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Patient Education
Ossatron
A Highly-Effective, Non-Invasive Solution for Chronic Plantar Fasciitis
What Is The OssaTron®?
What Are The Expected Results? Is It Safe?
Who Should Consider The OssaTron®?
What Other Treatments are Available?
Why Consider The OssaTron® Instead of Invasive Surgery?
Who Should Not Have The OssaTron® Procedure?
What If You Have A Special Health Condition?
What Will Happen On The Day Of The Procedure?
What Will Happen After The Procedure?
What Are The Possible Side Effects/ Complications?
Will My Insurance Pay?
How Can I Get More Information?
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The OssaTron® is a high-energy shock wave system that provides a non-invasive surgical alternative for patients diagnosed with chronic proximal plantar fasciitis (severe heel pain). This non-invasive outpatient procedure represents a breakthrough for this condition.
Using a unique process known as Orthotripsy®, the OssaTron® emits high-energy shock waves, similar to those used to treat kidney stones, to increase blood flow and stimulate healing of the affected heel.
The OssaTron® is a non-invasive procedure - there are no scalpels, incisions or stitches. Patients can return to normal activity within a few days of the procedure.
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What Are The Expected Results?
Orthotripsy® with the OssaTron® has been proven to be effective over 80% of the time with only one procedure. Some patients have reported immediate pain relief, 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 device specifically designed and FDA approved for orthopaedic 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.
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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.
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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.
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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.
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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
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What If You Have A Special Health Condition?
The effect, safety, and efficacy of the OssaTron® has not 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
- 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.
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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.
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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.
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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.
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Many health insurance companies nationwide are incorporating high-energy shock wave surgery with the OssaTron® into their policies. It is recommended that you ask your insurance provider if this is a covered benefit. SANUWAVE 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.
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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.
