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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02104167
Other study ID # ROIC100
Secondary ID
Status Completed
Phase
First received
Last updated
Start date September 2013
Est. completion date June 2015

Study information

Verified date January 2019
Source LDR Spine USA
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 110
Est. completion date June 2015
Est. primary completion date April 2015
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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

Study Design


Intervention

Device:
ROIC interbody cage with VerteBRIDGE plating


Locations

Country Name City State
United States Greater Baltimore Medical Center Baltimore Maryland
United States St Francis Hospital Greenville South Carolina
United States Orange County Neurological Associates Laguna Hills California
United States Orthpedic Specialists of Northwest Indiana Munster Indiana
United States Baystate Medical Center Springfield Massachusetts
United States New England Orthopedic Surgeons Springfield Massachusetts
United States Franciscan Neurosurgery Associates Tacoma Washington

Sponsors (1)

Lead Sponsor Collaborator
LDR Spine USA

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Percentage of Participants With Fusion 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. 12 months or more after device implantation; mean follow up 20.7 months
Secondary Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain 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. 12 months (Last available visit) post surgery
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