Wallis Mechanical Normalization System for Low Back Pain
NCT ID: NCT00134537
Last Updated: 2011-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
300 participants
INTERVENTIONAL
2004-11-30
2012-04-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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1
Interspinous process and dynamic stabilization
Interspinous process and dynamic stabilization
Interspinous process and dynamic stabilization
2
Conservative Care
Conservative Care
Medication, exercise and spinal injections
Interventions
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Interspinous process and dynamic stabilization
Interspinous process and dynamic stabilization
Conservative Care
Medication, exercise and spinal injections
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Zimmer Spine
INDUSTRY
Responsible Party
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Locations
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Spine Specialists of Arizona
Phoenix, Arizona, United States
Arizona Institute for Minimally Invasive Spine Care
Phoenix, Arizona, United States
Spine Source
Beverly Hills, California, United States
UCLA Spine Center
Santa Monica, California, United States
Boulder Neurosurgical Associates
Boulder, Colorado, United States
The Spine Education & Research Institute
Thornton, Colorado, United States
Emory University Medical Center
Atlanta, Georgia, United States
Illinois Bone & Joint Institute
Morton Grove, Illinois, United States
Fort Wayne Orthopedics
Fort Wayne, Indiana, United States
Greater Baltimore Medical Center
Baltimore, Maryland, United States
Orthopaedic Associates
Towson, Maryland, United States
The Orthopedic Center of St. Louis
Chesterfield, Missouri, United States
Orthopedic Spine Care of Long Island
Melville, New York, United States
Orthopedic Spine Associates
Eugene, Oregon, United States
The Orthopedic Specialty Center (Abington Hospital)
Willow Grove, Pennsylvania, United States
Central Texas Spine Institute
Austin, Texas, United States
TBI/ Plano Presbyterian Hospital
Plano, Texas, United States
Countries
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Other Identifiers
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SN002-001-05
Identifier Type: -
Identifier Source: org_study_id