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

Sponsor

Hospital for Special Surgery, New York (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT02539394

Collaborator

(none)

120

Enrollment

Arms

Duration (Months)

Study Details

Study Description

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	N/A

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:

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.

Study Design

Study Type:

Interventional

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 :

Aug 1, 2015

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 1, 2021

Arms and Interventions

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 Names: 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.

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 Names:

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.

Outcome Measures

Primary Outcome Measures

Change in the degree of dysphagia patients experience over 1 year [Post-Op Day 1, Post-Op Day 2, Week 4-6, 3 Months, 6 Months, 12 Months]

Secondary Outcome Measures

Change in patient reported swallowing difficulty over 1 year [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 [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 [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 [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 [Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months]
Fusion rate [Pre-Op, Post-Op Day 1, Week 4-6, 3 Months, 6 Months, 12 Months]