Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion

CLINICAL EVALUATION OF GENEX® DS IN INSTRUMENTED POSTEROLATERAL FUSION

The overall goal of this clinical study is to characterize the fusion rate of geneX® ds bone graft substitute in comparison to autograft, which is considered the gold standard for posterolateral fusion. Assessments are made using AP and Lateral x-rays, F/E x-rays, and CT scans geneX® ds has been cleared by the FDA for use in these procedures; however this study will allow more detailed characterization of geneX® ds performance in the long-term (1 year). By using the patient as their own control, direct comparison to autograft can be performed while minimizing other variables.

Inclusion Criteria:

• Men or women 18-75 years of age
• Have ability to understand the requirements of the study, to provide written informed consent, and to comply with the study protocol
• Have a spinal condition of the lumbar spine (L1-S1) requiring instrumented posterolateral fusion at one or two levels

Exclusion Criteria:

• Patients undergoing instrumented fusion for trauma, tumor, psuedoarthrosis, or same- - level recurrent stenosis
• Patients where placing graft material on both sides (posterolateral gutters) is not possible, for example in the case of a complete facetectomy
• Patients requiring instrumented fusion in the cervical or thoracic spine
• Extraspinal cause of back pain such as trauma, infection, instrumentation failure, or neoplasm
• Severe degenerative bone disease
• Hypercalcemia
• Active local or systemic infection
• Morbid obesity defined as BMI > 40
• Patients who are pregnant / able to become pregnant and not following a reliable contraceptive method
• Uncooperative patients who can't or won't follow post-operative instructions including individuals who abuse drugs or alcohol
• Anatomy or other factors that prohibit safe surgical access to the surgical site
• Allergy or sensitivity to any component of the treatment procedure
• Inadequate tissue coverage over the operative site
• Inadequate bone stock or bone quality
• Fever or leukocytosis
• Uncorrectable coagulopathy or hemorrhagic diathesis
• Uncontrolled diabetes
• Severe vascular disease or cardiopulmonary conditions that present prohibitive anesthesia risk
• Neuromuscular disease or disorder
• Mental illness
• Has an active workman's compensation lawsuit