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

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Device: ROIC interbody cage with VerteBRIDGE plating

• Registration Number: NCT02104167
• Lead Sponsor: LDR Spine USA

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-09
• Study First Submitted: 2014-04-01
• Study First Submitted QC: 2014-04-03
• Study First Posted: 2014-04-04
• Primary Completion: 2015-04
• Study Completion: 2015-06
• Results First Submitted: 2017-11-07
• Status Verified: 2019-01
• Results First Submitted QC: 2019-01-15
• Last Update Submitted: 2019-01-15
• Results First Posted: 2019-04-16
• Last Update Posted: 2019-04-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 110

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Operated Subjects	ROIC interbody cage with VerteBRIDGE plating	ROIC interbody cage with VerteBRIDGE plating

Primary Outcome Measures

Name	Time	Method
Percentage of Participants With Fusion	12 months or more after device implantation; mean follow up 20.7 months	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.

Secondary Outcome Measures

Name	Time	Method
Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain	12 months (Last available visit) post surgery	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.

Trial Locations

Locations (7)

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

Franciscan Neurosurgery Associates; 🇺🇸 Tacoma, Washington, United States

New England Orthopedic Surgeons; 🇺🇸 Springfield, Massachusetts, United States

St Francis Hospital; 🇺🇸 Greenville, South Carolina, United States