RadiculopathySTRiDENCT01338766
Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression
A study testing Decompression using the iO-Flex® system in people with Radiculopathy and Spondylolisthesis, run by Baxano Surgical, Inc. at 14 sites in United States.
Trial summary
The purpose of this study is to evaluate the clinical performance of a decompression using the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a 55% positive response rate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Radiculopathy, Spondylolisthesis, Lumbar Spinal Stenosis
- What is being tested?
- Decompression using the iO-Flex® system
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 14 sitesUnited States
- Study dates
- Apr 2011to Dec 2014
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult (> 18 years of age)
- Leg/buttock pain, with or without back pain
- Grade 1 degenerative spondylolisthesis (≤25% slippage)
- NRS pain score for leg pain of 4/10 or greater
- ODI score of 30/100 or greater
- Failed non-operative medical management for a period of at least 6 months
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- Confirmed clinical diagnosis of lumbar spinal stenosis
- Confirmation of central and/or lateral recess stenosis with or without foraminal stenosis, at one level or at two adjacent levels from L2-S1, with concordant symptoms. Subjects with central and/or lateral recess stenosis and spondylolisthesis at one level, may have symptomatic central, lateral recess or foraminal stenosis treated at one adjacent level. A "below-the pedicle" pass to decompress a third segment can be completed provided laminotomies are performed at no more than 2 levels. Subjects that, following an intraoperative decision, have a 3-level laminotomy and decompression will not be considered enrolled. Confirmation of spinal stenosis is shown on MRI or CT scan with evidence of nerve root impingement (displacement or compression) by either osseous or non-osseous elements.
- Ability to give voluntary, written informed consent to participate in this clinical investigation and ability to participate in follow up examinations and complete patient questionnaires
Who cannot join
- Back pain only
- Diagnosis of moderate to severe peripheral neuropathy such as diabetic or idiopathic peripheral neuropathy, by EMG/NCS or a Neurologist.
- History of pathologic fractures of the vertebrae
- Primary disc pathology; planned or incidental discectomies will NOT be excluded as long as surgeon believes the disc pathology is not the primary reason for the surgical intervention.
- Subjects for whom removal of the midline structures is planned, likely or is the result of an intraoperative decision; every attempt should be made to spare the supraspinous, interspinous and facet capsular ligaments.
- Significant instability of the lumbar spine as defined by ≥ 4mm translational motion between standing lateral view flexion and extension radiographs
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- Prior surgery of the lumbar spine
- Spondylolisthesis greater than grade 1 (on a scale of 1 to 4)
- Spondylolysis (pars fracture) at any level in the lumbar spine
- Degenerative lumbar scoliosis with a Cobb angle of ≥ 25°
- Vascular claudication in the lower extremities
- Cauda equina syndrome
- Evidence of active (systemic or local) infection at time of surgery
- 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.
- Prisoner or transient
- Any significant psychological disturbance past or present, 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
- Inability to communicate clearly in the English language
- Morbid obesity (BMI > 40)
- Pregnant, nursing, or planning on becoming pregnant.
- History of narcotic abuse
- Current involvement in another drug or device clinical trial
- Uncontrolled diabetes
- Irreversible coagulopathy or bleeding disorder (patients on anticoagulant therapy may participate. Investigators should follow routine practices for perioperative discontinuation and reinitiation of anticoagulants.)
- Plans to relocate in the next 2 years
- Subject unwilling to undergo a blood transfusion, if necessary
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Suburban Orthopedics
Bartlett, Illinois, 60103
Indiana Spine Group
Carmel, Indiana, 46032
Eden Medical Center
Castro Valley, California, 94546
Resurgens Orthopaedics
Cumming, Georgia, 30041
Olympia Medical Center
Los Angeles, California, 90036
Orange County Neurological Associates
Mission Viejo, California, 92691
Medical Center of Trinity
Odessa, Florida, 33556
University California Irvine
Orange, California, 92868
VCU Medical Center
Richmond, Virginia, 23219
Tuckahoe Orthopedics
Richmond, Virginia, 23226
Scott and White Memorial Hospital
Temple, Texas, 76508
Florida Orthopaedic Institute
Temple Terrace, Florida, 33637
Southern California Orthopedic Institute
Van Nuys, California, 91405
Georgetown University
Washington D.C., District of Columbia, 20057
About this study
Official title: Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression (STRiDE)
The purpose of this study is to evaluate the clinical performance of a decompression using the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a 55% positive response rate.
Read the detailed description
This is a prospective, non-randomized, multi-center (up to 30 sites) controlled clinical study enrolling 100 subjects following a pre-specified protocol with no site enrolling more than 30 subjects. All eligible subjects providing written informed consent and meeting study eligibility criteria will receive a facet preserving decompression using the FDA cleared iO-Flex® system on label. Treatment success using the iO-Flex® System will be analyzed using a precision estimate assuming a 55% positive response rate.
In addition to baseline characteristics and procedural parameters, subject outcomes will be assessed at 6 weeks, 6-, 12-, and 24 months. The study will have an extended follow-up phase with annual follow-up contact through 5 years to evaluate retreatment for the original indication at these late time points.
- Conditions
- Radiculopathy, Spondylolisthesis, Lumbar Spinal Stenosis
- Being tested
- Decompression using the iO-Flex® system
- Keywords
- spondylolisthesis, lumbar spinal stenosis
- Medical subject headings
- Radiculopathy, Spondylolisthesis, Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decompression using the iO-Flex® systemProcedure or surgery
Decompression using the iO-Flex® system
| Study group | Role | What they receive |
|---|---|---|
| Surgery | Experimental | Decompression using the iO-Flex® system Receives: Procedure: Decompression using the iO-Flex® system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Oswestry Disability Index (ODI)
Responder analysis
Measured: 24 Months
Secondary outcomes (7)
Operative success
Achieving intended decompression using the iO-Flex® System. The number of neural foramen in which the iO-Flex® System was used for decompression compared to the number in which an attempt was made but not completed.
Measured: Operative (day 1)
Oswestry Disability Index (ODI)
Responder analysis
Measured: 6, 12, 36, 48 and 60 months
Oswestry Disability Index (ODI)
Comparison of ODI scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits
Measured: 6, 12, 24, 36, 48 and 60 months
Numerical Rating Scale (NRS)
Comparison of NRS scores for back and leg pain between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits
Measured: 6, 12, 24, 36, 48 and 60 months
Zurich Claudication Questionnaire (ZCQ)
Comparison of ZCQ scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits
Measured: 6, 12, 24, 36, 48 and 60 months
SF-36 Health Survey
Comparison of SF-36 scores between baseline and each of the following follow-up visits: 6, 12, 24, 36, 48, and 60 month visits
Measured: 6, 12, 24, 36, 48 and 60 months
Treatment survival rate
To characterize longevity of the treatment effect of a decompression using the iO-Flex® System.
Measured: Ongoing out to 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2011 (estimated)
- Study startApr 2011
- Primary completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RadiculopathyStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baxano Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sylvain Palmer, M.D., Principal investigator, Neurological Surgery Medical Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01338766
- Sponsor's protocol ID
- CP-1967
- Acronym
- STRiDE
- Status last verified
- Apr 2014
- First submitted
- 18 Apr 2011
- Last updated
- 23 Apr 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spondylolisthesis Treated With an iO-Flex® System Enabled Decompression (STRiDE)
- ClinicalTrials.gov ID
- NCT01338766
- Acronym / sponsor ID
- STRiDE / CP-1967
- Conditions
- Radiculopathy, Spondylolisthesis, Lumbar Spinal Stenosis
- Keywords
- spondylolisthesis, lumbar spinal stenosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Baxano Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2011
- Primary completion
- Dec 2014 (estimated)
- First posted
- 20 Apr 2011 (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 study is to evaluate the clinical performance of a decompression using the FDA cleared iO-Flex® System on-label in treating patients with spinal stenosis and stable grade I degenerative lumbar spondylolisthesis using a precision estimate assuming a 55% positive response rate.
Detailed description
This is a prospective, non-randomized, multi-center (up to 30 sites) controlled clinical study enrolling 100 subjects following a pre-specified protocol with no site enrolling more than 30 subjects. All eligible subjects providing written informed consent and meeting study eligibility criteria will receive a facet preserving decompression using the FDA cleared iO-Flex® system on label. Treatment success using the iO-Flex® System will be analyzed using a precision estimate assuming a 55% positive response rate.
In addition to baseline characteristics and procedural parameters, subject outcomes will be assessed at 6 weeks, 6-, 12-, and 24 months. The study will have an extended follow-up phase with annual follow-up contact through 5 years to evaluate retreatment for the original indication at these late time points.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Surgery | Experimental | Procedure: Decompression using the iO-Flex® systemDecompression using the iO-Flex® system |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult (> 18 years of age)
- Leg/buttock pain, with or without back pain
- Grade 1 degenerative spondylolisthesis (≤25% slippage)
- NRS pain score for leg pain of 4/10 or greater
- ODI score of 30/100 or greater
Key exclusion criteria (27 listed)
- Back pain only
- Diagnosis of moderate to severe peripheral neuropathy such as diabetic or idiopathic peripheral neuropathy, by EMG/NCS or a Neurologist.
- History of pathologic fractures of the vertebrae
- Primary disc pathology; planned or incidental discectomies will NOT be excluded as long as surgeon believes the disc pathology is not the primary reason for the surgical intervention.
- Subjects for whom removal of the midline structures is planned, likely or is the result of an intraoperative decision; every attempt should be made to spare the supraspinous, interspinous and facet capsular ligaments.
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 |
|---|---|---|
| Decompression using the iO-Flex® systemDecompression using the iO-Flex® system | Procedure or surgery | Surgery |
Primary outcome
Oswestry Disability Index (ODI)
Time frame: 24 Months
Responder analysis
7 secondary outcomes
Operative success
Time frame: Operative (day 1)
Oswestry Disability Index (ODI)
Time frame: 6, 12, 36, 48 and 60 months
Oswestry Disability Index (ODI)
Time frame: 6, 12, 24, 36, 48 and 60 months
Numerical Rating Scale (NRS)
Time frame: 6, 12, 24, 36, 48 and 60 months
Zurich Claudication Questionnaire (ZCQ)
Time frame: 6, 12, 24, 36, 48 and 60 months
SF-36 Health Survey
Time frame: 6, 12, 24, 36, 48 and 60 months
Treatment survival rate
Time frame: Ongoing out to 60 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2014.
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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.
Sylvain Palmer, M.D. principal investigator
Neurological Surgery Medical Associates
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decompression using the iO-Flex® system in people with Radiculopathy and Spondylolisthesis, run by Baxano Surgical, Inc. at 14 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 27 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: status not confirmed, as of the sponsor's last update on 23 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
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?
Oswestry Disability Index (ODI) (time frame: 24 Months). 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 23 Apr 2014.