Conditions: Cervical Disc Herniation Cervical Degenerative Disc Disease Cervical Spondylotic Myelopathy Dysphagia Osteoarthritis of Cervical Spine
Keywords: Anterior Cervical Discectomy and Fusion Dysphagia ACDF
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 128
Healthy volunteers: no

Brief summary:
The purpose of this study is to determine what effect intraoperative topical steroids have on reducing swallowing difficulty following Anterior Cervical Discectomy and Fusion surgery.

Detailed description:
Background: Dysphagia is a serious post-operative concern in patients following anterior cervical surgery. Although many experts 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. This is the first randomized study to examine the use of topical steroids for the prevention of dysphagia postoperatively after anterior cervical discectomy and fusion.

Study Design: This study is a single site, double blinded randomized control trial. 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 Methylprednisolone Acetate delivered with one Hemostatic Matrix Kit injectable delivery vehicle prior to closure in the prevertebral soft tissues. The control group will receive only Hemostatic Matrix Kit prior to closure in the prevertebral soft tissues.

Outcomes: Patients will be asked to fill out questionnaires that assess dysphagia, general swallowing difficulty, and how neck pain impacts their quality of life. Additionally Radiographic images will be obtained at set time points to evaluate soft tissue inflammation and bony fusion.

Arms:
arm 1: Procedure: Anterior Cervical Discectomy and Fusion. The treatment arm will receive 40 mg of Methylprednisolone Acetate delivered with a Hemostatic Matrix Kit prior to closure. arm 2: Procedure: Anterior Cervical Discectomy and Fusion. The control group will receive only a Hemostatic Matrix Kit prior to closure.

Interventions: intervention 1: Methylprednisolone Acetate intervention 2: Hemostatic Matrix Kit
Intervention descriptions: intervention 1: Methylprednisolone Acetate is a corticosteroid known to reduce swelling and inflammation. intervention 2: Hemostatic Matrix Kits help prevent uncontrollable bleeding in a operative site during a procedure.

Protocol document:
Prot_SAP_000.pdf: 
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 

ICF_001.pdf: 
 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 1 of 11 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
4/19/2016 Thru 2/23/2017 
HOSPITAL FOR SPECIAL SURGERY 
535 East 70th Street  
New York, NY 10021 
 
 
INFORMED CONSENT TO PARTICIPATE IN RESEARCH 
 
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 
 
PROTOCOL NO.: 
 
SPONSOR: Not Applicable 
 
INVESTIGATOR: Todd J. Albert, MD 
 
SITE(S): Hospital for Special Surgery, New York, NY 
 
STUDY-RELATED PHONE NUMBER(S): (212) 774-7183 
 
IRB #: 2014-145 
 
 
You are being asked to take part in a research study conducted by Hospital for Special Surgery 
(HSS).  You are being asked to participate in this study because you are undergoing spine fusion 
surgery on your neck. 
  
You will still be responsible for the cost of your medical care just as you would be if you 
were not part of this study.  For example, any co-pays, deductibles, and co-insurance 
associated with your medical care. 
 
This document provides you with information about this study.  After reading this document, any 
questions you may have will be answered.  You may take home a copy of this document to 
consider or discuss with family and friends before making your decision.  
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required by 
U.S. Law. This Web site will not include information that can identify you. At most, the Web site 
will include a summary of the results. You can search this Web site at any time. 
  
1.  WHY IS THIS STUDY BEING DONE? 
 
You have been asked to participate in this research study because you are scheduled to have 
spine surgery on the front of your neck. One of the known complications after spine surgery 
from the front of the neck is difficulty or painful swallowing. This complication can result from 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 2 of 11 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
4/19/2016 Thru 2/23/2017 
soft tissue swelling in front of the bones that make up the spine in your neck. The research study 
involves the application of topical steroids directly in the surgical site. Topical steroids are 
known to reduce swelling where they are applied. The purpose of this study is to determine if 
topical steroids can decrease the risk of swallowing difficulties after the type of neck surgery you 
will undergo. Steroids are being used “off-label” for this study.  While steroids are approved for 
a variety of uses by the Food and Drug Administration, but because they have not been studied in 
this type of procedure, this is what is known as “off label” use.  It is important to understand that 
the study does not change your neck surgery. The study only involves the application of topical 
steroids during your surgery if you are selected to receive it.  
 
Your overall participation will continue over the course of 12 months. 
 
The surgical procedure, imaging studies, and doctor visits you will have are exactly the same 
whether or not you participate in this study with the exception of: 
 
1) Whether you receive topical steroids during your neck surgery will be randomized (like a 
flip of a coin). 
 
2) You will be asked to complete the following questionnaires: 
a. how swallowing problems have been affecting your quality of life 
b. how often you are experiencing problems consuming liquids and solids 
c. how much neck pain you have and how neck related pain affects your quality of 
life 
 
2.  WHAT WILL YOUR PARTICIPATION REQUIRE?   
 
If you decide to be in this study, the following routine and/or experimental procedures will be 
performed:  
 
Your participation in the study will last up to 12 months after your neck spine surgery. For the 
study, your participation will include 7 study visits. The visits include your pre-operative visit, 
the first and second days after your surgery, while you are in the hospital, and when you return to 
see your surgeon for routine post-operative follow at 4-6 weeks, 3 months, 6 months and 12 
months. 
 
This study will select your treatment by chance.  You will be assigned at random, similar to a flip 
of a coin, to one of two study groups that will receive different treatments.  The possible 
treatments you may receive during surgery are one of the following: 1) neck spine surgery as 
planned with your surgeon (standard of care) or 2) neck spine surgery with topical steroid 
application. You will be blinded to the treatment you are assigned to receive. It is not known if 
any treatment you receive will benefit you.  The likelihood of being assigned one of these 
treatments is a one in two chance. It is not known if any treatment you receive will benefit you. It 
is hoped the knowledge gained will benefit others in the future. 
 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 3 of 11 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
4/19/2016 Thru 2/23/2017 
You will complete questionnaires at each study visit that ask you about swallowing problems 
affecting your quality life and how often you have problems consuming liquids and solid foods. 
If you are unable to return for your routine follow-up visits, we will contact you by phone about 
these questions. 
 
Study Visit # 
Surveys Randomization 
Surgery 
X-
Rays 
CT 
Physical 
Exam 
Phone 
Contact 
#1 Pre-op 
X 
X 
SOC* 
SOC 
SOC 
SOC 
 
#2 Post-op Day 1 
X 
 
 
SOC! 
 
SOC 
 
#3 Post-op Day 2 
X 
 
 
 
 
SOC 
 
#4 Post-op week 4-6 (± 1 week) 
X 
 
 
SOC 
 
SOC 
X 
#5 Post-op month 3 (± 2 weeks) 
X 
 
 
SOC 
 
SOC 
X 
#6 Post-op month 6 (± 4 weeks) 
X 
 
 
SOC 
 
SOC 
X 
#7 Post-op month 12 (± 8 weeks) 
X 
 
 
SOC 
SOC 
SOC 
X 
 
X= Research procedures 
SOC= Standard of care (care you would receive if you were not participating in this study) 
*= If randomized to receive the study medication, this is considered a research procedure 
!= Depending on patient condition Post-op Day 1 x-rays will be collected within 24-72 hours 
of the operation 
 
You and/or your insurance will be responsible for any costs of all procedures performed that are 
standard of care, that is, care that you would receive even if you were not in this study. 
 
A total of 100120 participants will participate in this study at HSS.   
 
Your participation will involve a total of 7 study visits.  Most visits are expected to last 30 
minutes.  
 
3.  WHAT ADVERSE (BAD) EFFECTS CAN HAPPEN FROM BEING IN THE STUDY?  
WHAT RISKS ARE KNOWN ABOUT THE STUDY DRUG/STUDY DEVICE? 
 
There are risks associated with your surgery, which your surgeon will discuss with you prior to 
surgery.  
 
The known effects, discomforts and foreseeable risks of physical, psychological, sociological, or 
other harm which you may reasonably expect to occur from being in this study are: none. 
Potential risks which are unlikely to occur, but which may theoretically occur, are related to 
topical administration of steroid and may include infection, increased blood glucose, allergic 
reaction, and failure of fusion of the bone. We consider the likelihood of these risks to be very 
low. 
 
Participation in this research involves the potential risk of a breach of confidentiality to your 
stored health information.  HSS tries to minimize those risks by (i) removing some direct 
identifiers from stored information [(i.e., names, social security numbers, medical record 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 4 of 11 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
4/19/2016 Thru 2/23/2017 
numbers); (ii) securing, in a separate location, and limiting access to information that would 
identify you; and (iii) limiting access to information stored to HSS investigators. 
 
There may be risks or side effects that are unknown at this time. If we learn about new risks that 
may affect your willingness to continue your participation, we will make you aware of them and 
you will be asked to re-consent to continue your participate in the study.  
 
Your condition may not get better from being in this study. 
 
4.  WHAT BENEFIT CAN YOU EXPECT?  
 
This study includes experimental/investigational treatments which may or may not give you 
immediate benefit or any benefit. Potential direct benefit would be improved swallowing post-
operatively. The knowledge gained may benefit others in the future. 
 
5.  COST  
 
There will be no cost to you for participation in this study because this study does not involve 
any additional visits, tests, or procedures. If you are randomized to the steroid treatment group 
the cost of the steroid will be covered by the study. 
 
You will still be responsible for the cost of your medical care, and for any co-pays, deductibles, 
and co-insurance associated with your medical care, just as you would be if you were not part of 
this study. 
 
HSS is committed to providing financial assistance when financially warranted and consistent 
with its resources, regardless of age, gender, religion, race or sexual orientation.  So if you do not 
have health insurance, or if your health insurance does not pay for your medical care, you may 
seek financial assistance from HSS.  Eligibility determinations are made on a case-by-case basis 
in accordance with HSS’s financial assistance policy.  You will be responsible for any costs not 
covered by financial assistance, which could be all of the costs (if HSS determines that you are 
not eligible for financial assistance) or some of the costs (if financial assistance awarded by HSS 
does not cover all of the costs). For more information about the Financial Assistance Program or 
to request a Financial Assistance Application call (212) 606-1505 to speak with a Financial 
Assistance Counselor or you can visit the following site:  http://www.hss.edu/patient-financial-
assistance-notice.asp. 
 
6.  PREGNANCY 
 
Due to inherent risks, HSS policy prevents pregnant women from receiving the type of 
intervention needed to qualify for this research study.  Therefore, women who are pregnant or 
nursing a child may not participate in this study.  You must confirm that, to the best of your 
knowledge, you are not now pregnant, and that you do not intend to become pregnant during the 
next year. If you suspect that you have become pregnant during this study, you must notify the 
study doctor immediately.  


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 5 of 11 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
4/19/2016 Thru 2/23/2017 
 
 
 
7.  PAYMENT FOR PARTICIPATION 
 
You will not be paid for your participation in this study. 
 
8.  COMMERCIAL ISSUES:  YOUR RIGHTS IN THE RESULTS OF THE STUDY 
 
There are no plans to compensate you for the use of the findings of this study, or any of the 
information or biologic materials (such as blood or tissue) collected from you during the study, 
even if they are used to develop or make a commercial product (such as a drug, device, biologic 
substance, or test).   
 
9.  ALTERNATIVES:  WHAT OTHER TREATMENT IS AVAILABLE IF YOU DON’T 
WANT TO BE IN THE STUDY?  
 
You do not have to participate in this study to receive treatment for your condition. If your spine 
surgeon routinely administers intraoperative topical steroids, you will receive them without 
needing to participate in the study.  
 
You should ask the study doctor about other alternative treatments that may be available for your 
condition.  
 
10.  WHO WILL BE ABLE TO SEE YOUR RECORDS AND PERSONAL 
INFORMATION AND KNOW THAT YOU ARE IN THE STUDY? 
 
Federal regulations give you certain rights related to your health information.  These include the 
right to know who will be able to see your information and why they will be able to see it.  The 
study doctor must obtain your authorization (permission) to use or give out any health 
information that might identify you.  
 
What information may be used or given to others?   
 
If you choose to be in the study, the study doctor will get personal information about you.  The 
information might identify you.  The study doctor may also get information about your health 
including:  
 
 Medical and research records 
 Records about phone calls 
 Records about your study visits  
 Records of physical exams 
 Laboratory, x-ray, and other test results 
 Questionnaires 
 Records about any study device you received 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 6 of 11 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
4/19/2016 Thru 2/23/2017 
 
 
 
Who may use, disclose, or receive my information? 
  
The following person(s) class(es) of persons, and/or organization(s) may use, disclose, or receive 
my information: 
 The Principal Investigator and other Investigators for this study, including your study 
doctor. 
 The research coordinator, research nurses, and other members of the HSS research team 
working on this study. 
 Every research site for this study, including Hospital for Special Surgery and its affiliates, 
New York-Presbyterian Hospital, and Memorial Sloan-Kettering Cancer Center. This 
includes the research staff and medical staff at each institution. 
 The Patient Advocate or Research Ombudsman at these institutions. 
 Staff members of HSS responsible for administering clinical trials and other research 
activities. 
 Any laboratories and other individuals and organizations that analyze your health 
information for this study. 
 Any health care provider that you have used in the past or may use up to the time this study 
ends. 
 The United States Food and Drug Administration (FDA), the federal Office for Human 
Research Protections (OHRP), any federal agency that provides support for this study, and 
any federal, state, or local agency responsible for overseeing HSS, the study doctor, or any 
other member of the HSS research team involved in this study. 
 The members and staff of the affiliated Institutional Review Boards (IRBs) at HSS, New 
York-Presbyterian Hospital, and Memorial Sloan-Kettering Cancer Center. An IRB is a 
committee of health care providers, community representatives, and others that initially 
approves and periodically reviews biomedical and behavioral research that involves human 
subjects in order to protect the rights, safety and welfare of study participants. 
 Data Safety Monitoring Boards and others authorized to monitor the conduct of this study 
for safety or quality assurance, for example a Clinical Events Committee. 
 
Why will this information be used and/or given to others?   
 
Your health information may be given to others to carry out this study.  The sponsor will analyze 
and evaluate the results of this study.  People working for the sponsor also visit HSS and other 
research sites to make sure this study is being done correctly.   
 
Your health information may be given to the FDA.  It may also be given to governmental 
agencies in other countries. This is done so the sponsor can get approval to market new products 
resulting from this study.  Your information may also be used to meet the reporting requirements 
of governmental agencies.  
 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 7 of 11 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
4/19/2016 Thru 2/23/2017 
The results of this study may be published in scientific journals or presented at medical meetings, 
but your identity will not be disclosed.   
 
 
What if I decide not to give permission to use and give out my health information?   
 
By signing this informed consent form, you are giving permission to use and give out your health 
information as described above.  If you refuse to give permission, you cannot be in this study.  
 
May I review or copy the information obtained from me or created about me? 
   
You have the right, in accordance with Hospital policy and applicable law, to review and copy 
your health information that is created or obtained in the course of this study.  However, if you 
decide to be in this study and sign this informed consent form, you will not be able to look at or 
copy your information until after the study is completed if doing so would impact the validity of 
the study (for example, if the study is “blinded” so that during the study you will not know what 
treatment or other intervention you are receiving). 
 
May I revoke (take back) my permission?  
 
Yes. Your permission will never expire unless you revoke it.  To revoke your permission, you 
must write to the study doctor at Hospital for Special Surgery, 535 East 70th Street, New York, 
NY 10021. 
 
You may revoke your permission to use and disclose your health information at any time.  If you 
revoke your permission, you cannot continue to participate in this study.   
 
After you revoke your permission, no new health information that might identify you will be 
gathered. Information that has already been gathered may still be used and given to others. This 
would be done if the information is needed for this study to be reliable.   
 
Is my health information protected after it has been given to others?  
 
Some persons who receive your health information may not be required to protect it, and they 
may share your information with others without your permission, if permitted by laws governing 
them.  Therefore, there is a risk that your information will be released to others without your 
permission. 
 
11.  CONFLICT OF INTEREST NOTIFICATION 
  
HSS is concerned about possible conflicts of interest in research, and has policies that require all 
investigators and senior research staff to report to HSS significant financial interests (such as 
stock ownership, royalty payments, and consulting agreements) and relationships (such as 
membership on a scientific advisory board) that are related to their research studies.  When an 
investigator reports a significant financial interest or relationship that relates to one of his/her 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 8 of 11 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
4/19/2016 Thru 2/23/2017 
studies, HSS’s Conflict of Interest Committee for Research reviews the information to evaluate 
the risk that the interest or relationship might influence how the investigator conducts the study 
or interprets the results of the study.  HSS may also take steps to minimize that risk.   
 
 
The Conflict of Interest Committee for Research has determined that there are no 
conflicts of interest associated with this study. 
 
 
The Conflict of Interest Committee for Research has determined that there is a 
potential conflict of interest associated with this study.  Please read the information 
below carefully. 
 
12.  VOLUNTARY PARTICIPATION/WITHDRAWAL 
 
Your decision to take part in this study is completely voluntary.  You are free to choose not to 
take part in the study and may change your mind and withdraw at any time.  Your relationship 
with physicians at HSS and your medical care at HSS, now or in the future, will not be affected 
in any way if you withdraw or refuse to participate.  You will not lose any benefits to which you 
are otherwise entitled. 
 
The study doctor and/or the sponsor may terminate your participation in this study at any time 
without your consent if, in their judgment, it is inadvisable for you to continue.   
 
13.  COMPENSATION FOR INJURY 
 
If you are injured as a result of participating in this study, the study doctor, other members of the 
research team, or other HSS professional medical staff will provide you with emergency medical 
treatment (or arrange to have such treatment provided to you), and will assist you in obtaining 
appropriate follow-up medical treatment. However, there is no plan to routinely provide 
compensation for additional medical care or other costs. 
 
Your health insurance may or may not pay for treatment of injuries as a result of your 
participation in this study.  
 
14.   SOURCE OF FUNDING  
 
Funding for this study will be provided by the Spine Service at Hospital for Special Surgery. 
 
15.  QUESTIONS   
 
If you have any additional questions later on, or if you wish to report a medical problem that may 
be related to this study, Dr. Todd J. Albert can be reached at (212) 606-1004 during office hours 
and after business hours.  
 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 9 of 11 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
4/19/2016 Thru 2/23/2017 
If you have any questions about your rights as a participant in this study or any questions about 
your participation that you would like to ask an institutional representative who is not part of this 
study, you can call the Manager of the HSS Institutional Review Board at (212) 774-7154.  
 
If you would like to have more information about the Hospital’s financial disclosure review 
process in general, or in regard to this study, you may contact the Hospital’s Office of Legal 
Affairs at (212) 606-1592.   You may also ask the Hospital’s patient advocate at (212) 774-2403, 
to arrange for you to have this information. 
 
Do not sign this consent form unless you have had a chance to ask questions and have received 
satisfactory answers to all of your questions.  


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 10 of 11 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
4/19/2016 Thru 2/23/2017 
Agreement to Participate: Witnessing and Signature 
 
To be in this study, you or your legal representative must sign the next page of this informed 
consent form. By signing the next page, you are voluntarily agreeing to be in this study at HSS. 
 
Before signing, you should be sure of the following: 
 
 You have read all of the information in this “Informed Consent to Participate in Research” 
form (or had it read to you).  
 You have discussed the implications of your being in this study with your doctor, your 
study doctor and/or the study coordinator.  
 You have had the chance to ask questions about this study. 
 You received answers to your questions. 
 If you did not understand any of the answers, you asked the study doctor or the study 
coordinator to explain them to you. 
 The information given to you is based on what is now known about the study drug(s), 
device(s), or procedure(s).  There may be other risks or complications that are not known at 
this time. 
 You have had time to think about the information and decide whether or not to be in the 
study. 
 
Please check one of the following: 
 
   I AM NOT in another research study at this time. 
 
   I AM in another research study at this time. 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 11 of 11 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
4/19/2016 Thru 2/23/2017 
If you decide to be in this study: 
 
 You are expected to follow the study procedures. 
 You are expected to provide the information needed by the study doctor, the study 
coordinator, nurses, or other staff members for the study. 
 You will be told in a timely manner of any significant new information that may affect 
your willingness to stay in the study. 
 You may freely choose to stop being in the study at any time. 
 
By signing below, you are voluntarily agreeing to be in this study. 
 
You must be given a signed copy of this informed consent form to keep for yourself. 
 
 
 
______________________________________ 
_______________________________________ 
Print Name of Participant  
 
 
Signature of Participant 
 
            Date 
 
______________________________________           ______________________________________ 
Print Name of Parent/Legal Guardian (if applicable)1 
Signature of Parent/Legal Guardian  
Date 
 
____________________________________ 
_______________________________________ 
Print Name of Person Obtaining Consent 
 
Signature of Person Obtaining Consent       Date 
 
 
 
_____________________________________  
As an HSS representative, please sign here to indicate that you have given a signed copy of this informed consent 
form to the participant 
 
 
NOTE TO INVESTIGATORS: 
 
THE ORIGINAL OF THIS INFORMED CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S STUDY FILE. 
 
A SIGNED COPY OF THIS INFORMED CONSENT FORM MUST BE GIVEN TO THE 
PARTICIPANT. 
 
A COPY OF THE INFORMED CONSENT FORM MUST BE PLACED IN THE 
PARTICIPANT’S HOSPITAL MEDICAL RECORD IF THE PARTICIPANT IS (OR WILL 
BE) HOSPITALIZED AT ANY TIME DURING THE STUDY. 
                                                 
1 The parent or legal guardian of a child participant should sign this form on behalf of the child.  The signature of 
one parent is sufficient when the research is of minimal risk to the child, or when the research presents the prospect 
of direct benefit to the child.  The signature of both parents is required when the research involves greater than 
minimal risk with no prospect of direct benefit to the child.  The requirements for signature of both parents may be 
waived if one parent is deceased, unknown, incompetent, or not reasonably available, or when one parent has sole 
legal responsibility for the care and custody of the child.  If the participant is a child who is capable of giving assent, 
the child should also sign the attached Assent Form.