Trials / Completed
CompletedNCT00931515
Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
A Prospective, Multi-center, Randomized, Controlled Clinical Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 30 (actual)
- Sponsor
- Pioneer Surgical Technology, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | NuBac | NuBac device implanted at the L4/5 level. |
| DEVICE | Prodisc-L | Prodisc-L implanted at the L4/5 level. |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2012-12-01
- Completion
- 2012-12-01
- First posted
- 2009-07-02
- Last updated
- 2014-05-26
- Results posted
- 2014-05-15
Locations
17 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00931515. Inclusion in this directory is not an endorsement.