NCT02104167

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Sep 2013

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

April 1, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 4, 2014

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
3.9 years until next milestone

Results Posted

Study results publicly available

April 16, 2019

Completed
Last Updated

April 16, 2019

Status Verified

January 1, 2019

Enrollment Period

1.6 years

First QC Date

April 1, 2014

Results QC Date

November 7, 2017

Last Update Submit

January 15, 2019

Conditions

Degenerative Disc Disease

Keywords

DDDdegenerative disc diseasecervical spinefusion rate

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Mean Neck Disability Index (NDI), Visual Analog Scale (VAS)- Neck Pain, Visual Analog Scale (VAS)-Right and Left Arm Pain

    12 months (Last available visit) post surgery

Study Arms (1)

Operated Subjects

ROIC interbody cage with VerteBRIDGE plating

Device: ROIC interbody cage with VerteBRIDGE plating

Interventions

ROIC interbody cage with VerteBRIDGE platingDEVICE
Operated Subjects

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Orange County Neurological Associates

Laguna Hills, California, United States

Location

Orthpedic Specialists of Northwest Indiana

Munster, Indiana, United States

Location

Greater Baltimore Medical Center

Baltimore, Maryland, United States

Location

Baystate Medical Center

Springfield, Massachusetts, United States

Location

New England Orthopedic Surgeons

Springfield, Massachusetts, United States

Location

St Francis Hospital

Greenville, South Carolina, United States

Location

Franciscan Neurosurgery Associates

Tacoma, Washington, United States

Location

MeSH Terms

Conditions

Intervertebral Disc Degeneration

Condition Hierarchy (Ancestors)

Spinal DiseasesBone DiseasesMusculoskeletal Diseases

Limitations and Caveats

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.

Results Point of Contact

Title
Clinical Affairs
Organization
Zimmer Biomet
tammy.stinson2@zimmerbiomet.com
303-501-8571

Study Officials

  • Robert J Jackson, MD

    Orange County Neurosurgical Associates

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 1, 2014

First Posted

April 4, 2014

Study Start

September 1, 2013

Primary Completion

April 1, 2015

Study Completion

June 1, 2015

Last Updated

April 16, 2019

Results First Posted

April 16, 2019

Record last verified: 2019-01

Locations

US(7)