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NCT03733626 · ClinicalTrials.gov registry record · NA
Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease
A NA study, sponsored by Corewell Health East.
- Completed
- Registry status
- NA
- Development phase
- 46
- Enrollment target
NCT03733626 is a NA study that has completed, run by Corewell Health East. The registered enrollment target is 46 participants.
The verdict
NCT03733626, a NA study, has completed, sponsored by Corewell Health East.
- COMPLETED
- Registry status
- NA
- Development phase
- 46 participants
- Enrollment target
Study Summary
The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively, using Depuy ViviGen® Cellular Bone Matrix mixed with cortical/cancellous allograft in conjunction with an approved Depuy Synthes pedicle screw system compared to autograft mixed with cortical/cancellous allograft in conjunction with the same DePuy Synthes pedicle screw system used for a one or two - level posterolateral lumbar fusion.
Interventions
- COMBINATION_PRODUCT ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system
- COMBINATION_PRODUCT Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2019-03-19 |
| Est. Completion | 2024-06-25 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03733626
The ClinicalTrials.gov registry entry for NCT03733626 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 46 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Corewell Health East, which has 106 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system is the first listed.
NCT03733626 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03733626 about?
NCT03733626 is a clinical study titled "Clinical Outcomes Associated With the Use of ViviGen® for the Treatment of Lumbar Degenerative Disc Disease". The objective of this study is to perform a prospective, randomized, controlled clinical trial to compare radiographic fusion rates and patient reported outcomes, including pain and function preoperatively and postoperatively, using Depuy ViviGen® Cellular Bone Matrix mixed with cortical/cancellous ...
What is the current status of trial NCT03733626?
This trial is currently completed. It is a NA study. The enrollment target is 46 participants. The study started on 2019-03-19. Estimated completion is 2024-06-25.
What interventions are being tested in trial NCT03733626?
The interventions under investigation include: ViviGen® Cellular Bone Matrix with DePuy Synthes Spinal Pedicle screw system (COMBINATION_PRODUCT), Local Bone Autologous Bone Graft with DePuy Synthes Spinal pedicle screw system (COMBINATION_PRODUCT).
Who is sponsoring clinical trial NCT03733626?
This trial is sponsored by Corewell Health East, which has 106 total clinical trials registered on ClinicalTrials.gov.
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