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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: Completed NA study, sponsored by Corewell Health East.
NCT03733626 is a NA study that has completed, run by Corewell Health East. The registered enrollment target is 46 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Count of participants with successful lumbar bone fusion as measured by CT scan and flexion/extension x-rays at 12-months as evidenced by the following three criteria: bony bridging, no presence of radiolucency and no development of pseudoarthrosis at the treated lumbar level
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 |
What the finished NCT03733626 record still lists
NCT03733626 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
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 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03733626's enrollment target sits among peer trials
46 1402nd of 2000 higher than 590 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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