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OpenTrials
Completed

NCT Number: NCT02104141

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

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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ROIA Interbody Cage with VerteBRIDGE plating

Device

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

LDR Spine USA

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2016
Study completion
2016
First posted
Apr 4, 2014
Registry last updated
Apr 24, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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