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The purpose of this trial is to evaluate the performance, safety and effectiveness of the Luna system for the treatment of degenerative disc disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Luna Interbody System | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal fusion | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | |
| 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 | |
| Improvement in Oswestry Disability Index (ODI) score from baseline | 12 Month Post-op |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Alphonse Lubansu, M.D. | Erasme University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique du Parc Leopold | Brussels | 1040 | Belgium | |||
| Hôpital Erasme |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| D055959 | Intervertebral Disc Degeneration |
| D001416 | Back Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D013123 | Spinal Fusion |
| ID | Term |
|---|---|
| D001174 | Arthrodesis |
| D019637 | Orthopedic Procedures |
| D013514 | Surgical Procedures, Operative |
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|
| 12 Month Post-op |
| Brussels |
| 1070 |
| Belgium |
| CHC Liege | Liège | Belgium |
| Universitatsklinikum Bonn | Bonn | 53105 | Germany |
| Paracelsus Kliniken | Zwickau | 08008 | Germany |
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |