Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion System in patients undergoing lumbar fusion surgery.

Detailed Description
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All subjects enrolled in this study will receive the The Biomet Osteobiologic Treatment System which is comprised of the SpF® Spine Fusion Stimulator and any or all of the following can be utilized in the study: any Pedicle Screw System, autograft and an Interbody Spacer

Official Title
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A Prospective Multicenter Lumbar Spine Fusion Study to Evaluate the Effectiveness of the Biomet Lumbar Spinal Fusion System

Conditions
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Degenerative Disc Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: The subject must, in the investigator's opinion, be psychosocially, mentally, and physically able to fully comply with this protocol including the required follow-up visits, the filling out of required forms, and have the ability to understand and give written informed consent. The subject must be diagnosed with degenerative disc disease at up to 2 levels from L2-S1 inclusive and undergoing up to 2 level posterior lumbar spinal fusion surgery with or without anterior column fusion. Subjects must be between 18 and 75 years of age. The patient must be skeletally mature (epiphyses closed). Exclusion Criteria: Subject is pregnant, lactating or interested in becoming pregnant during the duration of the study. Any active litigation. Subject is currently involved in another investigational study. Subject has a history (present or past) of substance abuse (recreational drugs, prescription drugs or alcohol) that in the investigator's opinion may interfere with protocol assessments and/or with the subject's ability to complete the protocol required follow-up. Subject is incarcerated. More than 2 prior spine surgeries/revision surgeries or any previous spinal fusions at levels being currently treated. Traumatic instability. Any parathyroid or metabolic bone disease. Any active malignancy. Osteopenia/Osteoporosis - All subjects will be screened for osteoporosis using SCORE (Simple Calculated Osteoporosis Risk Estimation) with a threshold value of 6. All subjects with a SCORE value greater than 6 will be referred for Dual-energy X-ray absorptiometry (DEXA) Scan. Subjects with a T-Score of £-1-2.5 will be excluded.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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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What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiographic Fusion |  | 12 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale (VAS) change from baseline | Mean VAS % change from baseline | 24 Months | 
| Oswestry Disability Index change from baseline | Oswestry Disability Index % change from baseline | 24 Month | 
| Neurologic Assessment, Maintenance or improvement from baseline |  | 12 Month | 
| Short Form Health Survey (SF-36) % change from baseline |  | 24 Month | 
| Time to return to work |  | 24 month | 
| Time to return to normal activity |  | 24 month | 
| Narcotic Use | pre and post-operatively | 24 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Spinal Fusion, Degenerative Disc Disease