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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-28

Study Completion Date

2017-06-30

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Cervical Spine

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Control group

No steroid

Group Type NO_INTERVENTION

No interventions assigned to this group

IV steroid

10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate

Group Type EXPERIMENTAL

Decadron

Intervention Type DRUG

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

Group Type EXPERIMENTAL

Triamcinolone

Intervention Type DRUG

40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate

Interventions

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Decadron

10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate

Intervention Type DRUG

Triamcinolone

40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No