Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System



Status:Completed
Conditions:Orthopedic
Therapuetic Areas:Orthopedics / Podiatry
Healthy:No
Age Range:18 - 75
Updated:4/21/2016
Start Date:September 2008
End Date:August 2012

Use our guide to learn which trials are right for you!

A Prospective Multicenter Lumbar Spine Fusion Study to Evaluate the Effectiveness of the Biomet Lumbar Spinal Fusion System

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

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 posterior lumbar spinal fusion surgery with or without
anterior column fusion.

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.
We found this trial at
4
sites
Terre Haute, Indiana 47807
?
mi
from
Terre Haute, IN
Click here to add this to my saved trials
?
mi
from
Columbus, OH
Click here to add this to my saved trials
Flint, Michigan 48507
?
mi
from
Flint, MI
Click here to add this to my saved trials
Waukesha, Wisconsin 53188
?
mi
from
Waukesha, WI
Click here to add this to my saved trials