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Boulder Neurological Associates

Clinical Trials

FDA-Regulated Clinical Trials

Facet Replacement System to Treat Spinal Stenosis

Principal Investigator: Alan T. Villavicencio, MD
Sub-Investigators: E. Lee Nelson, MD; Sharad Rajpal, MD; Kara Beasley, DO
Sponsor: Globus Medical Inc
Status: Enrolling patients

Purpose

The purpose of this study is to determine if the ACADIA® Facet Replacement System is effective in the treatment of spinal stenosis. The primary objective of the study is to evaluate the overall success rate of the Anatomic Facet Replacement System in patients with spinal stenosis when compared to a posterior spinal fusion control.

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Phase 3 Study of Fibrocaps™ in Surgical Bleeding (FINISH-3)

Principal Investigator: Alan T. Villavicencio, MD
Sub-Investigators: E. Lee Nelson, MD; Alexander Mason, MD: Sharad Rajpal, MD; Kara Beasley, DO
Sponsor: ProFibrix, Inc.
Status: Enrolling patients

Purpose

The primary objective of the study is to demonstrate the superiority of Fibrocaps plus gelatin sponge, as compared to gelatin sponge alone, for achieving hemostasis in subjects with mild to moderate surgical bleeding during spine, liver, vascular or soft tissue surgery. This is a Phase 3, international, multi-center, randomized, single-blind, controlled trial that will be conducted at clinical trial sites in the EU and US.

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DuraSeal Exact Spine Sealant System Post-Approval Study (DuraSeal PAS)

Principal Investigator: Alan T. Villavicencio, MD
Sub-Investigators: E. Lee Nelson, MD; Alexander Mason, MD: Sharad Rajpal, MD
Sponsor: Covidien
Status: Enrolling patients

Purpose

This is a non-randomized, post-approval study to further evaluate the rate of post-operative CSF leaks in subjects who undergo a spinal procedure and receive DuraSeal Exact Spine Sealant System.

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Trinity Evolution in Posterior or Transforaminal Lumbar Interbody Fusion

Principal Investigator: Alan T. Villavicencio, MD
Sub-Investigators: E. Lee Nelson, MD; Alexander Mason, MD
Sponsor: Orthofix Inc.
Status: Enrollment completed

Trinity Evolution is a novel, allogeneic cancellous bone matrix containing viable osteoprogenitor cells, mesenchymal stem cells and a demineralized cortical bone (DCB) component to provide the required osteoconduction, osteogenesis, and osteoinduction necessary for successful bone grafting. Preclinical studies with Trinity Evolution have demonstrated in-vitro and in-vivo safety and effectiveness. Trinity Evolution is considered an allograft and as such is a "minimally manipulated" tissue and is labeled for bone repair for spinal, orthopedic and podiatric indications where autograft is used. The dosage will be dependent upon the specific requirements of the case.

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

Principal Investigator: Alan T. Villavicencio, MD
Sub-Investigators: E. Lee Nelson, MD
Sponsor: Alphatec Spine, Inc.
Status: Enrollment completed

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

http://www.osseofixtrial.com


Wallis® System - Clinical Trial for Lumbar Degenerative Disc Disease

Principal Investigator: Alan T. Villavicencio, MD
Sub-Investigators: E. Lee Nelson, MD
Sponsor: Zimmer Spine
Status: Completed

Boulder Neurosurgical & Spine Associates (BNA) 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.

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The Advent™ Cervical Disc Clinical Trial

BNA 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.

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MAVERICK™ – FDA Lumbar Artificial Disc Study

Principal Investigator: Alan T. Villavicencio, MD
Sponsor: Medtronic
Status: Completed

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.

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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: E. 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.

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CAFÉ

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

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

BNA 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.

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