Sponsor study identifier
observational
2
1 country
2
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2016
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
December 8, 2014
Actual (reported)December 15, 2014
Actual (reported)December 2016
Actual (reported)December 2016
Actual (reported)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
Complications
1 year
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
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.
Hospital for Special Surgery
New York, New York, 10021, United States
Carolina Neurosurgery and Spine Associates
Charlotte, North Carolina, 20284, United States
2 participants (actual enrollment reported by the registry).
First Submitted
December 8, 2014
First Posted
December 15, 2014
Study Start
December 2014
Date type not reportedThis date has not been verified as actual or estimated.
Rate of Bony Fusion Using NanoBone® Synthetic Bone Graft Versus Local Autologous Bone Graft.
Contact the study team to confirm eligibility.
Primary Completion
December 2016
Actual (reported)Study Completion
December 2016
Actual (reported)Last Updated
April 19, 2018
Record last verified: 2018-04
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Source: ClinicalTrials.gov.
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