OsseoFix Spinal Fracture Reduction System

Clinical trial for the treatment of vertebral compression fracture in the middle and lower back.

Introduction

The OsseoFix Spinal Fracture Reduction System is for the treatment of vertebral compression fractures in the middle and lower back. It provides internal fixation and stabilization using a permanent implant made of titanium and bone cement.

How OsseoFix works?

The fractured vertebral body is assessed by the physician and the desired size of the OsseoFix implant is selected.


The physician will then create a small pathway into the fractured vertebral body for the placement of the OsseoFix implant.


The OsseoFix is then inserted into the anterior one-third of the vertebral body.


The OsseoFix Implant is then expanded.


Under fluoroscopic guidance (radiologic imaging to assist in the placement of instruments), the OsseoFix+ Radiopaque Bone Cement is then injected into the OsseoFix implant. The expanded OsseoFix implant allows for the cement to interdigitate (lock together) through the vertebral body in a controlled manner.

Study objectives

The purpose of the study is to provide reasonable assurance on safety and effectiveness of the OsseoFix Spinal Fracture Reduction System for market release approval in the United States.

Study overview

The study will be conducted at up to 15 investigational centers in the United States in 115 (up to 125) subjects with one or two vertebral compression fractures between levels T6 and L5 implanted with the investigational device(s).

Patients that have been recently diagnosed with a vertebral compression fracture that are enrolled will be implanted with the OsseoFix Spinal Fracture Reduction System. Patients are required to come in for follow-up visits after 4-weeks, 3-months, 6-months, and 12-months. The overall patient-satisfaction will be evaluated at all post-implant scheduled follow-up visits.

Study sponsor

Alphatec Spine, Inc.

Status

Recruiting

Who can participate in the OsseoFix Study?

Subjects must meet all of the inclusion criteria and none of the exclusion criteria. Some of the major inclusion criteria are listed below:

Inclusion criteria

• 50 years old or older
• Diagnosed with Osteoporosis
• Suffering from back pain
• Conservative therapy has failed, e.g., medication, bed rest, bracing
• Recently diagnosed with a vertebral compression fracture

There are additional inclusion/exclusion criteria. Only a surgeon participating in the OsseoFix study will be able to determine if a patient meets all of the inclusion criteria and none of the exclusion criteria, and thus, is eligible to be a study participant.

Participating sites

• La Jolla, CA
• Boulder, CO
• Littleton, CO
• Jacksonville, FL
• Savannah, GA
• Springfield, IL
• Louisville, KY
• Peabody, MA
• Edmond, OK
• Eugene, OR
• Easton, PA
• Bristol, TN
• Arlington, VA
• Richmond, VA
• Spokane, WA

Interested in participating?

You or someone you know may be eligible to participate in this study.

To see if you may qualify for participation in this clinical study, please take this short survey.

Caution: Investigational device. Limited by Federal (or United States) law to investigational use.