Luna Interbody System for Fusion Trial

Not Applicable

• Conditions: Degenerative Disc Disease (DDD); Lower Back Pain
• Interventions: Device: Spinal fusion

• Registration Number: NCT01551901
• Lead Sponsor: Benvenue Medical, Inc.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-02-02
• Study First Submitted QC: 2012-03-09
• Study First Posted: 2012-03-13
• Status Verified: 2014-09
• Last Update Submitted: 2014-09-18
• Last Update Posted: 2014-09-19
• Primary Completion: 2014-12
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Luna Interbody System	Spinal fusion	-

Primary Outcome Measures

Name	Time	Method
Maintenance or improvement of neurologic function related to the spine	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
Improvement in pain score on the Visual Analog Scale (VAS) from baseline	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

Name	Time	Method
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

Trial Locations

Locations (5)

Universitatsklinikum Bonn; 🇩🇪 Bonn, Germany

Paracelsus Kliniken; 🇩🇪 Zwickau, Germany

Hôpital Erasme; 🇧🇪 Bruxelles, Belgium

Clinique du Parc Leopold; 🇧🇪 Bruxelles, Belgium

CHC Liege; 🇧🇪 Liege, Belgium