The Crosstrees System for PVA - new treatment for compression fractures

Vertebroplasty is a percutaneous (through the skin) treatment for vertebral compression fractures. A special needle is inserted into the spine and liquid bone cement is injected into the vertebral cavity to strengthen the bone and relieve pain. Vertebroplasty is a minimally invasive procedure that is often performed under general anesthesia.

Kyphoplasty is a similar type of percutaneous (through the skin) treatment for vertebral compression fractures. A small balloon is inserted into the vertebra using a hollow instrument. The balloon is inflated to raise the collapsed vertebra and once positioned correctly, is deflated and removed. The cavity is then filled with bone cement to support the bone. Kyphoplasty is performed using local or general anesthesia.

Nearly 90% of patients experience an immediate and significant reduction in pain.¹ Other benefits include improvements in mobility and quality of life from resuming normal daily activity.

The Crosstrees System for percutaneous vertebral augmentation (PVA) is an investigational procedure similar to vertebroplasty and kyphoplasty, the standard surgical treatments for vertebral compression fractures. However, the Crosstrees PVA system is designed to control bone cement delivery and may decrease the risk of cement leakage associated with vertebroplasty and kyphoplasty. In a small percentage of patients, those cement leaks can result in significant health issues.

As in vertebroplasty and kyphoplasty procedures, the physician will insert the Crosstreess Pod into the fractured vertebral body through a very small incision in the spine. The Pod will be filled with liquid bone cement and then opened and removed so that only the bone cement remains. The Crosstrees procedure may be comparable in time to other PVA treatments and can be performed under local or general anesthesia. Your physician will decide whether or not an overnight stay in the hospital is required. Recovery time is expected to be brief and most patients are expected to be up and walking within hours.

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A clinical trial is being conducted to evaluate the performance of the Crosstrees System in reducing pain and decreasing the risk of cement leakage associated with vertebroplasty and kyphoplasty. Submit the form above if you are interesting in finding out more about participating.

In the United States alone, more than 700,000 vertebral compression fractures occur every year. Some fractures are caused by trauma, but the vast majority—85 percent—of vertebral compression fractures are caused by osteoporosis. In this case, even a sneeze or reaching overhead can cause a fracture. The bone inside the vertebral body causes it to weaken and collapse, resulting in severe pain. Vertebral compression fractures usually occur in the middle and lower sections of the spine. If not treated properly, they can lead to the loss of height, posture deformity and pulmonary complications.² Certain types of spine fractures are not currently treated by vertebroplasty or kyphoplasty and would not be eligible for this trial.

• Females over the age of 50
• Women are four times more likely than men to develop osteoporosis.
• Family history
• Inactive lifestyle
• Long term use of steroid medication
• Low lifetime intake of calcium
• Smoking
• Excessive use of alcohol
• Women who are thin and have a small bone structure
• Caucasian and Asian women are more likely to develop osteoporosis
• Prior bone fracture

If you have any of the following symptoms, you should be evaluated by a medical professional to determine whether or not you have a spinal fracture:

• Sudden onset of back pain
• Unable to perform normal activities and exercise due to back pain
• Ongoing chronic back pain
• Loss in height with associated back pain

• Take calcium supplements
• Take vitamin D or eat food rich in vitamin D and calcium
• Get regular exercise, especially strength-building exercise
• If you are at high risk, consult with your doctor about bones strengthening medications

Osteoporosis is a disease of bone that leads to a decrease in bone density and an increased risk of fracture. Osteoporosis may result in bones that have become weak and brittle. If undetected, osteoporosis can lead to a fracture, or compression in the spine, even from normal daily activities. This is often referred to as a spinal fracture or vertebral compression fracture (VCF).

Contact us today to discuss your eligibility for the clinical study of the Crosstrees System™ for Percutaneous Vertebral Augmentation (PVA). This study is designed to evaluate the system performance in reducing pain and reducing risk associated from compression fractures and reduce risk associated with cement leakage.

Learn about Clinical Trials at the comprehensive website www.clinicaltrials.gov. The following information is an excerpt from this website.

Although there are many definitions of clinical trials, they are generally considered to be biomedical or health-related research studies in human beings that follow a pre-defined protocol. ClinicalTrials.gov includes both interventional and observational types of studies. Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.

Participants in clinical trials can play a more active role in their own health care, gain access to new research treatments before they are widely available, and help others by contributing to medical research.

All clinical trials have guidelines about who can participate. Using inclusion/exclusion criteria is an important principle of medical research that helps to produce reliable results. The factors that allow someone to participate in a clinical trial are called "inclusion criteria" and those that disallow someone from participating are called "exclusion criteria". These criteria are based on such factors as age, gender, the type and stage of a disease, previous treatment history, and other medical conditions. Before joining a clinical trial, a participant must qualify for the study. Some research studies seek participants with illnesses or conditions to be studied in the clinical trial, while others need healthy participants. It is important to note that inclusion and exclusion criteria are not used to reject people personally. Instead, the criteria are used to identify appropriate participants and keep them safe. The criteria help ensure that researchers will be able to answer the questions they plan to study.

The clinical trial process depends on the kind of trial being conducted. The clinical trial team includes doctors and nurses as well as social workers and other health care professionals. They check the health of the participant at the beginning of the trial, give specific instructions for participating in the trial, monitor the participant carefully during the trial, and stay in touch after the trial is completed.

Some clinical trials involve more tests and doctor visits than the participant would normally have for an illness or condition. For all types of trials, the participant works with a research team. Clinical trial participation is most successful when the protocol is carefully followed and there is frequent contact with the research staff.

Informed consent is the process of learning the key facts about a clinical trial before deciding whether or not to participate. It is also a continuing process throughout the study to provide information for participants. To help someone decide whether or not to participate, the doctors and nurses involved in the trial explain the details of the study. If the participant's native language is not English, translation assistance can be provided. Then the research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and key contacts. Risks and potential benefits are explained in the informed consent document. The participant then decides whether or not to sign the document. Informed consent is not a contract, and the participant may withdraw from the trial at any time.

Clinical trials that are well-designed and well-executed are the best approach for eligible participants to:
• Play an active role in their own health care.
• Gain access to new research treatments before they are widely available.
• Obtain expert medical care at leading health care facilities during the trial.
• Help others by contributing to medical research.

• There may be unpleasant, serious or even life-threatening side effects to experimental treatment.
• The experimental treatment may not be effective for the participant.
• The protocol may require more of their time and attention than would a non-protocol treatment, including
trips to the study site, more treatments, hospital stays or complex dosage requirements.

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