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

LDR Medical

Status: Completed

Conditions: Degenerative Disc Disease

Treatments: Device: ROIC interbody cage with VerteBRIDGE plating

Study type: Observational

Funder types: Industry

Identifiers

NCT02104167

ROIC100

Details and patient eligibility

About

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.

Enrollment: 110 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

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

Trial design

110 participants in 1 patient group

Operated Subjects

Description:

ROIC interbody cage with VerteBRIDGE plating

Treatment:

Device: ROIC interbody cage with VerteBRIDGE plating