NCT02577991

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

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)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Cervical Spine

Interventions

Type	Name	Description
DRUG	Decadron	10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate
DRUG	Triamcinolone	40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate

Timeline

• Start date: 2014-02-01
• Primary completion: 2017-06-01
• Completion: 2017-06-01
• First posted: 2015-10-16
• Last updated: 2019-05-30
• Results posted: 2019-05-30

Locations

1 site across 1 country: United States