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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

110 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-09-30

Study Completion Date

2015-06-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Degenerative Disc Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Operated Subjects

ROIC interbody cage with VerteBRIDGE plating

Intervention Type DEVICE

Interventions

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ROIC interbody cage with VerteBRIDGE plating

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No