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

Degenerative Disc Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02104167
• Other study ID #: ROIC100
• Status: Completed
• Start date: September 2013
• Est. completion date: June 2015

Study information

• Verified date: January 2019
• Source: LDR Spine USA
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 110
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 21 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration

Intervention

Device:
• ROIC interbody cage with VerteBRIDGE plating

Locations

Country	Name	City	State
United States	Greater Baltimore Medical Center	Baltimore	Maryland
United States	St Francis Hospital	Greenville	South Carolina
United States	Orange County Neurological Associates	Laguna Hills	California
United States	Orthpedic Specialists of Northwest Indiana	Munster	Indiana
United States	Baystate Medical Center	Springfield	Massachusetts
United States	New England Orthopedic Surgeons	Springfield	Massachusetts
United States	Franciscan Neurosurgery Associates	Tacoma	Washington

Sponsors (1)

Lead Sponsor	Collaborator
LDR Spine USA

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of Participants With Fusion	Rate of fusion using A/P, lateral, and flexion/extension radiographs at each time point; defined by the presence of bridging bone with less than 2° segmental motion in flexion/extension and less than 3mm of A/P translation.	12 months or more after device implantation; mean follow up 20.7 months
Secondary	Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain	NDI is a standard instrument for measuring self-rated disability due to neck pain. It is scored from 0-50, with results multiplied by 2 to arrive at a percentage. Lowest scores represent no disability, high scores represent worse disability. A VAS is a measurement instrument for pain that measures the degree across a continuum or straight line. The endpoints define extreme limits, from 0-10, with 0 representing no pain and 10 severe pain.	12 months (Last available visit) post surgery