Lumbar Spinal StenosisPhase 4EXELSNCT00558129
Effects of X-STOP® Versus Laminectomy Study
A Phase 4 study testing X-STOP® and Laminectomy in people with Lumbar Spinal Stenosis, run by Medtronic Spine LLC.
Trial summary
To determine if the effectiveness of the X-STOP® implant is equivalent (non-inferior) to that of conventional laminectomy in patients with lumbar spinal stenosis as measured by the Zurich Claudication Questionnaire. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Lumbar Spinal Stenosis
- What is being tested?
- X-STOP® and Laminectomy
- 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
- No sites listed yet
- Study dates
- Nov 2007to Nov 2011
- Phase
- Phase 4
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 50
- Has completed at least 6 months of conservative therapy which may include but is not limited to epidural steroid injection, oral steroids, NSAIDS, analgesics, physical therapy, and/or spinal manipulation.
- Symptoms of leg/buttock/groin pain with or without back pain that are exacerbated by lumbar extension and relieved in flexion. If back pain is also present it must be partially relieved when the patient flexes.
- Diagnosis of NIC due to lumbar stenosis at 1 or 2 lumbar levels confirmed by X-ray, MRI or CT.
- Subject is a surgical candidate with disease severity justifying that BOTH laminectomy and X-STOP IPD placement are clinically appropriate treatment options.
- Baseline score of >2.0 in the Physical Function domain of the Zurich Claudication Questionnaire (ZCQ). Because this is a post-market study, the Inclusion Criteria are consistent with FDA approved X-STOP indication for use (moderately impaired physical function), which requires a ZCQ physical function score of >2.0.
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- Subject is able to walk at least 50 feet.
- Subject is willing and able to comply with required follow-up testing and expected to be physically able to return for evaluation at scheduled follow-up visits.
- Subject is able to understand the risks and benefits of participating in the study.
- Subject understands and has signed the study informed consent form.
Who cannot join
- Spinal stenosis involving more than 2 lumbar levels.
- Any previous lumbar spine surgery.
- Subject has unremitting pain in any spinal position or axial back pain only without leg/buttock/groin pain.
- Evidence that subject's symptoms are due to vascular claudication.
- Subject has significant instability of the lumbar spine, e.g., isthmic spondylolisthesis or degenerative spondylolisthesis greater than Grade 1 (on a scale of 1 to 4).
- Subject has an ankylosed segment at the affected level(s).
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- Subject has significant scoliosis (Cobb angle is greater than 25 degrees).
- Subject has cauda equina syndrome defined as neural compression causing neurogenic bowel (rectal incontinence) or bladder (bladder retention or incontinence) dysfunction.
- Subject has a fixed motor deficit or known peripheral neuropathy.
- Subject has a degenerative neurologic disease.
- Subject has any mass lesions (e.g. disc herniations, synovial cysts, spinal tumors).
- Any evidence of spinal or systemic infection.
- Subject has a history of spinous process fracture or pars interarticularis fracture.
- Subject has history or radiographic evidence of 1 or more osteoporotic fractures (e.g., vertebral, hip, wrist) OR subject has severe osteoporosis of the spine or hip, defined as bone mineral density (BMD) in the spine or hip more than 2.5 SD below the mean of adult normals. If the Investigator suspects osteoporosis, a DEXA scan should be done.
- Subject has a known allergy to the implant materials (this includes titanium or titanium alloy and polyetheretherketone for X-STOP IPD).
- Subject has a bleeding disorder or an active systemic disease such as HIV, hepatitis, etc.
- Subject has any medical condition that would limit availability for follow-up.
- Subject has a recent history of narcotic abuse (i.e., within last 3 years).
- Subject is immunologically suppressed, or has received or is receiving 7.5 milligrams prednisone (or equivalent) daily for more than six months immediately prior to enrollment.
- Subject is currently involved in a study of another investigational product that may affect the outcome of this study.
- Subject is not able to undergo MRI or tolerate closed MRI scanning. Subject is pregnant or of child-bearing potential and not currently on adequate birth control method.
- Subject is pregnant or of child-bearing potential and not currently on adequate birth control method.
About this study
Official title: Prospective Randomized Trial Comparing X-STOP® Interspinous Process Decompression® System Versus Laminectomy for Treatment of Neurogenic Intermittent Claudication
To determine if the effectiveness of the X-STOP® implant is equivalent (non-inferior) to that of conventional laminectomy in patients with lumbar spinal stenosis as measured by the Zurich Claudication Questionnaire.
Read the detailed description
The clinical study described herein aims to compare surgical outcomes of X-STOP® Interspinous Process Decompression® (IPD) system implantation and conventional laminectomy in subjects requiring surgical intervention due to symptoms of lumbar spinal stenosis (LSS) and a confirmed diagnosis on MRI, X-ray or CT. Patients with LSS meeting entry criteria will be randomized to either X-STOP® IPD or laminectomy treatment. Patients will remain blinded to the procedure received. The primary study outcome is group differences in the Zurich Claudication Questionnaire (ZCQ) at 12 months post-operative. In addition, each subject will undergo follow-up assessment at 2 weeks and 2, 12 and 24 months post-operative. The secondary objective is to compare safety profiles and the radiographic outcomes between groups using pre- and post-operative MRI and flexion/extension X-rays, to measure changes in canal and neuroforaminal cross sectional areas and spinal stability, respectively.
- Conditions
- Lumbar Spinal Stenosis
- Being tested
- X-STOP®, Laminectomy
- Keywords
- Lumbar Spinal Stenosis, X-STOP® IPD, Interspinous process decompression, Neurogenic Intermittent Claudication
- Medical subject headings
- Spinal Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
X-STOP®Device
Also called X-STOP® PEEK IPD
Surgical implantation of X-STOP IPD device
LaminectomyProcedure or surgery
Standard laminectomy techniques will be used and may include laminotomy, foraminotomy and/or laminectomy as appropriate. In some cases at the discretion of the treating physician, fusion may indicated to stabilize the segment.
| Study group | Role | What they receive |
|---|---|---|
| Investigational | Experimental | X-STOP® PEEK IPD Receives: Device: X-STOP® |
| Control | Active comparator | Laminectomy Receives: Procedure: Laminectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in the Zurich Claudication Questionnaire (ZCQ)
Measured: 1 year post-operative
Secondary outcomes (1)
ZCQ symptom severity, physical function and satisfaction; pain rating; quality of life (SF-36®); operative data; canal, subarticular and neuroforaminal measurements on MRI; spinal stability using flexion/extension (serious adverse events)
Measured: Out to 2 years postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2007 (estimated)
- Study startNov 2007
- Study completionNov 2011 (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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic Spine LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Volker Sonntag, MD, Principal investigator, Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00558129
- Sponsor's protocol ID
- LSS0702
- Acronym
- EXELS
- Status last verified
- Jan 2012
- First submitted
- 12 Nov 2007
- Last updated
- 8 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Trial Comparing X-STOP® Interspinous Process Decompression® System Versus Laminectomy for Treatment of Neurogenic Intermittent Claudication
- ClinicalTrials.gov ID
- NCT00558129
- Acronym / sponsor ID
- EXELS / LSS0702
- Conditions
- Lumbar Spinal Stenosis
- Keywords
- Lumbar Spinal Stenosis, X-STOP® IPD, Interspinous process decompression, Neurogenic Intermittent Claudication
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Medtronic Spine LLCIndustry (pharma, biotech, devices)
- Study start
- Nov 2007
- Study completion
- Nov 2011 (estimated)
- First posted
- 14 Nov 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.
To determine if the effectiveness of the X-STOP® implant is equivalent (non-inferior) to that of conventional laminectomy in patients with lumbar spinal stenosis as measured by the Zurich Claudication Questionnaire.
Detailed description
The clinical study described herein aims to compare surgical outcomes of X-STOP® Interspinous Process Decompression® (IPD) system implantation and conventional laminectomy in subjects requiring surgical intervention due to symptoms of lumbar spinal stenosis (LSS) and a confirmed diagnosis on MRI, X-ray or CT. Patients with LSS meeting entry criteria will be randomized to either X-STOP® IPD or laminectomy treatment. Patients will remain blinded to the procedure received. The primary study outcome is group differences in the Zurich Claudication Questionnaire (ZCQ) at 12 months post-operative. In addition, each subject will undergo follow-up assessment at 2 weeks and 2, 12 and 24 months post-operative. The secondary objective is to compare safety profiles and the radiographic outcomes between groups using pre- and post-operative MRI and flexion/extension X-rays, to measure changes in canal and neuroforaminal cross sectional areas and spinal stability, respectively.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Investigational | Experimental | Device: X-STOP®X-STOP® PEEK IPD |
| Control | Active comparator | Procedure: LaminectomyLaminectomy |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age > 50
- Has completed at least 6 months of conservative therapy which may include but is not limited to epidural steroid injection, oral steroids, NSAIDS, analgesics, physical therapy, and/or spinal manipulation.
- Symptoms of leg/buttock/groin pain with or without back pain that are exacerbated by lumbar extension and relieved in flexion. If back pain is also present it must be partially relieved when the patient flexes.
- Diagnosis of NIC due to lumbar stenosis at 1 or 2 lumbar levels confirmed by X-ray, MRI or CT.
- Subject is a surgical candidate with disease severity justifying that BOTH laminectomy and X-STOP IPD placement are clinically appropriate treatment options.
Key exclusion criteria (22 listed)
- Spinal stenosis involving more than 2 lumbar levels.
- Any previous lumbar spine surgery.
- Subject has unremitting pain in any spinal position or axial back pain only without leg/buttock/groin pain.
- Evidence that subject's symptoms are due to vascular claudication.
- Subject has significant instability of the lumbar spine, e.g., isthmic spondylolisthesis or degenerative spondylolisthesis greater than Grade 1 (on a scale of 1 to 4).
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 |
|---|---|---|
| X-STOP®Also: X-STOP® PEEK IPDSurgical implantation of X-STOP IPD device | Device | Investigational |
| LaminectomyStandard laminectomy techniques will be used and may include laminotomy, foraminotomy and/or laminectomy as appropriate. In some cases at the discretion of the treating physician, fusion may indicated to stabilize the segment. | Procedure or surgery | Control |
Primary outcome
Change from baseline in the Zurich Claudication Questionnaire (ZCQ)
Time frame: 1 year post-operative
1 secondary outcome
ZCQ symptom severity, physical function and satisfaction; pain rating; quality of life (SF-36®); operative data; canal, subarticular and neuroforaminal measurements on MRI; spinal stability using flexion/extension (serious adverse events)
Time frame: Out to 2 years postoperative
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 8 Dec 2017.
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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.
Volker Sonntag, MD principal investigator
Barrow Neurological Institute, St. Joseph's Hospital and Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing X-STOP® and Laminectomy in people with Lumbar Spinal Stenosis, run by Medtronic Spine LLC.
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 10 inclusion and 22 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 8 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline in the Zurich Claudication Questionnaire (ZCQ) (time frame: 1 year post-operative). 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 8 Dec 2017.