Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02104167
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : April 15, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Degenerative Disc Disease Device: ROIC interbody cage with VerteBRIDGE plating

Layout table for study information
Study Type : Observational
Actual Enrollment : 110 participants
Observational Model: Cohort
Time Perspective: Other
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
Study Start Date : September 2013
Actual Primary Completion Date : April 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. Percentage of Participants With Fusion [ Time Frame: 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 :
  1. Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain [ Time Frame: 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02104167


Locations
Layout table for location information
United States, California
Orange County Neurological Associates
Laguna Hills, California, United States
United States, Indiana
Orthpedic Specialists of Northwest Indiana
Munster, Indiana, United States
United States, Maryland
Greater Baltimore Medical Center
Baltimore, Maryland, United States
United States, Massachusetts
Baystate Medical Center
Springfield, Massachusetts, United States
New England Orthopedic Surgeons
Springfield, Massachusetts, United States
United States, South Carolina
St Francis Hospital
Greenville, South Carolina, United States
United States, Washington
Franciscan Neurosurgery Associates
Tacoma, Washington, United States
Sponsors and Collaborators
LDR Spine USA
Investigators
Layout table for investigator information
Principal Investigator: Robert J Jackson, MD Orange County Neurosurgical Associates

Layout table for additonal information
Responsible Party: LDR Spine USA
ClinicalTrials.gov Identifier: NCT02104167     History of Changes
Other Study ID Numbers: ROIC100
First Posted: April 4, 2014    Key Record Dates
Results First Posted: April 15, 2019
Last Update Posted: April 15, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by LDR Spine USA:
DDD
degenerative disc disease
cervical spine
fusion rate
Additional relevant MeSH terms:
Layout table for MeSH terms
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases