Dynamic Stabilization for Lumbar Spinal Stenosis With Stabilimax NZ® Dynamic Spine Stabilization System

Stopped early · Not applicable

Conditions studied: Lumbar Spinal Stenosis

In brief

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 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.

Key facts

Study ID

NCT00529997

Run by

Applied Spine Technologies

People needed

480

Starts

2007-02-01

Expected to finish

2010-12-01

Last updated by the study team

2010-08-11

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Radiographic:
• Degenerative spinal stenosis of the lumbar spine, central, lateral recess, or foraminal;
• Evidence of the cal 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 ≥ 40 mm on a 100 mm scale;
• 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.

You may not qualify if…

• Initial Screening:
• Prior surgery at any lumbar level including the level being treated except for: Lamino/Foraminotomy, 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 and predominate diagnosis of discogenic back pain, e.g. torn disc, herniated disc inflamed or irritated disc, or other disc pathology;
• 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 (≥ 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;

Where it is running

• Surgical Specialty Hospital — Phoenix, Arizona, United States
• Cedars Sinai Medical Center Hospital — Los Angeles, California, United States
• Tri-City Medical Center — Oceanside, California, United States
• Littleton Adventist Hospital — Littleton, Colorado, United States
• New Britain General Hospital — New Britain, Connecticut, United States
• Morton Plant Mease — Clearwater, Florida, United States
• Largo Medical Center — Largo, Florida, United States
• University Community Hospital at Carrolwood — Tampa, Florida, United States
• Rush University Medical Center — Chicago, Illinois, United States
• Upstate Medical Center — Syracuse, New York, United States
• North Carolina Specialty Hospital — Durham, North Carolina, United States
• Blanchard Valley Hospital — Findlay, Ohio, United States
• Sacred Heart Medical Center — Eugene, Oregon, United States
• Lehigh Valley Hospital — Allentown, Pennsylvania, United States
• Wellmont Bristol Regional Medical Center — Bristol, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Presbyterian Plano Center for Diagnostics & Surgery — Plano, Texas, United States
• University of Utah Hospital — Salt Lake City, Utah, United States
• DePaul Medical Center — Norfolk, Virginia, United States

Full record on ClinicalTrials.gov

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