The purpose of this trial is to evaluate the performance, safety and effectiveness of the Luna system for the treatment of degenerative disc disease.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
100
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
Clinique du Parc Leopold
Brussels, Belgium
Hôpital Erasme
Brussels, Belgium
CHC Liege
Liège, Belgium
Universitatsklinikum Bonn
Bonn, Germany
Paracelsus Kliniken
Zwickau, Germany
Proportion of subjects with device in place showing lack of device migration or subsidence and absence of device related serious adverse event
Time frame: 12 Month Post-op
Improvement in pain score on the Visual Analog Scale (VAS) from baseline
Time frame: 12 Month Post-op
Maintenance or improvement of neurologic function related to the spine
Time frame: 12 Month Post-op
Proportion of subjects with lack of revision, removal, reoperation or use of additional supplemental fixation
Time frame: 12 Month Post-op
Improvement in Oswestry Disability Index (ODI) score from baseline
Time frame: 12 Month Post-op
Improvement from baseline in quality of life as measured by SF-36
Time frame: 12 Month Post-op
Rate of device-related serious adverse events
Time frame: 12 Month Post-op
Proportion of subjects with radiographic fusion of target segments
Time frame: 12 Month Post-op
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