Overview

This trial is active, not recruiting.

Condition degenerative disc disease
Treatment roia interbody cage with vertebridge plating
Sponsor LDR Spine USA
Start date November 2013
End date April 2016
Trial size 51 participants
Trial identifier NCT02104141, ROIA100

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Arm
ROIA Interbody Cage with VerteBRIDGE plating
roia interbody cage with vertebridge plating

Primary Outcomes

Measure
Time to Fusion
time frame: 12 months after device implantation

Secondary Outcomes

Measure
Percentage of subjects with an improvement in Oswestry Disability Index
time frame: 12 mo. or more after initial date of surgery

Eligibility Criteria

Male or female participants at least 21 years old.

Inclusion Criteria: - Subjects must have degenerative disc disease (DDD) of the lumbar spine between L2 and S1 - Subjects may have up to a Grade 1 spondylolisthesis at the involved level(s) - Subject must have the ROI-A® device at one level or at two contiguous levels between L2 and S1 only - Subject should have had a minimum of 6 months non-surgical treatment prior to receiving the ROI-A® device - Subject may have had NO MORE THAN two previous non-fusion surgeries to the lumbar spine at the same levels as the ROI-A® - Subject must be at least 21 years of age at the time of surgery - Subject must be willing to signed an informed consent document and return for a 12 month visit Exclusion Criteria: - Subject had more than Grade 1 spondylolisthesis at the operated level - Subject is a prisoner. - Subject was pregnant at the time of surgery. - Subject had an active infection or sepsis at the time of surgery.

Additional Information

Official title 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
Principal investigator Christian M DuBois, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2016.
Information provided to ClinicalTrials.gov by LDR Spine USA.