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Trial record 6 of 7 for:    "Esophageal Disease" | "Methylprednisolone"

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

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ClinicalTrials.gov Identifier: NCT02539394
Recruitment Status : Active, not recruiting
First Posted : September 3, 2015
Last Update Posted : February 1, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cervical Disc Herniation Cervical Degenerative Disc Disease Cervical Spondylotic Myelopathy Dysphagia Osteoarthritis of Cervical Spine Drug: Methylprednisolone Acetate Other: Hemostatic Matrix Kit Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Study Start Date : August 2015
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019


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 Name: 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.




Primary Outcome Measures :
  1. Change in the degree of dysphagia patients experience over 1 year [ Time Frame: Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months ]

Secondary Outcome Measures :
  1. Change in 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 ]
  2. Change in patients' Bazaz Dysphagia Score over 1 year [ Time Frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months ]
  3. Change in the degree of disability caused by neck pain over 1 year [ Time Frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months ]
  4. Change in patients' pain scores on the Visual Analog Scale over 1 year [ Time Frame: Pre-Op, Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months ]
  5. 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 ]
  6. Fusion rate [ Time Frame: Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539394


Sponsors and Collaborators
Hospital for Special Surgery, New York
Investigators
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Principal Investigator: Todd Albert, MD Hospital for Special Surgery, New York

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Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT02539394     History of Changes
Other Study ID Numbers: 2014-145
First Posted: September 3, 2015    Key Record Dates
Last Update Posted: February 1, 2019
Last Verified: January 2019
Keywords provided by Hospital for Special Surgery, New York:
Anterior Cervical Discectomy and Fusion
Dysphagia
ACDF
Additional relevant MeSH terms:
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Esophageal Diseases
Methylprednisolone
Methylprednisolone Acetate
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone acetate
Prednisolone hemisuccinate
Prednisolone phosphate
Intervertebral Disc Degeneration
Deglutition Disorders
Spinal Cord Diseases
Musculoskeletal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Pharyngeal Diseases
Otorhinolaryngologic Diseases
Spinal Diseases
Bone Diseases
Central Nervous System Diseases
Nervous System Diseases
Hemostatics
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists