Luna Interbody System for Fusion Trial

Lower Back Pain Clinical Trial

— LIFT  

Official title:

LIFT: Luna Interbody System for Fusion Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01551901
• Other study ID #: BEN 007
• 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

Related Conditions & MeSH terms

• Back Pain
• Degenerative Disc Disease (DDD)
• Intervertebral Disc Degeneration
• Low Back Pain
• Lower Back Pain

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