Degenerative Disc Disease Clinical Trial
Official title:
A Prospective, Multi-center, Randomized, Controlled Clinical Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
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
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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