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

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 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.

Study Overview

• Status: Completed
• Conditions: Degenerative Disc Disease
• Intervention / Treatment: Device: ROIC interbody cage with VerteBRIDGE plating

• Study Type: Observational
• Enrollment (Actual): 110

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects will be drawn from community surgeon practices in which the subjects have already received the device and who meet the Inclusion/Exclusion criteria

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Operated Subjects; ROIC interbody cage with VerteBRIDGE plating	Device: ROIC interbody cage with VerteBRIDGE plating

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: LDR Spine USA
• Investigators: Principal Investigator: Robert J Jackson, MD, Orange County Neurosurgical Associates

Study record dates

Study Major Dates

• Study Start: September 1, 2013
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): June 1, 2015

Study Registration Dates

• First Submitted: April 1, 2014
• First Submitted That Met QC Criteria: April 3, 2014
• First Posted (Estimate): April 4, 2014

Study Record Updates

• Last Update Posted (Actual): April 16, 2019
• Last Update Submitted That Met QC Criteria: January 15, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: DDD; degenerative disc disease; cervical spine; fusion rate
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Intervertebral Disc Degeneration
• Other Study ID Numbers: ROIC100

Drug and device information, study documents

• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No