Degenerative Disc DiseaseNCT02104167

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

An observational study of Degenerative Disc Disease, run by LDR Spine USA at 7 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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. Read more about this study

Who is it for?: Ages 21 years and older
Conditions the study is for: Degenerative Disc Disease
What is being tested?: ROIC interbody cage with VerteBRIDGE plating
Type of treatment: Medical device
How many people: 110 participants
Where: 7 sitesUnited States
Study dates: Sep 2013to Jun 2015
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 21 years and older
All sexes
No healthy volunteers
Adult, Older adult

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

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

7 sites in 1 country.

City, postcode or hospital

7 sites in 1 country

United States7 sites

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

Other trials in United States

About this study

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

Conditions: Degenerative Disc Disease
Being tested: ROIC interbody cage with VerteBRIDGE plating
Keywords: DDD, degenerative disc disease, cervical spine, fusion rate
Medical subject headings: Intervertebral Disc Degeneration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

ROIC interbody cage with VerteBRIDGE platingDevice

Study groups in NCT02104167
Study group	Role	What they receive
Operated Subjects		ROIC interbody cage with VerteBRIDGE plating Receives: Device: ROIC interbody cage with VerteBRIDGE plating

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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
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.
Measured: 12 months (Last available visit) post surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2013Jun 2015

First posted4 Apr 2014 (estimated)
Study startSep 2013
Primary completionApr 2015
Study completionJun 2015

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Degenerative Disc DiseaseStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Other
Enrolment: 110 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02104167
Sponsor's protocol ID: ROIC100
Status last verified: Jan 2019
First submitted: 1 Apr 2014
Last updated: 16 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated device: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
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Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
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Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease

All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02104167
Acronym / sponsor ID: ROIC100
Conditions: Degenerative Disc Disease
Keywords: DDD, degenerative disc disease, cervical spine, fusion rate
Study type: Observational
Recruitment status: Completed
Enrolment: 110 participants (actual)
Lead sponsor: LDR Spine USAIndustry (pharma, biotech, devices)
Study start: Sep 2013
Primary completion: Apr 2015 (actual)
Study completion: Jun 2015 (actual)
First posted: 4 Apr 2014 (estimated)
Results: Posted 16 Apr 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Cohort
Time perspective: Other
Number of arms: 1

Arm	Type	Receives
Operated Subjects	–	Device: ROIC interbody cage with VerteBRIDGE platingROIC interbody cage with VerteBRIDGE plating

Who may qualify

Ages: 21 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
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

Key inclusion criteria (5 listed)

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

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
ROIC interbody cage with VerteBRIDGE plating	Device	Operated Subjects

Primary outcome

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.

1 secondary outcome

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

Results and safety

Results posted to the registry on 16 Apr 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Operated Subjects With ROI-C Device	110	110

Primary outcome: Percentage of Participants With Fusion

Time frame: 12 months or more after device implantation; mean follow up 20.7 months. Number. Unit: Percentage of Participants

Measure	Operated Subjects With ROI-C Device n = 110
Value	99.1

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Date of surgery through last follow up visit, mean of 20.7 months. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Operated Subjects With ROI-C Device	2 of 110 (1.8%)	42 of 110 (38.2%)	0 of 110

Limitations and caveats (from the sponsor): 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.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Degenerative Disc Disease

Not yet recruiting
CANLINK: Evaluation of the Intralink Intradiscal Device for Low Back Pain Due to Degenerative Disc Disease
Degenerative Disc Disease(DDD)
Active, not recruiting
Post Marketing Study of MagnetOs Easypack Putty Standalone Compared to Demineralized Bone Matrix or Fibers Mixed With Autograft in Patients Undergoing Posterolateral Lumbar Fusion
Degenerative Disc Disease, Spine Fusion
Not yet recruitingObservational study
Relationship Between Disability, Flexibility, Back Muscles, and Thoracolumbar Fascia in Patients With Lumbar Disc Degeneration
Intervertebral Disc Degeneration
Active, not recruiting
ASCEND: A Clinical Trial to Evaluate the Safety and Effectiveness of VIA Disc NP, a Supplement for Degenerated Intervertebral Discs
Degenerative Disc Disease, Disc Degeneration
Active, not recruiting
The Synergy Disc for the Treatment of 2 Level Cervical Degenerative Disc Disease Compared With Cervical Fusion Surgery
Cervical Degenerative Disc Disease

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Robert J Jackson, MD principal investigator

Orange County Neurosurgical Associates

7 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Degenerative Disc Disease, run by LDR Spine USA at 7 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With Fusion (time frame: 12 months or more after device implantation; mean follow up 20.7 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02104167.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2019.