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

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

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.

Study Overview

• Status: Completed
• Conditions: Dysphagia; Cervical Disc Herniation; Cervical Degenerative Disc Disease; Cervical Spondylotic Myelopathy; Osteoarthritis of Cervical Spine
• Intervention / Treatment: Drug: Methylprednisolone Acetate; Other: Hemostatic Matrix Kit

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.

• Study Type: Interventional
• Enrollment (Actual): 128
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure.	Drug: Methylprednisolone Acetate; Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.; Other Names: Depo-Medrol; Other: Hemostatic Matrix Kit; Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.
Placebo Comparator: Control; Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.	Other: Hemostatic Matrix Kit; Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Degree of Dysphagia Patients Experience (Burden)	SWAL-QOL survey - Burden domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Eating Desire)	SWAL-QOL survey - Eating desire domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Eating Duration)	SWAL-QOL survey - Eating duration domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Food Selection)	SWAL-QOL survey - Food Selection domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Communication)	SWAL-QOL survey - Communication domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Fear Swallow)	SWAL-QOL survey - Fear swallow domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Social)	SWAL-QOL survey - Social domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Mental)	SWAL-QOL survey - Mental domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Sleep)	SWAL-QOL survey - Sleep domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Degree of Dysphagia Patients Experience (Fatigue)	SWAL-QOL survey - Fatigue domain Score ranges between 0 and 100 (worst-best)	Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Reported Swallowing Difficulty Over 1 Year	The Eating Assessment Tool (EAT-10) is used to screen for self-perceived oropharyngeal dysphagia (OD) in community-dwelling elders. A summated EAT-10 total score ranges from 0 to 40, with a score ≥ 3 indicative of OD. Modified Eat-10 : Eat-10 questionnaire without questions 1 ("My swallowing problem has caused me to lose weight") and 2 ("My swallowing problem interferes with my ability to go out for meals") to be applicable during hospitalization. Eat-10 interpretation: Score ranging from 0 to 40 (best-worst); each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response Modified EAT-10 interpretation: Score ranging from 0 to 32 (best-worst); each question response is 0-4, 0=no problem and 4=severe problem; score is a summation of each question's response	Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Patients' Bazaz Dysphagia Score - Liquid	Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods.	Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Patients' Bazaz Dysphagia Score - Solid	Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods.	Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Patients' Neck Disability	Neck Disability Index (NDI) Range from 0 to 100 (best-worst)	Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months
Patients' Pain Scores on the Visual Analog Scale - Neck Pain	Visual Analog Scale (VAS) - Neck pain Range from 0 to 100 (best-worst)	Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain	Visual Analog Scale (VAS) - Left arm pain Range from 0 to 100 (best-worst)	Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain	Visual Analog Scale (VAS) - Right arm pain Range from 0 to 100 (best-worst)	Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months
Change in Pre-vertebral Soft Tissue Swelling Over 1 Year	We are unable to report this outcome measure because soft tissue swelling was not assessed. The PI deemed it would not be included for this study as there is not a clinical or research standard to do so, nor is there normative data over time to compare against. Thus, data were not collected.	Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months
Fusion Rate	Flex-Ex X-rays; Bony bridging on a CT scan; Obvious bony remodeling on lateral X-ray	12 Months
Adverse Event	Adverse Event (AE) following surgical treatment. Adverse event were classified by severity based on the AO-ISSG criteria and treatment required: Mild: Observed, medication, consult, X-ray. Essentially any management that was quick and easy and could be done at bedside Moderate: ICU admission, re-intubation, complication that had a documented prolonged hospital stay, medical procedure (such as flexible endoscopy), re-presentation to ED Severe: Inpatient re-admission, return to OR for any reason, mortality, failed OR. AE were also categorize as Surgery-site related or unrelated adverse event. Finally, AE were also categorize as potentially related to steroid use (example: leukocytosis, pseudoarthrosis, or wound complications)	12 month

Collaborators and Investigators

• Sponsor: Hospital for Special Surgery, New York
• Investigators: Principal Investigator: Todd Albert, MD, Hospital for Special Surgery, New York

Study record dates

Study Major Dates

• Study Start: August 1, 2015
• Primary Completion (Actual): November 12, 2020
• Study Completion (Actual): November 12, 2021

Study Registration Dates

• First Submitted: August 27, 2015
• First Submitted That Met QC Criteria: August 31, 2015
• First Posted (Estimated): September 3, 2015

Study Record Updates

• Last Update Posted (Actual): July 10, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Dysphagia; ACDF; Anterior Cervical Discectomy and Fusion
• Additional Relevant MeSH Terms: Digestive System Diseases; Central Nervous System Diseases; Nervous System Diseases; Gastrointestinal Diseases; Musculoskeletal Diseases; Pharyngeal Diseases; Otorhinolaryngologic Diseases; Pathological Conditions, Anatomical; Spinal Diseases; Bone Diseases; Esophageal Diseases; Hernia; Intervertebral Disc Displacement; Deglutition Disorders; Intervertebral Disc Degeneration; Spinal Cord Diseases; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antineoplastic Agents; Antiemetics; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Antineoplastic Agents, Hormonal; Neuroprotective Agents; Protective Agents; Coagulants; Prednisolone; Methylprednisolone Acetate; Methylprednisolone; Methylprednisolone Hemisuccinate; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate; Hemostatics
• Other Study ID Numbers: 2014-145