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Use of Extracorporeal Shock Wave Treatment (ECSWTT) for Orthopedic Indications

Use of Extracorporeal Shock Wave Treatment (ECSWTT) for Orthopedic Indications. Orthospec.

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Use of Extracorporeal Shock Wave Treatment (ECSWTT) for Orthopedic Indications

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  1. Use of Extracorporeal Shock Wave Treatment (ECSWTT) for Orthopedic Indications

  2. Orthospec The Orthospecorthopedic shock wave device provides a non-surgical, non-invasive alternative for patients suffering from pathological bone and joint conditions, calcification and diseases of the tendon. This method of treatment is proving increasingly popular with patients and physicians alike. Over 100,000 cases worldwide have been treated with shock wave therapy for orthopedic ailments.

  3. History and Background • 1980: first clinical use of ECSWT lithotripsy for renal calculi (Chaussy et al, 2:1265, 1980) • 1984: first ECSWT lithotripter for renal calculi approved by FDA • 1986: first use of ECSWT treatment for tissue healing in skin grafts (Haupt and Chavpil, J. Surg. Re., 49:45, 1990) • 1991: first clinical use of ECSWT treatment for nonunion fractures (Valchanou and Michailov, Internat. Ortho. 15:181-184, 1991)

  4. Definition and Characterization of Shock Waves • A shockwave is a sonic pulse • High peak pressure(500 bar) • Short Life Cycle (10 ms) • Fast Rise Time (<10 ns) • Broad Frequency spectrum (up to 20MHZ) • Direct Mechanical Force(Primary Effect) • Indirect Mechanical Force (Secondary Effect) • Water Jet Phenomena

  5. Formation of A Shockwave When an electrical charge is produced inside of the water-filled ellipsoid; there are two reactions which occur inside the treatment head. There is and initial expansion of the water molecules (direct effect/positive pressure of the shockwave); followed by an implosion of the water molecules (indirect effect/negative pressure/tensile wave).

  6. How do shockwaves travel? • The shock waves that are produced in a water medium reflect off the interior walls of the ellipsoid and converge at a second focus, known as F2 • F2 is positioned to be at the treatment location

  7. ECSWT • The shockwaves are not hindered by water or high water content tissues due to the fact that the acoustic impedance of water and most soft tissues of the body are similar • Therefore, shockwave energy passes through soft tissues relatively unobstructed without damaging the tissue

  8. Types of Shockwaves • Electrohydraulic – high energy (.20mj/mm2 < ) • Incorporates an electrode submerged in a water-filled housing composed of an ellipsoid & a patient interface. Shock wave generated by an electrical spark. • Electromagnetic – medium energy (~.12mj/mm2 > 20mj/mm2 ) • Uses an electromagnetic coil & an opposing metal membrane. Electromagnetic forces induce a slow & low acoustic pulse focused by an acoustic lens. • Piezoelectric – low energy (> ~.12mj/mm2) • Formacoustical wavesby mounting piezoelectric crystals to a spherical surface. High voltage pulse is applied & focused by the geometric shape of the sphere.

  9. Electrohydraulic Highest Positive Pressure and highest total energy at all power settings Treatment area becomes larger as power increases Because treatment area becomes larger, the amount of energy delivered in a mm2 has minimal variability as energy levels increase allowing the delivery of the highest total energy at all settings in a safer concentration Electromagnetic Positive pressure is under one half the strength of electrohydraulic at same power settings Treatment area becomes smaller as power increases Because treatment area narrows as energy levels increase, the energy in a mm2 becomes rapidly concentrated to above therapeutic levels1. Differences in Shockwave Parameters 1Rompe, JD et al, Dose-related effects of shock waves on rabbit tendo Achillis. A sonographic and histological study. J Bone Joint Surg BR 1998 May; 80(3):546-52

  10. Biological Effects • Disruption of cell membranes • Neovascularization • Stimulate osteoblasts, chondroblasts, macrophages

  11. Possible Mechanisms of Healing Fracture Healing • Microfracture; disruption of sclerotic bone (Haupt, Chvapil; 1990) • Subperiosteal hemorrhage, stimulation of healing (Delius et al, 1995) Tendinopathies • Microhemorrhage; thrombus formation, stimulation of healing (Drach et al, 1992)

  12. Inclusion Criteria: Chronic Heel Pain Syndrome Study • Pain over origin of plantar fascia on medical calcaneal tuberosity • Minimum 6 months duration of symptoms • Failure to respond to 3 prior courses of noninvasive treatment (e.g., NSAID’s, orthotic device, PT/stretching exercises) • Potential surgical candidate

  13. Exclusion Criteria: Chronic Heel Pain Syndrome • Rule out vascular insufficiency or complicating neuropathy • Rule out fracture, osteo- or rheumatoid arthritis, malignancy

  14. Primary Evaluation Parameters: Chronic Heel Pain Syndrome Study • Investigator’s assessment of point tenderness, affected heel (10cm VAS) • Subject’s assessment of pain, affected heel (10cm VAS) • Subject’s assessment of activity • Pain medication requirements

  15. Treatment Protocol: Chronic Heel Pain Syndrome Study • Localize treatment area • Anesthesia - heel block • 1500 shocks at 18 kV • May repeat treatment if failure to respond at 3 months

  16. Success Criteria: Chronic Heel Pain Syndrome Study • Physician Assessment/Patient Self-Assessments: Improvement > 50% and VAS < 5.0 • No pain medications or anti-inflammatory medications • No adjunct treatments or interventions

  17. COMPLICATIONS: Heel Pain Pivotal Study • Overall complication rate = 4.7% • Primarily localized bruising at treatment site • Symptoms were mild and transient in nature

  18. Indications • Plantar fasciitis • Tennis elbow • Jumpers knee • Calcifictendinits shoulder • Achilles tendinopathy • Stress fractures • Non unions • Avascular necrosis • Peyronies

  19. Indications for Orthotripsy • Six months or more of symptoms • Proper diagnosis by treating physician to rule out other heel pain conditions • Failure of at least three conservative treatments • Patient is a candidate for invasive surgery

  20. Non Operative Treatment • NSAIDS • U/S • Ice • Rest • Steroids • Orthotics

  21. CONTRAINDICATIONS: • Pediatric patients with an open physis • Pregnant patients • Significant PVD • Severe osteoporosis • Rheumatoid arthritis • Diabetic neuropathy • Tarsal tunnel syndrome/nerve entrapment syndromes

  22. ADDITIONAL CONTRAINDICATIONS: • Fracture of the calcaneus • Metabolic disorders • Malignancies • Paget’s disease • Osteomyelitis • Systemic infections • Patients with bleeding disorders

  23. Patient Pre-op Instructions: • Patient must d/c NSAIDs or ASA at least 3 days prior to the procedure. • Bring running shoes to the surgery center

  24. Treatment Protocol • Prior to Anesthesia Physician localizes treatment area - point of maximum pain and marks area on heel • Patient receives anesthesia - Type of anesthesia is at physician’s discretion • 1500 shocks at 18 kV are administered

  25. Discharge Orders: • The patient is transported to the recovery room. • After recovery from anesthesia patient can ambulate and weight bear immediately. • DO NOT allow the patient to take any NSAIDs post-op for 12-16 weeks. • The patient may take Tylenol post-op.

  26. Indications for Use Heel Pain Syndrome • FDA Approved October 12th, 2000 Chronic Lateral Epicondylitis • FDA Approved March 18th, 2003

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