Lumbar Spinal StenosisNCT01067014
The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery
An observational study of Lumbar Spinal Stenosis, run by Baxano Surgical, Inc. at 18 sites in United States.
Trial summary
The purpose of this study is to evaluate the clinical performance of the iO-Flex® System in reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis that requires surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- Baxano iO-Flex® System
- Type of treatment
- Medical device
- How many people
- 75 participants
- Where
- 18 sitesUnited States
- Study dates
- Feb 2010to Dec 2014
- Phase
- Observational
- 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
Study population: Patients at least 18 years of age presenting with failed conservative treatment for one or two level lumbar spinal stenosis
Who may be able to join
- Candidates for this study must meet ALL of the following criteria:
- Age ≥18 years
- Leg/buttock pain with or without back pain
- Failed nonoperative medical management
- A minimum leg pain score of 4.0 cm on the Visual Analogue Scale (VAS)
- Clinical/radiographic diagnosis of LSS in the L2-L3 to L5-S1 region
- Able and willing to give voluntary, written informed consent to participate in this clinical study
Who cannot join
- Candidates will be excluded from the evaluation if ANY of the following apply:
- Back pain only
- A diagnosis of central stenosis only
- More than two levels requiring decompression
- Fixed motor deficit
- Significant instability of the lumbar spine as defined by ≥ 4mm translation between standing flexion and extension lumbar spine plain film radiographs
Show all 28Show fewer
- Sustained pathologic fractures of the vertebrae or multiple fractures of the vertebrae and/or hips
- Primary disc pathology and/or patients who will undergo a discectomy
- Prior surgery of the lumbar spine at the level(s) of planned treatment
- Spondylolisthesis or degenerative 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 greater than or equal to 25°
- Symptomatic vascular claudication in the lower extremities
- Cauda equina syndrome (neural compression causing neurogenic bowel or bladder dysfunction)
- 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
- Recent history of known narcotic abuse
- 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)
- Plans to relocate within the next 2 years
- Pregnant or planning to become pregnant
- Irreversible coagulopathy or bleeding disorder
- Subjects on Coumadin or other anticoagulants may participate. Investigators should follow routine practices for perioperative discontinuation and reinitiation of anticoagulants.
- Subject unwilling to undergo blood transfusion, if necessary
Trial locations and contacts
18 sites in 1 country.
18 sites in 1 country
United States18 sites
Suburban Orthopedics
Bartlett, Illinois, 60103
Rothman Institute
Bensalem, Pennsylvania, 19020
Neurospine Solutions, PC
Bristol, Tennessee, 37620
Eden Medical Center
Castro Valley, California, 94546
Triangle Orthopaedic Associates
Chapel Hill, North Carolina, 27514
Resurgens Orthopaedics
Cumming, Georgia, 30041
Easton Hospital
Easton, Pennsylvania, 18017
Moses Cone Hospital
Greensboro, North Carolina, 27401
Carolina Neurosurgery & Spine Center
Greenwood, South Carolina, 29646
Spine Midwest, Inc.
Jefferson City, Missouri, 65101
McCune-Brooks Regional Hospital
Joplin, Missouri, 64804
Caldwell Memorial Hospital
Lenoir, North Carolina, 28645
Buffalo Spine Surgery
Lockport, New York, 14094
Olympia Medical Center
Los Angeles, California, 90036
Spine Works Institute
North Richland Hills, Texas, 76182
Tuckahoe Orthopaedic Associates
Richmond, Virginia, 23226
University of Utah
Salt Lake City, Utah, 84132
Watsonville Community Hospital
Watsonville, California, 95076
About this study
The purpose of this study is to evaluate the clinical performance of the iO-Flex® System in reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis that requires surgery.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- Baxano iO-Flex® System
- Keywords
- Lumbar spinal stenosis, Decompression, Lumbar spinal decompression, Lumbar spinal decompressive 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.
Baxano iO-Flex® SystemDevice
Decompressive lumbar surgery using Baxano iO-Flex® System
| Study group | Role | What they receive |
|---|---|---|
| iO-Flex | Not described Receives: Device: Baxano iO-Flex® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Symptom Severity domain of the Zurich Claudication Questionnaire (ZCQ) from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 0.5 points
Measured: 6 months
Change in Visual Analog Scale (VAS) for leg pain related to lumbar spinal stenosis at the treatment level from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 30%
Measured: 6 months
Re-operation at the treatment level(s) at one year post-procedure
Measured: One year
Acute safety outcomes will be determined by evaluating the type, frequency, severity, and relatedness of adverse events through discharge visits for all subjects
Measured: Hospital discharge
Secondary outcomes (5)
Changes in Visual Analog Scale scores compared to baseline
Measured: 6 weeks, 3 months, 6 months, 12 months, 24 months
Changes in Zurich Claudication Questionnaire scores compared to baseline
Measured: 6 weeks, 3, 6, 12, and 24 months
Changes in Oswestry Disability Index scores compared to baseline
Measured: 6 weeks, 3, 6, 12, and 24 months
Flexion/extension lumbar spine plain film radiographs will be collected and assessed for presence/absence of instability at baseline, 6-month, 12-month, and 24-months
Measured: 6, 12, and 24 months
Long term safety outcomes that occur after discharge through 2 years post-procedure will be determined by evaluating adverse events involving the musculoskeletal or neurological systems
Measured: Through 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2010 (estimated)
- Study startFeb 2010
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baxano Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01067014
- Sponsor's protocol ID
- CP-1318
- Status last verified
- Sep 2013
- First submitted
- 9 Feb 2010
- Last updated
- 23 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The iO-Flex® Study: Evaluation of the Baxano iO-Flex® System for Decompressive Lumbar Surgery
- ClinicalTrials.gov ID
- NCT01067014
- Acronym / sponsor ID
- CP-1318
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Lumbar spinal stenosis, Decompression, Lumbar spinal decompression, Lumbar spinal decompressive surgery
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Baxano Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 11 Feb 2010 (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 the iO-Flex® System in reducing pain and symptom severity in patients with one or two level lumbar spinal stenosis that requires surgery.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iO-Flex | – | Device: Baxano iO-Flex® System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients at least 18 years of age presenting with failed conservative treatment for one or two level lumbar spinal stenosis
Key inclusion criteria (7 listed)
- Age ≥18 years
- Leg/buttock pain with or without back pain
- Failed nonoperative medical management
- A minimum leg pain score of 4.0 cm on the Visual Analogue Scale (VAS)
- Clinical/radiographic diagnosis of LSS in the L2-L3 to L5-S1 region
Key exclusion criteria (28 listed)
- Back pain only
- A diagnosis of central stenosis only
- More than two levels requiring decompression
- Fixed motor deficit
- Significant instability of the lumbar spine as defined by ≥ 4mm translation between standing flexion and extension lumbar spine plain film radiographs
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 |
|---|---|---|
| Baxano iO-Flex® SystemDecompressive lumbar surgery using Baxano iO-Flex® System | Device | iO-Flex |
Primary outcome
Change in the Symptom Severity domain of the Zurich Claudication Questionnaire (ZCQ) from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 0.5 points
Time frame: 6 months
Change in Visual Analog Scale (VAS) for leg pain related to lumbar spinal stenosis at the treatment level from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 30%
Time frame: 6 months
Re-operation at the treatment level(s) at one year post-procedure
Time frame: One year
Acute safety outcomes will be determined by evaluating the type, frequency, severity, and relatedness of adverse events through discharge visits for all subjects
Time frame: Hospital discharge
5 secondary outcomes
Changes in Visual Analog Scale scores compared to baseline
Time frame: 6 weeks, 3 months, 6 months, 12 months, 24 months
Changes in Zurich Claudication Questionnaire scores compared to baseline
Time frame: 6 weeks, 3, 6, 12, and 24 months
Changes in Oswestry Disability Index scores compared to baseline
Time frame: 6 weeks, 3, 6, 12, and 24 months
Flexion/extension lumbar spine plain film radiographs will be collected and assessed for presence/absence of instability at baseline, 6-month, 12-month, and 24-months
Time frame: 6, 12, and 24 months
Long term safety outcomes that occur after discharge through 2 years post-procedure will be determined by evaluating adverse events involving the musculoskeletal or neurological systems
Time frame: Through 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2013.
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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.
18 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lumbar Spinal Stenosis, run by Baxano Surgical, Inc. at 18 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 7 inclusion and 28 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 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 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?
Change in the Symptom Severity domain of the Zurich Claudication Questionnaire (ZCQ) from baseline to 6 months post-procedure quantified as a percentage of subjects with an improvement of at least 0.5 points (time frame: 6 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 23 Sep 2013.