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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.
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
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| Measure | Description | Time Frame |
|---|---|---|
| Radiographic Fusion | 12 Month |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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This study is open to all patients with one or two level Degenerative Disease who are between the ages of 18 and 75.
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| Name | Affiliation | Role |
|---|---|---|
| Joel Batts | Biomet Spine | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Union Hospital Neurosurgical | Terre Haute | Indiana | 47807 | United States | ||
| Family Orthopedic Associates |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| 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 |
| Flint |
| Michigan |
| 48507 |
| United States |
| Orthopedics and Neurological Consultants, Inc | Columbus | Ohio | 43212 | United States |
| Neurological Associates of Waukesha | Waukesha | Wisconsin | 53188 | United States |