Lumbar Spinal Fusion System
This study has been completed.
Information provided by (Responsible Party):
First received: September 9, 2008
Last updated: September 19, 2012
Last verified: September 2012
The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion System in patients undergoing lumbar fusion surgery.
Degenerative Disc Disease
||Time Perspective: Prospective
||A Prospective Multicenter Lumbar Spine Fusion Study to Evaluate the Effectiveness of the Biomet Lumbar Spinal Fusion System
Primary Outcome Measures:
- Radiographic Fusion [ Time Frame: 12 Month ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Mean VAS % change from baseline [ Time Frame: 24 Months ] [ Designated as safety issue: No ]
- Oswestry Disability Index % change from baseline [ Time Frame: 24 Month ] [ Designated as safety issue: No ]
- Neurologic Assessment, Maintenance or improvement from baseline [ Time Frame: 12 Month ] [ Designated as safety issue: Yes ]
- SF-36 % change from baseline [ Time Frame: 24 Month ] [ Designated as safety issue: No ]
- Return to work [ Time Frame: 24 month ] [ Designated as safety issue: No ]
- Return to normal activity [ Time Frame: 24 month ] [ Designated as safety issue: No ]
- Narcotic Usage, pre and post-operatively [ Time Frame: 24 month ] [ Designated as safety issue: No ]
- Serious Surgical Complications [ Time Frame: 24 month ] [ Designated as safety issue: Yes ]
- Clinical Success [ Time Frame: 24 month ] [ Designated as safety issue: No ]
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||August 2012 (Final data collection date for primary outcome measure)
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
|Ages Eligible for Study:
||18 Years to 75 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
This study is open to all patients with one or two level Degenerative Disease who are between the ages of 18 and 75.
- 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 DDD 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).
- 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 DEXA Scan. Subjects with a T-Score of £-1-2.5 will be excluded.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00758719
|Union Hospital Neurosurgical
|Terre Haute, Indiana, United States, 47807 |
|Family Orthopedic Associates
|Flint, Michigan, United States, 48507 |
|Orthopedics and Neurological Consultants, Inc
|Columbus, Ohio, United States, 43212 |
|Neurological Associates of Waukesha
|Waukesha, Wisconsin, United States, 53188 |
||EBI, LLC dba Biomet Spine, Biomet Trauma, Biomet Osteobiologics and Biomet Bracing
No publications provided
History of Changes
|Other Study ID Numbers:
|Study First Received:
||September 9, 2008
||September 19, 2012
||United States: Institutional Review Board
Keywords provided by Biomet, Inc.:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on December 10, 2013
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