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Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating

NCT02104141 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 51

Last updated 2019-04-24

Study results available
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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

  • Degenerative Disc Disease

Interventions

DEVICE

ROIA Interbody Cage with VerteBRIDGE plating

Sponsors & Collaborators

  • LDR Spine USA

    lead INDUSTRY

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2016-04-30
Completion
2016-12-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02104141 on ClinicalTrials.gov