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Ossatron® for Elbow Pain

The Non-Invasive Surgical Alternative for Elbow Pain

Scientific Liturature

The OssaTron® is a high-energy shockwave device that provides a non-invasive surgical alternative for patients diagnosed with chronic lateral epicondylitis. This non-invasive out-patient procedure represents a breakthrough treatment for this condition.

Using a unique technology known as Orthotripsy®, the OssaTron® device emits a series of high-energy acoustic impulses (shockwaves) to stimulate healing of the affected elbow.

Is It Safe?

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

What are the Expected Results?

Orthotripsy® with the OssaTron® has been proven to be effective over 91% of the time with only one treatment.1 Pain relief typically begins within four weeks of the procedure and continues up through six months.

What are the Possible Side Effects or Complications?

Orthotripsy® has minimal risks. In some cases it may cause skin reddening, bruising, temporary numbness or tingling. In rare instances it may cause the lateral epicondyle to tear.

Why Consider Orthotripsy® Versus Surgery?

Orthotripsy® with the OssaTron® device has a proven success rate that exceeds that of open surgery. Orthotripsy® requires a minimal amount of time and patients can go home the same day the procedure is performed.

Most importantly, patients can continue to use their arm and return to normal activity within days of the procedure.

What if I Have a Special Health Condition?

The safety and effectiveness of the OssaTron® procedure has not yet been determined on people with the following health conditions. Your doctor will provide you with information about how these and other health conditions might affect the determination to perform the Orthotripsy® procedure:

  • Tarsal tunnel syndrome, or other nerve entrapment disorders
  • Diabetic neuropathy
  • Significant peripheral vascular disease
  • Severe osteoarthritis
  • Rheumatoid arthritis
  • Osteoporosis
  • Metabolic disorders
  • Malignancies
  • Paget’s disease
  • Osteomyelitis
  • Systemic infection
  • Anyone who is taking medication for bleeding problems, or has a history of bleeding or blood clotting problems should consult their doctor
  • This procedure is not recommended for pregnant women
  • This procedure is not recommended for children 

What Will Happen the Day of the Procedure?

You will be asked to arrive at the hospital or surgery center a few hours before your scheduled procedure. The staff may also need you to complete paperwork if you have not already done so.

Prior to administering anesthesia, the physician will palpate the elbow to determine the area of maximum tenderness (the target area) and mark the area with a surgical marking pen.

The procedure can cause discomfort or pain, so anesthesia is commonly given before the procedure.

You will stay at the hospital or surgery center for a short recovery period. You will receive post-operative instructions from your physician to follow during your recovery.

Will my Insurance Pay for the Procedure?

Many health insurance companies are incorporating high-energy Orthotripsy® procedures (CPT Code 0102T) into their medical policies. It is recommended that you ask your insurance provider if the procedure is a covered benefit.

Your doctor and the treating facility 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 are the strongest advocates in obtaining approval for insurance benefits. If you are denied coverage, you have the right to appeal that coverage decision to your insurance company's Medical Director.

Benefits of OssaTron® Orthotripsy®

Why is OssaTron® Orthotripsy® better than invasive surgeries?

Invasive surgical procedures permanently alter biomechanics by cutting part of the tendon. Non-invasive OssaTron® Orthotripsy® brings about a physiological change in the tendon without the complications of invasive surgery. This non-invasive procedure provides as effective or better results than the invasive surgery options, and results in a long term resolution. Most patients can return to work or activities of daily living within 24-48 hours after just one procedure, whereas open surgical procedures require patients to limit the use of the treated extremity for 4-8 weeks.

OssaTron® Results in Significant Patient Satisfaction

LATERAL EPICONDYLITIS (TENNIS ELBOW)

Tennis elbow is a syndrome characterized by pain over the outer aspect of the elbow. Pain can be aggravated by gripping, heavy lifting, or simple tasks of daily living and is a result of repetitive and cumulative injury. Symptoms are commonly associated with inadequate muscle power and endurance. Chronic patients are unresponsive to conservative care such as stretching, splints, injections, and anti-inflammatory medications and have had the condition for a minimum of 6 months.

Non-Invasive Surgery with the OssaTron® Invasive, Open, or Endoscopic Surgery
Patients are able to immediately have use of their arm post Orthotripsy®.
Patients are limited in the use of their arm for several weeks and have a period of immobilization.

Patients requiring bilateral Orthotripsy® can be treated in a single procedure, and return to work or activities of daily living the next day.

Surgical bilateral patients must have two separate procedures due to limitations on weight bearing and/or due to limitations on the use of their arm. Many patients must wait 6 to 12 months between procedures to allow for healing and rehab.

There is no incision with Orthotripsy®, and therefore no risk of infection, scarring, or post-operative bleeding.

Invasive procedures carry a risk of infection. Incisions lengthen the return to normal activities and are susceptible to ongoing tenderness and scarring.

Patients are able to resume strenuous activity, such as jogging, racquet sports, standing for long periods of time, repetitive job functions, etc. after only 4 weeks.

Surgical patients are just experiencing healing of their incision at 4 weeks and may require physical therapy before resuming certain activities. Bracing is often indicated with the elbow.

Patients are evaluated for success at 8-12 weeks, and less than 5% require a re-treatment.

Patients receiving invasive procedures may not see results until 5-10 months post treatment.

80% of chronic elbow patients demonstrated a benefit in clinical studies. Studies 5 years or more post treatment show that over 80% of patients retain their successful outcomes.

Studies on invasive procedures report only 50% to 71% patient satisfaction with outcomes. Potential for future biomechanical problems and infection is greatly increased with invasive procedures.

Orthotripsy® does not involve cutting so the biomechanics of the tendon are not adversely altered. Likewise, the non-invasive Orthotripsy® procedure does not narrow future treatment options like an open procedure could.

With the elbow, conditions such as extensor aponeurosis, detached or relaxed ligaments, invaginated scar tissue, etc. can occur.

  1. Shock Wave Therapy for Patients with Lateral Epicondylitis of the Elbow: A One to Two Year Follow-up Study, TheAmerican Journal of Sports Medicine, Vol. 30, No. 3, 2002. C. Wang, M.D.