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Sponsored by: |
Applied Spine Technologies |
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Information provided by: | Applied Spine Technologies |
ClinicalTrials.gov Identifier: | NCT00529997 |
The purpose of this trial is to assess whether the Stabilimax NZ® is at least as safe and effective as the control therapy of fusion in patients receiving decompression surgery for the treatment of clinically symptomatic spinal stenosis at one or two contiguous vertebral levels from L1-S1. Safety and effectiveness will be assessed by means of primary study endpoints which address improvements in pain and function in the absence of major device related complications.
The study hypothesis criteria for demonstrating safety and efficacy requires scientific evidence that patients classified as satisfying the primary study endpoint post device implantation is at least as good for Stabilimax NZ® recipients as that for patients undergoing fusion with posterior pedicle screw instrumentation at the 24 month followup assessment.
Condition | Intervention |
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Lumbar Spinal Stenosis |
Device: Stabilimax NZ® Dynamic Spine Stabilization System |
Study Type: | Interventional |
Study Design: | Active Control, Parallel Assignment, Randomized, Safety/Efficacy Study, Single Blind (Subject), Treatment |
Official Title: | Clinical Study Comparing Dynamic Stabilization of the Lumbar Spine With the Stabilimax NZ® Dynamic Spine Stabilization System to Posterolateral Instrumented Fusion - In Patients With Lumbar Spinal Stenosis |
Estimated Enrollment: | 480 |
Study Start Date: | February 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Posterior Dynamic Stabilization with the Stabilimax NZ
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Device: Stabilimax NZ® Dynamic Spine Stabilization System
Surgical Implantation
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2: Active Comparator
Posteriolateral instrumented fusion
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Device: Stabilimax NZ® Dynamic Spine Stabilization System
Surgical Implantation
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Degenerative spine disease is a normal part of the aging process. This degeneration can sometimes cause significant pain and limit normal movement.
The pain can be from many sources. For patients being enrolled into this study the pain has been diagnosed to be primarily as a result of a condition called spinal stenosis. The current standard of care for the treatment of moderate to severe spinal stenosis is a surgical procedure that relieves the pressure on the spinal cord and nerves is called decompression surgery. The surgeon removes the tissue and bone that are causing the narrowing thus relieving the pinching of the spinal cord and nerve roots. After surgery, the patient may have a spine that is too unstable. In other words the muscles and ligaments around the spine have to work too hard to maintain normal posture and to control movement. For many years those patients with unstable backs have received fusion therapy. Fusion is the development of bone between the vertebra to stabilize the spine and prevent motion. This is done by inserting a bone graft around the vertebra being treated and placing a rigid brace called a fusion device to prevent movement. Eventually bone will form between the vertebra and the spine will become "fused".
In this study we will be conducting research to evaluate a new, investigative medical device that is designed to brace and support the spine just like fusion but without fusing in the patient's spine. Devices that do this are called "motion preserving" or "dynamic stabilizing" spinal devices. The investigational device that is being evaluated in this study is called the Stabilimax NZ® Dynamic Spinal Stabilization System. The Stabilimax NZ® is inserted and fixed to the vertebra by means of pedicle screws in exactly the same way a fusion device is inserted and attached. The only difference is that for the Stabilimax NZ® no bone graft will be placed around or between the vertebra to promote bone growth for fusion. Patients in the study will receive either the Stabilimax NZ® or will receive a fusion procedure. The study is a randomized controlled clinical trial using a 2:1 investigational:control randomization scheme. The study will enroll 480 patients at approximately 20 investigational sites across the United States.
Ages Eligible for Study: | 21 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
INCLUSION CRITERIA:
Radiographic:
General:
EXCLUSION CRITERIA:
Initial Screening:
Radiographic:
Contact: Jason Ross | 203-503-0280 ext 37 | clinicaltrial@appliedspine.com |
United States, Arizona | |
Surgical Specialty Hospital | Recruiting |
Phoenix, Arizona, United States, 85015 | |
Contact: Jennifer Camariano 602-944-2900 jewel@cox.net | |
Principal Investigator: Anthony Yeung, M.D. | |
Sub-Investigator: Christopher Yeung, M.D. | |
Sub-Investigator: Justin Field, M.D. | |
United States, California | |
Tri-City Medical Center | Recruiting |
Oceanside, California, United States, 92056 | |
Contact: Renee Marinelli 760-489-9490 reneescins@mpowercom.net | |
Principal Investigator: Mark Stern, M.D. | |
Cedars Sinai Medical Center Hospital | Not yet recruiting |
Los Angeles, California, United States, 90048 | |
Contact: Rebecca Roseman 310-423-9714 Rosemanr@cshs.org | |
Principal Investigator: Neel Anand, M.D. | |
Sub-Investigator: J. Patrick Johnson, M.D. | |
Sub-Investigator: Eli Baron, M.D. | |
Sub-Investigator: Khawar Siddique, M.D. | |
Sub-Investigator: Srinath Samudrala, M.D. | |
United States, Colorado | |
Littleton Adventist Hospital | Not yet recruiting |
Littleton, Colorado, United States, 80122 | |
Contact: Breton Line 303-788-5230 breton.line@gmail.com | |
Principal Investigator: Robert Bess, M.D. | |
Sub-Investigator: John A. Prall, M.D. | |
United States, Connecticut | |
New Britain General Hospital | Recruiting |
New Britain, Connecticut, United States, 06052 | |
Contact: Cathy Couch, RN 860-225-1251 ccouch@centralctneuro.com | |
Principal Investigator: Ahmed Khan, M.D. | |
Sub-Investigator: Lane Spero, M.D. | |
United States, Florida | |
University Community Hospital at Carrolwood | Not yet recruiting |
Tampa, Florida, United States, 33614 | |
Contact: Debbi Clabeaux, RN 813-876-6885 ext 3 dclabeaux@floridaortho.com | |
Principal Investigator: Anthony E Castellvi, M.D. | |
Morton Plant Mease | Not yet recruiting |
Clearwater, Florida, United States, 33756 | |
Contact: Aileen Bair 727-449-2599 OrthospecAB@tampabay.rr.com | |
Principal Investigator: J. Byron Davidson, D.O. | |
Sub-Investigator: Mike R. Piazza, M.D. | |
United States, Illinois | |
Rush University Medical Center | Not yet recruiting |
Chicago, Illinois, United States, 60612 | |
Contact: Margaret Hickey, RN, MS, MBA 312.432.2358 margaret.hickey@rushortho.com | |
Principal Investigator: Frank M Phillips, M.D. | |
Sub-Investigator: Edward J Goldberg, M.D. | |
Sub-Investigator: Gunnar B. J. Andersson, M.D., Ph.D. | |
Sub-Investigator: Kern Singh, M.D. | |
Sub-Investigator: Howard S. An, M.D. | |
United States, New York | |
Upstate Medical Center | Recruiting |
Syracuse, New York, United States, 13210 | |
Contact: Tina Craig 315-464-8618 craigt@upstate.edu | |
Principal Investigator: Richard Tallarico, M.D. | |
Sub-Investigator: Michael Sun, M.D. | |
United States, North Carolina | |
North Carolina Specialty Hospital | Recruiting |
Durham, North Carolina, United States, 27704 | |
Contact: Crystal Hill, BSN 919-281-1870 chill@triangleortho.com | |
Sub-Investigator: David Musante, M.D. | |
Principal Investigator: Thomas Dimmig, M.D. | |
Sub-Investigator: Ralph Liebelt, M.D. | |
United States, Ohio | |
Blanchard Valley Hospital | Not yet recruiting |
Findlay, Ohio, United States, 45840 | |
Contact: Kay Alexander 419-424-0131 kaalexander@ohioorthopaedics.com | |
Principal Investigator: Josue Gabriel, M.D. | |
United States, Oregon | |
Sacred Heart Medical Center | Not yet recruiting |
Eugene, Oregon, United States, 97401 | |
Contact: Shawn Altree 541-284-0530 saltree@neurospinellc.com | |
Principal Investigator: Scott Kitchel, M.D. | |
Sub-Investigator: Chris Miller, M.D. | |
Sub-Investigator: Chris Noonan, M.D. | |
United States, Pennsylvania | |
Lehigh Valley Hospital | Recruiting |
Allentown, Pennsylvania, United States, 18105 | |
Contact: Emese Futchko 610-402-1625 emese.futchko@lvh.com | |
Principal Investigator: Jeff McConnell, M.D. | |
Sub-Investigator: James C Weis, M.D. | |
Sub-Investigator: Stephen P Falatyn, M.D. | |
Sub-Investigator: Amir H Fayyazi, M.D. | |
Sub-Investigator: Christopher Lycette, M.D. | |
Sub-Investigator: Mark Li, M.D. | |
Sub-Investigator: Stefano Camici, M.D. | |
United States, Tennessee | |
Wellmont Bristol Regional Medical Center | Recruiting |
Bristol, Tennessee, United States, 37620 | |
Contact: Kimberly Butterworth, MS, PA-C 423-844-0501 butterworth@neurospinesolutions.net | |
Principal Investigator: Morgan Lorio, M.D. | |
Vanderbilt University Medical Center | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Contact: Christy Hagewood, RN 615-322-2579 christy.hagewood@vanderbilt.edu | |
Principal Investigator: Joseph Cheng, M.D. | |
Sub-Investigator: Kurt Eichholz, M.D. | |
United States, Texas | |
Presbyterian Plano Center for Diagnostics & Surgery | Not yet recruiting |
Plano, Texas, United States, 75093 | |
Contact: Dawn DeLacy 972-403-5544 ddelacy@spinemarkcro.com | |
Sub-Investigator: Jack Zigler, M.D. | |
Sub-Investigator: Daniel Bradley, M.D. | |
Sub-Investigator: Rey Bosita, M.D. | |
Principal Investigator: Richard Guyer, M.D. | |
United States, Utah | |
University of Utah Hospital | Not yet recruiting |
Salt Lake City, Utah, United States, 84132 | |
Contact: Lori Blackburn 801-585-7916 lori.blackburn@hsc.utah.edu | |
Principal Investigator: Ken S Yonemura, M.D. | |
Sub-Investigator: Darryl S Brodke, M.D. | |
Sub-Investigator: Andrew Dailey, M.D. | |
Sub-Investigator: Michael Daubs, M.D. | |
United States, Virginia | |
DePaul Medical Center | Recruiting |
Norfolk, Virginia, United States, 23505 | |
Contact: Celeste Driskell 757-567-2049 Celestejbcb@yahoo.com | |
Principal Investigator: Grant Skidmore, M.D. | |
Sub-Investigator: John Partington | |
DePaul Medical Center | Not yet recruiting |
Norfolk, Virginia, United States, 23505 | |
Contact: Katrina Burch 757-321-3317 burchk@atlanticortho.com | |
Principal Investigator: John A Byrd III, M.D. |
Principal Investigator: | Richard Guyer, MD | Texas Back Institute |
Principal Investigator: | David Musante, M.D. | Triangle Orthopedics Associates |
Principal Investigator: | Neel Anand, M.D. | Cedars Sinai Medical Center Hospital |
Responsible Party: | Applied Spine Technologies, Inc. ( Michele Lucey - Vice President of Regulatory Affairs and Quality Assurance ) |
Study ID Numbers: | AST-A-01 |
Study First Received: | September 13, 2007 |
Last Updated: | February 26, 2009 |
ClinicalTrials.gov Identifier: | NCT00529997 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Arthroplasty Back Pain Dynamic Stabilization Investigational Leg Pain |
Lumbar Spinal Stenosis Lumbar Spine Motion Preserving Randomized Spondylolisthesis |
Spinal Diseases Pathological Conditions, Anatomical Musculoskeletal Diseases Constriction, Pathologic Pain |
Spondylolisthesis Bone Diseases Back Pain Spinal Stenosis |
Spinal Diseases Pathological Conditions, Anatomical Musculoskeletal Diseases |
Constriction, Pathologic Bone Diseases Spinal Stenosis |