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Luna Interbody System for Fusion Trial (LIFT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01551901
Recruitment Status : Unknown
Verified September 2014 by Benvenue Medical, Inc..
Recruitment status was:  Active, not recruiting
First Posted : March 13, 2012
Last Update Posted : September 19, 2014
Information provided by (Responsible Party):
Benvenue Medical, Inc.

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
Lower Back Pain Degenerative Disc Disease (DDD) Device: Spinal fusion Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : January 2012
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

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 Name: Luna Interbody System

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 [ Time Frame: 12 Month Post-op ]
  2. Improvement in pain score on the Visual Analog Scale (VAS) from baseline [ Time Frame: 12 Month Post-op ]
  3. Maintenance or improvement of neurologic function related to the spine [ Time Frame: 12 Month Post-op ]
  4. Proportion of subjects with lack of revision, removal, reoperation or use of additional supplemental fixation [ Time Frame: 12 Month Post-op ]
  5. Improvement in Oswestry Disability Index (ODI) score from baseline [ Time Frame: 12 Month Post-op ]

Secondary Outcome Measures :
  1. Improvement from baseline in quality of life as measured by SF-36 [ Time Frame: 12 Month Post-op ]
  2. Rate of device-related serious adverse events [ Time Frame: 12 Month Post-op ]
  3. Proportion of subjects with radiographic fusion of target segments [ Time Frame: 12 Month Post-op ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01551901

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Clinique du Parc Leopold
Bruxelles, Belgium, 1040
Hôpital Erasme
Bruxelles, Belgium, 1070
CHC Liege
Liege, Belgium
Universitatsklinikum Bonn
Bonn, Germany, 53105
Paracelsus Kliniken
Zwickau, Germany, 08008
Sponsors and Collaborators
Benvenue Medical, Inc.
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Principal Investigator: Alphonse Lubansu, M.D. Hôpital Erasme
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Responsible Party: Benvenue Medical, Inc. Identifier: NCT01551901    
Other Study ID Numbers: BEN 007
First Posted: March 13, 2012    Key Record Dates
Last Update Posted: September 19, 2014
Last Verified: September 2014
Keywords provided by Benvenue Medical, Inc.:
Back pain
Spinal fusion
Degenerative disc disease (DDD)
Lower back pain
Additional relevant MeSH terms:
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Intervertebral Disc Degeneration
Back Pain
Low Back Pain
Neurologic Manifestations
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases