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

LDR Spine USA0 sites51 target enrollmentNovember 2013

ConditionsDegenerative Disc Disease

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Degenerative Disc Disease
Sponsor: LDR Spine USA
Enrollment: 51
Primary Endpoint: Number of Participants With Fusion
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

November 2013

End Date

December 2016

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

LDR Spine USA

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of Participants With Fusion

Time Frame: 12 months after device implantation

Fusion was assessed utilizing both AP and flexion/extension radiographs. Fusion was noted when all three of the criteria were present: 1) presence of bridging bone as identified by radiography, 2)Less than 5 degrees of segmental motion on flexion/extension radiographs, and 3) Less than 3 mm of A/P translation on flexion/extension radiographs