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
340 participants
INTERVENTIONAL
2007-01-31
2014-11-30
Brief Summary
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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 [email protected]
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
Wallis Stabilization System
Interspinous process and dynamic stabilization (Wallis System)
Interspinous stabilization
2
Total Disc Replacement
Total Disc Replacement
Total disc
Interventions
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Interspinous process and dynamic stabilization (Wallis System)
Interspinous stabilization
Total Disc Replacement
Total disc
Eligibility Criteria
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Inclusion Criteria
* 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).
Exclusion Criteria
* 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.
18 Years
60 Years
ALL
No
Sponsors
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Zimmer Biomet
INDUSTRY
Zimmer Spine
INDUSTRY
Responsible Party
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Principal Investigators
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John J. Regan, MD
Role: PRINCIPAL_INVESTIGATOR
Spine Source
Christopher Bergin, MD
Role: PRINCIPAL_INVESTIGATOR
Illinois Bone & Joint Institute
Locations
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Spine Source
Beverly Hills, California, United States
Core Orthopaedic Medical Center
Encinitas, California, United States
Boulder Neurosurgical Associates
Boulder, Colorado, United States
Denver Spine
Greenwood Village, Colorado, United States
Illinois Bone & Joint Institute
Morton Grove, Illinois, United States
Fort Wayne Orthopaedics
Fort Wayne, Indiana, United States
Medical University of South Carolina
Charleston, North Carolina, United States
Triangle Orthopaedic Associates, P.A.
Durham, North Carolina, United States
Lehigh Valley Hospital
Allentown, Pennsylvania, United States
University of Utah-Dept. of Neurosurgery-Dept. of Orthopedic Surgery
Salt Lake City, Utah, United States
Aurora BayCare Medical Center
Green Bay, Wisconsin, United States
Countries
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Other Identifiers
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6000-1006-P1-R1
Identifier Type: -
Identifier Source: org_study_id