INDEPENDENCE Spacer for Lumbar Fusion

Study Overview
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Brief Summary
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The primary objective of this study is to evaluate radiographic outcomes, intra-operative parameters, clinical outcomes, and patient satisfaction following circumferential fusion using the INDEPENDENCE® integrated plate and spacer with REVOLVE® Stabilization System for the treatment of severe low back pain due to lumbar disc degeneration unresponsive to 6 months of non-operative treatment.

Detailed Description
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A total of thirty subjects will be enrolled at Scott & White Healthcare. The INDEPENDENCE spacer will be filled with autogenous bone graft material. The devices subject to this Agreement have received 510(k) clearance from the FDA for the indications specified in this Agreement. Patients will be followed for 2 years with evaluations at the following time intervals: preoperatively (within 2 months of surgery) and postoperatively at 6 weeks, 3 months, 6 months, 12 months, and 24 months.

Official Title
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Circumferential Lumbar Spinal Fusion for Treatment of Degenerative Disc Disease: A Prospective, Non-Randomized Clinical Study

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Device: INDEPENDENCE


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Objective evidence of degenerative disc disease at 1 or 2 level(s) between L2 and S1 with degeneration confirmed by patient history and radiographic examination Experience pain, functional deficit and/or neurological deficit for a minimum of six months Unresponsiveness to documented non-surgical treatment modalities for a minimum of six months and/or presentation with progressive symptoms of nerve root or spinal cord compression prior to enrollment At least 18 years of age and maximum 65 years of age Ability to provide Informed Consent for study participation and to return for all follow-up visits Exclusion Criteria: • Presence of systemic or localized infection at the site of surgery More than 2 levels to be instrumented Previous fusion attempt at the involved level(s) More than three previous open, posterior, lumbar spinal surgical procedures at the involved level(s) Trauma at the level(s) to be fused More than grade 1 spondylolisthesis Previous documentation of osteopenia, osteoporosis, or osteomalacia to a degree that spinal instrumentation would be contraindicated Diagnosis of a condition or requires postoperative medication(s), which may interfere with bony/soft tissue healing Presence of a disease entity or condition which totally precludes possibility of bony fusion (e.g. metastatic cancer, HIV, long term use of steroids, etc.) Immunosuppressive disorder Pregnant or interested in becoming pregnant during the duration of the study History of substance abuse (drugs or alcohol) Any known allergy to a metal alloy Mentally incompetent or prisoner Currently a participant in another study

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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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: INDEPENDENCE|Lumbar Integrated plate and spacer, with percutaneous screws and rods.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic fusion evaluation | Anterior Posterior / Lateral, Flexion-Extension X-rays at every timepoint will be evaluated for signs of fusion, pseudoarthrosis and implant subsidence or migration | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Self- Assessment for pain scores | VAS questionnaires to be completed at every follow-up timepoint | 2 years | 
| Patient Satisfaction | Questionnaire to be completed at every follow-up timepoint | 2 years |