Ossatron - Non Invasive Treatment of Heel Pain

What Is The OssaTron?

The OssaTron is a high energy shockwave system that provides a non-surgical alternative for patients diagnosed with chronic proximal plantar fasciopathy (severe heel pain), usually referred to as fasciitis. This non-invasive out-patient treatment represents a breakthrough for this condition. Using a unique process known as Orthotripsy, the OssaTron emits shock waves, similar to those used to treat kidney stones, to increase blood flow and stimulate healing of the affected heel.

What Are The Expected Results?

Orthotripsy with the OssaTron has been proven to be effective over 80% of the time with only one treatment. Some patients report immediate pain relief after treatment, although it can take up to four weeks for pain relief to begin.

Is It Safe?

Yes. Developed in 1991 and widely used in Europe, the OssaTron is the first Orthotripsy device specifically designed and FDA-approved for orthopedic use. A wealth of medical experience, state-of-the-art engineering and optimal quality have been built into the OssaTron, and extensive clinical studies and tests have confirmed its safety and efficacy.

Why Consider OssaTron Treatment Versus Surgery?

Many times, invasive surgery leads to the development of thick scar tissue and a recurrence of equal or greater pain in the affected heel. Post-surgical protocol is four weeks or more of zero weight bearing, typically followed by casting and therapy. Total time for recovery and maximum medical improvement can be as much as a year. The OssaTron has a proven success rate that is equal to or greater than that of surgery-usually with just one treatment and without the inherent risks, complications and lengthy recovery time of surgery. The procedure takes about 30 minutes, is performed as an outpatient procedure, and requires no overnight hospital stay. Patients can bear weight (i.e., walk) and return to normal activity within a few days of the procedure. Your doctor has recommended OssaTron treatment as the most medically appropriate option for you based on your patient history.

Who Should Not Have OssaTron Treatment?

The OssaTron is not recommended for:

• anyone who is taking medications for bleeding problems or has a history of bleeding or blood clotting problems
• children
• pregnant women

What If You Have A Special Health Condition?

The effect, safety and effectiveness of OssaTron treatments has not yet been determined on people with the following health conditions:

• tarsal tunnel syndrome or other nerve entrapment disorders
• diabetic neuropathy
• fracture of the foot or ankle
• significant peripheral vascular disease
• severe osteoarthritis
• rheumatoid arthritis
• osteoporosis
• metabolic disorders
• malignancies
• Paget's disease
• osteomyelitis
• systemic infection

Your doctor will provide you with information about how these and other health conditions might affect the decision to perform OssaTron treatment.

What Will Happen On The Day Of Treatment?

Your doctor or healthcare facility will commonly ask you to arrive at the hospital or surgery center a few hours before your scheduled treatment. It is recommended that you should wear shorts or loose-fitting clothing that can easily be rolled up to the knee of your affected leg. You may be asked to change into a hospital gown. The staff may take your temperature, pulse and blood pressure, and ask some questions about your general health. They will also request that you sign a consent form for treatment, and indicate which side is to be treated. The treatment can cause some discomfort or pain, so anesthesia is commonly given before the procedure is administered.

Treatment Procedure
	Prior to administering anesthesia, the physician palpates the heel to determine the area of maximum tenderness (target tissue) and marks the area with a surgical marking pen. Once this has been completed, physician administers the form of anesthesia (either local or regional) he/she feels patient appropriate.
Once anesthesia has been administered, high viscosity ultrasound gel is applied to the area previously marked with the surgical marking pen (target tissue). The gel promotes shock wave conductance, enhancing treatment effectiveness.
	The patient's heel is firmly coupled to the treatment head.
The Ossatron Application Technician activates the shockwave via the shockwave release hand piece on the console.

What Will Happen After Treatment?

You'll stay at the hospital or surgery center until the anesthetic wears off enough to walk safely. Your doctor will probably ask you to restrict "stressful activity" such as jogging, heavy housework or yard work, and participating in sports for four weeks following treatment. Pain relief begins for patients at different times. For some patients it is immediate; for others it may take four weeks. The full effect of the OssaTron" procedure may not be realized until the twelfth week following treatment. If you haven't achieved any relief by then, you may consider having a second OssaTron procedure. This is a decision you will make with your physician.

What Are Possible Side Effects/Complications?

OssaTron treatment has minimal risks. In some cases it can cause skin reddening, bruising, tingling or the plantar fascia to tear. There may be changes in pain or temporary numbness.

Some patients reported a recurrence or episodes of pain following treatment, which may continue for a few days to several weeks. It is also normal to have some residual pain after intense exercise or a full day of work on your feet.

Who Should Consider OssaTron Treatment?

Treatment is recommended for patients who have had chronic proximal plantar fasciopathy for six months or more and who have tried at least three other conservative (non-surgical) therapies without success.

What Other Treatments Are Available?

Some people who have plantar fasciitis get better with time, even with no treatment. Others get better after trying one or more conservative treatments, which may include rest from strenuous activity; application of heat and/or cold; conditioning and stretching exercises; use oforthotic devices (shoe insert or heel cup); physical therapy, including ultrasound; over-the-counter pain relievers such as aspirin or Tylenol (acetaminophen); prescription pain relievers; non-steroidal anti-inflammatory medications such as Advil (ibuprofen) or Aleve (naproxen); and steroid (cortisone) injections. In difficult cases of plantar fasciitis, open or endoscopic surgery may be performed.

Will My Insurance Pay For Treatment?

Many health insurance companies nationwide are incorporating Orthotripsy treatment into their policies. It is recommended that you ask your insurance provider if this treatment is a covered benefit. HealthTronics may be an out-of-network provider for the OssaTron procedure. An out-of-network provider may increase your financial responsibility for treatment as well as the length of time you have to wait for an approval from your insurance company. Your doctor and HT Orthotripsy Management LLC (the company that handles insurance processing for the OssaTron procedure) will make every effort to obtain an approval from your insurance company. However, your insurance company has the final authority to approve or deny coverage. Patients themselves can and should be their own strongest advocates in obtaining approval for insurance benefits.

How Can I Get More Information?

You can talk to one of our physicians if you have questions or concerns about treatment with the OssaTron. They have extensive knowledge and specialized training on all aspects of its use, safety and effectiveness.