Clinical trial NCT02577991
Conditions: Cervical Spine
Sponsor: Northwestern University
Start date: 2014-02-01; Completion date: 2017-06-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Local application of steroids in ACDF surgery will lead to decreased incidence of dysphagia compared to intravenous steroids or a control group

Detailed description:
Dysphagia is a common complication after ACDF. PSTS is also a natural sequela of ACDF and can lead to airway compromise among other complications. Previous studies have demonstrated that administration of intravenous methylprednisolone (1mg/kg) after anterior cervical spine surgery reduced the incidence of pharyngolaryngeal lesions as identified by nasofibroscopic examination. Lee et al. prospectively evaluated 50 patients and determined that local application of steroids in the retropharyngeal area following ACDF reduced PSTS and odynophagia as measured by the Visual Analogue Scale (VAS) and the Neck Disability Index (NDI) compared to a control group. Furthermore, there were no adverse events/reactions from local application of steroid on a gel foam sponge in the setting of anterior spinal surgery. There are no studies in the current literature that investigate the incidence of dysphagia with application of local steroids after ACDF, nor are there any studies that stratify the efficacy of local steroids compared to intravenous steroids. There is also no current spine literature that directly compares the efficacy of intravenous steroids versus local steroids in the incidence of dysphagia or dysphonia. Our study will be the first in the literature to assess the efficacy of local steroids in reducing the incidence of dysphagia after anterior cervical spine surgery, and as a result, may improve patient outcomes after ACDF.

Dysphagia and dysphonia are common complications after anterior cervical spine surgery. Despite their clinical importance, studies on the treatment and/or prevention of these complications are limited due to the lack of valid and reliable outcome measures. The majority of research is found in the otolaryngology literature and has focused on disease pathophysiology, diagnosis, and therapy.

The Bazaz score has been used in the spine literature to evaluate dysphagia after anterior cervical discectomy and fusion (ACDF). This is a subjective questionnaire that has not been validated in the literature. Additionally, new patient-centered outcome measures, the Eating Assessment Tool (EAT-10) and Voice Handicap Index (VHI-10) have recently been developed, and in addition to the Bazaz score, have been shown to have excellent validity and reliability in the ENT patient population. These instruments can be used to document the initial dysphagia or dysphonia severity and monitor the treatment response in people with a wide array of swallowing and voice disorders.

Arms: arm 1: No steroid arm 2: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate arm 3: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate
Interventions: intervention 1: Decadron intervention 2: Triamcinolone
Intervention descriptions: intervention 1: 10 mg of intraoperative intravenous decadron with gel foam sponge placed on cervical plate intervention 2: 40 mg of triamcinolone on gel foam sponge dabbed on the anterior cervical plate

Protocol documents:
Prot_SAP_000.pdf: 
 
Version Date: 12/14/2015 
 
 
- 1 - 
 
A SINGLE BLIND, PROSPECTIVE, RANDOMIZED CONTROLLED TRIAL ON THE 
EFFECT OF LOCAL STEROID APPLICATION VERSUS INTRAVENOUS STEROIDS 
ON DYSPHAGIA FOLLOWING ANTERIOR CERVICAL DISECTION AND FUSION  
 
 
PRINCIPAL INVESTIGATOR:  
Alpesh A. Patel, MD, FACS 
 
Jason Savage, MD 
 
676 N. St. Clair, Suite 1350 
 
312-695-7540 
 
312-926-4643 
 
alpesh.patel@nm.org 
 
SUB-INVESTIGATORS: 
Rueben Nair, MD 
 
Northwestern University 
 
 
 
 
 
Wellington Hsu, MD 
 
Northwestern University 
 
 
 
Dr. Raymond Hah, MD 
 
University of Wisconsin-Madison 
 
 
Dr. Leo Spector, MD 
 
OrthoCarolina Research Institute 
 
 
PARTICIPATING SITES: 
Northwestern Memorial Faculty Foundation 
(NMFF) 
 
675 N. St. Clair, Suite 17-100 
 
Chicago, IL 60611 
 
312-695-6800 
 
 
 
Northwestern University (NU) 
 
676 N. St. Clair, Suite 1350 
 
Chicago, IL 60611 
 
 
 
OrthoCarolina Research Institute 
 
001 Vail Avenue, Suite 300 
 
Charlotte, NC 28207 
 
 
 
University of Wisconsin-Madison 
 
 
FUNDING AGENCY: 
 
Cervical Spine Research Society (CSRS) 
 
 
 
 
Synopsis 


 
Version Date: 12/14/2015 
 
 
- 2 - 
 
 
Title 
A single blind, prospective, randomized controlled trial on the effect of 
local steroid application versus intravenous steroids on dysphagia 
following anterior cervical discectomy and fusion (ACDF) 
Short Title 
Effect of local application vs. IV steroids on dysphagia after ACDF 
Protocol Date 
12/14/2015 
Study Duration 
2 years 
Study Center(s) 
Northwestern Memorial Faculty Foundation (NMFF), Northwestern 
University (NU), University of Wisconsin-Madison, OrthoCarolina 
Research Institute 
Objectives 
Local application of steroids in ACDF surgery will lead to decreased 
incidence of dysphagia compared to intravenous steroids or a control 
group 
Number of Subjects 
85 (randomized to group I (control group), group II (10 mg of 
intraoperative intravenous decadron), or group III (40mg of 
triamcinolone placed on cervical plate), i.e. 25 per group. 
Diagnosis and Main 
Inclusion Criteria 
Patients undergoing ACDF (single or multi-level) for the treatment of 
radiculopathy or myelopathy by Drs. Hsu, Patel, and Savage. 


 
Version Date: 12/14/2015 
 
 
- 3 - 
 
TABLE OF CONTENTS 
Synopsis ...........................................................................................................................................2 
 
1.0  Introduction .............................................................................................................................4 
 
2.0  Study Objectives...................................................................................................................4,5 
 
3.0  Selection of Subjects ...............................................................................................................5 
3.1  Inclusion Criteria ...................................................................................................................5 
3.2  Exclusion Criteria ..................................................................................................................5 
 
4.0  Subject Registration................................................................................................................5 
 
5.0  Study Design & Methods .....................................................................................................5,6 
 
6.0  Statistical Plan .........................................................................................................................6 
 
7.0  Data Collection & Record Keeping .......................................................................................6 
 
8.0  References ................................................................................................................................7 
 
Appendices ......................................................................................................................................8 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
Version Date: 12/14/2015 
 
 
- 4 - 
 
1.0 
INTRODUCTION - BACKGROUND AND RATIONALE  
Dysphagia is a common complication after ACDF.1  PSTS is also a natural sequela of 
ACDF and can lead to airway compromise among other complications.2  Previous studies 
have demonstrated that administration of intravenous methylprednisolone (1mg/kg) after 
anterior cervical spine surgery reduced the incidence of pharyngolaryngeal lesions as 
identified by nasofibroscopic examination.3  Lee et al. prospectively evaluated 50 patients 
and determined that local application of steroids in the retropharyngeal area following 
ACDF reduced PSTS and odynophagia as measured by the Visual Analogue Scale (VAS) 
and the Neck Disability Index (NDI) compared to a control group.4  Furthermore, there 
were no adverse events/reactions from local application of steroid on a gel foam sponge 
in the setting of anterior spinal surgery.  There are no studies in the current literature that 
investigate the incidence of dysphagia with application of local steroids after ACDF, nor 
are there any studies that stratify the efficacy of local steroids compared to intravenous 
steroids. There is also no current spine literature that directly compares the efficacy of 
intravenous steroids versus local steroids in the incidence of dysphagia or dysphonia.  
Our study will be the first in the literature to assess the efficacy of local steroids in 
reducing the incidence of dysphagia after anterior cervical spine surgery, and as a result, 
may improve patient outcomes after ACDF. 
 
Dysphagia and dysphonia are common complications after anterior cervical spine 
surgery.1 Despite their clinical importance, studies on the treatment and/or prevention of 
these complications are limited due to the lack of valid and reliable outcome measures. 
The majority of research is found in the otolaryngology literature and has focused on 
disease pathophysiology, diagnosis, and therapy.   
 
The Bazaz score has been used in the spine literature to evaluate dysphagia after anterior 
cervical discectomy and fusion (ACDF).5 This is a subjective questionnaire that has not 
been validated in the literature.  Additionally, new patient-centered outcome measures, 
the Eating Assessment Tool (EAT-10) and Voice Handicap Index (VHI-10) have recently 
been developed, and in addition to the Bazaz score, have been shown to have excellent 
validity and reliability in the ENT patient population.6 These instruments can be used to 
document the initial dysphagia or dysphonia severity and monitor the treatment response 
in people with a wide array of swallowing and voice disorders.   
 
2.0 
OBJECTIVES 
 To determine if the use of steroids decreases the incidence of dysphasia after 
anterior cervical discectomy and fusion (ACDF).   
 If steroids are useful, determine which method of steroid administration is most 
efficacious (IV versus local application).   
 We hypothesize that local application of steroids in ACDF surgery will lead to a 
decreased incidence of dysphagia, in the postoperative period as compared to 
intravenous steroids or a control group. 
 To evaluate the incidence of dysphonia, as measured by the Voice Handicap 
Index (VHI-10), as well as other validated outcome measures (NDI, VAS, EQ-
5D).  
  


 
Version Date: 12/14/2015 
 
 
- 5 - 
 
3.0 
SELECTION OF SUBJECTS 
 
3.1 
INCLUSION CRITERIA: 
 All patients undergoing ACDF (single or multi-level) for the treatment of 
cervical radiculopathy or myelopathy with Drs. Hsu, Patel, and Savage. 
 All subjects must have given signed, informed consent prior to registration on 
study. 
  
 
3.2 
EXCLUSION CRITERIA 
 Patients undergoing revision surgery, any operations for trauma, infection, 
tumor 
 Patients with general metabolic diseases such as rheumatoid arthritis, diabetes, 
chronic heart and renal diseases.   
 
4.0 
SUBJECT REGISTRATION  
The subjects will be recruited by the PI, co-investigators, or authorized study staff at the 
orthopaedic surgery clinic or prior to their ACDF surgery in the pre-operative hold area 
in. The study will be reviewed with the subjects and they will be consented by the PI, co-
investigator, or other authorized study staff. 
 
Each collaborating site will be involved in subject recruitment, consent, and all data 
collection for any patients that are enrolled in the study at each respective site. 
 
5.0 
STUDY DESIGN & METHODS 
We intend to prospectively evaluate 85 patients as part of a single blind, randomized 
controlled study.  Subjects would be randomized to group I (control group, no steroid), 
group II (10 mg of intraoperative intravenous decadron with gel foam sponge placed on 
cervical plate), or group III (40mg of triamcinolone on gel foam sponge dabbed on the 
anterior cervical plate).  Subjects will be blinded to the treatment arm.  Randomization 
will take place on the day of surgery.  85 envelopes will be sealed, 25 of which will 
contain a document specifying “control”, “iv steroids”, or “steroid sponge”.  The 75 
envelopes will then be shuffled to create a random assortment.  The circulating nurse in 
the OR will at random choose one envelop prior to the start of the operative procedure.  
This will in turn specify the treatment group for each patient. 
 
There is no standard of care regarding the use of IV or local steroids in the setting of 
ACDF.  Currently, the use of either IV or local steroids is at the discretion of the 
attending surgeon.  To my knowledge, there are several spine surgeons at our institution 
that currently use no steroid, and others who use a combination of IV and/or local 
steroids.      
The primary outcome measure is the incidence of dysphagia as measured by Eating 
Assessment Tool (EAT-10) and the Bazaz score.  The patients will prospectively fill out 
these surveys preoperatively, post-operative day 1, week 2, week 6, month 3, month 6, 
and 1 year as a measure of dysphagia.    The standard of care is to see patients in the 
office at 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery, and therefore, 
no extra visits will be necessary for this study.  X-rays will be taken at 6 weeks, 3 


 
Version Date: 12/14/2015 
 
 
- 6 - 
 
months, and 12 months post-op, which is the current standard of care.  No additional x-
rays will be obtained.   
 
A secondary outcome measure will be the incidence of dysphonia, as measured by the 
Voice Handicap Index (VHI-10), as well as other validated outcome measures (NDI, 
VAS, EQ-5D).  The questionnaires will take approximately 20 minutes to complete and 
will be administered in the hospital, during the post-operative clinic visits with the 
surgeon, or over the phone. The surgeons will also listen to the patient’s voice at these 
different time points and comment on dysphonia as being absent, mild, moderate, or 
severe.  
 
Additionally, a chart review will be performed from11/01/2013 to 12/30/2016 from NMH 
Medical records (PRIMES, Cerner PowerChart) and NMFF Medical Records (EpicCare, 
IDX/GE Centricity) to obtain the following data: Complications such as infection, post-
operative hematoma, airway compromise, and recurrent laryngeal nerve palsy. All data 
collected from chart review will be de-identified and noted on the Data Collection Form. 
Each subject will be assigned a study number and all data will be linked to that number 
using the Coded Identifier List. The PI will identify which charts will be reviewed. The 
chart review will be performed by the PI, co-investigators, or authorized study 
coordinator.  
 
There are potential physical risks from being in this study.  The use of steroids may have 
an adverse effect on wound healing and/or transiently elevate blood sugar.  There have 
been no documented wound complications from using either IV or local steroids in the 
setting of ACDF.  Furthermore, we purposely excluded patients with a history of diabetes 
or other endocrine disorder in an attempt to minimize this potential side-effect or 
complication. Another possible risk related with participation in this study is the loss of 
privacy. To reduce these risks, all of the information collected will be de-identified and 
stored in a password protected file on a password protected computer. Additionally, some 
of the questions asked in the surveys may be upsetting, or the subject may feel 
uncomfortable answering them. If the subject does not wish to answer a question, they 
may skip it and go to the next question. 
 
6.0 
STATISTICAL PLAN  
We will use T score or ANOVA to compare EAT-10 scores, VHI scores, andEQ-5D, and 
Chi square for subjective findings.  The P value will be set at 0.05. 
 
A power analysis was performed to determine the sample size needed.  Based on 
previous studies evaluating the EAT-10 in normal patients and those with dysphasia the 
analysis concluded: with total sample size 85 (Group I: 25, Group II: 25, Group III: 25) 
and estimated standard deviation of EAT-10 as 12.7, power = 0.92 
 
Drs. Savage, Patel, and Hsu, perform approximately 6 ACDFs a month. This would allow 
us to collect our proposed sample size in approximately 12-14 months. 
 
7.0 
DATA COLLECTION & RECORD KEEPING 


 
Version Date: 12/14/2015 
 
 
- 7 - 
 
All information regarding the nature of the proposed investigation provided to the 
investigator (with the exception of information required by law or regulations to be 
disclosed to the IRB, the subject, or the appropriate regulatory authority) will be kept in 
confidence by the investigator. All personal information will be treated as strictly 
confidential and not made publicly available.  All records and appendices are stored in 
separate locked filling cabinets as well as a password protected computers which are 
accessed only by the Principal Investigator, co-investigator, and authorized study staff. 
All identifiable data will be destroyed a year after the study is complete. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
Version Date: 12/14/2015 
 
 
- 8 - 
 
9.0 
REFERENCES  
 
1. Fountas KN, Kapsalaki EZ, Nikolakakos LG, et al. Anterior cervical discectomy and fusion 
associated complications. Spine, Oct 2007; 32(21):2310-7 
 
2. Sanfillipo JA Jr, Lim MR, Jacoby SM, et al. “Normal” prevertebral soft tissue swelling 
following elective anterior cervical decompression and fusion.  J Spinal Disord Tech, Aug 2006; 
19(6):399-401 
 
3. Pedram M, Castagnera L, Carat X, et al. Pharyngolaryngeal lesions in patients undergoing 
cervical spine surgery through the anterior approach: contribution of methylprednisolone.  Eur 
Spine J, Feb 2003;12(1):84-90 
 
4. Lee SH, Kim KT, Suk KS, et al. Effect of retropharyngeal steroid on prevertebral soft tissue 
swelling following anterior cervical discectomy and fusion: a prospective, randomized study. 
Spine, Dec 2011;36(26):2286-92 
 
5. McAfee PC, Cappuccino A, Cunningham BW, et al. Lower incidence of dysphagia with 
cervical arthroplasty compared with ACDF in a prospective randomized clinical trial. J Spinal 
Disord Tech, Feb 2010;23(1):1-8 
 
6. Belafsky PC, Mouadeb DA, Rees CJ, et al. Validity and reliability of the Eating Assessment 
Tool (EAT-10).  Ann Otol Rhinol Laryngol, Dec 2008; 117(12);919-24 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 


 
Version Date: 12/14/2015 
 
 
- 9 - 
 
APPENDICES 
 
CODED IDENTIFIER FORM 
 
Unique subject identifier 
Last 
Name 
First Name 
MRN 
1 
 
 
 
2 
 
 
 
3 
 
 
 
4 
 
 
 
5 
 
 
 
6 
 
 
 
7 
 
 
 
8 
 
 
 
9 
 
 
 
10 
 
 
 
11 
 
 
 
12 
 
 
 
13 
 
 
 
14 
 
 
 
15 
 
 
 
16 
 
 
 
17 
 
 
 
18 
 
 
 
19 
 
 
 
20 
 
 
 
21 
 
 
 
22 
 
 
 
23 
 
 
 
24 
 
 
 
25 
 
 
 
26 
 
 
 
27 
 
 
 
28 
 
 
 
29 
 
 
 
30 
 
 
 
31 
 
 
 
32 
 
 
 
33 
 
 
 
34 
 
 
 
35 
 
 
 
36 
 
 
 
37 
 
 
 
38 
 
 
 


 
Version Date: 12/14/2015 
 
 
- 10 - 
 
Unique subject identifier 
Name 
MRN 
Number 
Telephone Number 
39 
 
 
 
40 
 
 
 
41 
 
 
 
42 
 
 
 
43 
 
 
 
44 
 
 
 
45 
 
 
 
46 
 
 
 
47 
 
 
 
48 
 
 
 
49 
 
 
 
50 
 
 
 
51 
 
 
 
52 
 
 
 
53 
 
 
 
54 
 
 
 
55 
 
 
 
56 
 
 
 
57 
 
 
 
58 
 
 
 
59 
 
 
 
60 
 
 
 
61 
 
 
 
62 
 
 
 
63 
 
 
 
64 
 
 
 
65 
 
 
 
66 
 
 
 
67 
 
 
 
68 
 
 
 
69 
 
 
 
70 
 
 
 
71 
 
 
 
72 
 
 
 
73 
 
 
 
74 
 
 
 
75 
 
 
 
 
 
 
 
 
 


 
Version Date: 12/14/2015 
 
 
- 11 - 
 
 
DATA COLLECTION FORM 
 
Unique subject 
identifier 
Infection 
Post-
operative 
hematoma 
Airway 
compromise 
Recurrent 
laryngeal 
nerve palsy 
1 
 
 
 
 
2 
 
 
 
 
3 
 
 
 
 
4 
 
 
 
 
5 
 
 
 
 
6 
 
 
 
 
7 
 
 
 
 
8 
 
 
 
 
9 
 
 
 
 
10 
 
 
 
 
11 
 
 
 
 
12 
 
 
 
 
13 
 
 
 
 
14 
 
 
 
 
15 
 
 
 
 
16 
 
 
 
 
17 
 
 
 
 
18 
 
 
 
 
19 
 
 
 
 
20 
 
 
 
 
21 
 
 
 
 
22 
 
 
 
 
23 
 
 
 
 
24 
 
 
 
 
25 
 
 
 
 
26 
 
 
 
 
27 
 
 
 
 
28 
 
 
 
 
29 
 
 
 
 
30 
 
 
 
 
31 
 
 
 
 
32 
 
 
 
 
33 
 
 
 
 
34 
 
 
 
 
35 
 
 
 
 
36 
 
 
 
 
37 
 
 
 
 
38 
 
 
 
 
39 
 
 
 
 


 
Version Date: 12/14/2015 
 
 
- 12 - 
 
Unique subject 
identifier 
Infection 
Post-
operative 
hematoma 
Airway 
compromise 
Recurrent 
laryngeal 
nerve palsy 
40 
 
 
 
 
41 
 
 
 
 
42 
 
 
 
 
43 
 
 
 
 
44 
 
 
 
 
45 
 
 
 
 
46 
 
 
 
 
47 
 
 
 
 
48 
 
 
 
 
49 
 
 
 
 
50 
 
 
 
 
51 
 
 
 
 
52 
 
 
 
 
53 
 
 
 
 
54 
 
 
 
 
55 
 
 
 
 
56 
 
 
 
 
57 
 
 
 
 
58 
 
 
 
 
59 
 
 
 
 
60 
 
 
 
 
61 
 
 
 
 
62 
 
 
 
 
63 
 
 
 
 
64 
 
 
 
 
65 
 
 
 
 
66 
 
 
 
 
67 
 
 
 
 
68 
 
 
 
 
69 
 
 
 
 
70 
 
 
 
 
71 
 
 
 
 
72 
 
 
 
 
73 
 
 
 
 
74 
 
 
 
 
75 
 
 
 
 
 

ICF_001.pdf: 
Version Date: 012/21/2015 
 
 
 
Page 1 of 6 
 
 
 
 
 
 
Northwestern University  
Department of Orthopaedic Surgery 
 
Consent Form and HIPAA Authorization for Research 
 
PROTOCOL TITLE:  A single blind, prospective, randomized controlled trial on the effect of 
local steroid application versus intravenous steroids on dysphagia following anterior cervical 
discectomy and fusion (ACDF) 
 
PRINCIPAL INVESTIGATOR: Alpesh A. Patel, MD, FACS 
 
SUPPORTED BY:  Northwestern University (NU)  
 
 
Introduction 
You are being asked to take part in a research study. This document has important information 
about the reason for the study, what you will do if you choose to be in this research study, and the 
way we would like to use information about you and your health.   
 
Conflict of Interest Disclosure 
The following disclosure is made to give you an opportunity to decide if this relationship will affect 
your willingness to participate in this research study: 
 
Your doctor, who is also the person responsible for this research study, is interested in both your 
clinical care and the conduct of this research study.  You have the right to discuss this study with 
another person who is not part of the research team before making your decision whether or not to 
be in the study.  
 
What is the reason for doing this study? 
You are being asked to participate because you are undergoing anterior cervical dissection and 
fusion (ACDF) and therefore may experience the common side effects of dysphagia (difficulty 
swallowing) and dysphonia (voice changes). 
 
Previous studies have shown that administering steroids after surgery often relieve these symptoms. 
Through this study we would like to assess what method of administering these steroids is the most 
effective, i.e. intravenous compared to local application. 
 
How many people will take part in this study?   
The study investigators hope to enroll 85 subjects at NU.   
 
What will you do if you choose to be in this study?  
If you consent to participate, you will be randomized to one of the following groups: group I 
(Control group), group II (Intravenous Decadron), or group III (Triamcinolone on gel foam sponge 
dabbed on the cervical plate).  Randomization means you will be randomly assigned to a treatment 
based on chance, like a flip of a coin. Neither you nor the researcher chooses your assigned group. 
You will have an equal chance of being in either group. 
 


Version Date: 012/21/2015 
 
 
 
Page 2 of 6 
 
 
 
 
 
 
Additionally, we will also request you to fill out questionnaires about your swallowing, voice, 
general health, and quality of life. These questionnaires are called: 1. The Eating Assessment Tool 
(EAT-10) questionnaire, 2. The Voice Handicap Index (VHI-10) questionnaire, 3. The Neck 
Disability Index (NDI) questionnaire, 4. The VAS Pain score questionnaire, 5. The Bazaz score 
questionnaire, and the 6. EuroQol EQ-5D questionnaire. You will complete these questionnaires 
prior to surgery, as well as 1 day, 2 weeks, 6 weeks, 3 months, 6 months, and 1 year after surgery. 
These questionnaires will take approximately one hour to complete. These questionnaires will be 
administered in the hospital, during your post-operative clinic visits with your surgeon, or over the 
phone.  
 
What are some of the possible risks and discomforts?  
A potential risk related to your participation in this study is the loss of privacy. To reduce these 
risks, all of the information collected will be recorded by number, not by name and stored securely. 
Additionally, some of the questions asked may be upsetting, or you may feel uncomfortable 
answering them. If you do not wish to answer a question, you may skip it and go to the next 
question. 
 
There is also a physical risk from this study. The use of steroids may have an adverse effect on 
wound healing and/or transiently elevate blood sugar.  However, in order to minimize this risk, we 
will only enroll patients that do not have diabetes or other endocrine disorders in this study. 
 
What are the Possible Benefits for Me or Others? 
You are not likely to have any direct benefit from being in this research study. However, your 
participation in the study will help orthopaedic surgeons better understand how to treat dysphagia 
and dysphonia after ACDF surgery. 
 
What other procedures or courses of treatment might be available to me?    
You do not have to take part in this research study.  You can still have the procedure regardless of 
whether you consent to participate in the study. If you do not take part in this study, the care or 
treatment you receive at this hospital or any other hospital will not be affected.  
  
Are there any financial costs to being in this study? 
 There will be no costs to you for being in this study. 
 
The cost of your conventional medical care will be billed to you or to your health insurance 
company in the usual way. However, some health insurance plans will not pay the costs for people 
taking part in studies. Check with your health plan or insurance company to find out what they will 
pay for. Taking part in this study may or may not cost your insurance company more than the cost 
of getting regular treatment.  If your insurance does not pay, you will be responsible for the charges 
of your conventional medical care.  
 
Will I receive payment for participation in this study?     
You will not be paid for your participation in this study. 
   
What should I do if I am injured as a result of being in this study?  
If you become ill or get an injury or illness as a result of study (medications, devices or procedures), 
you should seek medical treatment through your doctor or treatment center of choice. You should 
promptly tell the study doctor about any illness or injury.   


Version Date: 012/21/2015 
 
 
 
Page 3 of 6 
 
 
 
 
 
 
The hospital [university, researchers] will not pay for medical care required because of a bad outcome 
resulting from your participation in this research study. This does not keep you from seeking to be paid 
back for care required because of a bad outcome. 
 
If I have questions or concerns about this research study, whom can I call? 
You can call us with your questions or concerns.  
 
If you have any illness or injury during your time on this study, you should call us promptly.  
 
Dr. Alpesh A. Patel, MD is the person in charge of this research study. You can call him at 312-
695-5902 during Monday through Friday, 9am to 5pm.   
 
You can also call Dr. Rueben Nair, MD with questions about this research study. You can call him 
at 734-644-6285 during Monday through Friday, 9am to 5pm.   
 
For problems arising evenings or weekends, you may call Dr. Rueben Nair, MD at (734) 644-6285. 
 
If you are unable to reach Drs. Patel or Nair, you may call Surabhi Bhatt at 312-472-6024 during 
Monday through Friday, 9am to 5pm. 
 
What are my rights as a research subject?  
If you choose to be in this study, you have the right to be treated with respect, including respect for 
your decision whether or not you wish to continue or stop being in the study.  You are free to 
choose to stop being in the study at any time.   
 
Choosing not to be in this study or to stop being in this study will not result in any penalty to you or 
loss of benefit to which you are entitled.  Specifically, your choice not to be in this study will not 
negatively affect your right to any present or future medical treatment. 
 
Any new findings developed during the course of this research that may affect your willingness to 
continue in this study will be shared with you.  
 
If you want to speak with someone who is not directly involved in this research, or have questions 
about your rights as a research subject, please contact the Northwestern University Institutional 
Review Board (IRB) Office. You can call them at 312-503-9338. 
 
What about my confidentiality and privacy rights?   
We are committed to respect your privacy and to keep your personal information confidential.  When 
choosing to take part in this study, you are giving us the permission to use your personal health information 
that includes health information in your medical records and information that can identify you. For 
example, personal health information may include your name, address, phone number or social security 
number. Your health information we may collect and use for this research includes:  
 
  All information in a medical record  
 Results of physical examinations 
 Medical history 
 Lab tests, or certain health information indicating or relating to a particular condition as well as 
questionnaires 


Version Date: 012/21/2015 
 
 
 
Page 4 of 6 
 
 
 
 
 
 
 Records about study medication or drugs 
 
During this study you may be coming to the Northwestern Medicine (NMG)clinical offices for 
research appointments or to get clinical services, such as lab tests, needed for the study.  When that 
happens, you will be scheduled for these services through the NMG computer system.  When a 
clinical exam or lab is done by NMG or one of its employees for the purpose of this research study, 
that information will be kept in both NMGs clinical records and in the study records. 
 
The following groups of people may give the researchers information about you:   
 All current and previous health care providers, including but not limited to the Northwestern Medicine 
Group (NMG) Northwestern Memorial Hospital (NMH).     
 
Once we have the health information listed above, we may share some of this information with the 
following people. Please note that any research information shared with people outside of Northwestern 
University and its clinical partners (or affiliates) will not contain your name, address, telephone or social 
security number or any other direct personal identifier unless disclosure of the direct identifier is required 
by law [except that such information may be viewed by the Study sponsor and its partners or contractors at 
the Principal Investigators office]   
 
 Authorized members of the Northwestern University workforce, who may need to see your information, 
such as administrative staff members from the Office for Research, Office for Research Integrity and 
members of the Institutional Review Board (a committee which is responsible for the ethical oversight 
of the study),  
 
 Clinical affiliates, including but not limited the Rehabilitation Institute of Chicago (RIC), Northwestern 
Memorial Hospital (NMH), and the Ann & Robert H. Lurie Children’s Hospital of Chicago (Lurie 
Children’s).  Your participation in this clinical trial will be tracked in an electronic database and may be 
seen by investigators running other trials that you are enrolled in and by your healthcare providers.    
 
 Study monitors and auditors who make sure that the study is being done properly,  
 
 Government agencies and public health authorities, such as the Food and Drug Administration (FDA) 
and the Department of Health and Human Services (DHHS). 
Those persons who get your health information may not be required by Federal privacy laws (such as the 
Privacy Rule) to protect it.  Some of those persons may be able to share your information with others 
without your separate permission. 
 
The results of this study may also be used for teaching, publications, or presentations at scientific meetings.  
 
 
 
 
Please note that: 


Version Date: 012/21/2015 
 
 
 
Page 5 of 6 
 
 
 
 
 
 
 You do not have to sign this consent form.  If you do not, it will not affect your treatment by health care 
providers, or the payment or enrollment in any health plans, or affect your eligibility for benefits. 
However, you will not be allowed to take part in this research study.  
 You may change your mind and “take back” (revoke) this consent at any time. Even if you revoke this 
consent, the Principal Investigator may still use or share health information that was obtained about you 
before you revoked your consent as needed for the purpose of this study. To revoke your consent for 
the use of your health information, you must do so in writing to:  
Dr. Alpesh A. Patel, MD, FACS 
Department of Orthopaedic Surgery 
676 N. St. Clair, Suite 1350 
Chicago, IL 60611 
 Unless you revoke your consent, it will not expire.   
 


Version Date: 012/21/2015 
 
 
 
Page 6 of 6 
 
 
 
 
 
 
Consent Summary:  
I have read this consent form and the research study has been explained to me. I have been given 
time to ask questions, and have been told whom to contact if I have more questions.  I agree to be in 
the research study described above. A copy of the consent form will be provided to me after I sign 
it.   
 
A copy of this signed consent document, information about this study and the results of any test or 
procedure done may be included in my medical record and may be seen by my insurance company. 
 
 
_____________________________________________________  
__________ 
Subject’s Name (printed) and Signature 
 
 
 
 
Date 
 
 
_____________________________________________________  
__________ 
Name (printed) and Signature of Person Obtaining Consent  
 
Date