Low Back PainPhase 3NCT00134537
Wallis Mechanical Normalization System for Low Back Pain
A Phase 3 study testing Interspinous process and dynamic stabilization and Conservative Care in people with Low Back Pain, run by Zimmer Spine at 17 sites in United States.
Trial summary
The purpose of this study is to compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Interspinous process and dynamic stabilization and Conservative Care
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 17 sitesUnited States
- Study dates
- Nov 2004to Apr 2012
- Phase
- Phase 3
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Ages 18-60; male/female.
- Diagnosis of mild to moderate degenerative disc disease (DDD), which requires:
- back pain of at least 30/100 as measured on a visual analog scale, with or without leg (radicular) pain; and
- radiographic confirmation of the following, as determined by computed tomography (CT), magnetic resonance imaging (MRI), discography, plain film, myelography and/or flexion/extension films: up to Modic I changes on MRI, with decreased disc height up to 50% of adjacent level, and no significant osteophytes; with or without a contained disc herniation.
- Candidate for either surgery with Wallis or aggressive conservative management.
- Requires treatment at one or two lumbar levels between L1 and L5.
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- Experienced symptoms for at least three months without significant resolution.
- Has undergone a regimen of at least four weeks of anti-inflammatory medication for the current episode of back pain and had exposure to physical therapy.
- Minimum baseline Oswestry score of 30% (15/50).
- Physically and mentally able to comply with the protocol, including ability to read and complete required forms, and willing and able to adhere to the follow-up requirements of the protocol.
- Voluntarily signs the subject informed consent.
Who cannot join
- Significant neuroforaminal compression requiring discectomy or foraminotomy
- Radiographic evidence of DDD at L5-S1
- Radiographic confirmation of severe facet joint disease or degeneration.
- History of any lumbar disc treatment intended to remove the disc, e.g. surgery, intradiscal electrothermal therapy (IDET), laser or enzymes such as chymopapain.
- Clinically compromised vertebral bodies at the affected level due to current or past trauma, e.g., sustained pathological fracture or multiple fractures of vertebrae.
- Unwilling to comply with 8 weeks of physical therapy.
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- Subject refuses to consider epidural or facet injections for leg or back pain.
- Active systemic infection or infection at the operative site
- Osteoporosis. The Simple Calculated Osteoporosis Risk Estimation (SCORE) questionnaire will be used to screen subjects for osteoporosis; subjects whose screening suggests risk will undergo a dual-energy x-ray absorptiometry (DEXA) scan. Subjects will be excluded if the DEXA scan results indicate a T-score equal to or worse than -2.5, in accordance with the World Health Organization definition of osteoporosis.
- Paget's disease, osteomalacia, or any other metabolic bone disease other than osteoporosis, which is addressed above
- Rheumatoid arthritis, lupus, or other autoimmune disease
- AIDS, HIV, or Hepatitis
- Known allergy to titanium, polyetheretherketone, or polyester
- Current pathological lesions, such as tumor
- Congenital lumbar spinal stenosis
- Clinically relevant instability on flexion-extension as determined by the investigator by overlaying films.
- Cauda equina syndrome
- Pregnant at time of enrollment or with plans to become pregnant within the next three years
- Concomitant conditions requiring steroid treatment or prior steroid usage for more than one of the preceding three months
- Diabetes mellitus requiring daily insulin management
- Extreme obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines (body mass index [BMI] > 35)
- Fusion previously performed at the same or an adjacent level; or other instrumented spinal surgery at the operative level.
- Prior participation in study of any experimental spinal implant or treatment
- Pending litigation against a health care professional
- Life expectancy of less than three years
- History of any invasive malignancy (except for non-melanoma skin cancer), unless treated with curative intent and with no clinical signs or symptoms of the malignancy for at least 5 years
- Current or recent history of substance abuse (alcoholism and/or narcotic addiction) requiring intervention
- Spondylolysis
- Translation greater than 2 mm at the symptomatic level
- Significant scoliosis (Cobb angle > 25 degrees) or scoliosis otherwise requiring surgical correction
- Kyphosis requiring surgical correction
Trial locations and contacts
17 sites in 1 country.
17 sites in 1 country
United States17 sites
Emory University Medical Center
Atlanta, Georgia, 30329
Central Texas Spine Institute
Austin, Texas, 78731
Greater Baltimore Medical Center
Baltimore, Maryland, 21204
Spine Source
Beverly Hills, California, 90212
Boulder Neurosurgical Associates
Boulder, Colorado, 80304
The Orthopedic Center of St. Louis
Chesterfield, Missouri, 63017
Orthopedic Spine Associates
Eugene, Oregon, 97401
Fort Wayne Orthopedics
Fort Wayne, Indiana, 46804
Orthopedic Spine Care of Long Island
Melville, New York, 11747
Illinois Bone & Joint Institute
Morton Grove, Illinois, 60053
Spine Specialists of Arizona
Phoenix, Arizona, 85015
Arizona Institute for Minimally Invasive Spine Care
Phoenix, Arizona, 85020
TBI/ Plano Presbyterian Hospital
Plano, Texas, 75093
UCLA Spine Center
Santa Monica, California, 90404
The Spine Education & Research Institute
Thornton, Colorado, 80229
Orthopaedic Associates
Towson, Maryland, 21204
The Orthopedic Specialty Center (Abington Hospital)
Willow Grove, Pennsylvania, 19090
About this study
The purpose of this study is to compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections.
- Conditions
- Low Back Pain
- Being tested
- Interspinous process and dynamic stabilization, Conservative Care
- Keywords
- Degenerative Disc Disease of the lumbar spine
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interspinous process and dynamic stabilizationDevice
Interspinous process and dynamic stabilization
Conservative CareDevice
Medication, exercise and spinal injections
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Interspinous process and dynamic stabilization Receives: Device: Interspinous process and dynamic stabilization |
| 2 | Active comparator | Conservative Care Receives: Device: Conservative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
To provide a safety cohort for the Prospective, Multi-center, Randomized, Active-Controlled Study of the Wallis System for the Treatment of Mild to Moderate Degenerative Disc Disease of the Lumbar Spine
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2005 (estimated)
- Study startNov 2004
- Primary completionApr 2011
- Study completionApr 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00134537
- Sponsor's protocol ID
- SN002-001-05
- Status last verified
- Oct 2011
- First submitted
- 23 Aug 2005
- Last updated
- 4 Oct 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Wallis Mechanical Normalization System for Low Back Pain
- ClinicalTrials.gov ID
- NCT00134537
- Acronym / sponsor ID
- SN002-001-05
- Conditions
- Low Back Pain
- Keywords
- Degenerative Disc Disease of the lumbar spine
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Zimmer SpineIndustry (pharma, biotech, devices)
- Collaborators
- Zimmer Biomet
- Study start
- Nov 2004
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2012 (estimated)
- First posted
- 25 Aug 2005 (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 compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: Interspinous process and dynamic stabilizationInterspinous process and dynamic stabilization |
| 2 | Active comparator | Device: Conservative CareConservative Care |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Ages 18-60; male/female.
- Diagnosis of mild to moderate degenerative disc disease (DDD), which requires:
- Candidate for either surgery with Wallis or aggressive conservative management.
- Requires treatment at one or two lumbar levels between L1 and L5.
- Experienced symptoms for at least three months without significant resolution.
Key exclusion criteria (31 listed)
- Significant neuroforaminal compression requiring discectomy or foraminotomy
- Radiographic evidence of DDD at L5-S1
- Radiographic confirmation of severe facet joint disease or degeneration.
- History of any lumbar disc treatment intended to remove the disc, e.g. surgery, intradiscal electrothermal therapy (IDET), laser or enzymes such as chymopapain.
- Clinically compromised vertebral bodies at the affected level due to current or past trauma, e.g., sustained pathological fracture or multiple fractures of vertebrae.
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 |
|---|---|---|
| Interspinous process and dynamic stabilizationInterspinous process and dynamic stabilization | Device | 1 |
| Conservative CareMedication, exercise and spinal injections | Device | 2 |
Primary outcome
To provide a safety cohort for the Prospective, Multi-center, Randomized, Active-Controlled Study of the Wallis System for the Treatment of Mild to Moderate Degenerative Disc Disease of the Lumbar Spine
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2011.
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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.
17 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Interspinous process and dynamic stabilization and Conservative Care in people with Low Back Pain, run by Zimmer Spine at 17 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 11 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: status not confirmed, as of the sponsor's last update on 4 Oct 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 17 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
To provide a safety cohort for the Prospective, Multi-center, Randomized, Active-Controlled Study of the Wallis System for the Treatment of Mild to Moderate Degenerative Disc Disease of the Lumbar Spine (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 4 Oct 2011.