hta_ knee intro.qxp - Ministero della Salute

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pared to those from a single region in which surgical practice (and maybe outcomes) are more
likely to be similar. The study of how contextual variables (e.g. number of procedures performed
by the surgeon or by the hospital) affect the outcomes in orthopaedic prosthetic surgery is not
part of the objectives of the present HTA report. However, this research question is being addressed
by the national research project, “Strumenti e metodi per il governo dei processi di innovazione
tecnologica, clinica ed organizzativa nel Servizio Sanitario Nazionale – Un sistema integrato di
ricerca” coordinated by Agenas and currently underway.
Table 7.17: Revision rates of cemented knee systems by implant model at 5 years of follow-up.
Estimates were calculated using Australia (AU) and Emilia-Romagna (ER) register data.
Knee system (cemented)
Level of
evidence
Total obs.
in patients
aged 50 years
and over
Source 5-years revision rate (95% CI)
ADVANCE (WRIGHT) 2 registers 1,029 AU (521 obs.); ER (508 obs.) AU = 6.6 (4.6; 9.4) ER = 3.3 (0.8; 5.7)
AGC (BIOMET) 2 registers 3,076 AU (2,605 obs.); ER (471 obs.) AU = 3.0 (2.3; 4.0) ER = 1.8 (0.2; 3.4)
GENESIS II (SMITH & NEPHEW) 2 registers 10,587 AU (9,726 obs.); ER (861 obs.) AU = 3.4 (2.9; 3.9) ER = 1.5 (0.3; 2.7)
LCS (DEPUY) 2 registers 4,278 AU (4,040 obs.); ER (238 obs.) AU = 4.9 (4.2; 5.7) ER = 4.1 (1.5; 6.8)
NEXGEN CR (ZIMMER) 2 registers 7,339 AU (7,013 obs.); ER (326 obs.) AU = 1.7 (1.3; 2.2) ER = 0.4 (0.0; 1.2)
NEXGEN LPS (ZIMMER) 2 registers 6,222 AU (3,742 obs.); ER (2,480 obs.) AU = 2.8 (2.2; 3.4) ER = 2.0 (1.4; 2.6)
PROFIX (SMITH & NEPHEW) 2 registers 7,123 AU (3,425 obs.); ER (3,698 obs.) AU = 3.8 (3.1; 4.7) ER = 2.4 (1.7; 3.1)
SCORPIO (STRYKER) 2 registers 5,663 AU (5,045 obs.); ER (618 obs.) AU = 3.5 (2.9; 4.3) ER = 1.7 (0.6; 2.8)
BALANSYS (MATHYS) 1 register 227 AU (227 obs.) 3.3 (1.4; 7.8)
DURACON (STRYKER) 1 register 8,039 AU (8,039 obs.) 3.1 (2.7; 3.6)
DURACON II (STRYKER) 1 register 205 ER (205 obs.) 2.6 (0.4; 4.8)
ENDOMODEL (LINK) 1 register 199 ER (199 obs.) 1.2 (0.0; 2.8)
GENESIS II O. (SMITH & NEPHEW) 1 register 6,049 AU (6,049 obs.) 4.5 (3.5; 5.6)
GKS PRIME (PERMEDICA) 1 register 242 ER (242 obs.) 1.8 (0.0; 3.8)
HLS NOETOS (TORNIER) 1 register 232 ER (232 obs.) 1.0 (0.0; 2.3)
NATURAL KNEE (ZIMMER) 1 register 1,149 AU (1,149 obs.) 1.8 (1.1; 3.0)
NEXGEN LPS-FLEX (ZIMMER) 1 register 6,449 AU (6,449 obs.) 3.3 (2.5; 4.2)
OPTETRAK (EXACTECH) 1 register 577 ER (577 obs.) 2.8 (0.8; 4.7)
P.F.C. SIGMA (DEPUY) 1 register 8,775 AU (8,775 obs.) 2.7 (2.2; 3.3)
RBK SYSTEM (G.M.T.) 1 register 605 AU (605 obs.) 3.1 (1.7; 5.7)
ROTAGLIDE+ (CORIN) 1 register 385 ER (385 obs.) 2.9 (1.1; 4.7)
Key: obs. = number of observations; CI = confidence interval; O. = Oxinium; G.M.T. = Global Manufacturing
Technology.
The horizontal black line indicates lack of overlap (portion below) by prostheses with other registry data.