Lumbar Spinal StenosisNCT00692276
Investigating Superion™ In Spinal Stenosis
A study testing Superion™ Interspinous Spacer and X-STOP® IPD® Device in people with Lumbar Spinal Stenosis and Intermittent Claudication, run by Boston Scientific Corporation at 32 sites in United States.
Trial summary
The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care. Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis, Intermittent Claudication
- What is being tested?
- Superion™ Interspinous Spacer and X-STOP® IPD® Device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 391 participants
- Where
- 32 sitesUnited States
- Study dates
- Jun 2008to Feb 2017
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female subjects ≥ 45 years of age
- Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart)
- Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal)
- Must be able to sit for 50 minutes without pain and to walk 50 feet or more
Who cannot join
- Axial back pain only
- Fixed motor deficit
- Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or experimental device
- Unremitting pain in any spinal position
- Significant peripheral neuropathy or acute denervation secondary to radiculopathy
- Lumbar spinal stenosis at more than two levels determined pre-operatively to require surgical intervention
Show all 18Show fewer
- Significant instability of the lumbar spine as defined by 3mm translation or 5 degrees angulation
- Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
- Spondylolisthesis or degenerative spondylolisthesis greater than grade 1.0 (on a scale of 1 to 4)
- Spondylolysis (pars fracture)
- Morbid obesity, defined as Body Mass Index (BMI) greater than 40kg/m2
- Insulin-dependent diabetes mellitus
- Prior surgery of the lumbar spine
- Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction)
- Infection in the disc or spine, past or present
- Paget's disease at involved segment or metastasis to the vertebra, osteomalacia, or other metabolic bone disease
- Tumor in the spine or a malignant tumor except for basal cell carcinoma
- Involved in pending litigation of the spine or worker's compensation related to the back
Trial locations and contacts
32 sites in 1 country.
32 sites in 1 country
United States32 sites
University of Colorado Hospital- The Spine Center- Anshutz Outpatient Pavilion
Aurora, Colorado, 80045
Greater Baltimore Neurosurgical Associates at GBMA
Baltimore, Maryland, 21204
D.I.S.C. Sports and Spine Center
Beverly Hills, California, 90211
Tower Orthopaedics and Sports Medicine/ Institute for Advanced Spinal Research
Beverly Hills, California, 90211
The Center for Pain Relief, Inc
Charleston, West Virginia, 25301
Rush University Medical Center
Chicago, Illinois, 60612
New England Center for Clinical Research
Cranston, Rhode Island, 02920
Florida Research Associates, LLC
DeLand, Florida, 32720
Durango Orthopedic Associates, P.C./Spine Colorado
Durango, Colorado, 81301
Triangle Orthopaedic Associates
Durham, North Carolina, 27704
NeuroSpine Institute, LLC
Eugene, Oregon, 97401
Shrock Orthopedic Research
Fort Lauderdale, Florida, 33316
East Tennessee Brain & Spine Center
Johnson City, Tennessee, 37604
Orange County Neurosurgical Associates
Laguna Hills, California, 92653-3665
Colorado Spine And Scoliosis Institute
Littleton, Colorado, 80122
Brain and Spine Research Institute
Los Angeles, California, 90027
Institute for Low Back and Neck Care
Minneapolis, Minnesota, 55425
Yale University
New Haven, Connecticut, 06520
Pacific Pain Medicine Consultants/Pacific Surgery Center
Oceanside, California, 92056
Sports Medicine North
Peabody, Massachusetts, 01960
Orthopedics Associates of the Greater Lehigh Valley
Phillipsburg, New Jersey, 08865
Arizona Center for Neurosurgery
Phoenix, Arizona, 85020
Texas Back Institute
Plano, Texas, 75093
Performance Spine and Sports Physicians
Pottstown, Pennsylvania, 19464
Spine Care and Rehabilitation, Inc.
Roseland, New Jersey, 07068
Orthopedics International Spine
Seattle, Washington, 98104
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Stony Brook University Medical Center, Dept. of Neurological Surgery
Stony Brook, New York, 11794
Upstate Medical Universtiy-Department of Orthopedics- Institute for Spine Care
Syracuse, New York, 13202
Tucson Orthopaedic Institute
Tucson, Arizona, 85712
The George Washington Universtiy Medical Facility
Washington D.C., District of Columbia, 20037
OrthopaediCare (Abington Orthopaedic Specialists)
Willow Grove, Pennsylvania, 19090
About this study
Official title: A Prospective, Multi-Center, Randomized Study Comparing the VertiFlex® Superion™ Interspinous Spacer (ISS) to the X-STOP® Interspinous Process Decompression (IPD®) System in Patients With Moderate Lumbar Spinal Stenosis
The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care.
Read the detailed description
The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care. The study endpoint is the rate of overall subject success at 24 months.
- Conditions
- Lumbar Spinal Stenosis, Intermittent Claudication
- Being tested
- Superion™ Interspinous Spacer, X-STOP® IPD® Device
- Medical subject headings
- Spinal Stenosis, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superion™ Interspinous SpacerDevice
Implantation of interspinous process spacer to treat lumbar spinal stenosis
X-STOP® IPD® DeviceDevice
Implantation of interspinous process spacer to treat lumbar spinal stenosis
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Interspinous Process Spacer Device Receives: Device: Superion™ Interspinous Spacer |
| 2 | Active comparator | Interspinous Process Spacer Device Receives: Device: X-STOP® IPD® Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Clinically Significant Improvement in Outcomes
Where clinically significant improvement in outcomes compared to baseline, as determined by meeting the following:
- At least two of three domains of the Zurich Claudication Questionnaire (ZCQ) [validated, condition-specific patient-reported questionnaire that captures data in three distinct domains]
- Improvement in physical function by ≥0.5 points
- Improvement in symptom severity by ≥0.5 points
- "Satisfied" or "somewhat satisfied" as defined by a score of ≤ 2.5 points on the patient satisfaction domain
- No re-operations, revisions, removals or supplemental fixation at the index level(s)
- No major implant- or procedure-related complications:
- No dislodgement, migration, or deformation
- No new or persistent worsened neurological deficit at the index level
- No spinous process fractures
- No deep infection, death, or other permanent device attributed disability
- No clinically significant confounding treatments:
- No epidural injections or nerve block proc
Measured: Baseline and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2008 (estimated)
- Study startJun 2008
- Primary completionFeb 2017
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lumbar Spinal StenosisStudies of the same condition, open and under way.
- More trials run by Boston Scientific CorporationThe sponsor's other registered studies.
- 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
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Scientific Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- VertiFlex, Incorporated
- Responsible party
- Sponsor
- Investigators
- Roshini Jain, Study director, Boston Scientific Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00692276
- Sponsor's protocol ID
- 08-VISS-01
- Status last verified
- Nov 2020
- First submitted
- 4 Jun 2008
- Last updated
- 16 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Patel VV, Whang PG, Haley TR, Bradley WD, Nunley PD, Miller LE, Block JE, Geisler FH. Two-year clinical outcomes of a multicenter randomized controlled trial comparing two interspinous spacers for treatment of moderate lumbar spinal stenosis. BMC Musculoskelet Disord. 2014 Jul 5;15:221. doi: 10.1186/1471-2474-15-221.
PubMed 24996648Loguidice V, Bini W, Shabat S, Miller LE, Block JE. Rationale, design and clinical performance of the Superion(R) Interspinous Spacer: a minimally invasive implant for treatment of lumbar spinal stenosis. Expert Rev Med Devices. 2011 Jul;8(4):419-26. doi: 10.1586/erd.11.24.
PubMed 21728727
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Multi-Center, Randomized Study Comparing the VertiFlex® Superion™ Interspinous Spacer (ISS) to the X-STOP® Interspinous Process Decompression (IPD®) System in Patients With Moderate Lumbar Spinal Stenosis
- ClinicalTrials.gov ID
- NCT00692276
- Acronym / sponsor ID
- 08-VISS-01
- Conditions
- Lumbar Spinal Stenosis, Intermittent Claudication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- Boston Scientific CorporationIndustry (pharma, biotech, devices)
- Collaborators
- VertiFlex, Incorporated
- Study start
- Jun 2008
- Primary completion
- Feb 2017 (actual)
- Study completion
- Feb 2017 (actual)
- First posted
- 6 Jun 2008 (estimated)
- Results
- Posted 25 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care.
Detailed description
The proposed prospective, multi-center, randomized clinical trial is designed to evaluate the safety and effectiveness of the Superion™ ISS compared to the X-STOP® IPD® device in healthy adults suffering from at least 6 months of moderate spinal stenosis symptoms who have been unresponsive to conservative care. The study endpoint is the rate of overall subject success at 24 months.
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: Superion™ Interspinous SpacerInterspinous Process Spacer Device |
| 2 | Active comparator | Device: X-STOP® IPD® DeviceInterspinous Process Spacer Device |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female subjects ≥ 45 years of age
- Persistent leg/buttock/groin pain, with or without back pain, that is relieved by flexion activities (example: sitting or bending over a shopping cart)
- Diagnosis of degenerative spinal stenosis of the lumbar spine, defined as the narrowing of the midline sagittal spinal canal (central) and/or narrowing between the facet superior articulating process (SAP), the posterior vertebral margin (lateral recess), and the nerve root canal (foraminal)
- Must be able to sit for 50 minutes without pain and to walk 50 feet or more
Key exclusion criteria (18 listed)
- Axial back pain only
- Fixed motor deficit
- Diagnosis of lumbar spinal stenosis which requires any direct neural decompression or surgical intervention other than those required to implant the control or experimental device
- Unremitting pain in any spinal position
- Significant peripheral neuropathy or acute denervation secondary to radiculopathy
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 |
|---|---|---|
| Superion™ Interspinous SpacerImplantation of interspinous process spacer to treat lumbar spinal stenosis | Device | 1 |
| X-STOP® IPD® DeviceImplantation of interspinous process spacer to treat lumbar spinal stenosis | Device | 2 |
Primary outcome
Percentage of Subjects With Clinically Significant Improvement in Outcomes
Time frame: Baseline and 24 months
Where clinically significant improvement in outcomes compared to baseline, as determined by meeting the following: * At least two of three domains of the Zurich Claudication Questionnaire (ZCQ) [validated, condition-specific patient-reported questionnaire that captures data in three distinct domains] * Improvement in physical function by ≥0.5 points * Improvement in symptom severity by ≥0.5 points * "Satisfied" or "somewhat satisfied" as defined by a score of ≤ 2.5 points on the patient satisfaction domain * No re-operations, revisions, removals or supplemental fixation at the index level(s) * No major implant- or procedure-related complications: * No dislodgement, migration, or deformation * No new or persistent worsened neurological deficit at the index level * No spinous process fractures * No deep infection, death, or other permanent device attributed disability * No clinically significant confounding treatments: * No epidural injections or nerve block proc
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24996648Patel VV, Whang PG, Haley TR, Bradley WD, Nunley PD, Miller LE, Block JE, Geisler FH. Two-year clinical outcomes of a multicenter randomized controlled trial comparing two interspinous spacers for treatment of moderate lumbar spinal stenosis. BMC Musculoskelet Disord. 2014 Jul 5;15:221. doi: 10.1186/1471-2474-15-221.
- Derived from this study: PubMed 21728727Loguidice V, Bini W, Shabat S, Miller LE, Block JE. Rationale, design and clinical performance of the Superion(R) Interspinous Spacer: a minimally invasive implant for treatment of lumbar spinal stenosis. Expert Rev Med Devices. 2011 Jul;8(4):419-26. doi: 10.1586/erd.11.24.
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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.
Roshini Jain study director
Boston Scientific Corporation
32 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superion™ Interspinous Spacer and X-STOP® IPD® Device in people with Lumbar Spinal Stenosis and Intermittent Claudication, run by Boston Scientific Corporation at 32 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 4 inclusion and 18 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: finished, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 32 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?
Yes. Results are posted in the registry (first posted 25 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects With Clinically Significant Improvement in Outcomes (time frame: Baseline and 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00692276, which also lists 2 linked publications.
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 16 Nov 2020.