Working… Menu

Retrospective/Prospective Data Collection on the LDR ROIA 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. Identifier: NCT02104141
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : April 15, 2019
Last Update Posted : April 24, 2019
Information provided by (Responsible Party):

Brief Summary:
The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level degenerative disc disease between L2 and S1, with a focus on fusion rates and patient outcomes.

Condition or disease Intervention/treatment
Degenerative Disc Disease Device: ROIA Interbody Cage with VerteBRIDGE plating

Layout table for study information
Study Type : Observational
Actual Enrollment : 51 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: An Open Label, Multicenter, Clinical Study of the Safety and Efficacy of the LDR Spine ROI-A Interbody Fusion System Using the VerteBRIDGE™ Plating System
Study Start Date : November 2013
Actual Primary Completion Date : April 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Group/Cohort Intervention/treatment
Operated Subjects
ROIA Interbody Cage with VerteBRIDGE plating
Device: ROIA Interbody Cage with VerteBRIDGE plating

Primary Outcome Measures :
  1. Number of Participants With Fusion [ Time Frame: 12 months after device implantation ]
    Fusion was assessed utilizing both AP and flexion/extension radiographs. Fusion was noted when all three of the criteria were present: 1) presence of bridging bone as identified by radiography, 2)Less than 5 degrees of segmental motion on flexion/extension radiographs, and 3) Less than 3 mm of A/P translation on flexion/extension radiographs

Secondary Outcome Measures :
  1. Mean Oswestry Disability Index [ Time Frame: 12 months after device implantation ]
    The Oswestry Disability Index (ODI) is and index to quantify disability for low back pain. There are 50 possible points which are multiplied by 2 to arrive at a percentage score. Zero is equated with no disability and 100 is the maximum disability possible

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.

Inclusion Criteria:

  • Subjects must have degenerative disc disease (DDD) of the lumbar spine between L2 and S1
  • Subjects may have up to a Grade 1 spondylolisthesis at the involved level(s)
  • Subject must have the ROI-A® device at one level or at two contiguous levels between L2 and S1 only
  • Subject should have had a minimum of 6 months non-surgical treatment prior to receiving the ROI-A® device
  • Subject may have had NO MORE THAN two previous non-fusion surgeries to the lumbar spine at the same levels as the ROI-A®
  • Subject must be at least 21 years of age at the time of surgery
  • Subject must be willing to signed an informed consent document and return for a 12 month visit

Exclusion Criteria:

  • Subject had more than Grade 1 spondylolisthesis at the operated level
  • Subject is a prisoner.
  • Subject was pregnant at the time of surgery.
  • Subject had an active infection or sepsis at the time of surgery.

Layout table for additonal information
Responsible Party: LDR Spine USA Identifier: NCT02104141     History of Changes
Other Study ID Numbers: ROIA100
First Posted: April 4, 2014    Key Record Dates
Results First Posted: April 15, 2019
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
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:
lumbar spine
fusion rate
degenerative disc disease
Additional relevant MeSH terms:
Layout table for MeSH terms
Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases