Luna Interbody System for Fusion Trial (LIFT)

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.

Study Overview

• Status: Unknown
• Conditions: Lower Back Pain; Degenerative Disc Disease (DDD)
• Intervention / Treatment: Device: Spinal fusion

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Bruxelles, Belgium, 1070
    • Hopital Erasme
  • Bruxelles, Belgium, 1040
    • Clinique du Parc Leopold
  • Liege, Belgium
    • CHC Liège
• Germany
  • Bonn, Germany, 53105
    • Universitatsklinikum Bonn
  • Zwickau, Germany, 08008
    • Paracelsus Kliniken

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Improvement from baseline in quality of life as measured by SF-36	12 Month Post-op
Rate of device-related serious adverse events	12 Month Post-op
Proportion of subjects with radiographic fusion of target segments	12 Month Post-op

Collaborators and Investigators

• Sponsor: Benvenue Medical, Inc.
• Investigators: Principal Investigator: Alphonse Lubansu, M.D., Hopital Erasme

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Anticipated): December 1, 2014
• Study Completion (Anticipated): December 1, 2014

Study Registration Dates

• First Submitted: February 2, 2012
• First Submitted That Met QC Criteria: March 9, 2012
• First Posted (Estimate): March 13, 2012

Study Record Updates

• Last Update Posted (Estimate): September 19, 2014
• Last Update Submitted That Met QC Criteria: September 18, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Back pain; Lower back pain; Fusion; Spinal fusion; Degenerative disc disease (DDD)
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Back Pain; Low Back Pain; Intervertebral Disc Degeneration
• Other Study ID Numbers: BEN 007