Degenerative Disc DiseaseNCT02068768

Multicenter Study of the Avenue L Interbody Spinal Fusion System Using VerteBRIDGE Plating and Posterior Fixation

An observational study of Degenerative Disc Disease, run by LDR Spine USA at 4 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Trial summary

The purpose of this prospective clinical study is to examine the short-term safety and efficacy of the Avenue®- L interbody Spinal Fusion System with VerteBRIDGE® plating to treat one and two level degenerative disc disease between L2 and S1 with a focus on fusion rate. 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?: Avenue® L Interbody Fusion System (LDR Spine)
Type of treatment: Medical device
How many people: 13 participants
Where: 4 sitesUnited States
Study dates: 15 Jul 2013to 23 Mar 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 the patient populations of the physicians participating in the study. The principal investigators include community physicians in private practice as well as physicians affiliated with academic institutions.

Who may be able to join

Subjects must be candidates for on-label use of the Avenue L device (have degenerative disc disease, use only at one or two contiguous levels, posterior fixation must be used, autograft must be used in the interbody cage)
Subject must be skeletally mature at the time of surgery, i.e. the subject must be at least 21 years of age at the time of surgery
Subject should have had a minimum of 6 months of non-operative treatment prior to surgery
The placement of the Avenue L device must be a primary surgery
Subject must be willing to sign the consent form and be able to return for all follow up visits.

Who cannot join

Subject must not have had prior surgery at the operative level(s)
Subject is known to have substance or alcohol addictions
Subject has lateral curvature of the spine (scoliosis, all types)
Subject is a prisoner
Subject is pregnant
Subject has an active infection or sepsis at the time of surgery
Subject has any neuromuscular disorder that would preclude accurate neurologic evaluations

Trial locations and contacts

4 sites in 1 country.

United States4 sites

Orthopedic Surgery
Atlanta, Georgia
Southern New York Neurosurgical Group
Johnson City, New York
Jersey Shore University Medical Center
Neptune City, New Jersey
Center for Spine and Orthopedics
Thornton, Colorado

Other trials in United States

About this study

Official title: A Prospective, Multicenter, Open Label Clinical Study of the Safety andEfficacy of the Avenue L Interbody Spinal Fusion System Using the VerteBRIDGE Plating System and Supplemental Posterior Fixation

Conditions: Degenerative Disc Disease
Being tested: Avenue® L Interbody Fusion System (LDR Spine)
Keywords: fusion, lateral interbody fusion system, lumbar spine, 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.

Avenue® L Interbody Fusion System (LDR Spine)Device
PEEK, intervertebral cage for interbody fusion of the lumbar spine

Study groups in NCT02068768
Study group	Role	What they receive
Operated Subjects		Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1 Receives: Device: Avenue® L Interbody Fusion System (LDR Spine)

What is being measured

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

Fusion Rate
Number of participants with fused disc space as measured radiographically
Measured: 12 months after device implantation

Secondary outcomes (2)

Mean Oswestry Disability Index (ODI)
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. Each question is scored on a scale of 0-5 with the first statement being zero and indicating the least amount of disability and the last statement is scored 5 indicating most severe disability.The scores for all questions answered are summed, then multiplied by two to obtain the index (range 0 to 100). Zero is equated with no disability and 100 is the maximum disability possible.
Measured: preop, 3 mo, 6 mo, 12 mo post op
Visual Analog Scale (VAS) of Back Pain
The pain VAS is a continuous scale comprised of a horizontal line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme of either "no pain" or "worst imaginable pain". The pain VAS is self-completed by the respondent. The respondent is asked to place a line perpendicular to the VAS line at the point that represents their pain intensity. The score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100.
Measured: preop, 3 mo, 6 mo, 12 mo

Timeline

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

15 Jul 201323 Mar 2016

First posted21 Feb 2014 (estimated)
Study start15 Jul 2013
Primary completion9 Mar 2016
Study completion23 Mar 2016

Why it stopped: Poor enrollment

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: Prospective
Enrolment: 13 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02068768
Sponsor's protocol ID: AveL100
Status last verified: Apr 2019
First submitted: 19 Feb 2014
Last updated: 5 Jul 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: 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?

See locations

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
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
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
RecruitingObservational study
OssDsign® Spine Registry Study ("Propel")
Degenerative Disc Disease, Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar Degenerative Disc Disease

All Degenerative Disc Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 5 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Prospective, Multicenter, Open Label Clinical Study of the Safety andEfficacy of the Avenue L Interbody Spinal Fusion System Using the VerteBRIDGE Plating System and Supplemental Posterior Fixation
ClinicalTrials.gov ID: NCT02068768
Acronym / sponsor ID: AveL100
Conditions: Degenerative Disc Disease
Keywords: fusion, lateral interbody fusion system, lumbar spine, degenerative disc disease
Study type: Observational
Recruitment status: TerminatedReason stopped: Poor enrollment
Enrolment: 13 participants (actual)
Lead sponsor: LDR Spine USAIndustry (pharma, biotech, devices)
Study start: 15 Jul 2013 (actual)
Primary completion: 9 Mar 2016 (actual)
Study completion: 23 Mar 2016 (actual)
First posted: 21 Feb 2014 (estimated)
Results: Posted 5 Jul 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: Prospective
Number of arms: 1

Arm	Type	Receives
Operated Subjects	–	Device: Avenue® L Interbody Fusion System (LDR Spine)Subjects scheduled to receive an Avenue® L Interbody Fusion System (LDR Spine) for fusion of the lumbar spine from L2-S1

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 the patient populations of the physicians participating in the study. The principal investigators include community physicians in private practice as well as physicians affiliated with academic institutions.

Key inclusion criteria (5 listed)

Subjects must be candidates for on-label use of the Avenue L device (have degenerative disc disease, use only at one or two contiguous levels, posterior fixation must be used, autograft must be used in the interbody cage)
Subject must be skeletally mature at the time of surgery, i.e. the subject must be at least 21 years of age at the time of surgery
Subject should have had a minimum of 6 months of non-operative treatment prior to surgery
The placement of the Avenue L device must be a primary surgery
Subject must be willing to sign the consent form and be able to return for all follow up visits.

Key exclusion criteria (7 listed)

Subject must not have had prior surgery at the operative level(s)
Subject is known to have substance or alcohol addictions
Subject has lateral curvature of the spine (scoliosis, all types)
Subject is a prisoner
Subject is pregnant

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
Avenue® L Interbody Fusion System (LDR Spine)PEEK, intervertebral cage for interbody fusion of the lumbar spine	Device	Operated Subjects

Primary outcome

Fusion Rate
Time frame: 12 months after device implantation
Number of participants with fused disc space as measured radiographically

2 secondary outcomes

Mean Oswestry Disability Index (ODI)
Time frame: preop, 3 mo, 6 mo, 12 mo post op
Visual Analog Scale (VAS) of Back Pain
Time frame: preop, 3 mo, 6 mo, 12 mo

Results and safety

Results posted to the registry on 5 Jul 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	13	6

Primary outcome: Fusion Rate

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

Measure	Operated Subjects n = 3
Value	3

Population analysed: Poor enrollment led to early termination and low number of participants available for analysis. Data were available for 13 participants preoperatively, 12 at 3 months, 8 at 6 months, and 6 at 12 months. Only 3 of 6 participants reaching 12 month follow up had radiographs available for analysis.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: From time of surgery through 12 months post op. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Operated Subjects	0 of 13 (0%)	6 of 13 (46.2%)	0 of 13

Limitations and caveats (from the sponsor): Poor enrollment led to early termination and low number of participants available for analysis

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Jul 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Degenerative Disc Disease

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
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
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
RecruitingObservational study
OssDsign® Spine Registry Study ("Propel")
Degenerative Disc Disease, Spinal Stenosis
Not yet recruiting
Kore Fiber PLF Study
Degenerative Lumbar Spine Diseases, Lumbar 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.

4 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 4 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 7 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: stopped early, as of the sponsor's last update on 5 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 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 5 Jul 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?

Fusion Rate (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 NCT02068768.

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 5 Jul 2019.