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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

Study Type Observational
Study Design Observational Model: Cohort;   Time Perspective: Other
Condition Degenerative Disc Disease
Intervention Device: ROIC interbody cage with VerteBRIDGE plating
Enrollment 110
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Operated Subjects With ROI-C Device
Hide Arm/Group Description Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
Period Title: Overall Study
Started 110
Completed 110
Not Completed 0
Arm/Group Title Operated Subjects With ROI-C Device
Hide Arm/Group Description Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
Overall Number of Baseline Participants 110
Hide Baseline Analysis Population Description
Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
<=18 years
0
   0.0%
Between 18 and 65 years
110
 100.0%
>=65 years
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 110 participants
51.9  (10.2)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 110 participants
Female
64
  58.2%
Male
46
  41.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 110 participants
110
1.Primary Outcome
Title Percentage of Participants With Fusion
Hide Description 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.
Time Frame 12 months or more after device implantation; mean follow up 20.7 months
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Operated Subjects With ROI-C Device
Hide Arm/Group Description:
Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
Overall Number of Participants Analyzed 110
Measure Type: Number
Unit of Measure: Percentage of Participants
99.1
2.Secondary Outcome
Title Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain
Hide Description 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.
Time Frame 12 months (Last available visit) post surgery
Hide Outcome Measure Data
Hide Analysis Population Description
Operated Subjects
Arm/Group Title Operated Subjects With ROI-C Device
Hide Arm/Group Description:
Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
Overall Number of Participants Analyzed 110
Mean (Full Range)
Unit of Measure: Units on a Scale
NDI
19.0
(0 to 72)
VAS Neck
26.5
(0 to 100)
VAS Left Arm
15.3
(0 to 89)
VAS Right Arm
12.5
(0 to 100)
Time Frame Date of surgery through last follow up visit, mean of 20.7 months
Adverse Event Reporting Description Any change from baseline in a subject’s condition during the clinical study. This includes events that are related to the device as well as events that are not related to the device.
 
Arm/Group Title Operated Subjects With ROI-C Device
Hide Arm/Group Description Subjects who were operated on or after Jan. 1, 2011 and who have a minimum of 12 months post-operative time prior to the final study visit.
All-Cause Mortality
Operated Subjects With ROI-C Device
Affected / at Risk (%)
Total   0/110 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Operated Subjects With ROI-C Device
Affected / at Risk (%) # Events
Total   2/110 (1.82%)    
Musculoskeletal and connective tissue disorders   
Pseudoarthrosis   1/110 (0.91%)  1
Cervical stenosis   1/110 (0.91%)  1
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Operated Subjects With ROI-C Device
Affected / at Risk (%) # Events
Total   42/110 (38.18%)    
Musculoskeletal and connective tissue disorders   
Upper extremity pain/numbness   11/110 (10.00%)  16
Fall/Injury   10/110 (9.09%)  12
Lower back pain   6/110 (5.45%)  6
Neck Pain   7/110 (6.36%)  10
Shoulder injury   8/110 (7.27%)  9
Indicates events were collected by systematic assessment
This was a single-arm study that enrolled participants retrospectively. An active control is not available for comparison of results and changes from baseline are not available.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Clinical Affairs
Organization: Zimmer Biomet
Phone: 303-501-8571
EMail: tammy.stinson2@zimmerbiomet.com
Layout table for additonal information
Responsible Party: LDR Spine USA
ClinicalTrials.gov Identifier: NCT02104167     History of Changes
Other Study ID Numbers: ROIC100
First Submitted: April 1, 2014
First Posted: April 4, 2014
Results First Submitted: November 7, 2017
Results First Posted: April 15, 2019
Last Update Posted: April 15, 2019