Wallis Mechanical Normalization System for Low Back Pain
1 other identifier
interventional
300
1 country
17
Brief Summary
The purpose of this study is to compare improvement in low back pain with Wallis (interspinous process implant) to exercise and injections.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 low-back-pain
Started Nov 2004
Longer than P75 for phase_3 low-back-pain
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2004
CompletedFirst Submitted
Initial submission to the registry
August 23, 2005
CompletedFirst Posted
Study publicly available on registry
August 25, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2012
CompletedOctober 4, 2011
October 1, 2011
6.4 years
August 23, 2005
October 3, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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
24 months
Study Arms (2)
1
EXPERIMENTALInterspinous process and dynamic stabilization
2
ACTIVE COMPARATORConservative Care
Interventions
Eligibility Criteria
You may not qualify if:
- 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.
- 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.
- +27 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Zimmer Spinelead
- Zimmer Biometcollaborator
Study Sites (17)
Spine Specialists of Arizona
Phoenix, Arizona, 85015, United States
Arizona Institute for Minimally Invasive Spine Care
Phoenix, Arizona, 85020, United States
Spine Source
Beverly Hills, California, 90212, United States
UCLA Spine Center
Santa Monica, California, 90404, United States
Boulder Neurosurgical Associates
Boulder, Colorado, 80304, United States
The Spine Education & Research Institute
Thornton, Colorado, 80229, United States
Emory University Medical Center
Atlanta, Georgia, 30329, United States
Illinois Bone & Joint Institute
Morton Grove, Illinois, 60053, United States
Fort Wayne Orthopedics
Fort Wayne, Indiana, 46804, United States
Greater Baltimore Medical Center
Baltimore, Maryland, 21204, United States
Orthopaedic Associates
Towson, Maryland, 21204, United States
The Orthopedic Center of St. Louis
Chesterfield, Missouri, 63017, United States
Orthopedic Spine Care of Long Island
Melville, New York, 11747, United States
Orthopedic Spine Associates
Eugene, Oregon, 97401, United States
The Orthopedic Specialty Center (Abington Hospital)
Willow Grove, Pennsylvania, 19090, United States
Central Texas Spine Institute
Austin, Texas, 78731, United States
TBI/ Plano Presbyterian Hospital
Plano, Texas, 75093, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 23, 2005
First Posted
August 25, 2005
Study Start
November 1, 2004
Primary Completion
April 1, 2011
Study Completion
April 1, 2012
Last Updated
October 4, 2011
Record last verified: 2011-10