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
Phase: NA
Conditions: Cervical Disc Herniation, Cervical Degenerative Disc Disease, Cervical Spondylotic Myelopathy, Dysphagia, Osteoarthritis of Cervical Spine
Sponsor: Hospital for Special Surgery, New York

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 
 
NCT#:  
NCT02539394 
 
Document Date: 
2/23/2023 
 
 
 

Project Description: 
This is a randomized, prospective trial with the primary aim of evaluating the effectiveness of 
intraoperative topical steroids in decreasing the severity of swallowing difficulty following anterior 
cervical fusion surgery. 
 
Principal Investigator: 
Todd Albert, MD 
 
Hypothesis:  
The null hypothesis is that there will be no difference in swallowing difficulty between patients who do 
and patients who do not receive intraoperative topical steroids in the wound at the end of the surgical 
case. 
Outcomes: 
To determine if topical steroids placed intraoperatively in the wound of an anterior cervical discectomy 
and fusion surgery reduce the incidence of postoperative swallowing difficulty using the SWAL-QOL 
outcome measure. SWAL-QOL will be administered pre-operatively, on post-operative day one, post-
operative day two, post-operative 4-6 weeks, post-operative 3 months, post-operative 6 months, and 
post-operative 12 months. Differences in SWAL-QOL scores will be stratified based on levels fused (2-, 
3-, and 4-levels). 
The Bazaz Dysphagia Score and the Eating assessment Tool 10 (EAT-10) will be administered at the same 
time points to provide additional data about swallowing difficulty 
Additionally, questionnaires that assess how neck and arm related pain affects the patient’s quality of 
life will be administered pre-operatively (NDI & VAS) , post-operatively day 1 and 2 (VAS) , week 4-6 (NDI 
& VAS), month 3 (NDI & VAS), month 6 (NDI & VAS), and at month 12 (NDI & VAS). 
 
Background: 
Swallowing difficulties are a major side effect of anterior neck fusion surgery. Steroids have the effect of 
reducing inflammation and swelling, factors considered likely to cause swallowing difficulties following 
anterior neck surgery. This study looks to determine if steroids placed into the wound at the end of an 
anterior neck fusion surgery decrease the severity of a patient having swallowing difficulty following the 
surgery. 
Dysphagia is a serious post-operative concern in patients following anterior cervical surgery. Although 
many authors 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. Lee et al (The Spine 
Journal 2007) found the incidence of post-operative dysphagia at 1, 2, 6, and 12 months post-
operatively to be 54.2%, 33.6%, 18.6%, 15.2%, and 13.6%, respectively. Rihn et al (CORR 2011) found the 

incidence to be 71% at two weeks post-operatively. Bazaz et al (Spine 2002), found it to be 50.2%, 
32.2%, 17.8%, and 12.5% at 1, 2 6, and 12 months post-operatively. Moreover, Lee et al (Spine 2010) 
performed a systematic review and found in 17 studies the average incidence of dysphagia to be 13-21% 
at one-year post-operatively. 
This study will utilize a validated questionnaire, SWAL-QOL, to evaluate swallowing difficulty and 
dysphagia. In addition, the study will investigate these outcomes in 2-4 level ACDFs, which have not 
been examined previously. 
If topical steroid use can be proven to be safe and effective, it is a relatively inexpensive, easy measure 
to institute to diminish the occurrence of a serious complication following anterior cervical surgery and 
improve patient-reported outcomes. 
This is a randomized, prospective clinical trial. 
 
Study Drug: 
Depo-Medrol (Methylprednisolone acetate) 
This drug is FDA-approved and being utilized in an "off-label" manner. We confirmed with clinical 
research administration that the use of this drug does not require notification to the FDA or filing of an 
IND. 
 
Inclusion Criteria: 
Any patient > 18 years undergoing a 2-4 level anterior cervical discectomy and fusion 
 
Exclusion Criteria: 
• 
Revision surgery 
• 
Pediatric patients 
• 
Patients with Cervical vertebra fracture(s) 
• 
Patients with Cervical Spine Tumors 
• 
Patients with active infection 
• 
Patients with a known allergy to Depo-Medrol 
• 
Patients who refuse to participate 
• 
Non English speakers 
 
Age Range: 
>18 years 
 

Target Enrollment: 
128 
 
Interventions and Observations: 
We plan to observe the effect on SWAL-QOL scores in patients following ACDF in groups that either 
receive or do not receive intraoperative topical steroid. 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 
Depo-Medrol delivered with one SURGIFLO Hemostatic Matrix Kit (Ethicon, Somerville, NJ, USA) 
injectable delivery vehicle prior to closure in the prevertebral soft tissues. The control group will receive 
only SURGIFLO Hemostatic Matrix Kit prior to closure. The surgeon will inject the material directly in the 
pre-vertebral soft tissue. 
 
Both groups will have the same standard evaluations both pre-operatively and post operatively. The 
SWAL-QOL questionnaire will be utilized as the primary instrument to measure outcome. Other 
questionnaires, the EAT-10 and Bazaz Dysphagia Score, which grades will be used to assess dysphagia 
and swallowing difficulty. Additionally, the Neck Disability Index and the Visual Analog Scale for neck and 
arm pain will be administered to assess how neck related pain impacts the patients' quality of life. The 
EAT-10, Bazaz, and Visual Analog scale will be utilized to assess secondary outcomes. These 
questionnaire will be given to the patients to complete pre-operatively, on post-operative day one, post-
operative day two, at post-operative week 4-6, post-operative month 3, post-operative month 6, and 
post-operative month 12. The Neck Disability Index will be completed pre-operatively, at post-operative 
week 4-6, post-operative month 3, post-operative month 6, and post-operative month 12.  
 
All test or images are standard of care. Administration of the EAT-10, SWAL-QOL survey, Neck Disability 
Index, VAS (Neck and Arm Pain), and Bazaz Dysphagia Score are not standard of care. Funds are not 
required for administration of these questionnaires. 
 
Randomization: 
The randomization will be done prior to surgery.  
The randomization protocol will be stratified by procedure to ensure proper distribution of cases in the 
study. This will also ensure equivalent numbers of patients in each group over the course of the study in 
case early stopping is required as well as randomize any procedure effect that may contribute to the 
results. Randomization will be concealed using sealed opaque envelopes containing the randomization 
assignment for each enrolled patient. Randomization assignment will be made known only to the 
unblinded research assistant. 

 
Statistical Plan: 
Steroid and Control arms were compared in terms of demographics and surgical information using a 
student’s independent t-test and chi square/fisher exact test for normally distributed data, and a Mann-
Whitney U test otherwise. In terms of PROs, a Mann-Whitney U test was performed to compare the 
group medians for dysphagia scores at Baseline, Post-op Day 1, Post-op Day 2, post-operative week 4-6, 
post-operative month 3, post-operative month 6, and post-operative month 12. In addition, a pre-post 
op comparison was conducted by calculating the change in PRO from baseline to each post-operative 
time point for each patient. Statistical significance was determined for all results with p<0.05. 
 
 
 

 
 
 
 
 
 
Assessed for eligibility (n= 277) 
Excluded (n= 149) 
   Not meeting inclusion criteria (n= 10 ) 
   Declined to participate (n= 90 ) 
    Identified for consent (n= 49 ) 
Reason: Missed Enrollment Period 
Analysed (n= 56) 
 Excluded from analysis (n= 6)  
Reason: Incomplete Dataset 
Lost to follow-up (n= 1) 
Reason: Withdrawn by investigator: Pt had a 
1 level ACDF performed (exclusion). 
Discontinued intervention (n= N/A) 
Allocated to Steroid Group (n= 64) 
 Received allocated intervention (n= 63  ) 
 Did not receive allocated intervention (n= 1 ) 
Reason: Self-withdrawal prior to surgery. 
Lost to follow-up (n= 2) 
Reason: Use of BMP (exclusion) and self-
withdrawal after surgery. 
Discontinued intervention (n= N/A) 
Allocated to Control Group (n= 64) 
 Received allocated intervention (n= 61 ) 
 Did not receive allocated intervention (n= 3 ) 
Reasons: Surgery was canceled by patient, self-
withdrawal prior to surgery, Screen failure 
Analysed (n= 53) 
 Excluded from analysis (n= 6)  
Reason: Incomplete Dataset 
Allocation 
Analysis 
Follow-Up 
Randomized (n= 128) 
Enrollment