Dynamic Stabilization for Lumbar Spinal Stenosis With Stabilimax NZ® Dynamic Spine Stabilization System
- Conditions
- Lumbar Spinal Stenosis
- Interventions
- Device: Stabilimax NZ® Dynamic Spine Stabilization System
- Registration Number
- NCT00529997
- Lead Sponsor
- Applied Spine Technologies
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 480
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Stabilimax NZ® Dynamic Spine Stabilization System Posterior Dynamic Stabilization with the Stabilimax NZ 2 Stabilimax NZ® Dynamic Spine Stabilization System Posteriolateral instrumented fusion
- Primary Outcome Measures
Name Time Method Decrease in leg pain of 20 mm on a VAS pain scale; Decrease of ≥ .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 2 years
- Secondary Outcome Measures
Name Time Method 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. 2 years
Trial Locations
- Locations (19)
Blanchard Valley Hospital
🇺🇸Findlay, Ohio, United States
Sacred Heart Medical Center
🇺🇸Eugene, Oregon, United States
DePaul Medical Center
🇺🇸Norfolk, Virginia, United States
Littleton Adventist Hospital
🇺🇸Littleton, Colorado, United States
Largo Medical Center
🇺🇸Largo, Florida, United States
Presbyterian Plano Center for Diagnostics & Surgery
🇺🇸Plano, Texas, United States
Surgical Specialty Hospital
🇺🇸Phoenix, Arizona, United States
Cedars Sinai Medical Center Hospital
🇺🇸Los Angeles, California, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
New Britain General Hospital
🇺🇸New Britain, Connecticut, United States
Morton Plant Mease
🇺🇸Clearwater, Florida, United States
North Carolina Specialty Hospital
🇺🇸Durham, North Carolina, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University Community Hospital at Carrolwood
🇺🇸Tampa, Florida, United States
Upstate Medical Center
🇺🇸Syracuse, New York, United States
Lehigh Valley Hospital
🇺🇸Allentown, Pennsylvania, United States
University of Utah Hospital
🇺🇸Salt Lake City, Utah, United States
Tri-City Medical Center
🇺🇸Oceanside, California, United States
Wellmont Bristol Regional Medical Center
🇺🇸Bristol, Tennessee, United States