N/A
Completed N=51
Retrospective/Prospective Data Collection on the LDR ROIA Interbody Fusion Device With VerteBRIDGE Plating
Source: ClinicalTrials.gov NCT02104141 ↗Enrolled (actual)
51
Serious AEs
0.0%
Results posted
Apr 2019
Primary outcomePrimary: Number of Participants With Fusion — 50 Participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Fusion |
50 | — |
| SECONDARY Mean Oswestry Disability Index |
28.9 | — |
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.
Data sourced from ClinicalTrials.gov (NCT02104141). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.