Luna Interbody System for Fusion Trial

NCT ID: NCT01551901

Last Updated: 2014-09-19

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-01-31
• Study Completion Date: 2014-12-31

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.

Conditions

Lower Back Pain; Degenerative Disc Disease (DDD)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Luna Interbody System

Group Type: EXPERIMENTAL

Spinal fusion

Intervention Type: DEVICE

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

Interventions

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

Intervention Type: DEVICE

Other Intervention Names

Luna Interbody System

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benvenue Medical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alphonse Lubansu, M.D.

Role: PRINCIPAL_INVESTIGATOR

H.U.B Erasme

Locations

Clinique du Parc Leopold

Brussels, , Belgium

Hôpital Erasme

Brussels, , Belgium

CHC Liege

Liège, , Belgium

Universitatsklinikum Bonn

Bonn, , Germany

Paracelsus Kliniken

Zwickau, , Germany

Countries

Belgium; Germany

Other Identifiers

BEN 007

Identifier Type: -

Identifier Source: org_study_id