Luna Interbody System for Fusion Trial (LIFT)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Benvenue Medical, Inc.
ClinicalTrials.gov Identifier:
NCT01551901
First received: February 2, 2012
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

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 Intervention
Lower Back Pain
Degenerative Disc Disease (DDD)
Device: Spinal fusion

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: LIFT: Luna Interbody System for Fusion Trial

Resource links provided by NLM:


Further study details as provided by Benvenue Medical, Inc.:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]
  • Improvement in pain score on the Visual Analog Scale (VAS) from baseline [ Time Frame: 12 Month Post-op ] [ Designated as safety issue: No ]
  • Maintenance or improvement of neurologic function related to the spine [ Time Frame: 12 Month Post-op ] [ Designated as safety issue: No ]
  • Proportion of subjects with lack of revision, removal, reoperation or use of additional supplemental fixation [ Time Frame: 12 Month Post-op ] [ Designated as safety issue: Yes ]
  • Improvement in Oswestry Disability Index (ODI) score from baseline [ Time Frame: 12 Month Post-op ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Improvement from baseline in quality of life as measured by SF-36 [ Time Frame: 12 Month Post-op ] [ Designated as safety issue: No ]
  • Rate of device-related serious adverse events [ Time Frame: 12 Month Post-op ] [ Designated as safety issue: Yes ]
  • Proportion of subjects with radiographic fusion of target segments [ Time Frame: 12 Month Post-op ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: January 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01551901

Locations
Belgium
Clinique du Parc Leopold
Bruxelles, Belgium, 1040
Hôpital Erasme
Bruxelles, Belgium, 1070
CHC Liege
Liege, Belgium
Germany
Universitatsklinikum Bonn
Bonn, Germany, 53105
Paracelsus Kliniken
Zwickau, Germany, 08008
Sponsors and Collaborators
Benvenue Medical, Inc.
Investigators
Principal Investigator: Alphonse Lubansu, M.D. Hôpital Erasme
  More Information

No publications provided

Responsible Party: Benvenue Medical, Inc.
ClinicalTrials.gov Identifier: NCT01551901     History of Changes
Other Study ID Numbers: BEN 007
Study First Received: February 2, 2012
Last Updated: March 14, 2014
Health Authority: Germany: Ethics Commission

Keywords provided by Benvenue Medical, Inc.:
Back pain
Spinal fusion
Degenerative disc disease (DDD)
Lower back pain
Fusion

Additional relevant MeSH terms:
Back Pain
Intervertebral Disc Degeneration
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 18, 2014