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

Hospital for Special Surgery (HSS)

Status: Completed

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

Treatments: Drug: Methylprednisolone Acetate; Other: Hemostatic Matrix Kit

Study type: Interventional

Funder types: Other

Identifiers

NCT02539394

2014-145

Details and patient eligibility

About

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.

Full 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.

Enrollment: 128 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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128 participants in 2 patient groups, including a placebo group

Treatment

Experimental group

Description:

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.

Treatment:

Other: Hemostatic Matrix Kit

Drug: Methylprednisolone Acetate

Control

Placebo Comparator group

Description:

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

Treatment:

Other: Hemostatic Matrix Kit