Effect of Local Intraoperative Steroid on Dysphagia After ACDF

• Status: Completed
• Trial end date: 2019-07-20
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to determine if the incidence and duration of postoperative dysphagia are improved in the participants receiving a local injection of methylprednisolone with systemic dexamethasone when compared to those receiving the usual systemic dexamethasone.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Rush University Medical Center
• Treatments: BB 1101; Dexamethasone; Dexamethasone acetate; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

Criteria

Inclusion Criteria:

• Patients undergoing a primary 1- to 3-level ACDF:

(a) Diagnosis: myelopathy, radiculopathy, myeloradiculopathy, stenosis, herniated nucleus pulposus, degenerative disc disease, spondylosis, osteophytic complexes, and foraminal stenosis

• Patients able to provide informed consent

Exclusion Criteria:

• Allergies or other contraindications to medicines in the protocol including:

(a) Existing history gastrointestinal bleeding

• Existing history of dysphagia

• Current Smokers

• Cervical spine trauma