Early postoperative results of a double blind randomised clinical trial demonstrate the benefit of local intraoperative corticosteroids (LIC) delivered with an absorbable haemostatic matrix to prophylactically reduce dysphagia following anterior cervical discectomy and fusion (ACDF) surgery. The findings were superior for the treatment group, especially two days postoperatively, and were maintained at one month.
While dysphagia is a common complication in the setting of ACDF surgery, the authors note that there is controversy in the literature regarding the effectiveness of LIC in reducing postoperative dysphagia. Daniel Stein and colleagues Hospital for Special Surgery, New York, USA, therefore conducted the study to determine if the application of an LIC during multilevel ACDF surgery impacts early postoperative dysphagia severity.
Senior investigator Todd J Albert recently presented these early results during a Best Paper session at the 34th Annual Meeting of the North American Spine Society (NASS 2019; 25–28 September, Chicago, USA), concluding that treatment arm had “significantly better” dysphagia scores than the control arm.
A total of 106 adult patients undergoing primary multilevel ACDF (defined as between two and four levels) at a single institution were enrolled in the study. The patients were randomised in a double blind fashion to either arm S (Steroid) or the control arm (C). Arm S received 1ml (40g) of methylprednisolone acetate delivered with an absorbable haemostatic matrix (vehicle) to the retro-esophageal space prior to closure. The control arm only received the vehicle prior to closure.
The study group collected dysphagia specific instruments (EAT-10 and the SWAL-QOL) preoperatively, and at day one, day two, and one month postoperatively. Potential randomisation biases were assessed by comparing the preoperative characteristics and surgical treatment of the two arms. Stein and colleagues comment: “Both arms demonstrated similar preoperative characteristics and underwent similar surgical procedures”. A Friedman test was used to investigate change over time in patient reported outcomes (PRO); a Mann-Whitney U test was performed to compare the median PRO scores (S versus C) at each time point.
Ninety-five of the patients included in the study—representing 90% of the cohort—had complete datasets and were included in the analysis. The overall mean age was 57.6 years old and just under half of the patients were female (48.4%). The most common diagnoses were cervical spondylosis (63.2%), radiculopathy (48.4%), myeloradiculopathy (30.5%), and myelopathy (24.2%).
Preoperatively, the investigators also found no significant difference in PRO, with the exception of the Eat-Desire domain (p=0.049), but similar median. Overall and for each randomised arm, significant change in dysphagia scores were observed from pre- to postop. Furthermore, the comparison of postoperative PRO across the study arms revealed that the S arm had better SWAL-QOL in Food selection (p=0.049, 87.5 [50–100] vs. 75 [37.5–100]) and Fear (p=0.027, 100 [89–100] vs. 93.7 [75–100]).
At postoperative day two, the S arm had better dysphagia scores in Burden (p=0.02), Eat Duration (p=0.008), Fear (0.017), Fatigue (p=0.047), and modified Eat-10 (p=0.013). Finally, better dysphagia scores were maintained one month postoperatively in terms of Eat desire (p=0.015), Eat duration (p=0.046), Fear Swallow (p=0.016), and Fatigue (p=0.003).
The comparison of the control arm (n=47) and the S arm (n=48) revealed no significant difference in demographics, diagnosis, or surgical information in numbers of number of levels fused (2.57±0.6 vs. 2.47±0.68, p=0.268), operation time (150min±37 vs. 136min±33, p=0.065), or estimated blood loss (100cc±42 vs. 90cc±52, p=0.358).
Talking to Spinal News International, Albert comments: This study demonstrates the efficacy of local steroid application in decreasing short-term swallowing difficulty after multilevel ACDFs and opens the door for further study on the effect of fusion and longer term swallowing function and health outcomes.”