Lumbar Fusion
BioSET is a product that is used to enhance fusion of the spine in patients undergoing transforaminal lumbar interbody fusion of the spine. It is mixed with some of the patient’s own bone obtained from the same incision site with a goal of increasing the fusion success. This clinical trial is to assess the safety and effectiveness of this research product. This will be used in subjects who have been diagnosed with Degenerative Disc Disease.
A partial list of the inclusion criteria includes
- Diagnoses with Degenerative Disc Disease
- Sensory or motor changes at the involved level, a single level (L2 - S1).
- 18 to 70 years of age.
- Six months of failed conservative treatment including Physical Therapy, anti-inflammatory medications, and administration of epidural or facet injections to relieve pain
- Have back pain or leg pain
- Women of child bearing potential must be willing to not become pregnant for an initial period of participation in the study and be willing to use a medically approved method of contraception.