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NCT01430299 · ClinicalTrials.gov registry record · NA
Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion
A NA study of Spondylosis and Stenosis, sponsored by SeaSpine.
- Completed
- Registry status
- NA
- Development phase
- 43
- Enrollment target
- 1
- Study location
NCT01430299: Completed NA study of Spondylosis and Stenosis, sponsored by SeaSpine.
NCT01430299 is a NA study of Spondylosis and Stenosis that has completed, run by SeaSpine. The registered enrollment target is 43 participants, below the 67-participant average among 8 other Spondylosis trials with a reported enrollment target (36% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01430299, a NA study of Spondylosis and Stenosis, has completed, sponsored by SeaSpine.
- COMPLETED
- Registry status
- NA
- Development phase
- 43 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient cohort.
Primary Outcome
Posterolateral fusion by radiographic assessment 12 months post surgery
Conditions Studied
Interventions
- DEVICE Demineralized Bone Matrix
- DEVICE rh-BMP2
Study Locations (1)
California
- University of CA-Davis, Dept. of Orthopaedics, Adult & Pediatric Spine Surgery - Sacramento
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2011-06 |
| Est. Completion | 2016-10 |
| Phase | NA |
What the finished NCT01430299 record still lists
NCT01430299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 43 participants, a relatively small participant target, below the 67-participant average among 8 other Spondylosis trials with a reported enrollment target (36% lower).
The record links to 3 conditions, with Spondylosis appearing as the primary indexed condition, and to 2 interventions - of which Demineralized Bone Matrix is the first listed.
NCT01430299 reports a single indexed study location in California.
Frequently Asked Questions
What is clinical trial NCT01430299 about?
NCT01430299 is a clinical study titled "Efficacy and Safety of Accell Evo3 Demineralized Bone Matrix (DBM) in Instrumented Posterolateral Lumbar Spine Fusion". The objective of this study is to prospectively evaluate the performance of Integra Accell Evo3 Demineralized Bone Matrix as an adjunct for posterolateral spine fusion with a retrospective comparison to a historical patient cohort.
What is the current status of trial NCT01430299?
This trial is currently completed. It is a NA study. The enrollment target is 43 participants. The study started on 2011-06. Estimated completion is 2016-10.
What conditions does trial NCT01430299 study?
This clinical trial studies the following conditions: Spondylosis, Stenosis, Degenerative Changes.
What interventions are being tested in trial NCT01430299?
The interventions under investigation include: Demineralized Bone Matrix (DEVICE), rh-BMP2 (DEVICE).
Who is sponsoring clinical trial NCT01430299?
This trial is sponsored by SeaSpine, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01430299 being conducted?
This trial has 1 study location across California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT01430299's enrollment target sits among peer trials
43 6th of 8 higher than 3 of 8 other Spondylosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Spondylosis 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.
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