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

Study Overview
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Brief Summary
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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
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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: treatment arm or 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.

Official Title
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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

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

Intervention / Treatment
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* Drug: Methylprednisolone Acetate
* Other: Hemostatic Matrix Kit


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br>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<br>* Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation.<br>* Other names: Depo-Medrol;Other: Hemostatic Matrix Kit<br>* Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.<br>|
| Placebo Comparator: Control<br>Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure. | Other: Hemostatic Matrix Kit<br>* Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anterior Cervical Discectomy and Fusion, Dysphagia, ACDF