RESUMEN
This paper offers a summary of the ethical guide for the European orthopaedic community; the full report will be published in the EFORT Journal.
Asunto(s)
Ortopedia/ética , Investigación Biomédica/ética , Ética Médica , Europa (Continente) , Humanos , Consentimiento Informado/ética , Relaciones Interprofesionales/ética , Ortopedia/normas , Guías de Práctica Clínica como Asunto , Apoyo a la Investigación como Asunto/éticaRESUMEN
OBJECTIVE: To assess revision rates after knee arthroplasty by comparing the cumulative results from worldwide clinical studies and arthroplasty registers. We hypothesised that the revision rate of all clinical studies of a given implant and register data would not differ significantly. METHODS: A systematic review of clinical studies in indexed peer-reviewed journals was performed followed by internal and external validation. Parameters for measurement of revision were applied (Revision for any reason, Revisions per 100 observed component years). Register data served as control group. RESULTS: Thirty-six knee arthroplasty systems were identified to meet the inclusion criteria: 21 total knee arthroplasty (TKA) systems, 14 unicondylar knee arthroplasty (UKA) systems, one patello-femoral implant system. For 13 systems (36%), no published study was available that contained revision data. For 17 implants (47%), publications were available dealing with radiographic, surgical or technical details, but power was too weak to compare revision rates at a significant level. Six implant systems (17%) had a significant number of revisions published and were finally analysed. In general, developers report better results than independent users. Studies from developers represent an overproportional share of all observed component years. Register data report overall 10-year revision rates of TKA of 6.2% (range: 4.9-7.8%), rates for UKA are 16.5% (range: 9.7-19.6%). CONCLUSION: Revision rates of all clinical studies of a given implant do not differ significantly from register data. However, significant differences were found between the revision rates published by developers and register data. Therefore the different data need to be interpreted in the context of the source of the information.
Asunto(s)
Artroplastia de Reemplazo de Rodilla/estadística & datos numéricos , Ensayos Clínicos como Asunto/estadística & datos numéricos , Sistema de Registros/estadística & datos numéricos , Reoperación/estadística & datos numéricos , Artroplastia de Reemplazo de Rodilla/clasificación , Artroplastia de Reemplazo de Rodilla/instrumentación , Salud Global , Humanos , Evaluación de Resultado en la Atención de Salud , Falla de Prótesis , Edición/estadística & datos numéricosRESUMEN
A comprehensive study of cholesterol, bile acid, and lipoprotein metabolism was undertaken in two strains of hamster that differed markedly in their response to a sucrose-rich/low fat diet. Under basal conditions, hamsters from the LPN strain differed from Janvier hamsters by a lower cholesterolemia, a higher postprandial insulinemia, a more active cholesterogenesis in both liver [3- to 4-fold higher 3-hydroxy 3-methylglutaryl coenzyme A reductase (HMG-CoAR) activity and mRNA] and small intestine, and a lower hepatic acyl-coenzyme A:cholesterol acyltransferase activity. Cholesterol saturation indices in the gallbladder bile were similar for both strains, but the lipid concentration was 2-fold higher in LPN than in Janvier hamsters. LPN hamsters had a lower capacity to transform cholesterol into bile acids, shown by the smaller fraction of endogenous cholesterol converted into bile acids prior to fecal excretion (0.34 vs. 0.77). In LPN hamsters, the activities of cholesterol 7alpha-hydroxylase (C7OHase) and sterol 27-hydroxylase (S27OHase), the two rate-limiting enzymes of bile acid synthesis, were disproportionably lower (by 2-fold) to that of HMG-CoAR. When fed a sucrose-rich diet, plasma lipids increased, dietary cholesterol absorption improved, hepatic activities of HMG-CoA reductase, C7Ohase, and S27OHase were reduced, and intestinal S27OHase was inhibited in both strains. Despite a similar increase in the biliary hydrophobicity index due to the bile acid enrichment in chenodeoxycholic acid and derivatives, only LPN hamsters had an increased lithogenic index and developed cholesterol gallstones (75% incidence), whereas Janvier hamsters formed pigment gallstones (79% incidence). These studies indicate that LPN hamsters have a genetic predisposition to sucrose-induced cholesterol gallstone formation related to differences in cholesterol and bile acid metabolism.
Asunto(s)
Ácidos y Sales Biliares/metabolismo , Colelitiasis/metabolismo , Colesterol/metabolismo , Lipoproteínas/metabolismo , Sacarosa/toxicidad , Animales , Secuencia de Bases , Sistema Biliar/metabolismo , Colelitiasis/genética , Colesterol/sangre , Cricetinae , Cartilla de ADN , Vesícula Biliar/metabolismo , Predisposición Genética a la Enfermedad , Cinética , Metabolismo de los Lípidos , Lípidos/sangre , Lipoproteínas/sangre , Masculino , Mesocricetus , Receptores de Lipoproteína/metabolismo , Especificidad de la EspecieRESUMEN
Cholesterol precipitation from supersaturated bile is the earliest and determinant step in the formation of cholesterol gallstones, which is thought to be diet-dependent. Bile composition, appearance and growth of cholesterol crystals were studied in fresh gall-bladder biles from pigs adapted to four different protein-containing diets over 3 weeks: 160 g dietary protein/kg as casein (C16; n 6), or as soyabean-protein concentrate (S16; n 6), or a mixture of both protein sources (casein-soyabean protein, 70:30, w/w) (CS16; n 6), or 320 g of the mixed protein/kg (CS32; n 6). Moreover, all four diets contained 3 g cholesterol/kg and 50 g beta-cyclodextrin/kg as modifiers of bile composition towards cholesterol pro-crystallization. Cholesterol precipitation was most active after the high-protein diet, CS32, and the casein diet, C16, and lowest after the soyabean-protein diet, S16. It was intermediate after the mixed diet, CS16, but still much lower than in the former two groups. These diet-induced variations were suggested to be mediated through modifications in the biliary profile of bile acids, whereas all other biliary constituents studied were essentially unchanged. The fasting level of plasma cholesterol was lowest in both 160 g protein/kg diets containing soyabean protein (S16 and CS16), highest for the high-protein diet CS32, and intermediate for the C16 diet. These results should encourage clinical studies on the effect of soyabean protein, or other vegetable proteins, for primary or recurrence prevention of cholelithiasis at its earliest stage.
Asunto(s)
Bilis/química , Colesterol/química , Ciclodextrinas/administración & dosificación , Proteínas en la Dieta/metabolismo , Proteínas de Soja/metabolismo , Animales , Bilis/metabolismo , Caseínas/administración & dosificación , Colesterol/administración & dosificación , Cristalización , Ciclodextrinas/efectos adversos , Masculino , Proteínas de Soja/administración & dosificación , PorcinosRESUMEN
Beta-Cyclodextrin (BCD), a cyclic oligosaccharide that binds cholesterol and bile acids in vitro, has been previously shown to be an effective plasma cholesterol lowering agent in hamsters and domestic pigs. This study examined the effects of BCD as compared with cholestyramine on cholesterol and bile acid metabolism in the LPN hamster model model for cholesterol gallstones. The incidence of cholesterol gallstones was 65% in LPN hamsters fed the lithogenic diet, but decreased linearly with increasing amounts of BCD in the diet to be nil at a dose of 10% BCD. In gallbladder bile, cholesterol, phospholipid and chenodeoxycholate concentrations, hydrophobic and lithogenic indices were all significantly decreased by 10% BCD. Increases in bile acid synthesis (+110%), sterol 27-hydroxylase activity (+106%), and biliary cholate secretion (+140%) were also observed, whereas the biliary secretion of chenodeoxycholate decreased (-43%). The fecal output of chenodeoxycholate and cholate (plus derivatives) was increased by +147 and +64%, respectively, suggesting that BCD reduced the chenodeoxycholate intestinal absorption preferentially. Dietary cholestyramine decreased biliary bile acid concentration and secretion, but dramatically increased the fecal excretion of chenodeoxycholate and cholate plus their derivatives (+328 and +1940%, respectively). In contrast to BCD, the resin increased the lithogenic index in bile, induced black gallstones in 34% of hamsters, and stimulated markedly the activities of HMG-CoA reductase (+670%), sterol 27-hydroxylase (+310%), and cholesterol 7alpha-hydroxylase (+390%). Thus, beta-cyclodextrin (BCD) prevented cholesterol gallstone formation by decreasing specifically the reabsorption of chenodeoxycholate, stimulating its biosynthesis and favoring its fecal elimination. BCD had a milder effect on lipid metabolism than cholestyramine and does not predispose animals to black gallstones as cholestyramine does in this animal model.
Asunto(s)
Anticolesterolemiantes/uso terapéutico , Colelitiasis/prevención & control , Resina de Colestiramina/uso terapéutico , Ciclodextrinas/uso terapéutico , beta-Ciclodextrinas , Animales , Bilis/metabolismo , Ácidos y Sales Biliares/metabolismo , Ácido Quenodesoxicólico/metabolismo , Colestanotriol 26-Monooxigenasa , Colesterol/sangre , Colesterol/metabolismo , Ácido Cólico/metabolismo , Cricetinae , Sistema Enzimático del Citocromo P-450/metabolismo , Heces/química , Vesícula Biliar/metabolismo , Absorción Intestinal/efectos de los fármacos , Hígado/metabolismo , Masculino , Mesocricetus , Fosfolípidos/sangre , Fosfolípidos/metabolismo , Esteroide Hidroxilasas/metabolismoRESUMEN
PURPOSE: The investigation of the effects of ionizing radiation on hepatic cholesterol metabolism and the concentration and composition of plasma lipoproteins in the male Syrian hamster. MATERIALS AND METHODS: After sublethal whole-body 60Co gamma-irradiation (8 Gy, 1 Gy/min), plasma lipoproteins were separated by density-gradient ultracentrifugation. Activities of hydroxymethylglutarylCoA (HMGCoA) reductase and of cholesterol 7alpha-hydroxylase were measured in hepatic microsomes and the low-density lipoprotein (LDL) receptor mass was determined in hepatic total membranes. Lipid peroxidation in LDL was assessed in vitro as the formation of conjugated dienes at 234 nm. A group of pair-fed animals served as controls as the food intake was markedly decreased with exposure to radiation. RESULTS: Plasma lipid concentrations decreased 2 days post-irradiation and then markedly increased by day 6 post-irradiation; plasma cholesterol was increased by 77% and triglycerides by +207%. LDL accumulated in plasma while high-density lipoprotein (HDL) levels decreased. HDL contained significant amounts of apo SAA, the acute phase apolipoprotein. The activities of hepatic HMGCoA reductase, the rate-limiting enzyme for cholesterol synthesis, increased (+125%, p=0.06); hepatic cholesterol 7alpha-hydroxylase, the rate-limiting enzyme for bile acid synthesis, decreased (-85%); and the hepatic LDL receptor mass also decreased (-44%). The susceptibility of LDL to oxidation was also increased when animals were exposed to radiation. CONCLUSIONS: Lipoprotein modifications that appeared following radiation exposure may result from an induced inflammatory state and may further contribute to vascular damage.
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Colesterol/metabolismo , Lipoproteínas/sangre , Hígado/efectos de los fármacos , Animales , Peso Corporal/efectos de la radiación , Cricetinae , Ingestión de Alimentos/efectos de la radiación , Rayos gamma , Hidroximetilglutaril-CoA Reductasas/efectos de la radiación , Peroxidación de Lípido/efectos de la radiación , Hígado/metabolismo , Masculino , Mesocricetus , Receptores de LDL/efectos de la radiaciónRESUMEN
The aim of the current study was to reveal whether 7 days of indomethacin treatment sufficiently prevents heterotopic ossification after cementless total hip arthroplasty. One group received indomethacin for 14 days (n = 102), and the second for 7 days (n = 99) after cementless total hip arthroplasty. At followup 1 year postoperatively, the average Harris Hip Score was 91 points in the 14-day treatment group and 89 points in the 7-day treatment group. The incidence of heterotopic ossification as outlined by Brooker was similar in both groups. Ninety-six patients in the 14-day treatment group had heterotopic ossification Grades 0 or 1, and 6 patients had Grade II heterotopic ossification; whereas in the 7-day treatment group, 95 patients had Grades 0 or 1 heterotopic ossification and 4 patients had Grade II ossification. None of the patients had Grades III or IV heterotopic ossification. In the 14-day treatment group, headache, dizziness, or gastritic disorders develop in 10 patients, and in the 7-day treatment group, 7 patients had these effects. This study shows that treatment with 100 mg indomethacin daily for 7 days is not significantly different than 14 days of treatment for the prevention of formation of severe heterotopic ossification after cementless hip arthroplasty.
Asunto(s)
Prótesis de Cadera/métodos , Indometacina/uso terapéutico , Osificación Heterotópica/prevención & control , Complicaciones Posoperatorias/prevención & control , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Indometacina/administración & dosificación , Masculino , Persona de Mediana Edad , Estudios Prospectivos , Diseño de Prótesis , Resultado del TratamientoRESUMEN
It can be stated that polyethylene wear can be shown as a problem in long term joint replacement. Metal-on-metal bearings are solving this problem as long term clinical and experimental investigations can demonstrate. To avoid the problem of high friction that was found to be a problem in older series, a new technique called Metasul with smaller diameter was invented. Intermediate results of Weber and our own data are showing promising results giving us the hope to solve the wear induced problem in hip replacement.