Skip to main content
OpenTrials
Completed

NCT Number: NCT02539394

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cervical Disc Herniation Cervical Degenerative Disc Disease Cervical Spondylotic Myelopathy Deglutition Disorders Digestive System Diseases Dysphagia Esophageal Diseases Gastrointestinal Diseases Osteoarthritis of Cervical Spine Otorhinolaryngologic Diseases Pharyngeal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Methylprednisolone Acetate

Drug

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

Other names: Depo-Medrol

Hemostatic Matrix Kit

Other

Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.

Primary outcomes

  1. Degree of Dysphagia Patients Experience (Burden)

    Time frame: 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)

  2. Degree of Dysphagia Patients Experience (Eating Desire)

    Time frame: 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)

  3. Degree of Dysphagia Patients Experience (Eating Duration)

    Time frame: 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)

  4. Degree of Dysphagia Patients Experience (Food Selection)

    Time frame: 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)

  5. Degree of Dysphagia Patients Experience (Communication)

    Time frame: 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)

  6. Degree of Dysphagia Patients Experience (Fear Swallow)

    Time frame: 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)

  7. Degree of Dysphagia Patients Experience (Social)

    Time frame: 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)

  8. Degree of Dysphagia Patients Experience (Mental)

    Time frame: 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)

  9. Degree of Dysphagia Patients Experience (Sleep)

    Time frame: 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)

  10. Degree of Dysphagia Patients Experience (Fatigue)

    Time frame: 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 outcomes

  1. Patient Reported Swallowing Difficulty Over 1 Year

    Time frame: 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

  2. Patients' Bazaz Dysphagia Score - Liquid

    Time frame: 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.

  3. Patients' Bazaz Dysphagia Score - Solid

    Time frame: 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.

  4. Patients' Neck Disability

    Time frame: Pre-Op, Week 4-6, 3 Months, 6 Months, 12 Months

    Neck Disability Index (NDI) Range from 0 to 100 (best-worst)

  5. Patients' Pain Scores on the Visual Analog Scale - Neck Pain

    Time frame: 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)

  6. Patients' Pain Scores on the Visual Analog Scale - Left Arm Pain

    Time frame: 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)

  7. Patients' Pain Scores on the Visual Analog Scale - Right Arm Pain

    Time frame: 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)

  8. Change in Pre-vertebral Soft Tissue Swelling Over 1 Year

    Time frame: 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.

  9. Fusion Rate

    Time frame: 12 Months

    • Flex-Ex X-rays
    • Bony bridging on a CT scan
    • Obvious bony remodeling on lateral X-ray

  10. Adverse Event

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hospital for Special Surgery, New York

Other

Registry information

Official study 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

Important dates

Study start
2015
Primary completion
2020
Study completion
2021
First posted
Sep 3, 2015
Registry last updated
Jul 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.