Dynamic Stabilization for Lumbar Spinal Stenosis with Stabilimax NZ® Dynamic Spine Stabilization System
This study is currently recruiting participants.
Verified by Applied Spine Technologies December 2007
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Purpose
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 |
| Lumbar Spinal Stenosis | Device: Stabilimax NZ® Dynamic Spine Stabilization System |
Study Type: Interventional
Study Design: Treatment, Randomized, Single Blind, Active Control, Parallel
Assignment, Safety/Efficacy
Study Number of arms in study: 2
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
Primary Outcome Measures:
- Decrease in leg pain of 20 mm on a VAS pain scale; Decrease of greater than or equal to .5 on ZCQ
for both Symptom Severity and Physical Function; No major device-related complications;
and No surgical revision, reoperation, removal, or supplemental fixation at
treated level [Time Frame: 2 years]
Secondary Outcome Measures:
- Reduction in OR Time, Blood Loss, Hospital Stay. Improvement in quality of
life and return to work. Improvement in the incidence of adverse events. Radiographic
evidence of nonfusion. [Time Frame: 2 years]
Further study details as provided by Applied Spine Technologies:
Total Enrollment: 480
Study start: February 2007; Expected completion: December 2010
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.
Eligibility
Ages Eligible for Study: 21 Years and above, Genders Eligible for Study: Both
Criteria
Inclusion Criteria:
Radiographic:
- Degenerative spinal stenosis of the lumbar spine, central, lateral recess,
or foraminal;
- Evidence of thecal sac and/or cauda equina compression, nerve root impingement,
hypertrophic facets with canal encroachment, with or without spondylolisthesis,
if present, no more than grade 1
General:
- The greater of the patients right and left VAS leg pain score is greater
than or equal to 40 mm on a 100 mm scale AND exceeds the VAS back pain score;
- Zurich Claudication Questionnaire Symptom Severity score greater than 2
on a scale of 1-5;
- Zurich Claudication Questionnaire Physical Function score greater than or
equal to 2 on a scale of 1-4;
- Intermittent neurogenic claudication
- At least six months of non-surgical management.
- Skeletally mature patients at least 21 years of age;
- Willing to provide written consent for participation and a Health Insurance
Portability and Accountability Act authorization;
- Willing to undergo all study procedures including physical therapy and adhere
to the follow-up schedule; and
- No additional surgical treatment is required outside the investigational
or control at the time of surgery.
Exclusion Criteria:
Initial Screening:
- Prior surgery at any lumbar level including the level being treated except
for: Lamino/Foraminotmy, Microdiscectomy, IDET, and Percutaneous Discectomy.
- Prior surgery at any lumbar level within one year of enrollment;
- No more than one prior surgery at any lumbar level;
- Previous acute trauma at the treated level within two years of enrollment;
- Primary diagnosis of discogenic back pain or degenerative disc disease;
- Symptomatic cervical and/or thoracic neurological compromise;
- Significant peripheral neuropathy or acute denervation secondary to radiculopathy,
caused by conditions other than spinal stenosis;
- Other neurological pathology that could confound study results;
- Cauda Equina Syndrome;
- Contraindicated for MRI;
- Morbid obesity (BMI > 40);
- Peripheral vascular disease requiring intervention (greater than or equal
to 50% stenosis of vessel);
- Active systemic or surgical site infection;
- Any significant medical conditions that would represent a significant increase
in surgical risk or interfere with normal healing;
- History of psychosocial disorders that could prevent accurate completion
of self reporting assessment scales
- Women who are pregnant, lactating or anticipate becoming pregnant within
24 months post-surgery;
- Insulin dependent diabetes mellitus;
- Immunocompromised such as but not limited to Acquired Immunodeficiency Syndrome,
genetic deficiencies of the complement system, Severe Combined Immunodeficiency
Disease, Thymic Hypoplasia;
- Receiving immunosuppressive therapy
- Receiving long-term steroid therapy. Autoimmune disease;
- Active hepatitis;
- Malignancy of any type within the last five years;
- Previous known allergy to the materials contained in the Stabilimax NZ™
device including nickel, cobalt, chromium, molybdenum, iron, titanium, or
Teflon™;
- Participation in another clinical study within four weeks of enrollment,
or;
- Receiving Worker's Compensation or is involved in active litigation relating
to his/her spinal condition;
- Patients who are prisoners.
Radiographic:
- Gross instability, defined as greater than 3 mm translational motion on
flexion/extension studies;
- Degenerative spondylolisthesis or retrolisthesis higher than grade 1
- Degenerative scoliosis > 10° at any level(s) in lumbar spine
- Lateral listhesis on A-P X Ray
- Spondylolysis at any level in lumbar spine
- Isthmic Spondylolisthesis at any level in lumbar spine
- Spondylolisthesis at more than one lumbar level;
- DEXA score equal to or below -2.5 T;
- Pathological vertebral fracture;
- Metastases to the spinal vertebra; Paget's disease of bone; Osteomalacia;
Pars defect or facet fracture;
- Facet arthropathy at the level(s) to be treated is less than grade 2 and
greater than grade 3 according to the Fujiwara scale;
- More than moderate disc degeneration defined as: > 66% loss of disc height
compared to the normal, superior adjacent level; and/or moderate to Severe
Osteophyte formation;
- Congentital lumbar spinal stenosis;
- Estimated interpedicular distance of less than 30 mm.
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00529997
Susan Hedden, BS
203-503-0280 Ext. 15
Shedden@appliedspine.com
Michele M Lucey, BA
203-503-0280 Ext. 16
Mlucey@appliedspine.com
Locations
United States, Arizona
Surgical Specialty Hospital, Phoenix, Arizona, 85015, United States; Recruiting
Jennifer Cammoriano, 602-944-2900, jewel@cox.net
Anthony Yeung, M.D., Principal Investigator
Christopher Yeung, M.D., Sub-InvestigatorUnited States, California
Tri-City Medical Center, Oceanside, California, 92056, United States; Recruiting
Renee Marinelli, 760-489-949, reneescins@mpowercom.net
Mark Stern, M.D., Principal InvestigatorCedars Sinai Medical Center Hospital, Los Angeles, California, 90048, United States; Recruiting
Marko Mijat, 310-423-9771, marko.mijat@cshs.org
Neel Anand, M.D., Principal InvestigatorUnited States, Connecticut
Yale New Haven Hospital, New Haven, Connecticut, 06511, United States; Recruiting
Kimberley Y. Price, 203-737-1861, Kimberly.Price@yale.edu
James Yue, M.D., Principal InvestigatorUnited States, Florida
University Community Hospital at Carrolwood, Tampa, Florida, 33614, United States; Recruiting
Debbi Clabeaux, R.N., 813-876-6885 ext 4, dclabeaux@floridaortho.com
Anthony E Castellvi, M.D., Principal InvestigatorUnited States, Maryland
Johns Hopkins Medical Center, Baltimore, Maryland, 21287, United States; Recruiting
Eunice Aikins-Afful, M.A., M.S., 410-502-6103, eaikins@jhmi.edu
Timothy Witham, M.D., Principal Investigator
John P Wolinsky, M.D., Sub-InvestigatorUnited States, New York
Upstate Medical Center, Syracuse, New York, 13210, United States; Recruiting
Megan Young, 315-464-8618, youngm@upstate.edu
Richard Tallarico, M.D., Principal Investigator
Michael Sun, M.D., Sub-InvestigatorUnited States, North Carolina
North Carolina Specialty Hospital, Durham, North Carolina, 27704 United States; Recruiting
Crystal Hill, B.S.N., 919-281-1870, chill@triangleortho.com
Thomas Dimmig, M.D., Principal Investigator
David Musante, M.D., Sub-Investigator
Ralph Liebelt, M.D., Sub-InvestigatorUnited States, Ohio
Blanchard Valley Hospital, Findlay, Ohio, 45840 United States; Recruiting
Jennifer Kibbey, 419-424-0131, jenbio@hotmail.com
Josue Gabriel, M.D., Principal InvestigatorUnited States, Tennessee
Wellmont Bristol Regional Medical Center, Bristol, Tennessee, 37620, United States; Recruiting
Rebecca Rosemann, M.S., P.A.-C., 423-844-0547, Rebecca@neurospinesolutions.net
Morgan Lorio, M.D., Principal InvestigatorVanderbilt University Medical Center, Nashville, 37232, Tennessee, United States; Recruiting
Christy Hagewood, R.N., 615-322-2579, christy.hagewood@vanderbilt.edu
Joseph Cheng, M.D., Principal Investigator
Kurt Eichholz, M.D., Sub-InvestigatorUnited States, Texas
Presbyterian Plano Center for Diagnostics & Surgery, Plano, Texas, 75093, United States; Recruiting
Marc Kowalkowski, 972-403-5544 ext 312, mkowalkowski@texasback.com
Richard Guyer, M.D., Prinicipal Investigator
Jack Zigler, M.D., Sub-Investigator
Daniel Bradley, M.D., Sub-Investigator
Rey Bosita, M.D., Sub-InvestigatorUnited States, Utah
University of Utah Hospital, Salt Lake City, Utah, 84132, United States; Recruiting
Lori Calkin, 801-585-1089, lori.calkin@hsc.utah.edu
Ken S Yonemura, M.D., Principal Investigator
Darryl S Brodke, M.D., Sub-Investigator
Andrew Dailey, M.D., Sub-Investigator
Michael Daubs, M.D., Sub-InvestigatorUnited States, Virginia
DePaul Medical Center, Norfolk, Virginia, 23505, United States; Recruiting
Kerri Allen, 757-321-3320, allenk@atlanticortho.com
John A Byrd III, M.D., Principal InvestigatorDePaul Medical Center, Norfolk, Virginia, 23505, United States; Recruiting
Lee Anne Lamkin, 757-625-4455 ext 27, lalamkin@att.net
Grant Skidmore, M.D., Principal Investigator
John Partington, Sub-Investigator
Study chairs or principal investigators
Richard Guyer, MD, Principal Investigator, Texas Back Institute
David Musante, M.D., Principal Investigator, Triangle Orthopedics Associates
More Information
Study ID Numbers: AST-A-01
Last Updated: December 19, 2007
Record first received: September 13, 2007
ClinicalTrials.gov Identifier: NCT00529997
Obsolete Identifier: NCT00479544
Health Authority: United States: Food and Drug Administration
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