Lower Back PainLIFTNCT01551901
Luna Interbody System for Fusion Trial
A study testing Spinal fusion in people with Lower Back Pain and Degenerative Disc Disease (DDD), run by Benvenue Medical, Inc. at 5 sites in 2 countries.
Trial summary
The purpose of this trial is to evaluate the performance, safety and effectiveness of the Luna system for the treatment of degenerative disc disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lower Back Pain, Degenerative Disc Disease (DDD)
- What is being tested?
- Spinal fusion
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 5 sitesin 2 countries
- Study dates
- Jan 2012to Dec 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 - 65 at the time of consent
- Patient has back pain consistent with symptomatic degenerative disc disease at one level or two contiguous levels from L2-S1 requiring surgical intervention.
- Patient has had at least 6 months of non-operative care
- Patient is mentally capable and willing to sign a study-specific informed consent form
- Patient is willing and able to comply with all study requirements
- Patient has a score on the back pain visual analog scale (VAS) of ≥ 40 mm
- Patient has an Oswestry Disability Index (ODI) score of ≥ 30%
Who cannot join
- DDD affecting >2 levels
- Back pain due to causes other than DDD
- Spine surgery within last 3 months or planned spine surgery within 6 weeks of post study procedure
- >Grade 1 spondylolisthesis or retrolisthesis
- Infection at or close to target disc level
- Active systemic infection
Show all 22Show fewer
- Patient has known osteoporosis
- Prior interbody fusion at the target level
- Prior failed interbody fusion at any level
- Known allergy to device materials
- Uncontrolled psychiatric illness or severe dementia
- Pregnant at time of enrollment or considering getting pregnant during study period
- Any metabolic or other bone disease that could significantly compromise pedicle screw and/or interbody device placement.
- Any severe illness that would prevent complete study participation
- Uncontrolled diabetes
- Current use of chronic steroids (more than equivalent of 10 mg prednisone daily)
- Contraindication to spinal surgery or general anesthesia
- Coagulopathy
- Body mass index >35
- Current smoker
- Known illicit substance abuser
- Currently participating in another investigational study that could affect responses to the study device
Trial locations and contacts
5 sites in 2 countries.
5 sites in 2 countries
Belgium3 sites
Clinique du Parc Leopold
Brussels, 1040
Hôpital Erasme
Brussels, 1070
CHC Liege
Liège
Germany2 sites
Universitatsklinikum Bonn
Bonn, 53105
Paracelsus Kliniken
Zwickau, 08008
About this study
Official title: LIFT: Luna Interbody System for Fusion Trial
The purpose of this trial is to evaluate the performance, safety and effectiveness of the Luna system for the treatment of degenerative disc disease.
- Conditions
- Lower Back Pain, Degenerative Disc Disease (DDD)
- Being tested
- Spinal fusion
- Keywords
- Back pain, Spinal fusion, Degenerative disc disease (DDD), Lower back pain, Fusion
- Medical subject headings
- Low Back Pain, Intervertebral Disc Degeneration, Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal fusionDevice
Also called Luna Interbody System
Spinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to grade 1 spondylolisthesis
| Study group | Role | What they receive |
|---|---|---|
| Luna Interbody System | Experimental | Not described Receives: Device: Spinal fusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of subjects with device in place showing lack of device migration or subsidence and absence of device related serious adverse event
Measured: 12 Month Post-op
Improvement in pain score on the Visual Analog Scale (VAS) from baseline
Measured: 12 Month Post-op
Maintenance or improvement of neurologic function related to the spine
Measured: 12 Month Post-op
Proportion of subjects with lack of revision, removal, reoperation or use of additional supplemental fixation
Measured: 12 Month Post-op
Improvement in Oswestry Disability Index (ODI) score from baseline
Measured: 12 Month Post-op
Secondary outcomes (3)
Improvement from baseline in quality of life as measured by SF-36
Measured: 12 Month Post-op
Rate of device-related serious adverse events
Measured: 12 Month Post-op
Proportion of subjects with radiographic fusion of target segments
Measured: 12 Month Post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2012 (estimated)
- Study startJan 2012
- Primary completionDec 2014 (estimated)
- Study completionDec 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lower Back PainStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Benvenue Medical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alphonse Lubansu, M.D., Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01551901
- Sponsor's protocol ID
- BEN 007
- Acronym
- LIFT
- Status last verified
- Sep 2014
- First submitted
- 2 Feb 2012
- Last updated
- 19 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- LIFT: Luna Interbody System for Fusion Trial
- ClinicalTrials.gov ID
- NCT01551901
- Acronym / sponsor ID
- LIFT / BEN 007
- Conditions
- Lower Back Pain, Degenerative Disc Disease (DDD)
- Keywords
- Back pain, Spinal fusion, Degenerative disc disease (DDD), Lower back pain, Fusion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Benvenue Medical, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2012
- Primary completion
- Dec 2014 (estimated)
- Study completion
- Dec 2014 (estimated)
- First posted
- 13 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this trial is to evaluate the performance, safety and effectiveness of the Luna system for the treatment of degenerative disc disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Luna Interbody System | Experimental | Device: Spinal fusion |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 - 65 at the time of consent
- Patient has back pain consistent with symptomatic degenerative disc disease at one level or two contiguous levels from L2-S1 requiring surgical intervention.
- Patient has had at least 6 months of non-operative care
- Patient is mentally capable and willing to sign a study-specific informed consent form
- Patient is willing and able to comply with all study requirements
Key exclusion criteria (22 listed)
- DDD affecting >2 levels
- Back pain due to causes other than DDD
- Spine surgery within last 3 months or planned spine surgery within 6 weeks of post study procedure
- >Grade 1 spondylolisthesis or retrolisthesis
- Infection at or close to target disc level
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 |
|---|---|---|
| Spinal fusionAlso: Luna Interbody SystemSpinal fusion procedures in skeletally mature patients with symptomatic degenerative disc disease (DDD) at one or two contiguous levels from L2-S1 with up to grade 1 spondylolisthesis | Device | Luna Interbody System |
Primary outcome
Proportion of subjects with device in place showing lack of device migration or subsidence and absence of device related serious adverse event
Time frame: 12 Month Post-op
Improvement in pain score on the Visual Analog Scale (VAS) from baseline
Time frame: 12 Month Post-op
Maintenance or improvement of neurologic function related to the spine
Time frame: 12 Month Post-op
Proportion of subjects with lack of revision, removal, reoperation or use of additional supplemental fixation
Time frame: 12 Month Post-op
Improvement in Oswestry Disability Index (ODI) score from baseline
Time frame: 12 Month Post-op
3 secondary outcomes
Improvement from baseline in quality of life as measured by SF-36
Time frame: 12 Month Post-op
Rate of device-related serious adverse events
Time frame: 12 Month Post-op
Proportion of subjects with radiographic fusion of target segments
Time frame: 12 Month Post-op
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2014.
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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.
Alphonse Lubansu, M.D. principal investigator
Erasme University Hospital
5 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal fusion in people with Lower Back Pain and Degenerative Disc Disease (DDD), run by Benvenue Medical, Inc. at 5 sites in 2 countries.
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 22 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: status not confirmed, as of the sponsor's last update on 19 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium, Germany. 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?
Results are not available in the source record.
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?
Proportion of subjects with device in place showing lack of device migration or subsidence and absence of device related serious adverse event (time frame: 12 Month Post-op). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Sep 2014.