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LIFT: Luna Interbody System for Fusion Trial

Sponsor
Benvenue Medical, Inc. (Industry)
Overall Status
Unknown status
CT.gov ID
NCT01551901
Collaborator
(none)
100
Enrollment
5
Locations
1
Arm
35
Duration (Months)
20
Patients Per Site
0.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase
  • Device: Spinal fusion
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
100 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
LIFT: Luna Interbody System for Fusion Trial
Study Start Date :
Jan 1, 2012
Anticipated Primary Completion Date :
Dec 1, 2014
Anticipated Study Completion Date :
Dec 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Luna Interbody System

Device: Spinal fusion
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
Other Names:
  • Luna Interbody System

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Proportion of subjects with device in place showing lack of device migration or subsidence and absence of device related serious adverse event [12 Month Post-op]

    2. Improvement in pain score on the Visual Analog Scale (VAS) from baseline [12 Month Post-op]

    3. Maintenance or improvement of neurologic function related to the spine [12 Month Post-op]

    4. Proportion of subjects with lack of revision, removal, reoperation or use of additional supplemental fixation [12 Month Post-op]

    5. Improvement in Oswestry Disability Index (ODI) score from baseline [12 Month Post-op]

    Secondary Outcome Measures

    1. Improvement from baseline in quality of life as measured by SF-36 [12 Month Post-op]

    2. Rate of device-related serious adverse events [12 Month Post-op]

    3. Proportion of subjects with radiographic fusion of target segments [12 Month Post-op]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 65 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    1. Age 18 - 65 at the time of consent

    2. Patient has back pain consistent with symptomatic degenerative disc disease at one level or two contiguous levels from L2-S1 requiring surgical intervention.

    3. Patient has had at least 6 months of non-operative care

    4. Patient is mentally capable and willing to sign a study-specific informed consent form

    5. Patient is willing and able to comply with all study requirements

    6. Patient has a score on the back pain visual analog scale (VAS) of ≥ 40 mm

    7. Patient has an Oswestry Disability Index (ODI) score of ≥ 30%

    Exclusion Criteria:

    1. DDD affecting >2 levels

    2. Back pain due to causes other than DDD

    3. Spine surgery within last 3 months or planned spine surgery within 6 weeks of post study procedure

    4. Grade 1 spondylolisthesis or retrolisthesis

    5. Infection at or close to target disc level

    6. Active systemic infection

    7. Patient has known osteoporosis

    8. Prior interbody fusion at the target level

    9. Prior failed interbody fusion at any level

    10. Known allergy to device materials

    11. Uncontrolled psychiatric illness or severe dementia

    12. Pregnant at time of enrollment or considering getting pregnant during study period

    13. Any metabolic or other bone disease that could significantly compromise pedicle screw and/or interbody device placement.

    14. Any severe illness that would prevent complete study participation

    15. Uncontrolled diabetes

    16. Current use of chronic steroids (more than equivalent of 10 mg prednisone daily)

    17. Contraindication to spinal surgery or general anesthesia

    18. Coagulopathy

    19. Body mass index >35

    20. Current smoker

    21. Known illicit substance abuser

    22. Currently participating in another investigational study that could affect responses to the study device

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Clinique du Parc Leopold Bruxelles Belgium 1040
    2 Hôpital Erasme Bruxelles Belgium 1070
    3 CHC Liege Liege Belgium
    4 Universitatsklinikum Bonn Bonn Germany 53105
    5 Paracelsus Kliniken Zwickau Germany 08008

    Sponsors and Collaborators

    • Benvenue Medical, Inc.

    Investigators

    • Principal Investigator: Alphonse Lubansu, M.D., Hôpital Erasme

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Benvenue Medical, Inc.
    ClinicalTrials.gov Identifier:
    NCT01551901
    Other Study ID Numbers:
    • BEN 007
    First Posted:
    Mar 13, 2012
    Last Update Posted:
    Sep 19, 2014
    Last Verified:
    Sep 1, 2014
    Keywords provided by Benvenue Medical, Inc.
    Back pain
    Spinal fusion
    Degenerative disc disease (DDD)
    Lower back pain
    Fusion
    Additional relevant MeSH terms:
    Intervertebral Disc Degeneration
    Back Pain
    Low Back Pain

    Study Results

    No Results Posted as of Sep 19, 2014