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NCT00996073 · ClinicalTrials.gov registry record · Phase 2
Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion
A Phase 2 study of Degenerative Disc Disease and Spinal Stenosis, sponsored by Mesoblast.
- Completed
- Registry status
- Phase 2
- Development phase
- 24
- Enrollment target
- 5
- Study locations
NCT00996073: Completed Phase 2 study of Degenerative Disc Disease and Spinal Stenosis, sponsored by Mesoblast.
NCT00996073 is a Phase 2 study of Degenerative Disc Disease and Spinal Stenosis that has completed, run by Mesoblast. The registered enrollment target is 24 participants, below the 168-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (86% lower). The trial reports 5 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00996073, a Phase 2 study of Degenerative Disc Disease and Spinal Stenosis, has completed, sponsored by Mesoblast.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 24 participants
- Enrollment target
- 5
- Study locations
Study Summary
The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1. All subjects in this study will undergo interbody fusion via Transforaminal Lumbar Interbody Fusion (TLIF) or Posterior Lumbar Interbody Fusion (PLIF) procedures with Food and Drug Administration (FDA) approved/cleared supplemental posterior instrumentation.
Conditions Studied
Interventions
- BIOLOGICAL Lumbar Interbody Fusion with Autograft
- BIOLOGICAL Lumbar Interbody Fusion with NeoFuse
Study Locations (5)
Colorado
- Denver Spine - Greenwood Village
- Rocky Mountain Associates in Orthopedic Medicine, P.C. - Loveland
California
- The Spine Institute - Santa Monica
Indiana
- Fort Wayne Orthopaedics - Fort Wayne
Texas
- Central Texas Spine Institute - Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2009-09 |
| Est. Completion | 2014-07 |
| Phase | Phase 2 |
What the finished NCT00996073 record still lists
NCT00996073 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 168-participant average among 42 other Degenerative Disc Disease trials with a reported enrollment target (86% lower).
The record links to 3 conditions, with Degenerative Disc Disease appearing as the primary indexed condition, and to 2 interventions - of which Lumbar Interbody Fusion with Autograft is the first listed.
NCT00996073 lists 5 locations in 4 states (Colorado, California, Indiana).
Frequently Asked Questions
What is clinical trial NCT00996073 about?
NCT00996073 is a clinical study titled "Safety and Preliminary Efficacy Study of NeoFuse in Subjects Requiring Lumbar Interbody Fusion". The purpose of this study is to evaluate the safety and preliminary efficacy of NeoFuse in subjects with a diagnosis of degenerative disc disease (DDD) in 1 or 2 adjacent vertebral levels between L1 and S1. All subjects in this study will undergo interbody fusion via Transforaminal Lumbar Interbody ...
What is the current status of trial NCT00996073?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 24 participants. The study started on 2009-09. Estimated completion is 2014-07.
What conditions does trial NCT00996073 study?
This clinical trial studies the following conditions: Degenerative Disc Disease, Spinal Stenosis, Degenerative Spondylolisthesis.
What interventions are being tested in trial NCT00996073?
The interventions under investigation include: Lumbar Interbody Fusion with Autograft (BIOLOGICAL), Lumbar Interbody Fusion with NeoFuse (BIOLOGICAL).
Who is sponsoring clinical trial NCT00996073?
This trial is sponsored by Mesoblast, which has 25 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT00996073 being conducted?
This trial has 5 study locations across California, Colorado, Indiana, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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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 NCT00996073's enrollment target sits among peer trials
24 40th of 42 higher than 3 of 42 other Degenerative Disc Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Degenerative Disc Disease 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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