NCT01551901UnknownNot Applicable
LIFT: Luna Interbody System for Fusion Trial
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Benvenue Medical, Inc.
- Enrollment
- 100
- Locations
- 9
- Primary Endpoint
- Maintenance or improvement of neurologic function related to the spine
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
Maintenance or improvement of neurologic function related to the spine
Time Frame: 12 Month Post-op
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
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
Secondary Outcomes
- 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)
Investigators
Study Sites (9)
Loading locations...
Similar Trials
Recruiting
Not Applicable
Extended One-level Interbody Fusion for Adjacent Vacuum Phenomenon in Lumbar Degenerative Disc DiseaseAdjacent Segment DegenerationNCT06029764Xuanwu Hospital, Beijing126
Completed
Not Applicable
OptiMesh® for Lumbar Interbody Fusion Trial (OLIF)Degeneration of Lumbar Intervertebral DiscNCT00764491Spineology, Inc156
Completed
Not Applicable
A Trial of the May Health Device in Transvaginal Ablation of Ovarian Tissue Under ULTRAsound Visualization in Women With PCOS InfertilityPolycystic Ovary SyndromeNCT03760926May Health28
Unknown
Not Applicable
Surefire Institutional DEB-TACEHepatocellular CarcinomaNCT03211598Alexander Kim15
Active, not recruiting
Not Applicable
Adaptix RCT Evaluating Adaptix™ Versus PEEK CagesSpinal Canal StenosisOsteophyteBony Growth FormationSpondylolisthesisDegenerative Disc DiseaseNCT05182489Ohio State University100