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Completed

NCT Number: NCT02104167

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

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.

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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

Primary location

Orange County Neurological Associates, Laguna Hills, California, United States

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Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

ROIC interbody cage with VerteBRIDGE plating

Device

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

LDR Spine USA

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Apr 4, 2014
Registry last updated
Apr 16, 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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