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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 three national trials of our own, the SLIP study, Cognitive Outcomes after Carotid Surgery Study and Cervical Spondylotic Myelopathy (CSM) study.and are participating with (Integra Life Sciences) DuragenPlus®Study. To date, we have raised 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) Duragen Plus adhesion barrier matrix to minimize adhesions following lumbar discectomy
Dr. Ghogawala is an investigator in this multi center randomized study. 30 centers across the country are participating in this study which aims to determine if using duragen plus adhesion barrier matrix prohibits the formation of scar tissue in patients undergoing lumbar discectomy for a single level lumbar disc herniation. If you have been diagnosed with lumbar disc herniation you may be eligible to participate in this important study. If asked to participate you will be asked to undergo MRI evaluation and a series of surveys.
v) 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.
vi) 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.
Selected Published Papers
CSM Paper
SLIP 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.
Donna Geppner
On October 12, 2009, Donna Geppner joined the staff of the WTC as the Manager of Data and Grants. She will be overseeing our NIH grant submission as well as assuming responsibility for the TLIF and XLIF vs. TLIF studies. She has ten years of research experience and most recently, was the Director of the Office of Clinical Trials at the Westchester Medical Center where she oversaw clinical trial compliance. She is also a smoking cessation treatment specialist.
Research Interns
Summer Interns and Research Fellows
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.
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 and her work has been submitted for publication.
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)
Manuscript: Zoher Ghogawala, MD, FACS, Brook Martin, MPH, Rachel Potter, BA, Fred G. Barker II, MD, FACS: Ventral Surgery versus Dorsal Decompression with Fusion for Cervical Spondylotic Myelopathy: A Hospital Charge Analysis (submitted for publication).
Eitan Burstein (2008)
(Medical school at SUNY Brooklyn)
Eitan worked on the Carotid Study. His work was presented orally at the International Stroke Conference in 2008.
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, February, 2009)
Ryan Din (2008 and 2009)
(Scarsdale High School)
-Ryan has served as an editor for the WTC Newsletters.
John Russell (2009)
(University of Pennsylvania)
-John worked on the Carotid Study. He worked on analyzing the cognitive data and applied non-parametric statistical methods to analyze the data. An abstract nad manuscript are in preparation.
Pasha Mirazimi (2009)
(Boston College, 2005)
Pasha is currently working on the Carotid Study. He is organizing the carotid database for the flow data and will be analyzing the data.
Grahame Gould, MD (2009)
(Yale University School of Medicine)
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 (Accepted for publication, Neurosurgery)
Nduka Amankulor, MD (2009)
(Yale University School of Medicine)
Robert Whitmore, MD (2010)
(Hospital of the University of Pennsylvania)
Dr. Whitmore will be working on the cost analysis of the CSM Study
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
Newsletters
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