Cervical Spine Clinical Trial
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)
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.
;
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT01376687 -
Osteopathic Manipulative Medicine and Kinetics
|
N/A | |
Completed |
NCT00728247 -
Objective Kinematic Correlates of Palpatory Diagnosis
|
N/A | |
Completed |
NCT03958149 -
Measurements of Angulation of the C-spine
|
N/A |