1. Extracorporeal Shockwave Therapy (ESWT) for Bone Indications Extracorporeal Shockwave Therapy (ESWT) for Bone Indications W. Schaden Trauma Center Meidling / Vienna Ludwig Boltzmann Institute for Experimental and Clinical Traumatology www.shockwavetherapy-vienna.at

2. Chronic tendinopathies: Plantar fasciitis with or without heel spur Achilles tendon Radial epicondylopathy (tennis elbow) Rotator cuff with or without calcification Patella tendon Greater trochanteric pain syndrome Impaired bone healing function: Delayed bone healing, pseudarthroses Stress fractures Early stage of avascular bone necrosis (native X-ray without pathology) Early stage osteochondritis dissecans (OD) post-skeletal maturity Approved standard indications (ISMST-Website)

3. First publication 1991 (Valchanov et al./ Bulgaria) 26 articles basic research 55 articles animal trials 68 articles clinical trials published in peer reviewed journals proving the osteogenetic effects of ESWT ESWT in Delayed Bone Healing - EBM

5. Furia (2010)

6. 43 patients with a fracture non-union of the fifth metatarsal (Jone´s fracture) (Jone´s fracture) 23 patients received high-energy ESWT (single session) + plaster cast 20 patients received intramedullary screw fixation + plaster cast Methods:

7. ESWT: 21/23 healed Surgery: 18/20 healed Results: ESWT: 1 (petechial bleeding) Surgery: 11 (1 re-fracture, 1 infection, 9 symptomatic hardware) Complications:

9. 1 ( Dornier Epos Ultra 0.40 mJ/mm 2 )  Group 1 ( Dornier Epos Ultra 0.40 mJ/mm 2 ) – 4 sessions at 1-week intervals in regional anesthesia (outpatient) – Cast immobilization for six weeks if possible – Return to pre-treatment weight-bearing status within 3 days mJ/mm 2 ) Group 2 (Storz Modulith; 0,70 mJ/mm 2 ) – – 4 sessions at 1-week intervals in regional anesthesia (outpatient) – – Cast immobilization for six weeks if possible – – Return to pretreatment weight-bearing status within 3 days Group 3 surgical revision Group 3 surgical revision – Removal of the previous implant – Decortication of the fracture site – Removal of interposed soft tissue – Recanalizing of the intramedullary canal – Reduction of the fracture – Re-osteosynthesis (10x Plate; 13x Nailing; 12x Nailing + Graft; 7x Ext. Fix.) – Application of a cancellous bone graft – Partial weight-bearing for 6 - 12 weeks

10. Radiographic Outcome At six months: 70%, 71%, and 74% had healed. At twenty-four months: 94%, 92%, and 95% had healed. At twelve months: 84%, 82%, and 87% had healed. The primary end point of this study was healing of the nonunion as determined with an independent and blinded radiographic assessment at six months. A nonunion was judged to be healed when callus bridged the nonunion site on all four cortices (X-ray or CT scan).

11. At three and six months, the PAIN score (VAS), and the FUNCTION scores (DASH, LEFS) were significantly better after shock-wave groups than after revision surgery. At twelve and twenty-four months, the differences between these groups were no longer significant. Clinical Outcome

12. Side effects - complications  Shockwave groups 1 + 2 – 23 / 84 superficial haematoma, petechial bleeding  Surgical revision group – 2 / 42 superficial infection – 1 / 42 deep infection – 1 / 42 temporarily paresis of radial nerve – 9 / 42 chronic pain at the donor site

13. Summary ESWT versus Surgery: o Comparable healing rate o Less and less severe complications in ESWT group o Shorter sick leave o Earlier back to every day life, work and sport o Significant less costs

14. ESWT for Bone Pathologies ESWT for bone pathologies is performed with focused, high energy shockwaves (electro-magnetic or electro-hydraulic) using big focus (big devices). Usually the therapy requires sedation or anesthesia.

15. Application for Bone pathologies electro-hydraulic/(electro-magnetic) Energy flux density: 0,3 – 0,4 mJ/mm 2 (0,4 – 0,6) Frequency: 1 – 5 Hz Number of pulses: 2000 – 4000 (3000 – 6000) Focus: focused, („big devices“) Number of treatments: 1 (2 - 4)

16. Conditions for ESWT of non-unions  Trained physician  Correct anatomic position  X-ray (positioning of the focus)  Stability after ESWT  Non-Union gap < 5 mm (for long bones)

17. Follow-up treatment Follow-up treatment after ESWT should follow the rules of conservative fracture treatment: avoid micro movements in the non-union gap for 3 to 5weeks o physical rest (stable osteosynthesis), o immobilization (plaster cast, orthotics, etc.), o no weight bearing, o external fixator

18. X-ray control without danger of fragment dislocation: o every four weeks (like after bone grafting) o up to 12 weeks: clinical symptoms more valid than x-ray o in case of doubt: CT!! o definitive result after 6 months (long bone) No bony healing after 12 to 16 weeks: o 2 nd ESWT (Progression in X-ray/CT) o surgery Follow-up treatment

19. Contra - Indications 1. alveolar tissue in the focus 2. malignant tumor in the focus 3. severe coagulopathy 4. epiphyseal plate in the focus 5. brain or spine in the focus 6. acute infection? 7. pregnancy?

20. After a series of pilot trials in 1998 a department for ESWT was established in the Trauma Center Meidling, Vienna. Since then more than 3500 patients with delayed and non healing fractures have been treated with ESWT with different technologies.

21. 64 (8,1%) „drop outs“ (no information for longer than one year) n = 725 243 (34%) female 243 (34%) female 482 (66%) male 482 (66%) male mean age: 49,1 years (10 - 91) mean age: 49,1 years (10 - 91) mean age of the non-union: 11,7 months mean age of the non-union: 11,7 months 77 referring hospitals

22. regionnumberhealedfailure humerus 75 (10%) 75 (10%) 49 (65%) 49 (65%) 26 (35%) 26 (35%) radius 41 ( 6%) 41 ( 6%) 36 (88%) 36 (88%) 5 (12%) 5 (12%) ulna 61 ( 8%) 61 ( 8%) 47 (77%) 47 (77%) 14 (23%) 14 (23%) scaphoid 30 ( 4%) 30 ( 4%) 17 (57%) 17 (57%) 13 (43%) 13 (43%) hand 24 ( 3%) 24 ( 3%) 23 (96%) 23 (96%) 1 ( 4%) 1 ( 4%) pelvis 17 ( 2%) 17 ( 2%) 12 (71%) 12 (71%) 5 (29%) 5 (29%) femural neck 5 ( 1%) 5 ( 1%) 4 (80%) 4 (80%) 1 (20%) 1 (20%) femur 138 (19%) 138 (19%) 107 (78%) 107 (78%) 31 (22%) 31 (22%) tibia 207 (29%) 207 (29%) 185 (89%) 185 (89%) 22 (11%) 22 (11%) Arthrodesis 28 ( 4%) 28 ( 4%) 18 (64%) 18 (64%) 10 (36%) 10 (36%) fibula 29 ( 4%) 29 ( 4%) 25 (86%) 25 (86%) 4 (14%) 4 (14%) Foot 70 (10%) 70 (10%) 64 (91%) 64 (91%) 6 ( 9%) 6 ( 9%) total 725 (100%) 725 (100%) 587 (81%) 138 (19%)

23. Quality of the non-union qualitynumberhealedfailureatrophic 510 (70%) 407 (80%) 103 (20%) 103 (20%) hypertrophic 189 (26%) 160 (85%) 29 (15%) 29 (15%) infected 26 ( 4%) 26 ( 4%) 20 (77%) 20 (77%) 6 (23%) 6 (23%) total 725 (100%) 725 (100%) 587 (81%) 138 (19%)

24. Complications: 0 temporary (side)effects: swelling, hematoma, petechial bleeding

25. A. W. UM: 2266/04 36 years old, male 9 months after trauma => ESWT + Plaster 4 weeks

26. 10 weeks after ESWT A. W. UM: 2266/04 36 years old, male

27. 17 basic research 12 clinical trials 1 review article published in peer reviewed journals proving the efficacy of ESWT in AVN ESWT in Avascular Bone Necrosis (AVN) - EBM

29. Patient Enrollments 48 patients (57 hips) Shockwave group: 23 patients (29 hips) Surgical group: 25 patients (28 hips) Both groups showed similar demographic characteristics.

30. The Dosages of Shockwave Each of the patients was treated with 4000 - 6000 impulses of high-energy shockwaves at 28 KV (0.4 mJ/mm 2 energy flux density) in a single treatment.

31. Surgical Treatment Core decompression and bone grafting of the hip (2-A) (2-B) Cancellous bone grafts Bone channel

32. Evaluation Parameters Follow-up examinations: 1, 3, 6, and 12 months, once a year Clinical assessment: pain score (VAS), Harris hip score (HHS), activities of daily living (ADL) and work activities of daily living (ADL) and work capacity capacity X-rays: 3, 6 and 12 months and then yearly MRI: 6 and 12 months and then once a year (MRI were not performed in hips showing gross radiographic deterioration.)

33. Results (P < 0.001) Pain Score Before and After Treatment

34. (P < 0.001) Results Harris Hip Score Before and After Treatment

35. Overall Clinical Outcomes Total cases ARCO IARCO IIARCO III SW Gr. Surg. Gr SW Gr. Surg. Gr. SW Gr. Surg. Gr. SW Gr. Surg. Gr. Number of hips 2928321017169 Improved 79% (23 of 29) 29% (8 of 28) 100% (3 of 3) 50% (1 of 2) 80% (8 of 10) 36% (6 of 17) 75% (12 of 16) 12% (1 of 9) Unchanged11% (3 of 29) 36% (10 of 28) 0% (0 of 3) 50% (1 of 2) 10% (1 of 10) 42% (7 of 17) 13% (2 of 16) 23% (2 of 9) Worsened11% (3 of 29) 36% (10 of 28) 0% (0 of 3) 0% (0 of 2) 10% (1 of 10) 30% (5 of 17) 13% (2 of 16) 56% (5 of 9) THI10% (3 of 29) 32% (9 of 28) 0% (0 of 3) 0% (0 of 2) 10% (1 of 10) 24% (4 of 17) 13% (2 of 16) 56% (5 of 9) P-value <0.001 (Chi Square)

36. Primary and Secondary End-points Primary end-point: need for THI 10% (3 of 29 hips) in the shockwave group 32% (9 of 28 hips) in the surgical group Secondary end-point: VAS, Harris Hip Score and ADL significant improvements (P < 0.001) in shockwave group not significant improvements (P = 0.116) in surgical group The hip function after treatment was significantly different between the two groups favoring the shockwave group (P < 0.001).

37. ESWT: 76% good and fair; 24% poor Surgery: 21% good and fair; 79% poor Biomed J ; Vol.35; No.6; 481-485; December 2012 THR ESWT: one year: 3%; two years: 10%; 8-9 years: 24% THR Surgery: one year: 21%; two years: 32%; 8-9 years: 64% Significant differences in pain and Harris Hip Scores at all follow-up visits in favor of the ESWT-group There was a trend of decrease in size of the lesion in the ESWT-group compared to surgical group. Conclusion: ESWT seems to be more effective than core decompression and bone grafting for early ONFH with 8 to 9 years long-term follow-up