At a glance
ClinicalIndex Comparison RecordN/ACompleted· 51 enrolled
Drug / intervention
ROIA Interbody Cage with VerteBRIDGE platingdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
An observational study evaluating ROIA Interbody Cage with VerteBRIDGE plating for Degenerative Disc Disease. Completed, enrolled 51 participants.
Detailed 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.
Study Details
Study Typeobservational
Allocation--
Masking--
Primary Purpose--
ConditionsDegenerative Disc Disease
Countries--
Collaborators--
Timeline
N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartNov 2013
First PostedApr 2014
Primary CompletionApr 2016
Study CompletionDec 2016
TodayJul 2026
First PostedApr 4, 2014
Enrollment StartNov 1, 2013
Primary CompletionApr 1, 2016
Study CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 12.2 years ago
Interventions
ROIA Interbody Cage with VerteBRIDGE platingdevice