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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 is a NA study that was terminated before completion, run by Alphatec Spine. The registered enrollment target is 15 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00961714
The ClinicalTrials.gov registry entry for NCT00961714 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Alphatec Spine, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which OsseoFix Spinal Fracture Reduction System is the first listed.
NCT00961714 reports 0 study locations.
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.
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