Lumbar Spinal Fusion System
Information source: Biomet, Inc.
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Degenerative Disc Disease
Phase: N/A
Status: Recruiting
Sponsored by: Biomet, Inc. Official(s) and/or principal investigator(s):
John Evangelsita, MD, Study Chair, Affiliation: EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
Overall contact:
Eileen Bridges, Phone: 973-299-9300, Ext: 2207, Email: eileen.bridges@biomet.com
Summary
The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal
Fusion System in patients undergoing lumbar fusion surgery.
Clinical Details
Official title: A Prospective Multicenter Lumbar Spine Fusion Study to Evaluate the Effectiveness of the Biomet Lumbar Spinal Fusion System
Study design: Time Perspective: Prospective
Primary outcome: Radiographic Fusion
Secondary outcome: Mean VAS % change from baselineOswestry Disability Index % change from baseline Neurologic Assessment, Maintenance or improvement from baseline SF-36 % change from baseline Return to work Return to normal activity Narcotic Usage, pre and post-operatively Serious Surgical Complications Clinical Success
Detailed description:
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, a Biomet Biologic Agent
and an Interbody Spacer
Eligibility
Minimum age: 18 Years.
Maximum age: 75 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
1. 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.
2. The subject must be diagnosed with DDD at up to 2 levels from L2-S1 inclusive and
undergoing up to 2 level lumbar spinal fusion surgery.
3. Subjects must be between 18 and 75 years of age.
4. The patient must be skeletally mature (epiphyses closed).
Exclusion Criteria:
1. Subject is pregnant, lactating or interested in becoming pregnant during the duration
of the study.
2. Any active litigation.
3. Subject is currently involved in another investigational study.
4. 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.
5. Subject is incarcerated.
6. More than 2 prior spine surgeries/revision surgeries or any previous spinal fusions
at levels being currently treated.
7. Traumatic instability.
8. Any parathyroid or metabolic bone disease.
9. Any active malignancy.
10. 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 DEXA Scan. Subjects
with a T-Score of £-1-2. 5 will be excluded.
Locations and Contacts
Eileen Bridges, Phone: 973-299-9300, Ext: 2207, Email: eileen.bridges@biomet.com
Union Hospital Neurosurgical, Terre Haute, Indiana 47807, United States; Recruiting
Angie Lindley, Phone: 812-238-4555, Email: alindley@uhhg.org
Pradeep Narotam, MD, Principal Investigator
Family Orthopedic Associates, Flint, Michigan 48507, United States; Recruiting
Kathy Shire, Phone: 810-733-1200, Email: KShire@power-net.net
David Fernandez, MD, Principal Investigator
Orthopedics and Neurological Consultants, Inc, Columbus, Ohio 43212, United States; Active, not recruiting
Neurological Associates of Waukesha, Waukesha, Wisconsin 53188, United States; Active, not recruiting
Additional Information
Starting date: September 2008
Last updated: September 16, 2010
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