Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion
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ClinicalTrials.gov Identifier: NCT02317185
Recruitment Status :
(For business reasons / product no longer available from Sponsor)
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.
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.
Secondary Outcome Measures :
Complications [ Time Frame: 1 year ]
Complications will be assessed by evaluating all reported adverse events. The analysis will be descriptive only.
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Layout table for eligibility information
Ages Eligible for Study:
18 Years to 75 Years (Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
The subject population will include adult (skeletally mature) men and women with spinal conditions for which instrumented posterolateral fusion (PLF) has been indicated as a course of treatment. Such spinal conditions may include symptomatic degenerative disc disease, spondylolisthesis (Grade I or II), or lumbar stenosis. The study is limited to those patients requiring instrumented PLF at one or two levels only. Subjects who are undergoing other spinal procedures during the same surgery (such as interbody fusions) are also eligible.
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
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
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
Severe vascular disease or cardiopulmonary conditions that present prohibitive anesthesia risk