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NCT01873586 · ClinicalTrials.gov registry record · NA
OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion
A NA study of Spondylosis and Stenosis, sponsored by SeaSpine.
- Completed
- Registry status
- NA
- Development phase
- 29
- Enrollment target
- 1
- Study location
NCT01873586: Completed NA study of Spondylosis and Stenosis, sponsored by SeaSpine.
NCT01873586 is a NA study of Spondylosis and Stenosis that has completed, run by SeaSpine. The registered enrollment target is 29 participants, below the 69-participant average among 8 other Spondylosis trials with a reported enrollment target (58% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01873586, a NA study of Spondylosis and Stenosis, has completed, sponsored by SeaSpine.
- COMPLETED
- Registry status
- NA
- Development phase
- 29 participants
- Enrollment target
- 1
- Study location
Study Summary
The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.
Primary Outcome
Posterolateral fusion study in which each patient undergoes posterolateral fusion. During the posterolateral fusion, each spinal level is treated with two grafts, the symptomatic posterolateral gutter is treated with study arm (OsteoStrux) and the contralateral posterolateral gutter is treated with the control arm (local autograft).
Conditions Studied
Interventions
- PROCEDURE Posterolateral Fusion
Study Locations (1)
New York
- Sherban Orthopaedic and Spine Surgery, PLLC - Kenmore
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2012-10 |
| Est. Completion | 2016-10 |
| Phase | NA |
What the finished NCT01873586 record still lists
NCT01873586 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 69-participant average among 8 other Spondylosis trials with a reported enrollment target (58% lower).
The record links to 3 conditions, with Spondylosis appearing as the primary indexed condition, and to 1 intervention - of which Posterolateral Fusion is the first listed.
NCT01873586 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT01873586 about?
NCT01873586 is a clinical study titled "OsteoStrux™ Collagen Ceramic Scaffold in Instrumented Lumbar Spine Fusion". The objective of this study is to prospectively evaluate the performance of Integra's OsteoStrux Collagen Ceramic Scaffold combined with bone marrow aspirate as an adjunct for instrumented posterolateral spine fusion, as compared to local autograft.
What is the current status of trial NCT01873586?
This trial is currently completed. It is a NA study. The enrollment target is 29 participants. The study started on 2012-10. Estimated completion is 2016-10.
What conditions does trial NCT01873586 study?
This clinical trial studies the following conditions: Spondylosis, Stenosis, Degenerative Changes.
What interventions are being tested in trial NCT01873586?
The interventions under investigation include: Posterolateral Fusion (PROCEDURE).
Who is sponsoring clinical trial NCT01873586?
This trial is sponsored by SeaSpine, which has 4 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01873586 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Spondylosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01873586's enrollment target sits among peer trials
29 9th of 8 the lowest 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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