Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
Completed
Conditions studied: Degenerative Disc Disease
In brief
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.
Key facts
- Study ID
- NCT02104167
- Run by
- LDR Spine USA
- People needed
- 110
- Starts
- 2013-09-01
- Expected to finish
- 2015-06-01
- Last updated by the study team
- 2019-04-16
Who can join
Age: 21 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- Orange County Neurological Associates — Laguna Hills, California, United States
- Orthpedic Specialists of Northwest Indiana — Munster, Indiana, United States
- Greater Baltimore Medical Center — Baltimore, Maryland, United States
- Baystate Medical Center — Springfield, Massachusetts, United States
- New England Orthopedic Surgeons — Springfield, Massachusetts, United States
- St Francis Hospital — Greenville, South Carolina, United States
- Franciscan Neurosurgery Associates — Tacoma, Washington, United States
Full record on ClinicalTrials.gov
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