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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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 August 28, 2014
Intervertebral Disc Degeneration