Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion

Study Overview
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Brief Summary
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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.

Official Title
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CLINICAL EVALUATION OF GENEX® DS IN INSTRUMENTED POSTEROLATERAL FUSION

Conditions
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Degenerative Disc Disease, Spondylolisthesis, Stenosis

Intervention / Treatment
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* Device: genex bone graft with bone graft
* Other: autogenous bone graft


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: genex bone graft with bone graft|nan|
|Other: autogenous bone graft|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion | Fusion will be assessed by a single, independent radiologist using study required x-rays (AP, Lateral, Flexion-Extension) and CT scans. On xray, fusion will be graded for bridging bone and lucencies. Flexion extension x-rays will also be evaluated to determine translational and angular motion. For these evaluations, fusion is defined as translational motion < 3mm and angular motion < 5º.CT assessments of fusion will include qualitative evaluation of the continuity of trabecular bone between the transverse processes, cortication at the peripheral edges of the fusion masses, and the absence of identifiable radiographic clefts. Quantitative volumetric measurements of the fusion mass will be performed by outlining the fusion area in each cross-sectional slice and summing all slices. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications | Complications will be assessed by evaluating all reported adverse events. The analysis will be descriptive only. | 1 year |