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Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF)

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ClinicalTrials.gov Identifier: NCT02577991
Recruitment Status : Completed
First Posted : October 16, 2015
Results First Posted : May 30, 2019
Last Update Posted : May 30, 2019
Sponsor:
Information provided by (Responsible Party):
Alpesh A. Patel, Northwestern University

Brief Summary:
Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia compared to intravenous steroids or a control group

Condition or disease Intervention/treatment Phase
Cervical Spine Drug: Decadron Drug: Triamcinolone Not Applicable

Detailed Description:

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Prospective, Randomized Controlled Trial on the Effect of Local Steroid Application on a Cervical Plate Versus Intravenous Steroids on Dysphagia Following Anterior Cervical Discectomy and Fusion (ACDF)
Actual Study Start Date : February 2014
Actual Primary Completion Date : June 2017
Actual Study Completion Date : June 2017


Arm Intervention/treatment
No Intervention: Control group
No steroid
Experimental: IV steroid
10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
Drug: Decadron
10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate

Experimental: Local steroid
40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
Drug: Triamcinolone
40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate




Primary Outcome Measures :
  1. Percentage of Patients Reporting Dysphagia/Severe Dysphagia Through EAT-10 From Baseline Through 1 Year Post-Op [ Time Frame: 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

  2. Percentage of Patients Reporting Abnormal Vocal Handicap Measured by the VHI-10 From Baseline Through 1 Year Post-Op [ Time Frame: 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

  3. Neck Disability Index (NDI) Mean Percentage Score From Baseline Through 1 Year Post Op [ Time Frame: 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.

  4. Median Visual Analog Scale Pain Score for Patients From Baseline Through 1 Year Post Op [ Time Frame: 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

  5. Percentage of Patients Reporting Mild/Moderate/Severe Dysphagia From Baseline Through 1 Year Post Op Measured With Bazaz Dysphagia Score [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02577991


Locations
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United States, Illinois
Northwestern Medicine Department of Orthopaedic Surgery
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
  Study Documents (Full-Text)

Documents provided by Alpesh A. Patel, Northwestern University:
Informed Consent Form  [PDF] December 21, 2015

Publications:

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Responsible Party: Alpesh A. Patel, Associate Professor, Northwestern University
ClinicalTrials.gov Identifier: NCT02577991    
Other Study ID Numbers: STU00085674
First Posted: October 16, 2015    Key Record Dates
Results First Posted: May 30, 2019
Last Update Posted: May 30, 2019
Last Verified: May 2019
Additional relevant MeSH terms:
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Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Triamcinolone
Anti-Inflammatory Agents
Physiological Effects of Drugs
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists