SummaryWe assessed the safety and efficacy of the novel low molecular weight heparinoid Lomoparan (Org 10172) for the prevention of deep-vein thrombosis in patients undergoing elective total hip replacement in a randomized, placebo-controlled, double-blind trial in 197 consecutive patients. The heparinoid (750 anti-factor Xa-units, s. c., b.i.d.) was administered to 97 patients and 99 patients received placebo. Study medication was started preoperatively and continued for 10 days. Efficacy was assessed by bilateral phlebography at day 10, postoperatively.The incidence of deep-vein thrombosis was 56.6% and 15.5% respectively in the placebo and heparinoid treated patients (incidence reduction: 74%; P <0.001). This reduction was observed both for proximal-vein thrombosis (25% to 8%; P <0.005) and isolated calf-vein thrombosis (31% to 7%; P <0001.No major hemorrhage was observed. The number of red-cell units transfused and drain-fluid loss were comparable for the two study groups. Six patients in the heparinoid group and none in the control group developed minor wound hematomas (P <0.05).During an 8-week post-discharge follow-up period three patients with a normal venogram at day 10 developed clinically apparent venous thromboembolism, which was confirmed by objective testing. All three patients belonged to the heparinoid-treated group.We conclude that 750 anti-factor Xa units Org 10172 s.c. twice daily starting preoperatively is safe and effectively reduces early deep-vein thrombosis following elective total hip replacement. Further studies on the incidence of post-discharge thromboembolism are required.
We retrospectively reviewed the experience of a large international multi-centre study of primary total knee arthroplasty with mobile bearing design and modifications of the tibial component to allow for bicruciate preservation, posterior cruciate retention, or sacrifice. Twenty-seven surgeons performed 4,743 total knee replacements between 1981 and 1997. Implants inserted were 324 that retained both cruciate ligaments, 2,165 that retained the posterior cruciate, and 2,254 that sacrificed both cruciates. The patella was resurfaced in 2,838 and unresurfaced in 1,905. With failure defined as revision or reoperation for any reason, the overall survivorship was 79% at 16 years' follow-up. Revision occurred in 259 (5.4%) knees out of the entire cohort. The risk adjusted rates of failure were higher in females, younger patients, osteoarthritis, posttraumatic arthritis, and in patients who had a meniscal bearing prosthesis or patellar resurfacing. The most common cause of revision was bearing-related issues including chronic instability, bearing subluxation, bearing dislocation, or bearing wear in 2.3%.Résumé Nous avons revu rétrospectivement une série multicentrique de prothèses totales primaires de genoux avec plateaux mobiles et pièce tibiale permettant le sacrifice ou la conservation d'un ou des deux ligaments croisés. Entre 1981Entre et 1997 prothèses ont été faite par 27 chirugiens. Les implants utilisés étaient pour 2254 sans ligaments croisés, pour 2165 avec croisé postérieur et pour 324 avec conservation des 2 croisés. La rotule a été resurfacée 2838 fois. Avec l'échec défini par la reprise chirurgicale, la survie était de 79% à 16 ans de recul. Une reprise a été faite 259 fois (5,4%). Le risque d'échec était plus grand chez les femmes, les patients jeunes, en cas d'arthrose primaire ou post traumatique et chez les patients avec une prothèse à ménisques mobiles ou avec une rotule prothèsée. Les causes les plus fréquentes de révision étaient l'instabilité chronique, la subluxation ou la luxation des plateaux mobiles et leur usure.
SummaryIn 196 consecutive patients who underwent elective total hip surgery we investigated the diagnostic accuracy of the thrombinantithrombin III complex immunoassay, as assessed on the first, fourth and tenth postoperative day, for the development of deep vein thrombosis (DVT). Patients received either LMWheparinoid (n = 97) or placebo (n = 99) and underwent contrast venography on the tenth postoperative day.Thrombin-antithrombin III (T-AT) plasma levels were raised in all patients on the first postoperative day and gradually decreased during the study period. T-AT plasma levels were significantly higher in patients developing DVT when compared to patients without DVT and remained so until day 10. This difference was apparent both in the LMW-heparinoid group as well as in the placebo-treated patients.ROC-curve analysis revealed no satisfactory discriminative power for the diagnosis of developing DVT at any of the studied cut-off values for T-AT.We conclude that the postoperative determination of T-AT complex plasma concentrations in hip surgery patients has no clinical utility in the prediction of postoperative DVT.
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