Osteoporosis is defined as a skeletal disorder characterized by compromised bone strength, presdisposing to an increased risk of fracture.

One possible consequence of Osteoporosis is a Vertebral Body Compression Fracture (VCF), which results in decompressed endplates, causing that portion of the spine to develop a wedge-shape, leading to a shorter spine that is tilted forward, as illustrated below:

This can lead to what is known as Progressive Spinal Deformity, illustrated here:

Reprinted with permission from Russel T, Woodburne MA, Crelin ES, et al. eds.

The Netter Collection of Medical Illustrations: Musculoskeletal System E Hanvover, NJ; Novartis Pharmaceuticals Corporation; 1999;8:218-219. Copyright 2001. Icon Learning Systems, LLC, a subsidiary of Medimedia US, Inc.

Vertebral Fractures can result in a loss of height, chronic and/or acute back pain, Gastrointestinal/respiratory difficulties, despression, loss of self-esteem, and an impact on the activities of daily living.

Past treatment options were restricted to conservative and open surgical treatments. Conservative treatments involved bracing, pain medications, PT and OT. The shortcomings, however, involved significant pain during recovery and causing patients to be bed-bound. Open surgical treatment consisted of instrumented fusion (anterior or posterior), but these procedures are extremely invasive, and often result in poor outcomes in osteopenic bone.A final current treatment option is Balloon Kyphoplasty, but problems with this procedure include cement extravasion and a loss of height restoration.

A prospective, Multi-Center Clinical study to assess the safety of the OsseoFix Spinal Fracture Reduction System is to be performed with Alphatec Spine. The OsseoFix Spinal Fracture Reduction System that corrects/reduces spinal fractures by internal fixation and stabilization using a titanium implant in conjunction with bone cement. The purpose of the study is to obtain safety data for the Osseofix Spinal Fracture Reduction System when used to treat vertebral compression fractures between T6 and L5. The study will involve up to 15 study centers across the United States. The study population will be adults fifty-five to eighty years old with vertebral compression fracture (s) of the spine between levels T6 and L5, with one to two-levels.