Clinical trial NCT02700451
Conditions: Lumbar Osteoarthritis Spondylosis Lumbar Disc Disease Spinal Stenosis
Keywords: IV acetaminophen IV Ketorolac Post-operative analgesia Opioid use
Sponsor: Hospital for Special Surgery, New York
Start date: 2016-03-01; Completion date: 2023-03-01
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients undergoing spine surgery often have considerable pain post-operatively and frequently require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively. The widespread use of opioids, however, is associated with a number of side effects. These include: sedation, dizziness, nausea, vomiting, constipation, dizziness and itching amongst others. Some investigators have suggested that anti-inflammatory medications (the same class of medicines as advil, ibuprofen, etc.) and acetaminophen (Tylenol) can reduce the total dose of opioid required postoperatively and, as a result, lower opioid-related side effects.

The purpose of this study is to test this hypothesis and determine if postoperative anti-inflammatory medications and postoperative acetaminophen can reduce the amount of opioid required to control pain following surgery. A secondary goal of this study is to examine if the change in pain medication will lead to decreased overall pain levels, decreased opioid-related side effects and improved function \[quicker ambulation with physical therapy (PT), earlier return to work, etc.\].

Detailed description:
Given the potential for non-steroidal anti inflammatory drugs (NSAIDs) and acetaminophen to decrease opioid requirements following spine surgery, the investigators propose a prospective, randomized, double-blinded clinical trial comparing the efficacy of intravenous (IV) acetaminophen (Group A) or IV ketorolac (Group K) versus placebo (Group P). The impact of treatment on perioperative opioid use, opioid-related complications, functional outcomes and rates of pseudarthrosis following 1 or 2 level lumbar fusion surgery will be measured in each group. The specific aims of this study are as follows:

* Specific Aim 1: Determine the impact of IV ketorolac or IV acetaminophen use on immediate postoperative opioid requirements, postoperative pain levels and opiate related symptoms using the Opiate-Related Symptom Distress Scale (ORSDS)
* Specific Aim 2: Determine the impact of IV ketorolac or IV acetaminophen use on functional outcomes defined by return to work, Oswestry Disability Index (ODI) and the Veterans Rand-12 (VR-12) Health Survey

The primary outcome is to determine the total postoperative opioid dose (in oral morphine equivalents) in each group. The investigators hypothesize that patients in Group A and Group K will have lower total opioid use, suffer from fewer opiate related symptoms and have similar rates of pseudarthrosis to patients in Group P. The investigators hypothesize that patients in Group A and Group K will have a quicker return to work and improved early functional outcomes although they acknowledge that long term functional outcomes may be the same for all groups.

Arms: arm 1: IV Placebo arm arm 2: IV Ketorolac arm arm 3: IV Acetaminophen arm
Interventions: intervention 1: Ketorolac intervention 2: Acetaminophen intervention 3: Placebo
Intervention descriptions: intervention 1: Age 18-64: Intravenous Ketorolac 30 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.

Age 65-75: Intravenous Ketorolac 15 milligrams (mg) every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. intervention 2: Intravenous Acetaminophen 1000mg every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed. intervention 3: Intravenous Normal Saline every 6 hours for 48 hours in addition to patient-controlled analgesia and oral opioids as needed.

Protocol documents:
Prot_SAP_000.pdf: 
Title:  
A Randomized Controlled Trial of Post-operative Acetaminophen versus Nonsteroidal Anti-Inflammatory 
Drug Use on Lumbar Spinal Fusion Outcomes 
 
NCT#:  
NCT02700451 
 
Document Date: 
2/23/2023 
 
Principal Investigator: 
Harvinder Sandhu, MD 
 
 
 
 


Brief Summary:  
Patients undergoing spine surgery often have considerable pain post-operatively and frequently require 
opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain postoperatively. 
The widespread use of opioids, however, is associated with a number of side effects. These include: 
sedation, dizziness, nausea, vomiting, constipation, dizziness and itching amongst others. Some 
investigators have suggested that anti-inflammatory medications (the same class of medicines as advil, 
ibuprofen, etc.) and acetaminophen (Tylenol) can reduce the total dose of opioid required 
postoperatively and, as a result, lower opioid-related side effects. 
 
The purpose of this study is to test this hypothesis and determine if postoperative anti-inflammatory 
medications and postoperative acetaminophen can reduce the amount of opioid required to control 
pain following surgery. A secondary goal of this study is to examine if the change in pain medication will 
lead to decreased overall pain levels, decreased opioid-related side effects and improved function 
[quicker ambulation with physical therapy (PT), earlier return to work, etc.]. 
 
  
Detailed Description: 
 
Given the potential for non-steroidal anti inflammatory drugs (NSAIDs) and acetaminophen to decrease 
opioid requirements following spine surgery, the investigators propose a prospective, randomized, 
double-blinded clinical trial comparing the efficacy of intravenous (IV) acetaminophen (Group A) or IV 
ketorolac (Group K) versus placebo (Group P). The impact of treatment on perioperative opioid use, 
opioid-related complications, functional outcomes and rates of pseudarthrosis following 1 or 2 level 
lumbar fusion surgery will be measured in each group. The specific aims of this study are as follows: 
 
Specific Aim 1: Determine the impact of IV ketorolac or IV acetaminophen use on immediate 
postoperative opioid requirements, postoperative pain levels and opiate related symptoms using the 
Opiate-Related Symptom Distress Scale (ORSDS) 
Specific Aim 2: Determine the impact of IV ketorolac or IV acetaminophen use on functional outcomes 
defined by return to work, Oswestry Disability Index (ODI) and the Veterans Rand-12 (VR-12) Health 
Survey 
The primary outcome is to determine the total postoperative opioid dose (in oral morphine equivalents) 
in each group. The investigators hypothesize that patients in Group A and Group K will have lower total 
opioid use, suffer from fewer opiate related symptoms and have similar rates of pseudarthrosis to 
patients in Group P. The investigators hypothesize that patients in Group A and Group K will have a 
quicker return to work and improved early functional outcomes although they acknowledge that long 
term functional outcomes may be the same for all groups. 
 


This is a Randomized Controlled Clinical Trial. 
 
Arms and Interventions: 
 
Arms
Assigned Interventions
Placebo Comparator: 
Intravenous (IV) 
Placebo 
IV Placebo arm 
Drug: Placebo 
Intravenous Normal Saline every 6 hours for 48 hours in 
addition to patient-controlled analgesia and oral opioids 
as needed. 
Other Names: 
 
Normal Saline 
Experimental: IV 
Ketorolac 
IV Ketorolac arm 
Drug: Ketorolac 
Age 18-64: Intravenous Ketorolac 30 milligrams (mg) 
every 6 hours for 48 hours in addition to patient-
controlled analgesia and oral opioids as needed. 
Age 65-75: Intravenous Ketorolac 15 milligrams (mg) 
every 6 hours for 48 hours in addition to patient-
controlled analgesia and oral opioids as needed. 
Other Names: 
 
Toradol 
Experimental: IV 
Acetaminophen 
IV Acetaminophen arm
Drug: Acetaminophen 
Intravenous Acetaminophen 1000mg every 6 hours for 
48 hours in addition to patient-controlled analgesia and 
oral opioids as needed. 
Other Names: 
 
Tylenol, Ofirmev 
 
 
 
 


Eligibility: 
Minimum Age: 18 Years   
Maximum Age: 75 Years   
Sex: All   
Gender Based:
Accepts Healthy Volunteers: No 
Criteria: Inclusion Criteria: 
 Age 18-75 
 Require 1 or 2 level lumbar spinal 
fusion through posterior or lateral 
approach 
 No history of long term opioid use 
(daily or almost daily opioid use > 2 
weeks) and not on opiates at time of 
presentation to clinic 
Exclusion Criteria: 
 Documented allergy to NSAIDs or 
Acetaminophen 
 History of: Peptic Ulcer Disease, 
Congestive heart failure, Chronic liver 
disease, Elevated alanine 
aminotransferase (ALT)/ aspartate 
aminotransferase (AST) greater than 
1.5 times control, Bleeding disorder, 
Renal dysfunction (Serum creatinine 
> 1.5 mg/dL), Glucocorticoid use 
within 1 month of surgery 
 Current smokers (quite date < 30 
days ago) 
 Revision for pseudarthrosis 
 Patients who are unable to physically 
or mentally provide consent to the 
study procedures. 
 


Statistical plan: 
 
All normally distributed variables are described using mean and standard deviation (SD) for normally 
distributed continuous variables, median and interquartile range (IQR) for non-normally distributed 
continuous variables and counts and percentages for categorical data. Normal distribution was assessed 
using a q-q plot prior to statistical analysis. Groups were compared using an analysis of variation 
(ANOVA) for normally distributed variables and a Kruskal-Wallis test for non-normally distributed 
variables; a chi-squared test was used for categorically distributed variables. Post-hoc pairwise 
comparisons (adjusted and unadjusted) were also performed.  
Assessment of spinal fusion was performed by consensus read with two board-certified radiologists, 
J.L.C. with certificate of added qualification in Neuroradiology and 9 years of post-fellowship experience 
and J.A.C. with subspecialty training in musculoskeletal imaging and 20 years of post-fellowship 
experience.  Interbody and posterolateral fusion was assessed on a 4-point scale, 0 = no fusion; 1 = 
probably not fused; 2 = probably fused; 3 = definitely fused. Fusion assessment was performed on 
multiplanar CT imaging when available or dedicated lumbosacral radiographs with a minimum of 
anteroposterior and lateral views. 
 
 
 


  
 
 
 

ICF_001.pdf: 
 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 1 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
10/30/2017 Thru 4/27/2018 
HOSPITAL FOR SPECIAL SURGERY 
535 East 70th Street  
New York, NY 10021 
 
 
INFORMED CONSENT TO PARTICIPATE IN RESEARCH 
 
TITLE: A Randomized Controlled Trial of Post-operative Acetaminophen versus 
Nonsteroidal Anti-Inflammatory Drug Use on Lumbar Spinal Fusion Outcomes 
 
PROTOCOL NO.:  
 
SPONSOR: Not Applicable 
 
INVESTIGATOR:  Harvinder S. Sandhu, MD 
 
SITE(S): Hospital for Special Surgery 
 
STUDY-RELATED PHONE NUMBER(S): 
 
IRB #: 2014-333 
 
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 to undergo spinal fusion 
surgery at HSS. 
 
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? 
 
Patients undergoing spine surgery often have considerable pain post-operatively and frequently 
require opioid medication (Percocet, Norco, oxycodone, morphine, etc.) to control their pain 
postoperatively. The widespread use of opioids, however, is associated with a number of side 
effects. These include: sedation, dizziness, nausea, vomiting, constipation, and itching amongst 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 2 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
10/30/2017 Thru 4/27/2018 
others. Some investigators have suggested that anti-inflammatory medications (the same class of 
medicines as Advil, ibuprofen, etc.) and acetaminophen (Tylenol) can reduce the total dose of 
opioid required postoperatively and, as a result, lower opioid-related side effects.  
 
The purpose of this study is to test this hypothesis and determine if postoperative anti-
inflammatory medications and postoperative acetaminophen can reduce the amount of opioid 
required to control pain following surgery. A secondary goal of this study is to examine if the 
change in pain medication will lead to decreased overall pain levels, decreased opioid-related 
side effects and improved function (quicker ambulation with Physical Therapy, earlier return to 
work, etc.). Your overall participation will continue over the course of 2 years and will occur 
during your hospital stay and at follow up visits to your surgeon’s office. If you plan to have 
your routine follow-up visits at another location, we may contact you by phone to complete the 
study questions. 
 
2.  WHAT WILL YOUR PARTICIPATION REQUIRE?   
 
If you decide to be in this study, the following routine and/or experimental procedures will be 
performed:  
 
Study Visit # 
Rando
mizati
on
Surveys / 
Questionnaires
Quantification 
of total opioid 
use
Surgery
Blood 
Draws
X-
Rays
Physical 
Therapy 
Pre-operative
X
X
SOC
During 
hospitalization
 
X 
X 
SOC 
SOC 
SOC
SOC 
6 week post-
op visit
 
X 
X 
 
 
SOC
 
3 month post-
op visit
 
X 
X 
 
 
SOC
 
1 year post-op 
visit
 
X 
 
 
 
SOC
 
2 year post-op 
visit
 
X 
 
 
 
SOC
 
 
X=  Research procedures 
SOC= Standard of care (care you would receive if you were not participating in this study) 
 
This study will select your treatment by chance.  You will be assigned at random to one of the 
following study groups: receive IV acetaminophen (Tylenol) for 48 hours after surgery, receive 
IV ketorolac (Toradol) for 48 hours after surgery or receive a placebo medication (Normal 
Saline) 48 hours after surgery. Regardless of what group you are assigned to, you will receive IV 
patient-controlled analgesia (PCA) and oral opioid medication (oxycodone or hydromorphone 
(Dilaudid)) to help control your pain. The Tylenol and Toradol will be given to you in addition to 
the opioids. You may choose to leave the study protocol at any time post-operatively. 
 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 3 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
10/30/2017 Thru 4/27/2018 
The randomization process is that you have a 1 in 3 chance of being assigned to each group.  It is 
not known if any treatment you receive will benefit you.  It is hoped the knowledge gained will 
benefit others in the future. 
 
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 300 participants will participate in this study at HSS.   
 
Your participation will involve a total of  4 study visits which will occur at the same time as your 
regular post-operative follow up visits.  Most visits are expected to require an additional 10-15 
minutes of your time to complete surveys. The surveys you complete will ask you questions 
about your working status (if you are working), about your low back pain (if any) and general 
questions designed to assess your overall health and function. 
 
3.  WHAT ADVERSE (BAD) EFFECTS CAN HAPPEN FROM BEING IN THE STUDY?  
WHAT RISKS ARE KNOWN ABOUT THE STUDY DRUG/STUDY DEVICE? 
 
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:  
 Anti-inflammatory medication (ketorolac, Toradol) – this medication is in the same class 
of drugs as ibuprofen, advil or aleve. The amount that will be administered as part of this 
trial is within the maximum daily dosage for this drug. Risks of the study medication are 
similar to these medications. The chief side effects are: possibility of increased bleeding 
and damage to your kidneys. These risks will be monitored using your laboratory results 
and other data (drain output) as per the current standard of care. The use of anti-
inflammatory medications may impair bone healing although it is unproven whether their 
use has an impact on spinal fusion. 
 
 Acetaminophen (Tylenol) – this medication may result in damage to the liver when used 
in excessive amounts. The amount that will be administered as part of this trial is within 
the maximum daily dosage for this drug. You are not eligible for this study if you have 
elevated liver enzymes pre-operatively. 
 
 Placebo – there are no significant risks to being assigned to the placebo group. You will 
receive opioid medication only for post-operative analgesia. This is similar to the pain 
control regimen you would receive if you were not enrolled in the study protocol. 
 
There is a low likelihood of adverse events. 
 
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); (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. 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 4 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
10/30/2017 Thru 4/27/2018 
 
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?  
 
If you consent to this study, the use of anti-inflammatory medication or toradol may result in the 
decreased use of opioid medication post-operatively. This may or may not result in decreased 
opioid-related side effects (nausea, vomiting, constipation, etc.) and may or may not result in 
improved function 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. 
 
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 women who are pregnant or nursing a child from 
receiving the type of surgery or procedure needed to qualify for this research study.  So if you 
are currently pregnant or nursing a child, you may not participate in this study.  But if you 
become pregnant or begin nursing a child after you have enrolled in this study and after the 
surgery or procedure has occurred, you may continue to participate in this study. 
 
7.  PAYMENT FOR PARTICIPATION 
 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 5 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
10/30/2017 Thru 4/27/2018 
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).  The results of this study will provide no commercial gain to the investigators. 
This study is not intended to develop any commercial products. 
 
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.  You may 
request to receive anti-inflammatory medication or acetaminophen (Tylenol) for post-operative 
pain control even if you are not enrolled in this study. Your surgeon, anesthesiologist or medical 
doctor can review the risks and benefits of these medications with you should you require or 
request them in the post-operative period. 
 
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 history 
 Records about phone calls (if you call to request a prescription refill) 
 Records about your study visits  
 Records of your vitals, pain levels, drain outputs and bowel movements recorded by 
nursing 
 Laboratory, x-ray, and other test results 
 Questionnaires 
 Records about total opioid medication received 
 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 6 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
10/30/2017 Thru 4/27/2018 
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?   
 
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? 
   


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 7 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
10/30/2017 Thru 4/27/2018 
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 
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. 


 
Form 10 - ICF Document (Template Version 2/14/13) 
 
 
 
 
 
 
Page 8 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
10/30/2017 Thru 4/27/2018 
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 department at HSS. 
 
 
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. Harvinder Sandhu can be reached at 212.606.1798 during office 
hours and through his answering service, via the same number, after business hours.  
 
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 9 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
10/30/2017 Thru 4/27/2018 
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 10 of 10 
 
IRB Administrative Use Only 
 
Hospital for Special Surgery Institutional 
Review Board Approval 
10/30/2017 Thru 4/27/2018 
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.