Clinical Trials for Spinal Fractures

There are many ongoing clinical trials that study spinal fractures.  Burst and compression fractures are two types of spinal fractures.  However, fractures also vary by the pattern of the bone (eg, vertebral body) after it breaks and/or collapses.  The force of spinal trauma can cause bone to pull apart (distract), which can disrupt and injure surrounding nerves and soft tissues; this is called a distraction injury.  Spinal fractures may occur suddenly and often cause severe pain.

What Do Spinal Fracture Clinical Trials Study?

Today’s spinal fracture treatment options have resulted from research and technology studied by previous trials.  Clinical trial studies have included fracture characteristics, vertebroplasty, balloon kyphoplasty, fracture secondary to (caused by) a primary cancer (eg, breast cancer or lung cancer), and risk factors such as steroid use and metabolic bone disease (eg, osteoporosis).  Medications, devices, and biologics are types of health-related studies conducted for spinal fractures. 

Can I Enroll in a Spinal Fracture Clinical Trial?

Enrollment in a clinical trial is not automatic.  Each patient must meet the study’s inclusion and exclusion criteria; those criteria form the foundation of the patient selection process.  They part of the study’s protocol.  The protocol is a meticulously designed clinical trial plan that sets forth the rules that govern how the study is conducted. 

When trying to find a clinical trial to participate in, make sure you check the inclusion and exclusion criteria.

How Is My Health Safeguarded?

First, any clinical trial, including those conducted to study medications, devices, and biologics related to spinal fracture diagnosis or treatment, must be approved by an Institutional Review Board (IRB).  The IRB is regulated by the United States Food and Drug Administration (FDA).  Patient safety begins with the selection process. 

The clinical trial is led by a Principal Investigator who often is a board-certified and fellowship-trained spinal fracture specialist, such as an orthopaedic spine surgeon, neurosurgeon or interventional radiologist.  Depending on the number of patients to be enrolled and study locations, two or more investigators may be involved and complemented by supporting clinical and research coordinators, and nurses.

Throughout the entire clinical trial, your health and safety will be paramount.  If you’re decide to participate in a spinal fracture clinical trial, you will be helping the medical community improve care for future patients who suffer a spinal fracture.