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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01551901
Other study ID # BEN 007
Secondary ID
Status Active, not recruiting
Phase N/A
First received February 2, 2012
Last updated September 18, 2014
Start date January 2012
Est. completion date December 2014

Study information

Verified date September 2014
Source Benvenue Medical, Inc.
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 100
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 65 Years
Eligibility 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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

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

Locations

Country Name City State
Belgium Clinique du Parc Leopold Bruxelles
Belgium Hôpital Erasme Bruxelles
Belgium CHC Liege Liege
Germany Universitatsklinikum Bonn Bonn
Germany Paracelsus Kliniken Zwickau

Sponsors (1)

Lead Sponsor Collaborator
Benvenue Medical, Inc.

Countries where clinical trial is conducted

Belgium,  Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Primary Improvement in pain score on the Visual Analog Scale (VAS) from baseline 12 Month Post-op No
Primary Maintenance or improvement of neurologic function related to the spine 12 Month Post-op No
Primary Proportion of subjects with lack of revision, removal, reoperation or use of additional supplemental fixation 12 Month Post-op Yes
Primary Improvement in Oswestry Disability Index (ODI) score from baseline 12 Month Post-op No
Secondary Improvement from baseline in quality of life as measured by SF-36 12 Month Post-op No
Secondary Rate of device-related serious adverse events 12 Month Post-op Yes
Secondary Proportion of subjects with radiographic fusion of target segments 12 Month Post-op No
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