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Boulder Neurological Associates

Clinical Trials

FDA-Regulated Clinical Trials

Evaluation of Safety and Effectiveness of the OsseoFix® Spinal Fracture Reduction System in Treating Spinal Compression Fracture

Principal Investigator: Alan T. Villavicencio, M.D.
Sub-Investigators: Lee Nelson, MD
Sponsor: Alphatec Spine, Inc.
Status: Enrolling patients

Alphatec Spine, Inc., is a medical device company that specializes in treating disorders that affect the aging spine. The company is conducting a clinical study with the OsseoFix® Spinal Fracture Reduction System which is for the treatment of vertebral compression fractures in the middle and lower back. The system provides internal fixation and stabilization using a permanent implant made of titanium and bone cement.

Some of the qualification criteria for study participation are the following:

  1. 50 years or older
  2. Recently diagnosed with a vertebral compression fracture and conservative therapy (medication, bed rest, bracing, etc.) has failed for you
  3. Diagnosed with Osteoporosis

If you feel you have some of the above qualifications, please speak with one of the study physicians about the possibility of participating in this study and what participation entails.

http://www.osseofixtrial.com


Wallis® System - Clinical Trial for Lumbar Degenerative Disc Disease

Principal Investigator: Alan T. Villavicencio, M.D.
Sub-Investigators: Lee Nelson, MD
Sponsor: Zimmer Spine
Status: No longer enrolling patients, follow-up only

Boulder Neurosurgical Associates participates in this clinical trial to establish the safety and effectiveness of the Wallis® System. The study compares the Wallis dynamic stabilization system to total lumbar artificial disc replacement.

Complete Listing


The Advent™ Cervical Disc Clinical Trial

Boulder Neurosurgical Associates participates in a clinical trial for a new investigational device, namely the Advent™ Cervical Disc. The Advent™ Cervical Disc is one of the first cervical artificial discs for the treatment of one level degenerative disc disease to incorporate a flexible elastomer core, which is designed to provide advanced biomechanical properties.

Complete Listing


MAVERICK™ – FDA Lumbar Artificial Disc Study

Principal Investigator: Alan T. Villavicencio, M.D
Sponsor: Medtronic
Status: No longer enrolling patients

The MAVERICK™ artificial disc is a spinal arthroplasty system intended for use in the lumbar spine to treat degenerative disc disease. The device is a permanent implant that is intended to maintain motion at the treated level. While a fusion remains the standard of care, the artificial disc may provide an alternative solution for those patients suffering from degenerative disc disease.

Complete Listing


A Study Evaluating the Efficacy and Safety of Fibrin Sealant for the Sealing of Dura Defect Sutures in Posterior Fossa Surgery

Principal Investigator: Alan T. Villavicencio, MD
Sub-Investigators: Lee Nelson, MD
Sponsor: Baxter Healthcare Corporation
Status: No longer enrolling patients

The purpose of this research is to investigate the efficacy and safety of FS VH S/D 500 s-apr, a double virus-inactivated biological two-component fibrin sealant, for use in posterior fossa surgery as an adjunct to dura and dura substitute sutures in preventing postoperative cerebrospinal fluid (CSF) leakage.

Complete Listing


CAFÉ

Randomized Clinical Trial Comparing Balloon Kyphoplasty to Non-Surgical Treatment in Cancer Patients

Principal Investigator: Alan T. Villavicencio, M.D.
Sub-Investigators: Lee Nelson, MD
Sponsor: Kyphon
Status: No longer enrolling patients

Boulder Neurosurgical Associates has been selected to participate in a landmark international clinical trial for cancer patients who have experienced a fracture of the spine known as a vertebral compression fracture (VCF). Many cancer patients, especially those suffering with multiple myeloma, experience such fractures of the spine, which can cause debilitating back pain and substantially reduce their quality of life.

Complete Listing