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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: Completed Phase 4 study of Vertebral Compression Fracture, sponsored by Hospital for Special Surgery, New York.
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, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The Oswestry Disability Index (ODI) is an index derived from the Oswestry Low Back Pain Questionnaire used by clinicians and researchers to quantify disability for low back pain. The self-completed questionnaire contains ten topics. Each topic category is followed by 6 statements describing different potential scenarios in the patient's life relating to the topic. The patient then checks the statement which most closely resembles their situation. Each question is scored on a scale of 0-5 with th
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 |
What the finished NCT01383616 record still lists
NCT01383616 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 84 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (84% lower).
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 a single indexed study location in 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.
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 NCT01383616's enrollment target sits among peer trials
84 929th of 2000 higher than 1,065 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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