What isThe OssaTron®?

The OssaTron® is a non-invasive procedure - there are no scalpels, incisions or stitches.

The OssaTron®  is a high-energy shockwave system that provides a non- surgical alternative for patients diagnosed with chronic lateral epicondylitis ( tennis elbow ) and chronic proximal plantar fasciitis (heel pain)  A  process known as Orthotripsy®, the OssaTron® emits shockwaves, similar to those used to treat kidney stones, to increase blood flow and stimulate healing to the selected area. The procedure is performed at an outpatient surgery center by board certified orthopaedic surgeons that have been specifically trained and credentialed to perform the OssaTron® procedure.

The OssaTron® has a proven success rate that is equal to or greater than surgery, usually with just one non- surgical shockwave and without the risks, complications, and lengthy recovery time of invasive surgery. The OssaTron® procedure requires a minimal amount of time and patients can go home the same day the OssaTron® procedure is performed. Patients can return to normal activity within a few days of the procedure.

90% of patients receiving Orthotripsy® with the OssaTron® received a benefit with only one procedure. Some patients have reported immediate pain relief after the procedure, although it can take up to four weeks for pain relief to begin.

What Is Plantar Fasciitis (heel pain syndrome)?
Each year over 40 million Americans suffer from "heel pain syndrome" often referred to as "heel spurs." The typical signs and symptoms for this problem are usually severe pain upon first arising in the morning. Resting provides only temporary relief. When you resume walking, particularly after a night's sleep, you may experience a sudden elongation of the fascia band, which stretches and pulls on the heel. As you walk, the heel pain may lessen or even disappear, but that may be just a false sense of relief. The pain often returns after prolonged rest. However, after sitting or resting later in the day then arising the severe heel pain returns. This intermittent pain often progresses to a daylong nagging pain. Conventional treatment for this extremely painful problem includes cortisone injections, use of custom made orthotics, use of non-steroidal anti-inflammatory medications such as Advil or Aleve, physical therapy and muscle stretching. Despite these techniques, the pain may persist for months or years.

Who Should Consider The OssaTron® Procedure?
The OssaTron® non-invasive surgical procedure is recommended for patients who have had chronic proximal plantar fasciitis 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 of orthotic 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.

Why Consider The OssaTron® Instead of Invasive 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 invasive surgery-usually with just one procedure and without the inherent risks, complications and lengthy recovery time of invasive 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.

Who Should Not Have The Ossa Tron® Procedure?
The OssaTron® is not recommended for:

• Anyone taking medications for bleeding problems or has a history of
  blood clotting problems
• Children
• Pregnant Woman

What Will Happen On The Day Of The Procedure?
Your doctor or healthcare facility will commonly ask you to arrive at the hospital or surgery center a few hours before your scheduled procedure. It is recommended that you should wear loose, comfortable clothing, no make-up, and no jewelry.

The staff may take your temperature, pulse and blood pressure, and ask some questions about your general health. They may also request that you sign a consent form, and indicate which foot is to be treated. The procedure can cause some discomfort or pain, so anesthesia is given before the procedure.

What Will Happen After The Procedure?
You’ll stay at the healthcare facility until the anesthetic wears off enough for you 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.

Pain relief begins for patients at different times. The full effect of the OssaTron® procedure may not be realized until the twelfth week. If you haven’t achieved any relief of pain by then, you may consider having a second OssaTron® procedure. This is a decision you will make with your physician.

What Are The Possible Side Effects/Complications?
The OssaTron® procedure 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 the procedure, 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.

Will My Insurance Pay?
Many health insurance companies nationwide are incorporating high-energy shockwave surgery with the OssaTron® into their policies. It is recommended that you ask your insurance provider if this 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 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?
Your doctor is the best person to talk with if you have questions or concerns about the OssaTron®. He or she has extensive knowledge and specialized training on all aspects of its use, safety and effectiveness.

What is Tennis Elbow?
Tennis Elbow (lateral epicondylitis) is a condition in which there is inflammation of the tendons (tendinitis) attached to the outside or lateral side, of the elbow. Patients with tennis elbow experience pain at the lateral aspect of the elbow that can radiate or travel into the forearm and occasionally the hand. The pain occurs with grasping activities and may be accompanied by a sense of weakness. An achy type of discomfort may also be present at rest or at night after activity. Once the tendons get inflamed, the condition can be difficult to get rid of because those tendons are used every time the hand grips or squeezes. Tennis Elbow is painful, but usually does not lead to serious problems. If the condition goes untreated or becomes severely painful, then loss of function and loss of motion at the elbow can develop. Treatment in these cases may require surgery.

What Causes Tennis Elbow?
Injury to these tendons can result from repetitive activity in which the tendons are essentially “overloaded” or “over stressed”. This situation can result from a variety of activities including sports and work or from a change in one’s regular activity. The “overload” or “over stressing” of tendons is commonly seen in someone who plays more tennis than usual, or from excessive use of a screwdriver, hammer, or performance of other activities requiring constant squeezing or gripping can lead to the problem.

Why Consider The OssaTron® Instead of Invasive Surgery?
Once your physician determines that your case of tennis elbow is not responding to conservative treatment, the OssaTron® non-invasive surgical solution may be recommended to resolve your pain. Many times, invasive surgery leads to the development of thick scar tissue and a recurrence of pain. Following invasive surgery, patients usually go home with their arm in a sling. The arm must be elevated and kept dry. Stitches are removed 5 to 7 days after surgery and motion is begun. The duration and type of rehabilitation depends on the type of invasive surgery performed. Most people cannot drive for a week. While return to daily activity is possible within 4 to 6 weeks, return to sports or heavy use of the arm can take several months.

The OssaTron® has a proven success rate that is equal to or greater than invasive surgery, usually with just one procedure and without the risks, complications, and lengthy recovery time of invasive surgery. The OssaTron® non-invasive surgical procedure requires a minimal amount of time and patients can go home the same day. Patients can return to normal activity within a few days of the procedure.

Who Should Consider The OssaTron® Procedure?
The OssaTron® non-invasive surgical procedure is recommended for patients who have had lateral epicondylitis for six months or more and who have failed at least three conservative (non-surgical) therapies without success.

Conservative (non-surgical) therapies include, but are not limited to:
• Modification of Activity
• Strapping
• Ice
• Wrist Braces
• Medication such as ibuprofen
• Medication such as ibuprofen
• Cortisone Injections
• Stretching and Strengthening

Who Should Not Have The OssaTron® Procedure?
The OssaTron® is not recommended for:

• Anyone 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 efficacy of the OssaTron® procedure has not been determined on people with the following health conditions:

• Severe Osteoarthritis
• Rheumatoid Arthritis
• Osteoporosis
• Metabolic Disorders
• Malignancies
• Osteomylitis
• Systemic Infection

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

What Will Happen On The Day Of The Procedure?
Your doctor or healthcare facility will commonly ask you to arrive at the hospital or surgery center a few hours before your scheduled procedure. It is recommended that you should wear loose, comfortable clothing, no make-up, and no jewelry.

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, and indicate which arm is to be treated. The treatment can cause some discomfort or pain, so anesthesia is commonly given before the procedure is administered.

What Will Happen After The OssaTron® Procedure?
You’ll stay at the healthcare facility until the anesthetic wears off enough for you to walk safely. Your doctor will probably ask you to restrict “stressful activity” such as tennis, hammering, or other activities for four weeks.

Pain relief begins for patients at different times. The full effect of the OssaTron® procedure may not be realized until the eighth week. If you haven’t achieved any relief of pain by then, you may consider having a second OssaTron® procedure. This is a decision you will make with your physician.

What Are The Possible Side Effects/Complications?
The OssaTron® procedure has minimal risks. In some cases it can cause skin reddening, bruising, tingling, or swelling at the treatment site.

Will My Insurance Pay?
Many health insurance companies nationwide are incorporating high-energy shockwave surgery with the OssaTron® into their policies. It is recommended that you ask your insurance provider if this 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 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?
Your doctor is the best source for information about the OssaTron®. Your doctor has extensive knowledge and specialized training on all aspects of its use, safety, and effectiveness. You may also find more information at www.ossatron.com