Status:
COMPLETED
Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
Lead Sponsor:
Zimmer Biomet
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-75 years
Brief Summary
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
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...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 1 2008
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2012
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT00758719
Start Date
September 1 2008
End Date
August 1 2012
Last Update
February 24 2020
Active Locations (4)
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1
Union Hospital Neurosurgical
Terre Haute, Indiana, United States, 47807
2
Family Orthopedic Associates
Flint, Michigan, United States, 48507
3
Orthopedics and Neurological Consultants, Inc
Columbus, Ohio, United States, 43212
4
Neurological Associates of Waukesha
Waukesha, Wisconsin, United States, 53188