Spinal Stenosis, Lumbar Region With Neurogenic ClaudicationASCENDNCT03048955
Assessing Superion Clinical Endpoints vs. Decompression
A study testing Superion® IDS and Direct decompression Surgery in people with Spinal Stenosis, Lumbar Region With Neurogenic Claudication, run by VertiFlex, Incorporated at 5 sites in United States.
Trial summary
PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical Success of the study group receiving the Superion® IDS is not inferior to the success rate observed in the study group treated by direct decompression at 60 months follow-up. Read more about this study
- Who is it for?
- Ages 45 years and olderHealthy volunteers can take part
- Conditions the study is for
- Spinal Stenosis, Lumbar Region With Neurogenic Claudication
- What is being tested?
- Superion® IDS and Direct decompression Surgery
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesUnited States
- Study dates
- 8 Feb 2017to 31 Jul 2025
- 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 45 years and older
- All sexes
- Healthy volunteers accepted
- 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 consistently relieved by flexion activities (example: sitting or bending over a shopping cart).
- Subjects who have been symptomatic and undergoing conservative care treatment for at least 6 months, without relief.
- 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 access), and the nerve root canal (foraminal).
- Radiographic confirmation of at least moderate spinal stenosis which narrows the central, lateral, or foraminal spinal canal at one or two contiguous levels from L1-L5. Moderate spinal stenosis is defined as ≤50% reduction in lateral/central foramen.
- Must present with moderately impaired Physical Function (PF) defined as a score of ≥ 2.0 of the Zurich Claudication Questionnaire (ZCQ).
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- Subjects who are able to give voluntary, written informed consent to participate in this clinical investigation and from whom consent has been obtained.
- Subjects, who, in the opinion of the Clinical Investigator, are able to understand this clinical investigation, cooperate with the investigational procedures and are willing to return for all the required post-treatment follow-ups.
- Note: In Criteria #5, all imaging used to confirm LSS should be completed within 4 weeks prior to enrollment. Radiographic confirmation of LSS may include MRI and/or CT.
Who cannot join
- Axial back pain only.
- Fixed motor deficit in lower extremity(ies).
- Diagnosis of lumbar spinal stenosis which, if the patient were randomized to the Superion arm, would not require any direct neural decompression or surgical intervention other than that required to implant the Superion® device or if randomized to the direct decompression arm, would not require a decompression procedure which would create significant instability requiring spinal fusion, with or without instrumentation.
- 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.
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- Significant instability of the lumbar spine as defined by ≥ 3mm translation or ≥ 5° angulation through flexion/extension films.
- Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips.
- Spondylolisthesis or degenerative spondylolisthesis greater than grade 1 (on a scale of 1-4).
- Spondylosis (pars fracture) at the treatment level(s).
- Degenerative lumbar scoliosis with a Cobb angle of > 10° at treatment level.
- Osteoporosis, defined as a DEXA bone density measurement T score ≤ -2.5.
- Morbid obesity, defined as Body Mass Index (BMI) >40kg/m2.
- Significant peripheral vascular disease (diminished dorsalis pedis or tibial pulses).
- Prior surgery of the lumbar spine at the treatment level(s).
- Cauda equina syndrome (defined as neural compression causing neurogenic bowel or bladder dysfunction).
- Active (systemic, or local in disc or spine) infection at time of surgery.
- Active systemic disease such as AIDS, HIV, hepatitis, etc.
- Paget's disease at involved segment or metastasis to the vertebrae, osteomalacia, or other metabolic bone disease.
- Currently undergoing immunosuppressive therapy or long-term steroid use.
- Known allergy to titanium or titanium alloys.
- Tumor in the spine or a malignant tumor except for basal cell carcinoma.
- Known or suspected history of alcohol and/or drug abuse.
- Prisoner or transient.
- Life expectancy less than two years.
- Any significant psychological disturbance, psychotic or neurotic, that could impair the consent process or ability to complete subject self-report questionnaires.
- Involved in pending litigation of the spine or worker's compensation related to the back.
- Enrolled in the treatment phase of another drug or device clinical investigation (currently within past 30 days).
- Congenital defect of the spine.
- Pregnant or lactating.
- Any condition that, in the opinion of the Investigator, would affect the patient's welfare or outcome of the clinical trial.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Alabama Clinical Therapeutics, LLC
Birmingham, Alabama, 35335
Coastal Pain Spinal Diagnostics
Carlsbad, California, 92009
Lake Nona Medical Arts
Celebration, Florida, 32827
Spine Institute of Louisiana
Shreveport, Louisiana, 71101
Rothman Institute
Willow Grove, Pennsylvania, 19090
About this study
Official title: A 2 and 5 Year Comparative Evaluation of Clinical Outcomes in the Treatment of Moderate Lumbar Spinal Stenosis With the Superion® Indirect Decompression System (IDS) vs. Direct Decompression Surgery for FDA Actual Conditions of Use Study
PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical Success of the study group receiving the Superion® IDS is not inferior to the success rate observed in the study group treated by direct decompression at 60 months follow-up. Secondarily, the trial is intended to establish that Composite Clinical Success of the study group receiving the Superion® IDS at 24 months is not inferior to the success rate observed at 24 months in patients treated with the Superion® IDS in the original IDE trial. Thirdly, the trial is intended to establish that Composite Clinical Success of the population receiving the Superion® IDS in this trial at 24 months is not inferior to the success rate observed at 24 months in patients treated with direct decompression.
Read the detailed description
STUDY DESIGN:This study is a prospective, multi-center, randomized controlled "Conditions of Use" clinical trial comparing the Superion® IDS to open, direct decompression in the treatment of subjects aged 45 or older suffering from moderate symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate LSS at one or two contiguous levels from L1 to L5, i.e. from the L1-L2 level to the L4-L5 level. A maximum of 20 investigative sites in the U.S. will enroll subjects into the trial using a 1:1 randomization assignment. Enrollment will include 358 subjects (152 per arm, plus 18% to account for lost to follow-up). An investigative site is defined as a facility or facilities in the same general geographic location if they are under the control of a local Institutional Review Board (IRB).
After implantation of the Superion® IDS or performance of the direct decompression, each Investigator will be permitted to provide a postoperative care regimen based on the subject's specific need. The regimen may include, but need not be limited to: medications, a corset or brace, acupuncture, traction, physical therapy, chiropractic treatment, use of a TENS unit and massage therapy. The type and amount of the postoperative care will be collected.
At each follow-up visit through 60 months, subjects will be interviewed to determine if they have experienced adverse events (AEs) since the previous follow-up visit. A neurological assessment will be performed for all patients at baseline and all follow-up visits. All subjects will be required to complete ZCQ, ODI, VAS, EQ-5D and the VertiFlex® Patient Satisfaction questionnaires to evaluate disability, function, pain, quality of life and satisfaction at each follow-up visit. Subjects are also required to complete a VAS questionnaire to evaluate pain status at discharge.
The potential impact of spinal injections/nerve blocks use on the ZCQ was evaluated based on review of the medical literature. As these are potentially confounding of the ZCQ outcomes, epidural steroid injections or nerve block procedures at the treated level(s) will be deemed failures. Further, rhizotomy procedures at the treated level(s) will be deemed failures.
With respect to spinal cord stimulators, because the use of a permanent implant would require a surgical procedure, this will be deemed a device failure.
Radiographic evaluations will be performed at discharge, and at each scheduled follow-up visit and prior to any re-operations, in accordance with the Radiographic Evaluation Protocol. The Investigator may also obtain x-rays at unscheduled visits or to assess adverse events, if clinically indicated.
- Being tested
- Superion® IDS, Direct decompression Surgery
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Superion® IDSDevice
Device is a non-fusion, spinal column load-sharing device used to stabilize the spine at the implanted leve
Direct decompression SurgeryProcedure or surgery
A surgical procedure - the control
| Study group | Role | What they receive |
|---|---|---|
| Indirect Decompression System | Active comparator | Superion® IDS surgical procedure Receives: Device: Superion® IDS |
| Direct decompression Surgery | Active comparator | Open, direct decompression surgical procedure Receives: Procedure: Direct decompression Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Composite Endpoint (Primary)
Subjects in each arm (Superion® IDS and direct decompression) will be evaluated for success at each follow-up interval
Measured: 60 Months
Zurich Claudication Questionnaire (ZCQ)
Clinically significant improvement in outcomes compared to baseline
Measured: 60 Months
No re-operations, revisions, removals, or supplemental fixation at the index level(s)
Review in outcomes compared to baseline
Measured: 60 Months
Epidural steroid injections for the treated level(s)
Review in outcomes compared to baseline
Measured: 60 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Feb 2017 (estimated)
- Study start8 Feb 2017
- Primary completion31 Jul 2022 (estimated)
- Study completion31 Jul 2025 (estimated)
Why it stopped: FDA and Sponsor closed trial. New post-marketing approval trial in development.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Stenosis, Lumbar Region With Neurogenic ClaudicationStudies 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
- Model description
- Prospective, multi-center, randomized, controlled
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- VertiFlex, Incorporated
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03048955
- Sponsor's protocol ID
- 15-VISS-01
- Acronym
- ASCEND
- Status last verified
- Jun 2019
- First submitted
- 25 Jan 2017
- Last updated
- 12 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A 2 and 5 Year Comparative Evaluation of Clinical Outcomes in the Treatment of Moderate Lumbar Spinal Stenosis With the Superion® Indirect Decompression System (IDS) vs. Direct Decompression Surgery for FDA Actual Conditions of Use Study
- ClinicalTrials.gov ID
- NCT03048955
- Acronym / sponsor ID
- ASCEND / 15-VISS-01
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: FDA and Sponsor closed trial. New post-marketing approval trial in development.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- VertiFlex, IncorporatedIndustry (pharma, biotech, devices)
- Study start
- 8 Feb 2017 (actual)
- Primary completion
- 31 Jul 2022 (estimated)
- Study completion
- 31 Jul 2025 (estimated)
- First posted
- 9 Feb 2017 (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.
PURPOSE: The primary purpose of this study is to demonstrate that the Composite Clinical Success of the study group receiving the Superion® IDS is not inferior to the success rate observed in the study group treated by direct decompression at 60 months follow-up. Secondarily, the trial is intended to establish that Composite Clinical Success of the study group receiving the Superion® IDS at 24 months is not inferior to the success rate observed at 24 months in patients treated with the Superion® IDS in the original IDE trial. Thirdly, the trial is intended to establish that Composite Clinical Success of the population receiving the Superion® IDS in this trial at 24 months is not inferior to the success rate observed at 24 months in patients treated with direct decompression.
Detailed description
STUDY DESIGN:This study is a prospective, multi-center, randomized controlled "Conditions of Use" clinical trial comparing the Superion® IDS to open, direct decompression in the treatment of subjects aged 45 or older suffering from moderate symptoms of neurogenic intermittent claudication secondary to a confirmed diagnosis of moderate LSS at one or two contiguous levels from L1 to L5, i.e. from the L1-L2 level to the L4-L5 level. A maximum of 20 investigative sites in the U.S. will enroll subjects into the trial using a 1:1 randomization assignment. Enrollment will include 358 subjects (152 per arm, plus 18% to account for lost to follow-up). An investigative site is defined as a facility or facilities in the same general geographic location if they are under the control of a local Institutional Review Board (IRB).
After implantation of the Superion® IDS or performance of the direct decompression, each Investigator will be permitted to provide a postoperative care regimen based on the subject's specific need. The regimen may include, but need not be limited to: medications, a corset or brace, acupuncture, traction, physical therapy, chiropractic treatment, use of a TENS unit and massage therapy. The type and amount of the postoperative care will be collected.
At each follow-up visit through 60 months, subjects will be interviewed to determine if they have experienced adverse events (AEs) since the previous follow-up visit. A neurological assessment will be performed for all patients at baseline and all follow-up visits. All subjects will be required to complete ZCQ, ODI, VAS, EQ-5D and the VertiFlex® Patient Satisfaction questionnaires to evaluate disability, function, pain, quality of life and satisfaction at each follow-up visit. Subjects are also required to complete a VAS questionnaire to evaluate pain status at discharge.
The potential impact of spinal injections/nerve blocks use on the ZCQ was evaluated based on review of the medical literature. As these are potentially confounding of the ZCQ outcomes, epidural steroid injections or nerve block procedures at the treated level(s) will be deemed failures. Further, rhizotomy procedures at the treated level(s) will be deemed failures.
With respect to spinal cord stimulators, because the use of a permanent implant would require a surgical procedure, this will be deemed a device failure.
Radiographic evaluations will be performed at discharge, and at each scheduled follow-up visit and prior to any re-operations, in accordance with the Radiographic Evaluation Protocol. The Investigator may also obtain x-rays at unscheduled visits or to assess adverse events, if clinically indicated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, multi-center, randomized, controlled
| Arm | Type | Receives |
|---|---|---|
| Indirect Decompression System | Active comparator | Device: Superion® IDSSuperion® IDS surgical procedure |
| Direct decompression Surgery | Active comparator | Procedure: Direct decompression SurgeryOpen, direct decompression surgical procedure |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male or female subjects ≥ 45 years of age.
- Persistent leg/buttock/groin pain, with or without back pain that is consistently relieved by flexion activities (example: sitting or bending over a shopping cart).
- Subjects who have been symptomatic and undergoing conservative care treatment for at least 6 months, without relief.
- 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 access), and the nerve root canal (foraminal).
- Radiographic confirmation of at least moderate spinal stenosis which narrows the central, lateral, or foraminal spinal canal at one or two contiguous levels from L1-L5. Moderate spinal stenosis is defined as ≤50% reduction in lateral/central foramen.
Key exclusion criteria (31 listed)
- Axial back pain only.
- Fixed motor deficit in lower extremity(ies).
- Diagnosis of lumbar spinal stenosis which, if the patient were randomized to the Superion arm, would not require any direct neural decompression or surgical intervention other than that required to implant the Superion® device or if randomized to the direct decompression arm, would not require a decompression procedure which would create significant instability requiring spinal fusion, with or without instrumentation.
- 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® IDSDevice is a non-fusion, spinal column load-sharing device used to stabilize the spine at the implanted leve | Device | Indirect Decompression System |
| Direct decompression SurgeryA surgical procedure - the control | Procedure or surgery | Direct decompression Surgery |
Primary outcome
Composite Endpoint (Primary)
Time frame: 60 Months
Subjects in each arm (Superion® IDS and direct decompression) will be evaluated for success at each follow-up interval
Zurich Claudication Questionnaire (ZCQ)
Time frame: 60 Months
Clinically significant improvement in outcomes compared to baseline
No re-operations, revisions, removals, or supplemental fixation at the index level(s)
Time frame: 60 Months
Review in outcomes compared to baseline
Epidural steroid injections for the treated level(s)
Time frame: 60 Months
Review in outcomes compared to baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Superion® IDS and Direct decompression Surgery in people with Spinal Stenosis, Lumbar Region With Neurogenic Claudication, run by VertiFlex, Incorporated at 5 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 9 inclusion and 31 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: withdrawn, as of the sponsor's last update on 12 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 withdrawn before enrolling participants, so there are no results.
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?
Composite Endpoint (Primary) (time frame: 60 Months). The study lists 4 primary outcomes in all. 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 12 Jun 2019.