Higher randomization rates needed to successfully complete the LEAK study: progress report and solutions for current issues

Claudia Löwik, Frank-Christiaan B. M. Wagenaar, Walter van der Weegen, Rudolf W. Poolman, Rob G. H. H. Nelissen, Sjoerd K. Bulstra, Yvette Pronk, Karin Vermeulen, Marjan Bakker, Inge Scheek, Martin Stevens, Paul C. Jutte

Research output: Contribution to journalArticleAcademicpeer-review


Prolonged wound leakage after joint arthroplasty is reported as a symptom of prosthetic joint infection (PJI) and a risk factor for developing a PJI. However, evidence-based guidelines on the treatment and timing of treatment of prolonged wound leakage after joint arthroplasty are lacking. Hence, treatment of prolonged wound leakage varies considerably in the Dutch orthopaedic community. Therefore, Consortium Orthopaedic Research (CORE) initiated a nationwide randomized controlled trial in 38 hospitals throughout the Netherlands, in which patients with wound leakage 9-10 days after total hip and knee arthroplasty are randomly allocated to early surgical treatment (debridement, antibiotics and implant retention (DAIR) at day 9-10) or non-surgical treatment (pressure bandages, (bed) rest and wound care) / late surgical treatment (DAIR at day 16-17). In order to successfully complete this large multicenter RCT and improve our clinical care, higher randomization rates are needed. To motivate hospitals to participate in this study and stimulate orthopaedic surgeons to randomize patients we proposed several solutions for current issues and composed an online magazine to offer additional support (https://leak.orthopeden.org).
Original languageEnglish
Pages (from-to)40-45
Number of pages6
JournalNederlands Tijdschrift voor Orthopedie
Issue number2
Publication statusPublished - Jun-2018

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