Clinical trial NCT00484458: Wallis Stabilization System for Low Back Pain
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Low Back Pain
Keywords: Degenerative Disc Disease
Total Disc Replacement
Lead sponsor: Zimmer Spine
Sponsor class: INDUSTRY
Collaborators: name: Zimmer Biomet
First posted: 2007-06-11
Enrollment: 340
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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


Eligibility criteria: Inclusion Criteria:

* 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).

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Non-inferior to commercially available lumber TDR after 24 months.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Spine Source
state: California
city: Encinitas
country: United States
facility: Core Orthopaedic Medical Center
state: California
city: Boulder
country: United States
facility: Boulder Neurosurgical Associates
state: Colorado
city: Greenwood Village
country: United States
facility: Denver Spine
state: Colorado
city: Morton Grove
country: United States
facility: Illinois Bone & Joint Institute
state: Illinois
city: Fort Wayne
country: United States
facility: Fort Wayne Orthopaedics
state: Indiana
city: Charleston
country: United States
facility: Medical University of South Carolina
state: North Carolina
city: Durham
country: United States
facility: Triangle Orthopaedic Associates, P.A.
state: North Carolina
city: Allentown
country: United States
facility: Lehigh Valley Hospital
state: Pennsylvania
city: Salt Lake City
country: United States
facility: University of Utah-Dept. of Neurosurgery-Dept. of Orthopedic Surgery
state: Utah
city: Green Bay
country: United States
facility: Aurora BayCare Medical Center
state: Wisconsin
Study officials:
affiliation: Spine Source
name: John J. Regan, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Illinois Bone & Joint Institute
name: Christopher Bergin, MD
role: PRINCIPAL_INVESTIGATOR
References: