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NCT00961714 · ClinicalTrials.gov registry record · NA
OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture
A NA study, sponsored by Alphatec Spine.
- Terminated
- Registry status
- NA
- Development phase
- 15
- Enrollment target
NCT00961714: Clinical Trial NA study, sponsored by Alphatec Spine.
NCT00961714 is a NA study that was terminated before completion, run by Alphatec Spine. The registered enrollment target is 15 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00961714, a NA study, was terminated before completion, sponsored by Alphatec Spine.
- TERMINATED
- Registry status
- NA
- Development phase
- 15 participants
- Enrollment target
Study Summary
The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures by providing internal fixation and stabilization using a titanium implant in conjunction with OsseoFix+™ polymethylmethacrylate (PMMA) bone cement. The purpose of the study is to provide reasonable assurance on safety and effectiveness of the OsseoFix Spinal Fracture Reduction System for market release approval in the US. This investigational device is intended to restore biomechanical integrity to a vertebral body that has suffered a painful compression fracture in the thoracic or lumbar spine between levels T6 and L5.
Primary Outcome
Back pain improvement is defined as a reduction in VAS score of ≥ 20mm at 12 months from baseline
Interventions
- DEVICE OsseoFix Spinal Fracture Reduction System
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 15 participants |
| Start Date | 2009-08 |
| Est. Completion | 2013-07 |
| Phase | NA |
Why NCT00961714 stopped before completion
NCT00961714 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 15 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 1 intervention - of which OsseoFix Spinal Fracture Reduction System is the first listed.
NCT00961714 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00961714 about?
NCT00961714 is a clinical study titled "OsseoFix™ Spinal Fracture Reduction System in Treating Spinal Compression Fracture". The OsseoFix Spinal Fracture Reduction System facilitates the treatment of spinal fractures by providing internal fixation and stabilization using a titanium implant in conjunction with OsseoFix+™ polymethylmethacrylate (PMMA) bone cement. The purpose of the study is to provide reasonable assurance...
What is the current status of trial NCT00961714?
This trial is currently terminated. It is a NA study. The enrollment target is 15 participants. The study started on 2009-08. Estimated completion is 2013-07.
What interventions are being tested in trial NCT00961714?
The interventions under investigation include: OsseoFix Spinal Fracture Reduction System (DEVICE).
Who is sponsoring clinical trial NCT00961714?
This trial is sponsored by Alphatec Spine, which has 7 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT00961714's enrollment target sits among peer trials
15 1881st of 2000 higher than 92 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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