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

Not Applicable

Completed

Conditions: Dysphagia
Osteoarthritis of Cervical Spine
Cervical Degenerative Disc Disease
Cervical Disc Herniation
Cervical Spondylotic Myelopathy

Interventions: Drug: Methylprednisolone Acetate
Other: Hemostatic Matrix Kit

Registration Number: NCT02539394

Lead Sponsor: Hospital for Special Surgery, New York

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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 128

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 & Design

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment	Hemostatic Matrix Kit	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.
Treatment	Methylprednisolone Acetate	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.
Control	Hemostatic Matrix Kit	Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Patients' Neck Disability	Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months	Neck Disability Index (NDI) Range from 0 to 100 (best-worst)
Patient Reported Swallowing Difficulty Over 1 Year	Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months	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
Patients' Bazaz Dysphagia Score - Solid	Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months	Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods.
Fusion Rate	12 Months	1. Flex-Ex X-rays 2. Bony bridging on a CT scan 3. Obvious bony remodeling on lateral X-ray
Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain	Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months	Visual Analog Scale (VAS) - Left arm pain Range from 0 to 100 (best-worst)
Patients' Bazaz Dysphagia Score - Liquid	Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months	Bazaz dysphagia scale defines dysphagia as none, mild, moderate and severe, depending on patients' symptoms with solid and liquid foods.
Patients' Pain Scores on the Visual Analog Scale - Neck Pain	Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months	Visual Analog Scale (VAS) - Neck pain Range from 0 to 100 (best-worst)
Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain	Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months	Visual Analog Scale (VAS) - Right arm pain Range from 0 to 100 (best-worst)
Change in Pre-vertebral Soft Tissue Swelling Over 1 Year	Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months	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.
Adverse Event	12 month	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)