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Clinical Trials/NCT02104141
NCT02104141CompletedNot Applicable

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 enrollmentStarted: November 2013Last updated:
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Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
51
Primary Endpoint
Number of Participants With Fusion
Study OverviewStudy DesignEligibility CriteriaOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Other

Eligibility Criteria

Ages
21 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Secondary Outcomes

  • Mean Oswestry Disability Index(12 months after device implantation)

Investigators

Sponsor
LDR Spine USA
Sponsor Class
Industry
Responsible Party
Sponsor

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