N/A
N=110
Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
Degenerative Disc Disease
Bottom Line
View on ClinicalTrials.gov: NCT02104167 ↗Enrolled (actual)
110
Serious AEs
1.8%
Results posted
Apr 2019
Primary outcome: Primary: Percentage of Participants With Fusion — 99.1 Percentage of Participants
Study Design & Population
- Study type
- Observational
- Phase
- N/A
- Interventions
- ROIC interbody cage with VerteBRIDGE plating (Device)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- LDR Spine USA
- Primary completion
- Apr 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Fusion |
99.1 | — |
| SECONDARY Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain |
19.0; 26.5; 15.3; 12.5 | — |
Summary
The purpose of this combined retrospective and prospective clinical study is to examine the clinical outcomes of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE® plating to treat single level degenerative disc disease between C2 and T1 in the short term, with a focus on fusion rates.
Eligibility Criteria
Inclusion Criteria
- Subject must have degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptoms at one level between C2 and T1.
- The subject can have the ROI-C device at only one level.
- Autograft must have been used with the ROI-C device.
- Subject should have had a minimum of 6 (six) weeks of non-operative treatment prior to surgery.
- Subject must be at least 21 years of age at the time of surgery
Exclusion Criteria
- No BMP was used in the interbody cage
- Subject was a prisoner at the time of surgery
- 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 (NCT02104167). 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.