Lumbar Spinal StenosisNCT00529997
Dynamic Stabilization for Lumbar Spinal Stenosis With Stabilimax NZ® Dynamic Spine Stabilization System
A study testing Stabilimax NZ® Dynamic Spine Stabilization System in people with Lumbar Spinal Stenosis, run by Applied Spine Technologies at 19 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Stabilimax NZ® Dynamic Spine Stabilization System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 19 sitesUnited States
- Study dates
- Feb 2007to Dec 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- 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;
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- 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;
- 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;
- Congenital lumbar spinal stenosis;
- Estimated interpedicular distance of less than 30 mm.
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
United States19 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18105
Wellmont Bristol Regional Medical Center
Bristol, Tennessee, 37620
Rush University Medical Center
Chicago, Illinois, 60612
Morton Plant Mease
Clearwater, Florida, 33756
North Carolina Specialty Hospital
Durham, North Carolina, 27704
Sacred Heart Medical Center
Eugene, Oregon, 97401
Blanchard Valley Hospital
Findlay, Ohio, 45840
Largo Medical Center
Largo, Florida, 33770
Littleton Adventist Hospital
Littleton, Colorado, 80122
Cedars Sinai Medical Center Hospital
Los Angeles, California, 90048
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
New Britain General Hospital
New Britain, Connecticut, 06052
DePaul Medical Center
Norfolk, Virginia, 23505
Tri-City Medical Center
Oceanside, California, 92056
Surgical Specialty Hospital
Phoenix, Arizona, 85015
Presbyterian Plano Center for Diagnostics & Surgery
Plano, Texas, 75093
University of Utah Hospital
Salt Lake City, Utah, 84132
Upstate Medical Center
Syracuse, New York, 13210
University Community Hospital at Carrolwood
Tampa, Florida, 33614
About this study
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
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.
Read the 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.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Stabilimax NZ® Dynamic Spine Stabilization System
- Keywords
- Lumbar Spine, Lumbar Spinal Stenosis, Spondylolisthesis, Dynamic Stabilization, Motion Preserving, Arthroplasty, Randomized, Investigational, Back Pain, Leg Pain
- Medical subject headings
- Spinal Stenosis, Spondylolisthesis, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stabilimax NZ® Dynamic Spine Stabilization SystemDevice
Surgical Implantation
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Posterior Dynamic Stabilization with the Stabilimax NZ Receives: Device: Stabilimax NZ® Dynamic Spine Stabilization System |
| 2 | Active comparator | Posteriolateral instrumented fusion Receives: Device: Stabilimax NZ® Dynamic Spine Stabilization System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 years
Secondary outcomes (1)
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2007 (estimated)
- Study startFeb 2007
- Primary completionDec 2010 (estimated)
- Study completionDec 2010 (estimated)
Why it stopped: Company has ceased operation
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Applied Spine Technologies
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Richard Guyer, MD, Principal investigator, Texas Back InstituteDavid Musante, M.D., Principal investigator, Triangle Orthopedics AssociatesNeel Anand, M.D., Principal investigator, Cedars Sinai Medical Center Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00529997
- Sponsor's protocol ID
- AST-A-01
- Status last verified
- Aug 2010
- First submitted
- 13 Sep 2007
- Last updated
- 11 Aug 2010
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00529997
- Acronym / sponsor ID
- AST-A-01
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Lumbar Spine, Lumbar Spinal Stenosis, Spondylolisthesis, Dynamic Stabilization, Motion Preserving, Arthroplasty, Randomized, Investigational
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Company has ceased operation
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Applied Spine TechnologiesIndustry (pharma, biotech, devices)
- Study start
- Feb 2007
- Primary completion
- Dec 2010 (estimated)
- Study completion
- Dec 2010 (estimated)
- First posted
- 17 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Stabilimax NZ® Dynamic Spine Stabilization SystemPosterior Dynamic Stabilization with the Stabilimax NZ |
| 2 | Active comparator | Device: Stabilimax NZ® Dynamic Spine Stabilization SystemPosteriolateral instrumented fusion |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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
- 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;
Key exclusion criteria (42 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stabilimax NZ® Dynamic Spine Stabilization SystemSurgical Implantation | Device | 1, 2 |
Primary outcome
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
Time frame: 2 years
1 secondary outcome
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
Results and safety
The study was stopped early (reason given: Company has ceased operation). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard Guyer, MD principal investigator
Texas Back Institute
David Musante, M.D. principal investigator
Triangle Orthopedics Associates
Neel Anand, M.D. principal investigator
Cedars Sinai Medical Center Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Stabilimax NZ® Dynamic Spine Stabilization System in people with Lumbar Spinal Stenosis, run by Applied Spine Technologies at 19 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 42 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Aug 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Company has ceased operation). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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 (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2010.