Degenerative Disc DiseaseNCT02104141

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

An observational study of Degenerative Disc Disease, run by LDR Spine USA.

Completed

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

Trial summary

The purpose of this combination retrospective and prospective post market study is to examine the short term safety and efficacy of the ROI-A® interbody fusion device with VerteBRIDGE® plates to treat single and two-level degenerative disc disease between L2 and S1, with a focus on fusion rates and patient outcomes. 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?: ROIA Interbody Cage with VerteBRIDGE plating
Type of treatment: Medical device
How many people: 51 participants
Where: No sites listed yet
Study dates: Nov 2013to Dec 2016
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

Subjects must have degenerative disc disease (DDD) of the lumbar spine between L2 and S1
Subjects may have up to a Grade 1 spondylolisthesis at the involved level(s)
Subject must have the ROI-A® device at one level or at two contiguous levels between L2 and S1 only
Subject should have had a minimum of 6 months non-surgical treatment prior to receiving the ROI-A® device
Subject may have had NO MORE THAN two previous non-fusion surgeries to the lumbar spine at the same levels as the ROI-A®
Subject must be at least 21 years of age at the time of surgery
Subject must be willing to signed an informed consent document and return for a 12 month visit

Who cannot join

Subject had more than Grade 1 spondylolisthesis at the operated level
Subject is a prisoner.
Subject was pregnant at the time of surgery.
Subject had an active infection or sepsis at the time of surgery.

About this study

Official title: An Open Label, Multicenter, Clinical Study of the Safety and Efficacy of the LDR Spine ROI-A Interbody Fusion System Using the VerteBRIDGE™ Plating System

Conditions: Degenerative Disc Disease
Being tested: ROIA Interbody Cage with VerteBRIDGE plating
Keywords: DDD, lumbar spine, fusion rate, degenerative disc disease
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.

ROIA Interbody Cage with VerteBRIDGE platingDevice

Study groups in NCT02104141
Study group	Role	What they receive
Operated Subjects		ROIA Interbody Cage with VerteBRIDGE plating Receives: Device: ROIA Interbody Cage with VerteBRIDGE plating

What is being measured

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

Number of Participants With Fusion
Fusion was assessed utilizing both AP and flexion/extension radiographs. Fusion was noted when all three of the criteria were present: 1) presence of bridging bone as identified by radiography, 2)Less than 5 degrees of segmental motion on flexion/extension radiographs, and 3) Less than 3 mm of A/P translation on flexion/extension radiographs
Measured: 12 months after device implantation

Secondary outcomes (1)

Mean Oswestry Disability Index
The Oswestry Disability Index (ODI) is and index to quantify disability for low back pain. There are 50 possible points which are multiplied by 2 to arrive at a percentage score. Zero is equated with no disability and 100 is the maximum disability possible
Measured: 12 months after device implantation

Timeline

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

Nov 2013Dec 2016

First posted4 Apr 2014 (estimated)
Study startNov 2013
Primary completionApr 2016
Study completionDec 2016

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: 51 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02104141
Sponsor's protocol ID: ROIA100
Status last verified: Apr 2019
First submitted: 1 Apr 2014
Last updated: 24 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

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?

Official record

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

All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Multicenter, Clinical Study of the Safety and Efficacy of the LDR Spine ROI-A Interbody Fusion System Using the VerteBRIDGE™ Plating System
ClinicalTrials.gov ID: NCT02104141
Acronym / sponsor ID: ROIA100
Conditions: Degenerative Disc Disease
Keywords: DDD, lumbar spine, fusion rate, degenerative disc disease
Study type: Observational
Recruitment status: Completed
Enrolment: 51 participants (actual)
Lead sponsor: LDR Spine USAIndustry (pharma, biotech, devices)
Study start: Nov 2013
Primary completion: Apr 2016 (actual)
Study completion: Dec 2016 (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: ROIA Interbody Cage with VerteBRIDGE platingROIA 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 (7 listed)

Subjects must have degenerative disc disease (DDD) of the lumbar spine between L2 and S1
Subjects may have up to a Grade 1 spondylolisthesis at the involved level(s)
Subject must have the ROI-A® device at one level or at two contiguous levels between L2 and S1 only
Subject should have had a minimum of 6 months non-surgical treatment prior to receiving the ROI-A® device
Subject may have had NO MORE THAN two previous non-fusion surgeries to the lumbar spine at the same levels as the ROI-A®

Key exclusion criteria (4 listed)

Subject had more than Grade 1 spondylolisthesis at the operated level
Subject is a prisoner.
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
ROIA Interbody Cage with VerteBRIDGE plating	Device	Operated Subjects

Primary outcome

Number of Participants With Fusion
Time frame: 12 months after device implantation
Fusion was assessed utilizing both AP and flexion/extension radiographs. Fusion was noted when all three of the criteria were present: 1) presence of bridging bone as identified by radiography, 2)Less than 5 degrees of segmental motion on flexion/extension radiographs, and 3) Less than 3 mm of A/P translation on flexion/extension radiographs

1 secondary outcome

Mean Oswestry Disability Index
Time frame: 12 months after device implantation

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	51	51

Primary outcome: Number of Participants With Fusion

Time frame: 12 months after device implantation. Count of participants. Unit: Participants

Measure	Operated Subjects n = 51
Value	50

1 secondary outcome is reported in the full results.

Adverse events

Time frame: From enrollment through final follow up (12 month) visit. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Operated Subjects	0 of 51 (0%)	5 of 51 (9.8%)	0 of 51

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

An observational study of Degenerative Disc Disease, run by LDR Spine USA.

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 7 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 24 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.

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?

Number of Participants With Fusion (time frame: 12 months after device implantation). 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 NCT02104141.

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 24 Apr 2019.