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Wallace Clinical Trials Center
About Us
The research office began its research efforts in 2002 under the leadership of Dr. Ghogawala, with the SLIP study, an ongoing study to compare fusion versus no fusion following spinal decompression. Today, at the Wallace Clinical Trials Center, we are running seven trials of our own: the SLIP study, Cognitive Outcomes after Carotid Surgery Study, Cervical Spondylotic Myelopathy (CSM) study, the TLIF study, the XLIF v. TLIF study, NeuroPoint SD, and the Scoliosis Registry. To date, we have raised over one million dollars in donations and grants, which shows that the public understands that clinical research has the potential to enhance the health and well-being of individual patients and society as a whole.
Ellyn Wasserberger has served as our clinical research coordinator since the beginning of our first study in 2002. For details about our studies please see
Research Studies.
Our Mission
Our mission at the Wallace Clinical Trials Center is to ask the important questions relevant to a patient's quality of life after surgery, design the appropriate studies to answer these questions, and maintain excellence in executing those studies.
Research Studies
The Wallace Clinical Trials Center is currently accruing patients for multi-center clinical trials:
i) Lumbar Stenosis SLIP Study
Dr. Ghogawala is a lead investigator in a national study aimed at better understanding the role of lumbar fusion for patients with a spinal condition known as lumbar stenosis with a spondylolisthesis (or SLIP). If your spinal condition meets certain conditions, you might be eligible to participate in this important study. At the present time, doctors from the Cleveland Clinic, Yale New Haven Hospital, Massachusetts General Hospital, Rhode Island Hospital and Greenwich Hospital, and Lahey Clinic are enrolling patients in this study. If asked to participate, your x-rays will be reviewed by a panel of surgeons and radiologists and your surgical outcome will be measured by an independent examiner for 5 years annually.
For more information about the SLIP study see
www.spine-slip-study.org
Patient Testimonials
Sandy Borowik
March 2008 will mark the two-year anniversary of my laminectomy with Dr. Ghogawala.
Prior to the surgery, I suffered serious back discomfort and leg spasms for approximately 1 ½ years. This was accompanied by great limitation in movement. As a candidate randomized for the Greenwich Lumbar Stenosis SLIP Study, I received decompression
surgery (laminectomy - no fusion) to correct my problem. My recuperation was amazing (only some surgical discomfort). All pre-op pain had disappeared. I was driving within 3 weeks. Participating in the SLIP Study gave me constant reassurance and follow-up.
Today I am pain free, strong, and fully mobile. Thank you Dr. Ghogawala for your superb care and guidance.
Beverly J. Shockley
During a pre-op meeting, my doctor asked me if I was interested in trying something new-a healing technique. He described the technique as something that could help with preparing/relaxing me before surgery and also to speed recovery after surgery. I was not familiar with 'Healing Hands', but thought I'd give it a try.
My laminectomy was scheduled during a very stressful time because I was being treated for colitis. I didn't know what to expect during my first pre-op visit to 'Healing Hands' but it was a wonderfully relaxing, non-invasive experience. My healer concentrated on the area I was having difficulty with and miraculously the colitis completely stopped. I went into surgery very much relaxed and relieved.
I've had several major surgeries and this is the first time I came out of the anesthesia fully alert. My recovery is going well and I believe that the 'Healing Hands' experience had a great deal to do with it.
ii) Cognitive Outcomes After Carotid Revascularization
Dr. Ghogawala is the lead investigator in a multi center non randomized study that aims to evaluate cognitive functioning as well as cerebral blood flow in patients before and after carotid revascularization. If you have been diagnosed with carotid stenosis you may be eligible to participate in this important study. If asked to participate you will undergo MRA evaluation and a battery of cognitive tests to evaluate your motor function, memory, new learning and reaction speeds.
Patient Testimonials
Allan Mascaro
It has been 2 ½ years since my operation, and I.m feeling great. I was happy to participate in the testing program. It was enjoyable, and I hope the information gained will be very useful. Again, I would like to thank Dr. Ghogawala and his fantastic staff.
iii) CSM Study
Dr. Ghogawala is lead investigator in this national Study designed to determine the optimal surgical approach (front vs. back) for patients with multi-level cervical spondylotic myelopathy (CSM). At the present time, doctors from Cleveland Clinic, University of Utah, Massachusetts General Hospital, University of Medicine and Dentistry of New Jersey, Lahey Clinic, Greenwich Hospital and Danbury Hospital are enrolling patients in this study. Patients enrolled in the Study will have their x-rays reviewed by a panel of neurosurgeons and their surgical outcome will be measured by an independent examiner for 2 years. For more information about the CSM Study please see:
www.csm-study.org
Patient Testimonials
Carmela Marino
I developed CSM six years ago and refused to have the surgery because it was a major operation. However, since the condition not only weakened my upper body, it started to affect my ability to walk. I researched the condition and the surgery and visited many doctors to plan for the operation. After an exhaustive search to find a doctor who fit my criteria, I had the pleasure of meeting Dr. Zoher Ghogawala. Dr. Ghogawala and his staff were the most highly qualified in this type of surgery and offered not only expertise, but compassion as well. I had the surgery on January 22, 2007, and it proved to be the best decision
I ever made.
iv) TLIF
Dr Abbed is the lead investigator in this multicenter non-randomized study that aims to compare patient outcomes after either an Open (traditional) or Minimally Invasive approach for Transforaminal Lumbar Interbody Fusion Surgery. Participants will be asked to complete pain questionnaires for 1 year after surgery. They will also have their post surgical radiology exams reviewed.
v) XLIF vs TLIF study
Dr. Douglas is the lead investigator for this single-center randomized study comparing two minimally invasive techniques for treating lower back and leg pain: XLIF (lateral interbody fusion) and TLIF (transforaminal lumbar interbody fusion). Participants will be evaluated for improvements in their level of pain and daily function for up to two years after surgery. Spinal imaging will also be reviewed for up to one year after surgery.
vi) Neurosurgery Patient Outcomes IN Treating Spinal Disorders (NeuroPoint SD)
Dr. Ghogawala is the lead investigator and Dr. Douglas is a site investigator in this prospective, multi-center registry that aims to collect comparative effectiveness outcomes for degenerative spine diseases after surgical procedures: lumbar discectomy and lumbar fusion. Participating institutions include: Greenwich Hospital, Yale University, Lahey Clinic, Columbia University, University of Calgary-Alberta, Carolina Neurosurgery and Spine, University of Medicine and Dentistry of New Jersey, University of Wisconsin, University of California San Francisco, Johns Hopkins, Vanderbilt University, University of Pennsylvania, and the University of Virginia. The American Association of Neurological Surgeons (AANS) has formed a non-profit company, the NeuroPoint Alliance, Inc. (NPA) to create an internet-based data management platform in conjunction with Outcome Sciences, Inc. (Outcome) a well-known clinical research organization to provide the highest level of infrastructure to ensure success.
For more information, see Neuropoint SD on clinicaltrials.gov:
Registration Number: NCT01220921
Link:
http://clinicaltrials.gov/ct2/show/NCT01220921
vii) Scoliosis Registry
Dr. Douglas is the lead investigator of this non-randomized degenerative lumbar spine scoliosis registry that aims to better understand the long term functional and quality of life outcomes of both conservative and surgical treatment options in these patients. Patients who enroll in this study will be given the option of initiating or continuing further conservative treatment options versus pursing surgical treatment options. Participants will be asked to complete questionnaires at regular intervals for 2 years after initiation of either conservative or surgical treatment. Spinal imaging will also be reviewed for up to 3 years after enrollment.
Selected Published Papers
CSM Eligibility for Randomization Paper
CSM Pilot Study Paper
SLIP Paper
Carotid Paper
Clinical Equipoise Paper
CSM Reoperation Paper
Our Staff
Sitting:
Dr. Zoher Ghogawala
Top row (standing left to right):
Ellyn Wasserberger
Susan Christopher
Lauren Stabile
Zoher Ghogawala, MD
Dr. Ghogawala is Director of the Wallace Trials Center at Greenwich Hospital and is the principal investigator on several national clinical trials including the SLIP (
www.spine-slip-study.org) and CSM (
www.csm-study.org) trials. He has been awarded multiple research grants including support from the National Institutes of Health (NIH).
Susan Christopher, R.N.
Susan is one of the study coordinators for the CSM and XLIF vs TLIF studies. She is also involved in the writing of various research papers and grants as well as helping to produce our biannual research newsletter.
Lauren Stabile
Lauren is the research coordinator for the Carotid Outcomes, TLIF and the DuragenPlus®Study. She divides her time between the research and clinical offices.
Ellyn Wasserberger
Ellyn is the NeuroClinical Research Manager at Greenwich Hospital. She has been working at the WTC since 2002. Ellyn oversees all the research studies at the Wallace Clinical Trials Center. Prior to Greenwich Hospital, Ellyn worked at the New York Presbyterian Hospital and has over 20 years of experience in the medical field.
Jill Curran
On April 12, 2010, Jill Curran joined the staff of the WTC as the
Manager of Data and Grants. She will assume responsibility for the
TLIF and XLIF vs. TLIF studies and will also be working on the CSM
study. She has 5 years of research experience holding a Master's
degree in Epidemiology and she most recently worked with oncology
clinical trials at the Albert Einstein Cancer Center.
Research Interns
Wallace Clinical Trials Center - Alumni
High School and College Students are encouraged to apply for summer internships at the WTC located at Greenwich Hospital. Each student is assigned a mentor and a specific project. The objective of the program is to introduce the student to clinical research and to teach best practices. Each student is assigned a problem. He or she is asked to perform a literature search, organize a database, analyze the data and construct meaningful graphs that accurately depict the data. Each student is expected to make a PowerPoint presentation at the conclusion of the internship. Many have been successful in submitting oral abstracts at national meetings and some have helped work on publications.
Neurosurgery and Orthopedic Surgery Residents are also encouraged to apply for a research fellowship at the WTC. Research meetings are held in conjunction with the Yale Spine Institute. Each resident will be given at least 2 research projects and will have several opportunities to submit their work for oral presentation at national meetings. Most have several publications and textbook chapters submitted by the end of their fellowship.
All inquiries about research positions should be directed to Ellyn Wasserberger at the WTC
Summer Interns
James Li (2001)
James was a senior at Greenwich High School when he worked with us. He worked on the preliminary data that served as a foundation for the SLIP study.
George Fraser (2002)
George created a Spine Database Application for scoring the SF36. We are still using his application for scoring the SF36 for both the SLIP and CSM Studies.
He also worked on a cost analysis of Fusion vs. Laminectomy for lumbar stenosis.
Nazish Omar (2002)
Nazish worked on a business plan for a stroke center and on cost analysis for the SLIP study.
Rhiddima Hinduja (2006)
Rhiddima worked on the cost analysis for the CSM Study.
Alex Mojcher (2007)
(University of Massachusetts)
Alex created and edited surgical videos. One of his videos is being used by a corporation sponsoring a clinical trial.
Kate Reid ( 2007)
(Duke University)
Kate worked on the Carotid study. Her preliminary work laid the foundation for future studies evaluating the effect of plaque length on cerebral blood flow. The work has been submitted for publication.
Rachel Potter (2007 and 2008)
(Colgate University)
Rachel developed a database and identified a significant cost differential in two common types of surgery for treating CSM. Her work has been presented at the AANS meeting in 2008. Her work helped lay the foundation for a published manuscript on cost analysis.
Abstract: Zoher Ghogawala, MD, FACS, Ellyn Wasserberger, Rachel Potter, Fred G. Barker II, MD: Ventral Surgery versus Dorsal Decompression with Fusion for Cervical Spondylotic Myelopathy: A Cost Analysis (Presented at AANS in Chicago, April, 2008)
Eitan Burstein (2008)
(Medical School at SUNY Brooklyn)
Eitan worked on the Carotid Study.
The aim of his work was to determine the effects of carotid revascularization surgery on cognitive performance.
His work was presented orally at the International Stroke Conference in 2009.
Abstract: Zoher Ghogawala, MD, Eitan Burstein, BS, Lauren Stabile, BS, Susan Christopher, RN, Sepideh Amin-Hanjani, MD: The Effect of Carotid Endarterectomy on Cerebral Blood Flow (Presented at Stroke Conference, San Diego, February, 2009)
Ryan Din (2008 and 2009)
(Scarsdale High School)
Ryan has served as an editor for the WTC Newsletters and worked on the Carotid Outcomes Study.
Ryan also worked on the effect of plaque length on intracerebral blood flow which is under revision for publication.
Manuscript: Andrea F. Douglas, MD, Susan Christopher, RN, Nduka Amankulor, MD, Ryan Din, Mike Poullis, MD, Sepideh Amin-Hanjani, MD, Zoher Ghogawala, MD: Extracranial Carotid Plaque Length and Parent Vessel Diameter Significantly Affect Baseline Ipsilateral Intracranial Blood Flow. Neurosurgery 69:767-73, 2011.
Pasha Mirazimi (2009)
(Boston College, 2005)
Pasha worked on the Carotid Study. He organized the carotid database and initiated the analysis of the flow data.
John Russell (2009 and 2010) - Mentor - Jill Curran
(University of Pennsylvania)
John worked on the Carotid Study. His work on analyzing cognitive data found a correlation between improved blood flow and cognitive function after carotid surgery. John's work has been selected for oral podium presentation at the CNS meeting in San Francisco.
Abstract: Zoher Ghogawala, MD, Lauren Stabile, BS, Michael Westerveld, PhD, John Russell, Alejandro Berenstein, MD, David Langer, MD, Sepideh Amin-Hanjani, MD: The Effect of Improving Cerebral Blood Flow on Cognitive Function after Carotid Endarterectomy (Presented at the CNS Meeting, San Francisco, October, 2010)
Ben Baskin (2010) Mentor - Ellyn Wasserberger
(University of Virginia)
Ben worked on the CSM Study.
Ben compared functional outcomes and complication rates in the dorsal group of patients, comparing patients who received laminectomy or laminoplasty alone versus patients with laminectomy plus fusion at 3 months, 6 months, and one year after surgery.
Sydney Simmons (2010) Mentors - Susan Christopher RN/ Z Ghogawala MD
(Greenwich Academy)
Sydney worked on the CSM Study.
Sydney looked at outpatient cost data for patients who had surgery for CSM and compared the costs of ventral surgery to dorsal surgery.
Manuscript: Robert G. Whitmore, MD, J. Sanford Schwartz, MD, Sydney Simmons, Sherman C. Stein, MD, Zoher Ghogawala, MD: Performing a Cost-Analysis In Spine Outcomes Research: Comparing Ventral versus Dorsal Approaches for Cervical Spondylotic Myelopathy. Neurosurgery (In Press).
Abstract: Sydney Simmons, Susan Christopher, RN, Robert G. Whitmore, MD, Zoher Ghogawala, MD: Ventral versus Dorsal Surgery for Cervical Spondylotic Myelopathy: An Outpatient Cost Analysis (Accepted for poster presentation at AANS annual meeting, April, 2011)
Andrew Becker (2010) Mentor - Susan Christopher RN
(Brown University)
Andrew worked on the CSM Study.
Andrew compared all CSM patients who had ventral fusion surgery, dorsal surgery with fusion and dorsal surgery without fusion. He looked at functional outcomes at 3 months, 6 months and 12 months after surgery.
Abstract: Andrew Becker, Susan Christopher, RN, Robert Whitmore, MD, Jill Curran, MS, Benjamin Baskin, and Zoher Ghogawala, MD: Comparative Effectiveness of Ventral versus Dorsal Surgery for Cervical Spondylotic Myelopathy: 3 or 4 Levels of Stenosis (Accepted for oral presentation AANS Spine Section Meeting, March, 2011)
Maryam Barma (2010) Mentor - Khalid Abbed MD
(Sevenoaks School)
London
Maryam worked on the TLIF Study.
Maryam compared functional outcomes of patients having minimally invasive surgery versus open surgery at 6 months after surgery.
Zoher Ghogawala (2010) Mentor - Andrea Douglas MD
(Greenwich High School)
Zoher will be working on the effect of the Obama Healthcare Bill on the cost of treating patients with spinal disorders in Connecticut.
Spine Research Fellows
Grahame Gould, MD (2009) Mentor - Z Ghogawala MD
(Yale University School of Medicine)
Dr. Gould is a senior resident in Neurosurgery. He worked on the CSM Study.
Manuscript: Joseph T. King, Jr., MD, MSCE, Khalid M. Abbed, MD, Grahame C. Gould, MD, Edward C. Benzel, MD, Zoher Ghogawala, MD: Cervical Spine Re-operation Rates and Hospital Resource Utilization following Initial Surgery for Degenerative Cervical Spine Disease in 12,644 Patients in the United States. Neurosurgery 65:1011-1023, 2009.
Nduka Amankulor, MD (2009) Mentor - Z Ghogawala MD
(Yale University School of Medicine)
Dr. Amankulor is a senior resident in Neurosurgery. He worked on the Carotid Study. He also wrote a textbook chapter on cervical spondylotic myelopathy.
Chapter: Zoher Ghogawala, MD, FACS, Nduka Amankulor, MD, Robert F. Heary, MD: Surgical Management of Cervical Spondylotic Myelopathy
(Spinal Cord Medicine, Second Edition)
Manuscript: Andrea F. Douglas, MD, Susan Christopher, RN, Nduka Amankulor, MD, Ryan Din, Mike Poullis, MD, Sepideh Amin-Hanjani, MD, Zoher Ghogawala, MD: Extracranial Carotid Plaque Length and Parent Vessel Diameter Significantly Affect Baseline Ipsilateral Intracranial Blood Flow (submitted)
Robert Whitmore, MD (2010) Mentor - Z Ghogawala MD
(Hospital of the University of Pennsylvania)
Dr. Whitmore is working on the cost analysis of the CSM Study. Dr. Whitmore is also working with Dr Ghogawala on several clinical guideline manuscripts on lumbar fusion surgery and has co-authored two textbook chapters so far.
Manuscript: Robert G. Whitmore, MD, J. Sanford Schwartz, MD, Sydney Simmons, Sherman C. Stein, MD, Zoher Ghogawala, MD: Performing a Cost-Analysis In Spine Outcomes Research: Comparing Ventral versus Dorsal Approaches for Cervical Spondylotic Myelopathy. Neurosurgery (In Press).
Abstracts:
Robert G. Whitmore, MD, Sherman C. Stein, MD, Subu N. Magge, MD, Ellyn Wasserberger, Zoher Ghogawala, MD
Comparative effectiveness analysis of dorsal surgical approaches for treatment of cervical spondylotic myelopathy (Presented at the PA Neurosurgical Society Annual Meeting, July, 2010 and accepted for poster presentation at the CSRS meeting, December, 2010))
Robert G. Whitmore, MD, Sherman C. Stein, MD, Ellyn Wasserberger, Zoher Ghogawala, MD
Surgical approach for treatment of cervical spondylotic myelopathy: Is there a financial incentive? (Presented at the PA Neurosurgical Society Annual Meeting, July, 2010)
Textbook Chapters:
Zoher Ghogawala, MD, FACS, Robert G. Whitmore, MD: The Art of the Clinical Trial ( Spine Surgery: Techniques, Complication Avoidance, and Management, Third Edition)
Robert G. Whitmore, MD, Zoher Ghogawala, MD, William T. Curry, Jr., MD, Sohrab Gollogly, MD, Darrel S. Brodke, MD: Postoperative Imaging
(Spine Surgery: Techniques, Complication Avoidance, and Management, Third Edition)
Contact Us
For more information about any of the research studies, please contact the Wallace Clinical Trials Center at 203 863 3474 or e-mail Ellyn Wasserberger at
Annual Report
Newsletters
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