Clinical Research
The Spine Center at UCH-Carrollwood participates in several clinical trials approved by the Food and Drug Administration (FDA). Participating in these trials allows us to offer the newest and most advanced technologies and treatments long before they are available to the general public and other physicians.

For more information about these studies or to learn how to enroll, visit the Foundation for Orthopaedic Research and Education.

Following is a list of our current clinical studies:

Principal Investigator: Dr. Antonio E. Castellvi

You can find more information about this clinical trial at the National Institutes of Health's Clinical Trials website.

In conjunction with the Foundation for Orthopaedic Research and Education, University Community Hospital-Carrollwood has been selected as a participating clinical site performing this trial.

Prinipal Invesitgators: Dr. Antonio E. Castellvi
Co-investigators: Drs. John Small and James Billys

You can find more information about this clinical trial at the National Institutes of Health's Clinical Trials website.

University Community Hospital-Carrollwood has been selected for this trial as one of 36 participating clinical sites across the United States and is the only facility in Florida performing this trial.

Prinipal Invesitgators: Dr. Antonio E. Castellvi

You can find more information about this clinical trial at the National Institutes of Health's Clinical Trials website.

In conjunction with the Foundation for Orthopaedic Research and Education, University Community Hospital-Carrollwood has been selected as a participating clinical site performing this trial.

Prinipal Invesitgators: Dr. Antonio E. Castellvi

You can find more information about this clinical trial at the National Institutes of Health's Clinical Trials website.

In conjunction with the Foundation for Orthopaedic Research and Education, University Community Hospital-Carrollwood has been selected as one of 19 sites in the United States participating clinical sites performing this trial.

In conjunction with the Foundation for Orthopaedic Research and Education, University Community Hospital-Carrollwood has been selected for this trial as one of 25 participating clinical sites across the United States and is the only facility in Florida performing this trial.

DIAM Spinal Stabilization System
This is a prospective, randomized, controlled pivotal clinical investigation of DIAM™ Spinal Stabilization System in patients with lumbar degenerative disc disease. This study is being conducted to evaluate the safety and effectiveness of the DIAM Spinal Stabilization System for the treatment of single-level degenerative (progressively deteriorates over time) spinal disc disease in your lumbar spine (lower back).

Principal Investigator: Dr. James Billys
Co-Investigator: Dr. John Small

You can find more information about this clinical trial at the National Institutes of Health's Clinical Trials website.

In conjunction with the Foundation for Orthopaedic Research and Education, University Community Hospital-Carrollwood has been selected as a participating clinical site performing this trial.

Impliant TOPS System
This is a prospective, multi-center clinical study to assess the safety and effectiveness of the Impliant TOPS System. The purpose of the study is to test the ability of the TOPS System in relieving the pain caused by diseased facet joints between your vertebrae. The spinal surgery using the TOPS System will be compared to the results of spinal fusion surgery. A maximum of 600 patients will be tested in this study in approximately 20 sites.

Principal Investigator: Dr. John Small
Co-Investigators: Drs. James Billys and Marc Weinstein

You can find more information about this clinical trial at the National Institutes of Health's Clinical Trials website.

In conjunction with the Foundation for Orthopaedic Research and Education, University Community Hospital-Carrollwood has been selected as a participating clinical site performing this trial.

The Score Study
Study of Curette Use for Obtaining Restoration of Vertebral Body Anatomy in Balloon Kyphoplasty. This study evaluates vertebral body compression fractures (spinal fractures) in patients with confirmed or suspected osteoporosis (loss of calcium from bone tissue resulting in bones that break easily) who are candidates for a balloon kyphoplasty procedure. Balloon kyphoplasty is a minimally invasive and accepted treatment for spinal fractures. The study will also compare the results of two non-experimental techniques for the balloon kyphoplasty procedure. Neither the devices nor the techniques used in this study are experimental (investigational). There will be approximately 120 subjects enrolled at one of up to 10 study sites in North America and Europe. Participation in this study will last up to 30 days after procedure.

Principal Investigator: Dr. John Small
Co-Investigators: Drs. James Billys, Marc Weinstein, and Antonio Castellvi

You can find more information about this clinical trial at the National Institutes of Health's Clinical Trials website.

In conjunction with the Foundation for Orthopaedic Research and Education, University Community Hospital-Carrollwood has been selected as a participating clinical site performing this trial.

Aesculap Activ-L Artificial Disc
The objective of this clinical study is to evaluate the safety and effectiveness of the Activ-L Artificial Disc for treatment of single-level degenerative disc disease of the lumbar spine in patients who have been unresponsive to at least six months of prior conservative care. The control device will be either (the Charité® Artificial Disc [DePuy Spine] or ProDisc-L® Total Disc Replacement [Synthes Spine]). Twenty investigational sites with an estimated 414 subjects will participate in the investigation and will be followed for 5 years.

Principal Investigator: Dr. Antonio Castellvi MD
Co-Investigators: Drs. James Billys and John Small

You can find more information about this clinical trial at the National Institutes of Health's Clinical Trials website.

In conjunction with the Foundation for Orthopaedic Research and Education, University Community Hospital-Carrollwood has been selected as a participating clinical site performing this trial.

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