Evaluate Effectiveness of the Biomet Lumbar Spinal Fusion System
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
The purpose of this study is to evaluate the effectiveness of the Biomet Lumbar Spinal Fusion System in patients undergoing lumbar fusion surgery.
Condition or disease
Degenerative Disc Disease
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
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, Learn About Clinical Studies.
Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes 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.
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.