Arthroscopy: The Journal of Arthroscopic & Related Surgery
Original ArticlesPrevention of venous thromboembolism after knee arthroscopy with low–molecular weight heparin (Reviparin): Results of a randomized controlled trial*
Section snippets
Patients
The study was approved by the Ethics Committee of our university hospital. There were 262 patients scheduled for knee arthroscopy between September 1994 and October 1997 who were potentially eligible for the study. Patients were excluded if they were pregnant, younger than 18 years, had a personal history of DVT, or if there was a contraindication to contrast venography or trial medication. Patients were also screened for additional risk factors for VTE, i.e., obesity, nicotine abuse, oral
Results
Between 1994 and 1997, 262 patients were enrolled in this monocentric, randomized, controlled, open trial. Twenty-three of them did not enter the trial because of secondary exclusion criteria (no surgery performed, spinal anesthesia, pregnancy, arthrotomy, unallowed concomitant medication). Two-hundred thirty-nine patients (122 control group, 117 treatment group) with evaluable objective diagnosis of the primary end-point represent the “intent-to-treat” population (ITT). Seventeen patients
Discussion
To our knowledge, this is the first randomized controlled trial to evaluate the efficacy and safety of drug treatment for prevention of VTE in knee arthroscopy using objective evaluation of thrombosis. Recently, reports of 2 clinical trials have been published on the incidence of VTE in patients who received no prophylaxis.13, 14, 22 Both trials used contrast venography as a diagnostic test, but reported rather different results: the total incidence of VTE in 1 trial was found to be 17.9% with
Acknowledgements
Acknowledgment: The authors thank Ms. P. Herrmann (clinical research assistant), T. Köhler, Ph.D. (drug safety), R. Seitz, M.D. (coagulation lab), U. Schwerk, M.D. (sonography), K. Görk, M.D. (sonography), U. Boudriot, M.D., and Ms. M. Kurnatowsky, M.D. (secondary investigators).
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Address correspondence and reprint requests to Thomas Wirth, M.D., Zentrum für Operative Medizin, Klinik für Orthopädie der Phillips-Universität Marburg, Baldingerstr., D-35033 Marburg, Germany. E-Mail: wirth @ mailer.uni-marburg.de