Locally administered steroid decreased dysphagia in patients after ACDF with BMP in level 1 study

LAS VEGAS — Results of a prospective randomized placebo-controlled and double-blinded study presented here showed steroids administered by way of a collagen sponge placed ventral to the plate in patients who underwent anterior cervical discectomy and fusion with low-dose bone morphogenetic protein was linked with a lower incidence and magnitude of dysphagia when compared with patients who received saline-soaked collagen sponges.

“This study provides level 1 evidence that the local application of steroid produces a significant reduction in the incidence and magnitude of dysphagia after [anterior cervical discectomy and fusion] ACDF with low-dose (bone morphogenetic protein)BMP,” said David Phillips, BS, during a presentation at the American Academy of Orthopaedic Surgeons Annual Meeting.

Phillips, a first-year medical student, is the study administrator for the project.

In the IRB-approved study, Phillips and colleagues randomized 50 consecutive adults undergoing 1-level, 2-level or 3-level ACDF to either a treatment or control group. Two surgeons performed all procedures using a left-sided Smith-Robinson surgical approach. The procedure involved the use of a PEEK spacer, local bone graft, plate fixation and low-dose BMP (0.35 cc or 0.5 mg per level). Immediately prior to closure, a 1 cm by 3 cm collagen sponge was placed ventral to the plate and soaked with either saline or depomedrol.

During the 4-week follow-up, a study administrator measured dysphagia at postoperative days 1, 4, 7, 14 and 28 using a customized dysphagia score that was calculated based upon patients’ responses to questions about their difficulty swallowing liquids or solids.

“Surprisingly, a significant difference in clinical outcomes for superiority of steroid was found and enrollment was thus discontinued at that point for ethical reasons as there was no longer apropos with respect to the treatment arms,” Phillips said.

According to Phillips, the incidence of dysphagia to any degree was similar between the groups on postoperative day 1.

“But at each subsequent time point, depomedrol had a significantly lower incidence of dysphagia,” he said.

Similarly, Phillips said the magnitude of dysphagia was similar between the groups on postoperative day 1, “whereas for each of the subsequent time points, they were significantly different with a substantially lower magnitude of dysphagia observed in the steroid group.”

The effect of the steroid in reducing the magnitude of dysphagia was clear and persistent throughout the study, and the treatment even proved beneficial in a subset of patients with moderate to severe dysphagia, he said. – by Gina Brockenbrough, MA

Reference:

Phillips D, et al. Paper #58. Presented at: American Academy of Orthopaedic Surgeons Annual Meeting; March 23-28, 2015; Las Vegas.

Disclosure: Phillips reports no relevant financial disclosures.