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Research
: Clinical Studies
The physicians at the Spine Institute
of New York are currently conducting a number of clinical studies
investigating the success of various surgical treatment options
for different conditions and disorders.
• Research Coordinator:
Dr. Ketevan K. Berekashvili
• Research Number: 212-844-8153
Study
Descriptions
Is provocative Lumbar Discography a Useful Predictor of Treatment Response
Status: Open to enrollment
Overview:
Lumbar discography is a test that is commonly used by doctors to determine if back pain is being caused by a painful disc. The purpose of the study is to determine if discography may also be used by doctors to predict patients’ response to treatment.
A Prospective Multicenter Controlled Clinical Trial of an Artificial Cervical Disc-LP at a Single Level for Symptomatic Cervical Disc Disease I
Status: Follow Up Phase
Overview:
The Spine Institute and Neurosurgery Department at Beth Israel Medical Center take part in a national multi-center study that is conducted to assess the safety and effectiveness of the Prestige® LP Cervical Disc in the treatment of symptomatic nerve root and/or spinal cord compression (e.g., arm pain with or without neck pain, functional deficit, and/or neurological deficit) associated with degenerative disc disease at one level between C3-C4 to C6-C7. The Prestige® LP Cervical Disc is a titanium ceramic composite device with two articulating components (ball on top & trough on the bottom) that are attached to the vertebral bodies. It is designed to provide for replication of normal physiological motion. The clinical trial will be used to help support an application to the FDA that could allow the approved future use of this device.
Press release: New York City- surgeons on cutting edge as they implant PRESTIGE® LP Cervical Disc for the neck.
Recombinant Human Bone Morphogenetic
Protein-2 and Compression Resistant Matrix with the CD Horizon
Spinal System for Posterolateral Lumbar Fusion in Patients
with Symptomatic Degenerative Disc Disease
Status: Follow up Phase
Overview:
This prospective, randomized clinical study aims to determine the effectiveness
of rhBMP-2 to treat degenerative disc disease in the lumbar spine (lower
back) when used in conjunction with the CRM carrier and instrumentation (CD
HORIZON® Spinal System).
Spine Institute Outcomes
Registry:
Status: Ongoing
Overview:
A registry of patients undergoing surgery at the Spine Institute to evaluate
the outcomes of the various procedures performed.
Scoliosis Surgery in Persons who refused Blood Transfusion
Status: Paper submitted for publication
Overview:
In order to better serve our population of patients in the bloodless program, we plan to conduct a study looking at the outcome of Scoliosis surgery in patients who refuses transfusion. The study will involve in depth chart and X-ray reviews.
Comparison of the Clinical and Radiological Outcomes of Fusion with Bone Morphogenetic Proteins vs. Bone Graft Fusion: a Retrospective Study
Status: Paper submitted for publication
Overview:
We plan to study the clinical and radiological outcomes observed in patients who underwent spinal fusions with a Bone Morphogenetic Protein (BMP). The results will be compared with existing data on clinical and radiological outcomes in patients who underwent fusions with bone grafts.We plan to conduct a retrospective study going back through medical charts.
Efficacy of Aprotinin in Blood Conservation during Spine Surgery
Status: Paper submitted for publication
Overview:
Aprotinin is used intraoperatively to reduce blood loss. It is frequently used in cardiac surgery. Since spine surgery can lead to a lot of blood loss, Aprotinin is more and more used by spine surgeons as well. This study aims at comparing the efficacy of Aprotinin as a blood conservation technique with other blood conservation techniques (i.e., hypotensive anesthesia, etc). We plan to conduct a retrospective chart review including only patients with multiple-level lumbar fusion/instrumentation.
For further information on Aprotinin, click here.
Anterior cervical surgery revision: complications when using the same side surgical approach
Status: Retrospective Study
Overview:
We plan to conduct a study that evaluates the safety of the revision anterior cervical spine surgery when using same side approach. We plan to conduct retrospective study going through medical charts.
Patient Satisfaction Following Three or More Level Circumferential Spinal Fusion for Degenerative Disc Disease
Status: Retrospective Study
Overview:
We plant to study the patient satisfaction after three or more level Circumferential Spinal Fusion (combined anteroposterior fusion). The study will involve in depth chart reviews and follow up questionnaires for patients who underwent 3 or more level circumferential spinal fusion surgery for Degenerative Disc Disease, at our institution.
Patient Satisfaction Following Three or More Level Circumferential Spinal Fusion for Degenerative Disc Disease
Study design: Prospective Study
Status: Open to Enrollment
Overview:
We plant to study the patient satisfaction after three or more level Circumferential Spinal Fusion (combined anteroposterior fusion). We will prospectively enroll patients who have 3 or more level spinal lumbar Degenerative Disc Disease that have failed to resolve with non-operative management and are indicated for 3 or more level anterior and posterior “circumferential” fusion surgery. Patients, who consent to participate in the study will be asked to answer several outcome questionnaires: Visual Analog Scale, SF36 and Oswestry Disability Index Questionnaires, preoperatively and postoperatively: at 3 month, 6 month, 1 year and 2 year follow up. Demographic data, medical history as well as postoperative complications will be collected.
We are expect to enroll approximately 60 patients.
Two-Stage Anterior and Posterior Reconstructive Surgery: early staged (1-2 days wait) vs late staged (5-10 days wait) procedures.
Study design: Prospective Study
Status: open to enrollment.Overview:We plan to determine if early staged anterior and posterior spinal reconstruction surgery (1-2 days wait between the procedures) has lower complications rate, better clinical outcome and higher patient satisfaction than staged reconstruction surgery with 5-7 days wait between the procedures (combined anteroposterior fusion).
To date, no study has compared the results of treating patients with early staged (1-2 days) vs stage (5-10) days, nor has the relative patient safety, patient satisfaction or total hospitalization costs been evaluated.
Patients, who consent to participate in the study, will be asked to fill out the outcome questionnaires SRS22 questionnaires, Health Outcome questionnaires (SF-36), Oswestry Disability Index and pain scale preoperatively and at their follow up visits (6 month, 12month, 24 month). Patients’ satisfaction will be assessed with patient satisfaction index.
Sexual Function in Men and Women after Lumbar Fusion Surgery for Law Back Pain.
Study Design: Prospective Study
Status: PendingOverview:The purpose of this study is to determine the overall affect on sexual function and to determine gender specific complications depending on surgical approach in patients with degenerative disease of the lumbar spine: anterior lumbar interbody fusion (ALIF) and posterior instrumented fusion (PF) in comparison to posterior lumbar interbody fusion (PLIF) and PF.
Anterior lumbar spine surgery is associated with concerns of impotence and sterility in male patients. Less attention has been paid to females. The reports of sexual function in female patients are very limited. To date no study has prospectively evaluated the sexual function of both males and females with respect to surgical approach to the lumbar spine and fusion technique along with the relationship of pain reduction, function and depression with sexual function. The patients who are indicated for ALIF and PLIF and consent to participate in the study will be asked to fill out Sexual function questionnaires, along with Visual Analog Scale (VAS), Oswestry Disability Index (ODI) and Zung Depression (ZD) scale preoperatively, postoperatively at 6 months, 12 months and at 24 month follow-up.
Change in Neuroforaminal Dimensions after Lumbar Interbody Fusion
Status: Open to Enrollment (after 1/25/07)
Overview:
Neuroforamen is opening of spinal canal where nerve roots exit. Prior studies have shown that lumbar interbody fusion surgery opens the neuroforamen and decompresses the exiting nerve roots. We would like to conduct the prospective cohort study to evaluate the change in dimension of the neuroforamen after lumbar interbody fusion. We would also like to study if the changes in dimensions of neuroforamen will correlate with clinical outcomes of the patients after Lumbar Interbody Fusion.
Efficacy and Safety of Different Therapeutic Methods of fluoroscopically guided epidural injections for Lumbosacral radicular Symptoms.
Study Design: Randomized Clinical Trial
Status: Pending
Fluoroscopically guided epidural steroid injections in combination with physical therapy are commonly used as a therapeutic intervention for lumbosacral radicular symptoms. However, the method of therapeutic action remains somewhat controversial. There are two conflicting hypothesis on the effect of epidural injections for lumbosacral radiculitis (sciatica): one hypothesis is that injected steroid produces an anti-inflammatory effect that reduces the inflammation around the nerve root. According to another hypothesis, the effect is simply a “wash-out” effect in which the injected fluid washes away the inflammatory mediators. The latter hypothesis favors using saline solution instead of steroids.
We want to conduct Randomized Clinical pilot study. The patients will be randomized into one of 3 groups: Group 1 will receive transforaminal epidural saline injections, Group 2 will receive transforaminal epidural steroid injections (Celestone) and Groups 3 will receive transforaminal epidural steroid injections(Dexamethasone).
The purpose of this study is to compare the efficacy, safety and patient satisfaction after different methods of therapeutic action for lumbosacral radicular symptoms, namely: epidural saline, particular steroid(Celestone) and non-particulate steroid(Dexamethasone) injections.
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