Clinical trial NCT01551901: Luna Interbody System for Fusion Trial
Official title: LIFT: Luna Interbody System for Fusion Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Lower Back Pain
Degenerative Disc Disease (DDD)
Keywords: Back pain
Spinal fusion
Degenerative disc disease (DDD)
Lower back pain
Fusion
Lead sponsor: Benvenue Medical, Inc.
Sponsor class: INDUSTRY
First posted: 2012-03-13
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Proportion of subjects with device in place showing lack of device migration or subsidence and absence of device related serious adverse event
timeFrame: 12 Month Post-op
measure: Improvement in pain score on the Visual Analog Scale (VAS) from baseline
timeFrame: 12 Month Post-op
measure: Maintenance or improvement of neurologic function related to the spine
timeFrame: 12 Month Post-op
measure: Proportion of subjects with lack of revision, removal, reoperation or use of additional supplemental fixation
timeFrame: 12 Month Post-op
measure: Improvement in Oswestry Disability Index (ODI) score from baseline
timeFrame: 12 Month Post-op
Secondary outcomes:
measure: Improvement from baseline in quality of life as measured by SF-36
timeFrame: 12 Month Post-op
measure: Rate of device-related serious adverse events
timeFrame: 12 Month Post-op
measure: Proportion of subjects with radiographic fusion of target segments
timeFrame: 12 Month Post-op
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Clinique du Parc Leopold
city: Bruxelles
country: Belgium
facility: Hôpital Erasme
city: Liege
country: Belgium
facility: CHC Liege
city: Bonn
country: Germany
facility: Universitatsklinikum Bonn
city: Zwickau
country: Germany
facility: Paracelsus Kliniken
Study officials:
affiliation: Hôpital Erasme
name: Alphonse Lubansu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: