Trials / Completed
CompletedNCT02104167
Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
An Open-Label Clinical Study of the Safety and Efficacy of the ROI-C Anterior Cervical Interbody Fusion Device Using the VerteBRIDGE Plating System
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 110 (actual)
- Sponsor
- LDR Spine USA · Industry
- Sex
- All
- Age
- 21 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this combined retrospective and prospective clinical study is to examine the clinical outcomes of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE® plating to treat single level degenerative disc disease between C2 and T1 in the short term, with a focus on fusion rates.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | ROIC interbody cage with VerteBRIDGE plating |
Timeline
- Start date
- 2013-09-01
- Primary completion
- 2015-04-01
- Completion
- 2015-06-01
- First posted
- 2014-04-04
- Last updated
- 2019-04-16
- Results posted
- 2019-04-16
Locations
7 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT02104167. Inclusion in this directory is not an endorsement.