The NuBac device is indicated for reconstruction following nucleotomy in skeletally mature patients at least 18 years of age with symptomatic single level degenerative disc disease (DDD) at L4/L5 only. DDD is defined as discogenic back pain with or without leg pain; with degeneration of the disc as confirmed by patient history, physical examination, radiographic studies showing: decreased disc height, contained herniated nucleus, vacuum phenomenon (dark disc) OR positive discography at the affected level. These DDD patients should have no more than Grade 1 spondylolisthesis at the involved level and should have failed at least six months of conservative, non-operative care. Demonstrate non-inferiority compared to ProDisc.
STUDY DESIGN: Multicenter, prospective, randomized (1:1), controlled study comparing the artificial nucleus to ProDisc. After implanting artificial nucleus in two patients during the training session, enrollment of randomized patients shall begin. The study is expected to be completed in four years. NUMBER OF INVESTIGATIONAL SITES and INVESTIGATORS: 10 - 20 investigational sites, 1 to 2 investigators per site, approximately 20-40 patients per site
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
30
Spine Group Beverly Hills
Beverly Hills, California, United States
Tower Orthopedics & Sports Medicine
Beverly Hills, California, United States
Bergey Spine Institute
Colton, California, United States
Loma Linda University - Faculty Physicians
Loma Linda, California, United States
University of Colorado, Anschutz Outpatient Pavilion
Aurora, Colorado, United States
The Spine Institute
Loveland, Colorado, United States
Florida Orthopaedic Institute
Tampa, Florida, United States
Bone & Joint Physicians
Oak Lawn, Illinois, United States
Heartland Hand & Spine Orthopedic Center
Merriam, Kansas, United States
Orthopaedic Surgical Associates
Marquette, Michigan, United States
...and 7 more locations
Participants With Improved Patient Function
The comparison of results was based on the proportion of participants with improved outcomes. The primary efficacy variable was treatment success based on the following criteria: 1. Oswestry Disability Index score improved by at least 15 points 2. Device success 3. Neurological success 4. Absence of major complications 5. Absence of fusion at the index level A patient was considered a success upon meeting all five criteria. Failure to meet any of these criteria resulted in classification as a treatment failure.
Time frame: 24 months
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