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NCT01383616 · ClinicalTrials.gov registry record · Phase 4
Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures
A Phase 4 study of Vertebral Compression Fracture, sponsored by Hospital for Special Surgery, New York.
- Completed
- Registry status
- Phase 4
- Development phase
- 84
- Enrollment target
- 1
- Study location
NCT01383616 is a Phase 4 study of Vertebral Compression Fracture that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 84 participants. The trial reports 1 study location across 1 state.
The verdict
NCT01383616, a Phase 4 study of Vertebral Compression Fracture, has completed, sponsored by Hospital for Special Surgery, New York.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 84 participants
- Enrollment target
- 1
- Study location
Study Summary
Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression fractures has been shown to be successful in providing acute pain relief, enabling improved function, and restoring of vertebral body height. However, limited prospective data exists in the investigation of unipedicular balloon kyphoplasty as a sufficient alternative to bipedicular balloon kyphoplasty. The purpose of this prospective randomized study was to compare the clinical and radiographic outcomes of unipedicular and bipedicular balloon kyphoplasty.
Conditions Studied
Interventions
- DEVICE Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA)
Study Locations (1)
New York
- Hospital for Special Surgery - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 84 participants |
| Start Date | 2006-07 |
| Est. Completion | 2012-12 |
| Phase | Phase 4 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01383616
The ClinicalTrials.gov registry entry for NCT01383616 describes a study currently listed as completed, categorized as Phase 4. The registered enrollment target is 84 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Vertebral Compression Fracture appearing as the primary indexed condition, and to 1 intervention - of which Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA) is the first listed.
NCT01383616 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.
Frequently Asked Questions
What is clinical trial NCT01383616 about?
NCT01383616 is a clinical study titled "Unipedicular vs. Bipedicular Kyphoplasty for the Treatment of Osteoporotic Vertebral Fractures". Balloon kyphoplasty for the treatment of patients with osteoporotic vertebral compression fractures has been shown to be successful in providing acute pain relief, enabling improved function, and restoring of vertebral body height. However, limited prospective data exists in the investigation of uni...
What is the current status of trial NCT01383616?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 84 participants. The study started on 2006-07. Estimated completion is 2012-12.
What conditions does trial NCT01383616 study?
This clinical trial studies the following conditions: Vertebral Compression Fracture.
What interventions are being tested in trial NCT01383616?
The interventions under investigation include: Kyphon® Balloon Kyphoplasty (Kyphon Inc; Sunnydale, CA) (DEVICE).
Who is sponsoring clinical trial NCT01383616?
This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01383616 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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