Low Back PainPhase 3NCT00484458
Wallis Stabilization System for Low Back Pain
A Phase 3 study testing Interspinous process and dynamic stabilization (Wallis System) and Total Disc Replacement in people with Low Back Pain, run by Zimmer Spine at 11 sites in United States.
Trial summary
The purpose of this study is to demonstrate that the Wallis System (interspinous process implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate degenerative disc disease (DDD) of the lumbar spine at the L4-L5 level. 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 (Wallis System) and Total Disc Replacement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 340 participants
- Where
- 11 sitesUnited States
- Study dates
- Jan 2007to Nov 2014
- 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
- Age 18-60 (inclusive) and skeletally mature.
- Diagnosis of mild to moderate DDD at L4-L5 as confirmed by radiography.
- Minimum of six months of failed conservative treatment.
- Pre-operative visual analog (VAS) low back pain score ≥ 40, on a scale of 100mm, with low back pain greater than left or right leg pain.
- Preoperative baseline Oswestry Disability Index (ODI) score of ≥ 40 on a 100 point scale.
- 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 patient informed consent form.
- Patient is a surgical candidate for an anterior approach to the lumbar spine (< 3 abdominal surgeries).
Who cannot join
- The investigator believes that the L1-L2, L2-L3, L3-L4, or L5-S1 level is symptomatic based upon objective evidence, e.g., radiograph, MRI, or discography.
- Evidence of a prior fracture or trauma to the vertebral bodies at the affected level and/or the spinous processes at the L4-L5 or adjacent levels.
- Osteoporosis or osteopenia or metabolic bone disease as confirmed by DEXA scan (T score < -1.0). Female subjects older than 45 years of age (or post-menopausal women, history of oophorectomy, or family history of osteoporosis) and male subjects older than 55 years will undergo a pre-operative, dual energy x-ray absorptiometry (DEXA) of the lumbar spine. The DEXA will be used to identify subjects with an indication of osteoporosis, osteopenia or metabolic bone disease. Subjects with a T-score of less than -1.0 will be excluded from the study.
- Congenital lumbar spinal stenosis.
- Bony lumbar stenosis.
- Extreme obesity, as defined by National Institutes of Health (NIH) Clinical Guidelines Body Mass Index (BMI > 40kg/m2).
- A history of any surgical procedure intended to remove or alter the disc (e.g. discectomy, intradiscal electrothermal therapy (IDET) or enzymes), decompress (laminectomy) or fuse, either the index or adjacent levels.
- Prior participation in study of any investigational spinal implant or investigational spinal treatment.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Lehigh Valley Hospital
Allentown, Pennsylvania, 18103
Spine Source
Beverly Hills, California, 90212
Boulder Neurosurgical Associates
Boulder, Colorado, 80504
Medical University of South Carolina
Charleston, North Carolina, 29425
Triangle Orthopaedic Associates, P.A.
Durham, North Carolina, 27302
Core Orthopaedic Medical Center
Encinitas, California, 92024
Fort Wayne Orthopaedics
Fort Wayne, Indiana, 46804
Aurora BayCare Medical Center
Green Bay, Wisconsin, 54311
Denver Spine
Greenwood Village, Colorado, 80111
Illinois Bone & Joint Institute
Morton Grove, Illinois, 60053
University of Utah-Dept. of Neurosurgery-Dept. of Orthopedic Surgery
Salt Lake City, Utah, 84132
About this study
Official title: A 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
The purpose of this study is to demonstrate that the Wallis System (interspinous process implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate degenerative disc disease (DDD) of the lumbar spine at the L4-L5 level.
This study will assess the safety and efficacy of the Wallis® System compared to commercially available lumbar TDR with respect to individual subject success rates at 24 months postoperative follow-up.
Study participants will receive all study related test articles and surgical procedures at no charge. Please scroll down to the "Locations" section to find a doctor in your area that is participating in this study. If you are interested in participating in this study and do not see a doctor in your area, please contact Jose Naveira at jose.naveira@abbottspine.com
- Conditions
- Low Back Pain
- Being tested
- Interspinous process and dynamic stabilization (Wallis System), Total Disc Replacement
- Keywords
- Degenerative Disc Disease, Total Disc Replacement
- Medical subject headings
- Low Back Pain, Intervertebral Disc Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Interspinous process and dynamic stabilization (Wallis System)Device
Interspinous stabilization
Total Disc ReplacementDevice
Total disc
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Wallis Stabilization System Receives: Device: Interspinous process and dynamic stabilization (Wallis System) |
| 2 | Active comparator | Total Disc Replacement Receives: Device: Total Disc Replacement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Non-inferior to commercially available lumber TDR after 24 months.
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 posted11 Jun 2007 (estimated)
- Study startJan 2007
- Primary completionNov 2013 (estimated)
- Study completionNov 2014 (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
- 340 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zimmer Spine
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Zimmer Biomet
- Responsible party
- Sponsor
- Investigators
- John J. Regan, MD, Principal investigator, Spine SourceChristopher Bergin, MD, Principal investigator, Illinois Bone & Joint Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00484458
- Sponsor's protocol ID
- 6000-1006-P1-R1
- Status last verified
- Oct 2011
- First submitted
- 7 Jun 2007
- 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
- A 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
- ClinicalTrials.gov ID
- NCT00484458
- Acronym / sponsor ID
- 6000-1006-P1-R1
- Conditions
- Low Back Pain
- Keywords
- Degenerative Disc Disease, Total Disc Replacement
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 340 participants (estimated)
- Lead sponsor
- Zimmer SpineIndustry (pharma, biotech, devices)
- Collaborators
- Zimmer Biomet
- Study start
- Jan 2007
- Primary completion
- Nov 2013 (estimated)
- Study completion
- Nov 2014 (estimated)
- First posted
- 11 Jun 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.
The purpose of this study is to demonstrate that the Wallis System (interspinous process implant) is equivalent to total disc replacement (TDR) for the treatment of mild to moderate degenerative disc disease (DDD) of the lumbar spine at the L4-L5 level.
This study will assess the safety and efficacy of the Wallis® System compared to commercially available lumbar TDR with respect to individual subject success rates at 24 months postoperative follow-up.
Study participants will receive all study related test articles and surgical procedures at no charge. Please scroll down to the "Locations" section to find a doctor in your area that is participating in this study. If you are interested in participating in this study and do not see a doctor in your area, please contact Jose Naveira at jose.naveira@abbottspine.com
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 stabilization (Wallis System)Wallis Stabilization System |
| 2 | Active comparator | Device: Total Disc ReplacementTotal Disc Replacement |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- Age 18-60 (inclusive) and skeletally mature.
- Diagnosis of mild to moderate DDD at L4-L5 as confirmed by radiography.
- Minimum of six months of failed conservative treatment.
- Pre-operative visual analog (VAS) low back pain score ≥ 40, on a scale of 100mm, with low back pain greater than left or right leg pain.
- Preoperative baseline Oswestry Disability Index (ODI) score of ≥ 40 on a 100 point scale.
Key exclusion criteria (8 listed)
- The investigator believes that the L1-L2, L2-L3, L3-L4, or L5-S1 level is symptomatic based upon objective evidence, e.g., radiograph, MRI, or discography.
- Evidence of a prior fracture or trauma to the vertebral bodies at the affected level and/or the spinous processes at the L4-L5 or adjacent levels.
- Osteoporosis or osteopenia or metabolic bone disease as confirmed by DEXA scan (T score < -1.0). Female subjects older than 45 years of age (or post-menopausal women, history of oophorectomy, or family history of osteoporosis) and male subjects older than 55 years will undergo a pre-operative, dual energy x-ray absorptiometry (DEXA) of the lumbar spine. The DEXA will be used to identify subjects with an indication of osteoporosis, osteopenia or metabolic bone disease. Subjects with a T-score of less than -1.0 will be excluded from the study.
- Congenital lumbar spinal stenosis.
- Bony lumbar stenosis.
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 stabilization (Wallis System)Interspinous stabilization | Device | 1 |
| Total Disc ReplacementTotal disc | Device | 2 |
Primary outcome
Non-inferior to commercially available lumber TDR after 24 months.
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.
John J. Regan, MD principal investigator
Spine Source
Christopher Bergin, MD principal investigator
Illinois Bone & Joint Institute
11 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 (Wallis System) and Total Disc Replacement in people with Low Back Pain, run by Zimmer Spine at 11 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 8 inclusion and 8 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 11 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?
Non-inferior to commercially available lumber TDR after 24 months. (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.