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score | Outcome measure used to measure the incidence and severity of postoperative trouble swallowing | 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 | Posted | Number | percentage of patients | 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 |
|
1 year
All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control Group | No steroid | 0 | 0 | 0 | 0 | 0 | 0 |
| EG001 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
| EG002 | 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 | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Surabhi Bhatt | Northwestern University Department of Orthopaedic Surgery | 312-472-6024 | surabhi.bhatt@nm.org |
| Mar 13, 2019 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Dec 21, 2015 | Mar 13, 2019 | ICF_001.pdf |
| ID | Term |
|---|---|
| D002123 | Calcium Dobesilate |
| D014221 | Triamcinolone |
| ID | Term |
|---|---|
| D001557 | Benzenesulfonates |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D001190 | Arylsulfonates |
| D017739 | Arylsulfonic Acids |
| D013451 | Sulfonic Acids |
| D013456 | Sulfur Acids |
| D013457 | Sulfur Compounds |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D013259 | Steroids, Fluorinated |
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| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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| Baseline Severe Dysphagia |
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| 1 Day Post Op Dysphagia |
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| 1 Day Post Op Severe Dysphagia |
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| 2 wk. Post Op Dysphagia |
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| 2 wk. Post Op Severe Dysphagia |
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| 6 wk. Post Op Dysphagia |
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| 6 wk. Post Op Severe Dysphagia |
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| 3 mo. Post Op Dysphagia |
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| 3 mo. Post Op Severe Dysphagia |
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| 6 mo. Post Op Dysphagia |
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| 6 mo. Post Op Severe Dysphagia |
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| 1 yr. Post Op Dysphagia |
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| 1 yr. Post Op Severe Dysphagia |
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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
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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 |
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| Units | Counts |
|---|---|
| Participants |
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