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

Dysphagia Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539394
• Other study ID #: 2014-145
• Status: Completed
• Phase: N/A
• Start date: August 2015
• Est. completion date: November 12, 2021

Study information

• Verified date: June 2023
• Source: Hospital for Special Surgery, New York
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: November 12, 2021
• Est. primary completion date: November 12, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cervical Degenerative Disc Disease
• Cervical Disc Herniation
• Cervical Spondylotic Myelopathy
• Deglutition Disorders
• Dysphagia
• Intervertebral Disc Degeneration
• Intervertebral Disc Displacement
• Osteoarthritis of Cervical Spine
• Spinal Cord Diseases

Intervention

Drug:
• Methylprednisolone Acetate
Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.

Other:
• Hemostatic Matrix Kit
Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospital for Special Surgery, New York

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Fusion Rate	Flex-Ex X-rays; Bony bridging on a CT scan; Obvious bony remodeling on lateral X-ray	12 Months
Secondary	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