At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Prospective, Multi-center, Randomized, Controlled Clinical Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
In Brief
A clinical study evaluating NuBac and Prodisc-L for Degenerative Disc Disease. Completed, enrolled 30 participants across 17 sites.
Detailed Summary
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 Details
Timeline
Interventions
NuBac device implanted at the L4/5 level.
Prodisc-L implanted at the L4/5 level.