- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00134537
Wallis Mechanical Normalization System for Low Back Pain
October 3, 2011 updated by: Zimmer Spine
The purpose of this study is to compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
300
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Arizona
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Phoenix, Arizona, United States, 85015
- Spine Specialists of Arizona
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Phoenix, Arizona, United States, 85020
- Arizona Institute for Minimally Invasive Spine Care
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California
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Beverly Hills, California, United States, 90212
- Spine Source
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Santa Monica, California, United States, 90404
- UCLA Spine Center
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Colorado
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Boulder, Colorado, United States, 80304
- Boulder Neurosurgical Associates
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Thornton, Colorado, United States, 80229
- The Spine Education & Research Institute
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Georgia
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Atlanta, Georgia, United States, 30329
- Emory University Medical Center
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Illinois
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Morton Grove, Illinois, United States, 60053
- Illinois Bone & Joint Institute
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Indiana
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Fort Wayne, Indiana, United States, 46804
- Fort Wayne Orthopedics
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Maryland
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Baltimore, Maryland, United States, 21204
- Greater Baltimore Medical Center
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Towson, Maryland, United States, 21204
- Orthopaedic Associates
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Missouri
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Chesterfield, Missouri, United States, 63017
- The Orthopedic Center of St. Louis
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New York
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Melville, New York, United States, 11747
- Orthopedic Spine Care of Long Island
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Oregon
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Eugene, Oregon, United States, 97401
- Orthopedic Spine Associates
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Pennsylvania
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Willow Grove, Pennsylvania, United States, 19090
- The Orthopedic Specialty Center (Abington Hospital)
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Texas
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Austin, Texas, United States, 78731
- Central Texas Spine Institute
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Plano, Texas, United States, 75093
- TBI/ Plano Presbyterian Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Subjects must meet all inclusion and exclusion criteria listed below for participation in the study.
Inclusion Criteria:
- 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.
- 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.
Exclusion Criteria:
- 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.
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: 1
Interspinous process and dynamic stabilization
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Interspinous process and dynamic stabilization
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Active Comparator: 2
Conservative Care
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Medication, exercise and spinal injections
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
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24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2004
Primary Completion (Actual)
April 1, 2011
Study Completion (Anticipated)
April 1, 2012
Study Registration Dates
First Submitted
August 23, 2005
First Submitted That Met QC Criteria
August 23, 2005
First Posted (Estimate)
August 25, 2005
Study Record Updates
Last Update Posted (Estimate)
October 4, 2011
Last Update Submitted That Met QC Criteria
October 3, 2011
Last Verified
October 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SN002-001-05
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Low Back Pain
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Dow University of Health SciencesRecruitingLow Back Pain | Chronic Low-back Pain | Low Back Pain, Mechanical | Mechanical Low Back Pain | Pain, Chronic | Pain, Back | Lower Back Pain Chronic | CLBP - Chronic Low Back PainPakistan
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Faculdade de Ciências Médicas da Santa Casa de...CompletedLow Back Pain, Mechanical | Low Back Pain, Postural | Lower Back Pain Chronic | Low Back Pain, Posterior CompartmentBrazil
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University School of Physical Education in WroclawCompletedLow Back Pain | Low Back Pain, Mechanical | Low Back Pain, PosturalPoland
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Texas Woman's UniversityTexas Physical Therapy AssociationCompletedLow Back Pain | Chronic Low Back Pain | Subacute Low Back PainUnited States
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University of ParmaKing's College London; Helmholtz Zentrum München; GENOS; Ip Research Consulting... and other collaboratorsUnknownChronic Low Back Pain | Acute Low Back PainUnited States, Australia, Belgium, Croatia, Italy, United Kingdom
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Ache Laboratorios Farmaceuticos S.A.Unknown
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Palmer College of ChiropracticDepartment of Health and Human ServicesCompletedChronic Low Back Pain | Subacute Low Back PainUnited States
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Universität Duisburg-EssenSiemens-BetriebskrankenkasseCompletedChronic Low Back Pain | Recurrent Low Back Pain
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Karolinska InstitutetCompletedChronic Low Back Pain | Recurrent Low Back Pain | Persistent Low Back PainSweden
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Apsen Farmaceutica S.A.CompletedLow Back Pain | Low Back Pain, Mechanical | Acute Low Back PainBrazil
Clinical Trials on Interspinous process and dynamic stabilization
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Zimmer SpineZimmer BiometUnknown
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Synthes USA HQ, Inc.TerminatedSpinal StenosisUnited States
-
Centre Hospitalier Universitaire de NiceCompletedDegenerative Lumbar Spinal Stenosis | Neurologic Intermittent ClaudicationFrance
-
Medtronic Spine LLCCompletedLumbar Spinal StenosisUnited States
-
Pacific Institute for Research and EvaluationUniversity of California, San Diego; U.S. Department of Justice; Restorative... and other collaboratorsTerminated
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Hospital de Egas MonizCentro Hospitalar Lisboa OcidentalCompletedBankart Lesion | Anterior Shoulder Dislocation | Hill Sachs LesionPortugal
-
Pacific Institute for Research and EvaluationEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsActive, not recruiting
-
Dow University of Health SciencesCompleted
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Paradigm SpineMCRATerminatedSpondylolisthesis | Kyphosis | Neurologic Deficits | PseudarthrosisUnited States
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Norwegian University of Science and TechnologyTerminatedRadiculopathy | Lumbar Spinal StenosisNorway