Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
Public ClinicalTrials.gov record NCT00931515. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Prospective, Multi-center, Randomized, Controlled Clinical Trial Evaluating the Safety and Effectiveness of NUBAC™ Disc Arthroplasty
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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 identification
- NCT ID
- NCT00931515
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 30 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Feb 2009 (Type not available)
- Primary completion
- Dec 2012 (Actual)
- Completion
- Dec 2012 (Actual)
- Last update posted
- May 26, 2014
2009 – 2012
United States locations
- U.S. sites
- 17
- U.S. states
- 12
- U.S. cities
- 16
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Spine Group Beverly Hills | Beverly Hills | California | 90211 | — |
| Tower Orthopedics & Sports Medicine | Beverly Hills | California | 90211 | — |
| Bergey Spine Institute | Colton | California | 92324 | — |
| Loma Linda University - Faculty Physicians | Loma Linda | California | 92354 | — |
| University of Colorado, Anschutz Outpatient Pavilion | Aurora | Colorado | 80045 | — |
| The Spine Institute | Loveland | Colorado | 80538 | — |
| Florida Orthopaedic Institute | Tampa | Florida | 33637 | — |
| Bone & Joint Physicians | Oak Lawn | Illinois | 60453 | — |
| Heartland Hand & Spine Orthopedic Center | Merriam | Kansas | 66204 | — |
| Orthopaedic Surgical Associates | Marquette | Michigan | 49855 | — |
| The Orthopedic Center of St. Louis | St Louis | Missouri | 63017 | — |
| Buffalo Neurosurgery | Buffalo | New York | 14224 | — |
| Southern New York NeuroSurgical Group | Johnson City | New York | 13790 | — |
| Carolina Neurosurgery and Spine Associates | Charlotte | North Carolina | 28204 | — |
| NeuroSpine Institute | Eugene | Oregon | 97401 | — |
| Neurospine Solutions, PC | Bristol | Tennessee | 37620 | — |
| Milwaukee Spinal Specialists | Milwaukee | Wisconsin | 53211 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00931515, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 26, 2014 · Synced Oct 26, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT00931515 live on ClinicalTrials.gov.