Vital Trek

Title:  CSM Study
Principal Investigator: Zoher Ghogawala, MD

Invitation to Participate and Description of Project 

You are invited to participate in a research study.  The purpose of the study is to determine the best surgical approach for patients who have spinal cord problems (myelopathy) caused by pressure (compression) from arthritic changes in your neck’s spinal column.  You have been asked to participate because your spinal condition is one where most spinal surgeons have no clear preference about which type of surgery (decompression/fusion from the front or decompression with our without fusion from the back) is better for your problem.  Both surgical procedures are accepted and neither is considered investigational.  The Greenwich Hospital is one of many centers in the United States participating in this study.  About 100-200 patients will be entered into the study nationwide over 1 year.  The study sponsor is the Wallace Clinical Trials Center.

In order to decide whether or not you wish to be a part of this research study you should know enough about its risks and benefits to make an informed judgment.  The consent form provides you with detailed information about the research study, which your surgeon will discuss with you.  The discussion should go over all aspects of this research: its purpose, the procedures that will be performed, any risks of the procedures, and possible benefits.  Once you understand the study, you will be asked if you wish to participate, if so, you will be asked to sign this form.

Description of Procedures

In this study each subject will be treated with either a Front Decompression/Fusion or Back of the Neck Decompression with or without fusion.

Treatment A:   Front decompression/fusion

Treatment B:   Back of the neck decompression with or without fusion.

The risks and benefits of both procedures will be explained to you. 


After the surgical procedure, you will be treated by your surgeon in a standard fashion and participation in the study will not affect your post-operative care at all.  You will be discharged from the hospital after surgery in standard fashion.   

A study coordinator will contact you before surgery, 3 months after surgery, 6 months after surgery, and one year after surgery.    You will be asked to fill out questionnaires and mail it to the Greenwich Clinical Trials Center before surgery and after surgery.    The questions will be from well-known outcomes scales (SF-36, Oswestry Neck, mJOA, Nurick, EuroQol-5D).  You may skip over any questions that you choose not to answer.  You will have an MRI done pre-op and possibly 3 months after surgery.  You will have a CT done 1-2 days after your surgery.  Two plain x-rays with you bending forward and backward will be done pre-op, 3 months, 6 months, 1 year, and 2 years after surgery.  While most surgeons obtain these types of x-rays as a routine after this kind of surgery, some surgeons do not.  If your surgeon feels that an x-ray is being performed only for the study then you and your insurance company will not be charged and the cost of the x-rays will be paid for by the study budget.  An independent radiologist will review the films at no cost to you.

Risks and Inconveniences

The risk associated with participating in the study is very low.  The standard risks of cervical spinal surgery apply to you and these risks will be outlined in detail by your surgeon.  Participating in the study does not increase these risks.  You will be asked to have post-operative x-rays done.  Most surgeons consider the films required in this study to be standard post-operative medical care.  The level of radiation exposure for these films is very low.    Also, you will be asked to fill out questionnaires pre-op, 3 months, 6 months, and one year after surgery.  These questionnaires will take about 5 minutes to complete.  You will be asked to mail these questionnaires to the Greenwich Clinical Trials Center at the Greenwich Hospital.








Benefits

You will be given the results of the study before the information is published and will have access to a study web page that will give frequent updates about the progress of this spine project.  The benefit of participating in this study is that you will be helping spine surgeons determine how best to treat surgically the condition that you now have.  The results of the study will be important in that regard.

Economic Considerations

You will not incur any expense by participating in this research study.  Your operation and the initial post-operative x-rays are considered standard clinical care and will be covered by you or your insurance.  Any x-rays in the post-operative period not considered standard clinical care by your surgeon would be billed directly to the research fund.  The x-rays outlined above are considered standard care by most surgeons.  If your surgeon feels that one of the x-rays is being done purely for research purposes then the surgeon will inform you and bill the research fund appropriately.



Alternative Treatments

You may choose not to participate in this study and have the operation that is deemed appropriate by you and the surgeon.  You may also consider non-surgical management.

Confidentiality

All efforts will be made to keep all of your medical information confidential. 
The information that you provide on the questionnaires will become a part of your office record and will be kept confidential.  Your information will be placed under a code for the purpose of analyzing the data.  Your name and other identifying information will be removed from questionnaires before they are mailed to the study center in Greenwich, CT.  Identifying information from your x-rays will be removed prior to mailing them for an independent review.  Some of the information gained from you will be entered into a web site.  No specific identifying information will be available from the web site.  The web site uses the highest level of encryption to protect your confidentiality.  Your record might be examined by an external auditor approved by the Greenwich Hospital IRB Committee or by a member of the committee to ensure that the highest standards of research practice are being obeyed by all of the investigators.  The study sponsor (or its agents) might review your record.  The Hospital will use reasonable efforts to protect your privacy and the confidentiality of your medical information. 

The results of this study may be published in a medical book or journal or used for teaching purposes.  However, your name or other identifiers will not be used in any publication or teaching materials without your specific written permission.  




In Case of Injury

Medical therapy will be offered to you for any physical injuries sustained as a consequence of your participation in this research.  The procedures are not investigational and therefore any costs associated with treatment for physical injuries that result would be covered by you or your insurer.  No additional financial compensation for injury is available.

Voluntary Participation

Participation in this study is voluntary.  You do not have to participate in this study.  Your present or future care will not be affected should you choose not to participate.  If you decide to participate, you can change your mind and drop out of the study at any time without affecting your present or future care in the Greenwich Hospital.  In addition, the doctor in charge of the study may decide to end your participation in this study.  He or she will explain the reasons for doing so and will make certain that your post-operative care will continue.





SUMMARY

This is a study comparing two accepted treatments for cervical spondylotic myelopathy, which is a condition caused by arthritis compressing your spinal cord.

Procedure A -  Front decompression /fusion

Procedure B –  Back of the neck decompression with or without fusion.

Both procedures are fully accepted and neither is investigational.

Routine follow-up by your surgeon.

Follow-up questionnaires before surgery, 3 months, 6 months, and one year after surgery.

Follow-up x-rays: 1-2 days,  3 months, 6 months, 1 year, and 2 years after surgery.


Risks of drugs and procedures

The risks of the surgery would be the same as if you were not participating in this study.  No additional physical risk is associated with participation in this study.  There is no additional cost for any patient.



Authorization:

I have read this form and decided that _________________________________ will
(name of subject)
participate in the project described above.  Its general purposes, the particulars of

involvement and possible hazards and inconveniences have been explained to my

satisfaction.  My signature also indicates that I have received a copy of this consent form.

                                                           Signature:    _________________________________

    Relationship:    _____________________________

Date:_____________________________________
   
   
___________________________________________    ___________________
Signature of Primary Investigator    Phone

                                      or

___________________________________________    ___________________
Signature of Person Obtaining Consent    Phone


If you have further questions about this project or if you have a research-related problem, you may contact the study doctor Dr. Zoher Ghogawala, MD at 203-661-3333.  If you have any questions concerning your rights as a research subject, you may contact the Greenwich Hospital Institutional Review Board Committee at 203-863-3571.