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NCT02317185 · ClinicalTrials.gov registry record
Clinical Evaluation of GENEX® DS in Instrumented Posterolateral Fusion
A clinical trial, sponsored by Spine Wave.
- Terminated
- Registry status
- 2
- Enrollment target
NCT02317185: Clinical Trial study, sponsored by Spine Wave.
NCT02317185 is a clinical trial that was terminated before completion, run by Spine Wave. The registered enrollment target is 2 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02317185 was terminated before completion, sponsored by Spine Wave.
- TERMINATED
- Registry status
- 2 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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 th
Interventions
- DEVICE genex bone graft with bone graft
- OTHER autogenous bone graft
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2 participants |
| Start Date | 2014-12 |
| Est. Completion | 2016-12 |
Why NCT02317185 stopped before completion
NCT02317185 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 2 participants, a relatively small participant target.
The record links to 0 conditions, and to 2 interventions - of which genex bone graft with bone graft is the first listed.
NCT02317185 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02317185 about?
NCT02317185 is a clinical study titled "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 cle...
What is the current status of trial NCT02317185?
This trial is currently terminated. The enrollment target is 2 participants. The study started on 2014-12. Estimated completion is 2016-12.
What interventions are being tested in trial NCT02317185?
The interventions under investigation include: genex bone graft with bone graft (DEVICE), autogenous bone graft (OTHER).
Who is sponsoring clinical trial NCT02317185?
This trial is sponsored by Spine Wave, which has 2 total clinical trials registered on ClinicalTrials.gov.
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