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

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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

Tracking Information
First Submitted Date April 1, 2014
First Posted Date April 4, 2014
Results First Submitted Date November 7, 2017
Results First Posted Date April 15, 2019
Last Update Posted Date April 15, 2019
Study Start Date September 2013
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 15, 2019)
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.
Original Primary Outcome Measures
 (submitted: April 3, 2014)
Time to Fusion [ Time Frame: 12 months or more after device implantation ]
Change History Complete list of historical versions of study NCT02104167 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 15, 2019)
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.
Original Secondary Outcome Measures
 (submitted: April 3, 2014)
Percentage of subjects with an improvement in Neck Disability Index (NDI) [ Time Frame: 12 mo. or more after initial date of surgery ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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
Condition Degenerative Disc Disease
Intervention Device: ROIC interbody cage with VerteBRIDGE plating
Study Groups/Cohorts Operated Subjects
ROIC interbody cage with VerteBRIDGE plating
Intervention: Device: ROIC interbody cage with VerteBRIDGE plating
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: January 15, 2019)
110
Original Estimated Enrollment
 (submitted: April 3, 2014)
100
Actual Study Completion Date June 2015
Actual Primary Completion Date April 2015   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT02104167
Other Study ID Numbers ROIC100
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement Not Provided
Responsible Party LDR Spine USA
Study Sponsor LDR Spine USA
Collaborators Not Provided
Investigators
Principal Investigator: Robert J Jackson, MD Orange County Neurosurgical Associates
PRS Account LDR Spine USA
Verification Date January 2019