Degenerative Disc Disease (DDD), Lower Back Pain
Conditions
Keywords
Back pain, Spinal fusion, Degenerative disc disease (DDD), Lower back pain, Fusion
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.
Interventions
DEVICESpinal 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
Sponsors
Benvenue Medical, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Improvement in Oswestry Disability Index (ODI) score from baseline | 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 |
| 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 |
Secondary
| Measure | Time frame |
|---|---|
| Rate of device-related serious adverse events | 12 Month Post-op |
| Proportion of subjects with radiographic fusion of target segments | 12 Month Post-op |
| Improvement from baseline in quality of life as measured by SF-36 | 12 Month Post-op |
Countries
Belgium, Germany
Outcome results
None listed