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

NCT ID: NCT02539394

Last Updated: 2023-07-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 128 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-08-31
• Study Completion Date: 2021-11-12

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.

Conditions

Cervical Disc Herniation; Cervical Degenerative Disc Disease; Cervical Spondylotic Myelopathy; Dysphagia; Osteoarthritis of Cervical Spine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Methylprednisolone Acetate

Intervention Type: DRUG

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

Hemostatic Matrix Kit

Intervention Type: OTHER

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

Control

Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.

Group Type: PLACEBO_COMPARATOR

Hemostatic Matrix Kit

Intervention Type: OTHER

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

Interventions

Methylprednisolone Acetate

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

Intervention Type: DRUG

Hemostatic Matrix Kit

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

Intervention Type: OTHER

Other Intervention Names

Depo-Medrol

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital for Special Surgery, New York

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Todd Albert, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital for Special Surgery, New York

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

2014-145

Identifier Type: -

Identifier Source: org_study_id