Clinical trial NCT02539394: Effect of Topical Corticosteroids on Dysphagia in Anterior Cervical Discectomy and Fusion
Official title: Do Intraoperative Topical Corticosteroids Aid in the Prevention of Postoperative Dysphagia Following Elective Anterior Cervical Discectomy and Fusion? A Randomized, Controlled, Double Blinded Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cervical Disc Herniation
Cervical Degenerative Disc Disease
Cervical Spondylotic Myelopathy
Dysphagia
Osteoarthritis of Cervical Spine
Keywords: Anterior Cervical Discectomy and Fusion
Dysphagia
ACDF
Lead sponsor: Hospital for Special Surgery, New York
Sponsor class: OTHER
First posted: 2015-09-03
Enrollment: 128
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

Detailed description: Background: Dysphagia is a serious post-operative concern in patients following anterior cervical surgery. Although many experts have acknowledged that dysphagia is often incompletely understood and defined, there is a significant amount of literature to support the significance of this clinical entity. This is the first randomized study to examine the use of topical steroids for the prevention of dysphagia postoperatively after anterior cervical discectomy and fusion.

Study Design: This study is a single site, double blinded randomized control trial. All individuals undergoing 2-4 level ACDF that meet the inclusion criteria will be randomized to either:

1. treatment arm or
2. control arm.

Both arms will undergo their planned surgeries and will receive the exact same procedure and standard of care as if they were not enrolled in a study. The only difference is that the treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with one Hemostatic Matrix Kit injectable delivery vehicle prior to closure in the prevertebral soft tissues. The control group will receive only Hemostatic Matrix Kit prior to closure in the prevertebral soft tissues.

Outcomes: Patients will be asked to fill out questionnaires that assess dysphagia, general swallowing difficulty, and how neck pain impacts their quality of life. Additionally Radiographic images will be obtained at set time points to evaluate soft tissue inflammation and bony fusion.

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

Primary outcomes:
measure: Degree of Dysphagia Patients Experience (Burden)
timeFrame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Degree of Dysphagia Patients Experience (Eating Desire)
timeFrame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Degree of Dysphagia Patients Experience (Eating Duration)
timeFrame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Degree of Dysphagia Patients Experience (Food Selection)
timeFrame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Degree of Dysphagia Patients Experience (Communication)
timeFrame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Degree of Dysphagia Patients Experience (Fear Swallow)
timeFrame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Degree of Dysphagia Patients Experience (Social)
timeFrame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Degree of Dysphagia Patients Experience (Mental)
timeFrame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Degree of Dysphagia Patients Experience (Sleep)
timeFrame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Degree of Dysphagia Patients Experience (Fatigue)
timeFrame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Secondary outcomes:
measure: Patient Reported Swallowing Difficulty Over 1 Year
timeFrame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Patients' Bazaz Dysphagia Score - Liquid
timeFrame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Patients' Bazaz Dysphagia Score - Solid
timeFrame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Patients' Neck Disability
timeFrame: Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Patients' Pain Scores on the Visual Analog Scale - Neck Pain
timeFrame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain
timeFrame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain
timeFrame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Change in Pre-vertebral Soft Tissue Swelling Over 1 Year
timeFrame: Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months
measure: Fusion Rate
timeFrame: 12 Months
measure: Adverse Event
timeFrame: 12 month
Other outcomes:
Locations:
Study officials:
affiliation: Hospital for Special Surgery, New York
name: Todd Albert, MD
role: PRINCIPAL_INVESTIGATOR
References: