Overview

This trial is active, not recruiting.

Conditions lower back pain, degenerative disc disease (ddd)
Treatment spinal fusion
Sponsor Benvenue Medical, Inc.
Start date January 2012
End date April 2014
Trial size 100 participants
Trial identifier NCT01551901, BEN 007

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
spinal fusion Luna Interbody System
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

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

Secondary Outcomes

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

Eligibility Criteria

Male or female participants from 18 years up to 65 years old.

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

Additional Information

Official title LIFT: Luna Interbody System for Fusion Trial
Principal investigator Alphonse Lubansu, M.D.
Trial information was received from ClinicalTrials.gov and was last updated in March 2014.
Information provided to ClinicalTrials.gov by Benvenue Medical, Inc..