The document discusses the Silent Hip prosthesis, including its design, a multicenter clinical study, and results from follow-up of patients. Key findings from the clinical study include low rates of complications, good functional outcomes according to Harris Hip Scores near 100, and no signs of prosthesis loosening or osteolysis seen on x-rays. The results provide support to continue a larger multicenter study of the Silent Hip prosthesis.

1. Abteilung Orthopädie und orthopädische Chirurgie Matthias Honl Silent Hip TM

2. Jugendliche Abenteuerlust Zurückhaltung Reife - zum Erfolg?! Die Silentprothese Gliederung

3. Benchmarker Mechanik Operationstechnik Klinische Studie mit 5-Jahres –Follow-Up Multicenterstudie Short stem ---- Resurfacing Reife - zum Erfolg?! Die Silentprothese Gliederung

5. Prospective Study: Patients: 593 patients age:

8. 1J 3J

10. 2J 3J

11. PROXIMAL FIXED ENDOPROSTHESES Cap prosthesis (Judet) - perspex cap

12. PROXIMAL FIXED ENDOPROSTHESES Bone-conserving hip system (Masini) - lateral threaded bolt - physiological load application...?? - question: primary stability?! - dared construction...!?

13. PROXIMAL FIXED ENDOPROSTHESES Kliefoth - Cap prosthesis - axial slide system - dynamic anchorage, lateral plate

14. PROXIMAL FIXED ENDOPROSTHESES MAYO - Conservative hip prosthesis

15. PROXIMAL FIXED ENDOPROSTHESES CFP - Collum Femoris Preserving (Peppino) not only proximal, but also distal fixation right left

16. PROXIMAL FIXED ENDOPROSTHESES ESKA - Femoral head prosthesis Type Cut - internal fixation

17. Silent-Design 1:

18. Silent-Design 6:

19. Finite Elements: TUHH Nick Bishop: (Patent Honl et al 1997)

20. SILENT CLASSIC SILENT PRO

22. Finite Elemente: Southampton - Andrew New:

23. Wie messe ich Relativbewegung

24. Implantation 1 2 4 3

25. Mechanische Messung Messung von Migration und Microbewegung

26. MTS Bionix 858 Zyklen 1000 Lasthöhe (Bergmann, 1993) Kraft 50 - 2100N Torsion max 18Nm Frequenz 2 Hz Belastungsrichtung - axial und torsional simultan Versuchsaufbau MTS

27. Methode Migration — Relativbewegung: z y x rechts

29. Ergebnis Translations- Relativbewegung 0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 Zyklen [#] 0.00 0.10 0.20 0.30 0.40 0.50 0.60 0.70 Translation [mm] 50 100 500 1000 50 100 500 1000 50 100 500 1000 50 100 500 1000 50 100 500 1000 IPS IPS IPS CFP Silent TPP DSP MAYO MAYO CUT CUT Anwendertagung 2002

30. Ergebnis Translations- Migration 0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 1.80 0.00 0.20 0.40 0.60 0.80 1.00 1.20 1.40 1.60 1.80 Translation [mm] Zyklen [#] 0-50 50-100 100-500 500-1000 0-50 50-100 100-500 500-1000 0-50 50-100 100-500 500-1000 0-50 50-100 100-500 500-1000 0-50 50-100 100-500 500-1000 IPS Silent DSP MAYO CUT

31. Methode: Implantation:

32. Methode Präparat Fixation: 10° Add., 10° Flex.

33. Methode Marker Fixation

34. Methode Kalibration

35. Prosthese Knochen Methode Coordinate Systems:

36. 0,00 0,05 0,10 0,15 0,20 0,25 0,30 0,35 100 500 1000 2000 5000 7500 10000 Zyklen Ergebnis Translations-Relativbewegung: TPP Silent TPP Silent

37. Ergebnis Rotations Relativbewegung: 0,00 0,10 0,20 0,30 0,40 0,50 0,60 100 500 1000 2000 5000 7500 10000 TPP Silent TPP Silent

38. 0,0 0,2 0,4 0,6 0,8 1,0 1,2 1,4 1,6 1,8 0-100 100-500 500-1000 1000 -2000 2000 -5000 5000 -7500 7500 -10000 Ergebnis Translational Migration: TPP Silent

39. 0,0 0,2 0,4 0,6 0,8 1,0 1,2 1,4 1,6 0-100 100-500 500-1000 1000 -2000 2000 -5000 5000 -7500 7500 -10000 950-500 Ergebnis Rotations- Migration: TPP Silent TPP Silent

40. Messen der Strecke zwischen Tuberculum Innominatum und dem Punkt bei dem die Prothesenlängsachse die laterale Femur- corticalis schneidet Präoperative Planung Schritt 4:

46. Navigation:

47. Austria Matthias Honl Germany Andreas Kurth Germany Uni Magdeburg Australia Dr Jim Sullivan Australia Dr Craig Waller Australia Dr Richard Verheul UK Mr Marci Maheson Ireland Professor Eric Masterson Italy Professor Pace US Dr Meere US Dr Buly France Dr Judet Dr. Piriot

48. A non-comparative, two centre, EN540, RSA, pilot study to evaluate the stability, efficacy and safety of the Silent Hip prosthesis in primary total hip replacement: 30 Patients Hamburg 18 Patients Sydney 12 Month ------------Multicenter

49. RSA Roentgenstereophotogrammetrie Analyse

53. Medial / Lateral Translation 0 0.1 0.2 0.3 0.4 0.5 0 200 400 600 800 days post-op mm Proximal/Distal Translation -0.7 -0.6 -0.5 -0.4 -0.3 -0.2 -0.1 0 0 200 400 600 800 days post-op mm RSA Data – Subject 1.16 Varus/Valgus Rotation (-ve indicates Varus) -3 -2.5 -2 -1.5 -1 -0.5 0 0 200 400 600 800 days post-op degrees

54. Silentprothese mit Tantalumbeats zementfreie Pfanne Keramik-Keramik-Gleitpaarung anterolateralen Zugang (DE) posterioren Zugang (AU) Material und Methode

55. Patienten 42 Patienten (Alter 51±14 J)

56. Patienten Indikation:

57. Periprothetisch wurde das Femur mit insgesamt 7 Tantalumkugeln markiert

58. Thrombosis/lung embolism (n=0) Infection (n=0) Prolonged wound healing (n=1) Revision of the silent stem (n=0) Revision of the cup - directly postop (n=2): 1 due to malpositioning of the cup 1 due to acetabular floor fracture 1 small fracture of lateral cortex (n=1), therefore no weight bearing for 6 weeks postop (3 month follow-up: on x-ray stem well integrated, Harris Score: 88) Ergebnis Komplikation:

59. Ergebnis Harrisscore:

60. Ergebnis Harrisscore:

61. In one case evidence of prothesis to bone radiolucency in zone 1 (0,8x20mm), otherwise no sign of stem-loosening. no evidence of stem loosening - Harris-Score 6m postop. 100 increase of bone density in zone 5 as a prove of proximal load transfer. Ergebnis X-ray findings:

62. Radiographic Appearance – Subject 1.16 Post-op 6 months 12 months Maximum clinical score at 2y and patient score at 4y Radiographic appearance remains stable at 5 years

70. Radiographic Performance Post-op 18 months No progressive femoral radiolucencies Increased bone density in the calcar region

71. 5 Year (Subject 2.01) Immediate post-op 5 years follow-up

76. 5 Year Radiographic (Subject 2.02) Immediate post-op 5 years follow-up

77. Röntgenstereo- photogrammetrie Ergebnis

78. Röntgenstereo- photogrammetrie Ergebnis

80. Fazit: Ergebnisse Grundlage für Multicenterstudie Jetzt sind 120 Patienten eingeschlossen Kleines Implantat Ein Bauteil Eine Geometrie Ein mechanisches Prinzip Kleines Instrumentenset Kleine Zugänge Geringe Operationszeit

82. Was ist die Gefahr Fehlende Primaerstabilitaet Lockerung === Bewegung zwischen Knochen und Prothese

87. Second Phase Study: Design Objectives: demonstrate safety and efficacy for CE marking assess transferability of the surgical technique to a wider group of surgeons Inclusion criteria widened from Pilot Study removal of 95kg weight limit removal of exclusion criteria for anatomical CCD angles of less than 125 o widened bearing choice to include large MoM Study population includes DEXA cohort

88. Second Phase Study: Population 7 sites, 8 surgeons: Australia (3), France (2), UK (1), Italy (1), Germany (1) Recruitment May 2005 – October 2008: total 100 hips implanted 67 male, 32 female Primary diagnosis: 83% OA, 8% DDH, 5% osteonecrosis, 1% SFE, 1% fracture 68% Charnley A, 32% Charnley B Mean age at surgery 52.6 years (range 20-68) Mean BMI 27.2 (range 18-40)

89. Results Summary 95 subjects remain available for follow up to date Mean follow up: 1.1 years (range 3 months – 3 years) Mean Harris Hip Score from last available assessment: 95.4 Mean Oxford Hip Score from last available assessment : 14.5 Radiographic performance is tracking the implant stability demonstrated in the pilot study Interim analysis of DEXA results planned when all 35 subjects in the cohort pass 1 year (due end 2009)

90. Radiographic Performance Immediate Post Op 2 years

91. Complications 4 revisions of Silent TM Hip: 3 fractures, 1 deep infection: none directly related to the Silent TM Hip No acetabular/femoral head revisions A review of these cases by an Independent surgeon concluded that these failures were further to a combination of sub optimal patient selection and surgical technique

92. LKH Klagenfurt NEU 16.1.2007