Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating

Status:	Completed
Conditions:	Orthopedic
Therapuetic Areas:	Orthopedics / Podiatry
Healthy:	No
Age Range:	21 - Any
Updated:	11/10/2017
Start Date:	September 2013
End Date:	June 2015

An Open-Label Clinical Study of the Safety and Efficacy of the ROI-C Anterior Cervical Interbody Fusion Device Using the VerteBRIDGE Plating System

The purpose of this combined retrospective and prospective clinical study is to examine
safety and efficacy 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.

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

We found this trial at

sites

Franciscan Neurosurgery Associates

Tacoma, Washington

from

Tacoma, WA