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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02539394
Recruitment Status : Active, not recruiting
First Posted : September 3, 2015
Last Update Posted : January 18, 2020
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Tracking Information
First Submitted Date  ICMJE August 27, 2015
First Posted Date  ICMJE September 3, 2015
Last Update Posted Date January 18, 2020
Study Start Date  ICMJE August 2015
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
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 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 31, 2015)
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • 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 ]
  • Fusion rate [ Time Frame: Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Topical Corticosteroids on Dysphagia in Anterior Cervical Discectomy and Fusion
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Cervical Disc Herniation
  • Cervical Degenerative Disc Disease
  • Cervical Spondylotic Myelopathy
  • Dysphagia
  • Osteoarthritis of Cervical Spine
Intervention  ICMJE
  • 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.
Study Arms  ICMJE
  • 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.
    Interventions:
    • Drug: Methylprednisolone Acetate
    • Other: Hemostatic Matrix Kit
  • Placebo Comparator: Control
    Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.
    Intervention: Other: Hemostatic Matrix Kit
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: January 31, 2019)
120
Original Estimated Enrollment  ICMJE
 (submitted: August 31, 2015)
100
Estimated Study Completion Date  ICMJE December 2021
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02539394
Other Study ID Numbers  ICMJE 2014-145
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Hospital for Special Surgery, New York
Study Sponsor  ICMJE Hospital for Special Surgery, New York
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Todd Albert, MD Hospital for Special Surgery, New York
PRS Account Hospital for Special Surgery, New York
Verification Date January 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP