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