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
Study Type
OBSERVATIONAL
Enrollment
53
Union Hospital Neurosurgical
Terre Haute, Indiana, United States
Family Orthopedic Associates
Flint, Michigan, United States
Orthopedics and Neurological Consultants, Inc
Columbus, Ohio, United States
Neurological Associates of Waukesha
Waukesha, Wisconsin, United States
Radiographic Fusion
Time frame: 12 Month
Visual Analog Scale (VAS) change from baseline
Mean VAS % change from baseline
Time frame: 24 Months
Oswestry Disability Index change from baseline
Oswestry Disability Index % change from baseline
Time frame: 24 Month
Neurologic Assessment, Maintenance or improvement from baseline
Time frame: 12 Month
Short Form Health Survey (SF-36) % change from baseline
Time frame: 24 Month
Time to return to work
Time frame: 24 month
Time to return to normal activity
Time frame: 24 month
Narcotic Use
pre and post-operatively
Time frame: 24 month
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