N/A N=128 Randomized Triple-blind Prevention

Effect of Topical Corticosteroids on Dysphagia in Anterior Cervical Discectomy and Fusion

Cervical Disc Herniation · Cervical Degenerative Disc Disease · Cervical Spondylotic Myelopathy · Dysphagia · Osteoarthritis of Cervical Spine

Bottom Line

View on ClinicalTrials.gov: NCT02539394 ↗

Enrolled (actual)

128

Serious AEs

5.5%

Results posted

Jul 2023

Primary outcome: Primary: Degree of Dysphagia Patients Experience (Burden) — 100; 100; 50; 75 score on a scale — p=0.394

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Methylprednisolone Acetate (Drug); Hemostatic Matrix Kit (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Hospital for Special Surgery, New York
Primary completion: Nov 2020

Outcome Measures

Outcome	Result	p-value
PRIMARY Degree of Dysphagia Patients Experience (Burden)	100; 100; 50; 75; 62.5; 75	0.394
PRIMARY Degree of Dysphagia Patients Experience (Eating Desire)	100; 100; 83.3; 87.5; 83.3; 91.7	0.043 sig
PRIMARY Degree of Dysphagia Patients Experience (Eating Duration)	100; 100; 75; 75; 50; 75	0.250
PRIMARY Degree of Dysphagia Patients Experience (Food Selection)	100; 100; 75; 93.75; 62.5; 75	0.376
PRIMARY Degree of Dysphagia Patients Experience (Communication)	100; 100; 100; 100; 100; 100	0.037 sig
PRIMARY Degree of Dysphagia Patients Experience (Fear Swallow)	100; 100; 93.75; 100; 87.5; 100	0.343
PRIMARY Degree of Dysphagia Patients Experience (Social)	100; 100; 95; 100; 85; 100	0.280
PRIMARY Degree of Dysphagia Patients Experience (Mental)	100; 100; 80; 100; 85; 97.5	0.148
PRIMARY Degree of Dysphagia Patients Experience (Sleep)	75; 81.25; 62.5; 56.25; 50; 62.5	0.161
PRIMARY Degree of Dysphagia Patients Experience (Fatigue)	83.33; 83.33; 58.33; 58.33; 58.33; 66.67	0.602
SECONDARY Patient Reported Swallowing Difficulty Over 1 Year	0; 0; 0; 0; 16; 9	0.933
SECONDARY Patients' Bazaz Dysphagia Score - Liquid	47; 54; 6; 2; 20; 36	0.121
SECONDARY Patients' Bazaz Dysphagia Score - Solid	44; 52; 8; 2; 0; 2	0.066
SECONDARY Patients' Neck Disability	35.5; 29.9; 35.3; 30.8; 27.3; 17.7	0.145
SECONDARY Patients' Pain Scores on the Visual Analog Scale - Neck Pain	54.5; 26; 51.5; 48.25; 51; 26.5	—
SECONDARY Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain	17.5; 19; 10; 5.35; 5; 6.45	—
SECONDARY Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain	20; 15.5; 2; 2.25; 3; 4	—
SECONDARY Change in Pre-vertebral Soft Tissue Swelling Over 1 Year	—	—
SECONDARY Fusion Rate	25; 23	0.99
SECONDARY Adverse Event	44; 47; 42; 46; 3; 3	—

Summary

The purpose of this study is to determine what effect intraoperative topical steroids have on reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.

Eligibility Criteria

Inclusion Criteria

Any patient > 18 years undergoing a 2-4 level Anterior Cervical Discectomy and Fusion

Exclusion Criteria

Patients undergoing revision surgery
Pediatric patients
Trauma patients with cervical spine fractures
Patients with cancer
Patients with active infection
Patients with a known allergy to Methylprednisolone Acetate
Patients who refuse to participate
Non English speakers

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02539394). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.