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

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ClinicalTrials.gov Identifier: NCT02104141
Recruitment Status : Completed
First Posted : April 4, 2014
Results First Posted : April 15, 2019
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
LDR Spine USA

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

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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

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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:

  • 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.

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Responsible Party: LDR Spine USA
ClinicalTrials.gov 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

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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:
DDD
lumbar spine
fusion rate
degenerative disc disease
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases