Trials / Completed
CompletedNCT02104141
Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating
An Open Label, Multicenter, Clinical Study of the Safety and Efficacy of the LDR Spine ROI-A Interbody Fusion System Using the VerteBRIDGE™ Plating System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 51 (actual)
- Sponsor
- LDR Spine USA · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level degenerative disc disease between L2 and S1, with a focus on fusion rates and patient outcomes.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ROIA Interbody Cage with VerteBRIDGE plating |
Timeline
- Start date
- 2013-11-01
- Primary completion
- 2016-04-01
- Completion
- 2016-12-01
- First posted
- 2014-04-04
- Last updated
- 2019-04-24
- Results posted
- 2019-04-16
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02104141. Inclusion in this directory is not an endorsement.