Luna Interbody System for Fusion Trial

Study Overview
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Brief Summary
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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.

Official Title
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LIFT: Luna Interbody System for Fusion Trial

Conditions
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Lower Back Pain, Degenerative Disc Disease (DDD)

Intervention / Treatment
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* Device: Spinal fusion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 - 65 at the time of consent Patient has back pain consistent with symptomatic degenerative disc disease at one level or two contiguous levels from L2-S1 requiring surgical intervention. Patient has had at least 6 months of non-operative care Patient is mentally capable and willing to sign a study-specific informed consent form Patient is willing and able to comply with all study requirements Patient has a score on the back pain visual analog scale (VAS) of ≥ 40 mm Patient has an Oswestry Disability Index (ODI) score of ≥ 30% Exclusion Criteria: DDD affecting >2 levels Back pain due to causes other than DDD Spine surgery within last 3 months or planned spine surgery within 6 weeks of post study procedure >Grade 1 spondylolisthesis or retrolisthesis Infection at or close to target disc level Active systemic infection Patient has known osteoporosis Prior interbody fusion at the target level Prior failed interbody fusion at any level Known allergy to device materials Uncontrolled psychiatric illness or severe dementia Pregnant at time of enrollment or considering getting pregnant during study period Any metabolic or other bone disease that could significantly compromise pedicle screw and/or interbody device placement. Any severe illness that would prevent complete study participation Uncontrolled diabetes Current use of chronic steroids (more than equivalent of 10 mg prednisone daily) Contraindication to spinal surgery or general anesthesia Coagulopathy Body mass index >35 Current smoker Known illicit substance abuser Currently participating in another investigational study that could affect responses to the study device

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Luna Interbody System<br> | Device: Spinal fusion<br>* 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<br>* Other names: Luna Interbody System;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |  | 12 Month Post-op | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Back pain, Spinal fusion, Degenerative disc disease (DDD), Lower back pain, Fusion