{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,2]],"date-time":"2026-10-02T10:26:38Z","timestamp":1790936798520,"version":"4.1.0"},"reference-count":26,"publisher":"BMJ","issue":"12","funder":[{"name":"Netherland Orthopaedic Association"},{"DOI":"10.13039\/501100001826","name":"ZonMw","doi-asserted-by":"publisher","id":[{"id":"10.13039\/501100001826","id-type":"DOI","asserted-by":"publisher"}]}],"content-domain":{"domain":["bmj.com"],"crossmark-restriction":true},"short-container-title":["BMJ Open"],"accepted":{"date-parts":[[2017,11,8]]},"published-print":{"date-parts":[[2017,12]]},"abstract":"<jats:sec>\n                    <jats:title>Introduction<\/jats:title>\n                    <jats:p>\n                      Total hip arthroplasty (THA) and total knee arthroplasty (TKA) are highly successful treatment modalities for advanced osteoarthritis. However, prolonged wound leakage after arthroplasty is linked to prosthetic joint infection (PJI), which is a potentially devastating complication. On the one hand, wound leakage is reported as a risk factor for PJI with a leaking wound acting as a\n                      <jats:italic>porte d\u2019entr\u00e9e<\/jats:italic>\n                      for micro-organisms. On the other hand, prolonged wound leakage can be a symptom of PJI. Literature addressing prolonged wound leakage is scarce, contradictory and of poor methodological quality. Hence, treatment of prolonged wound leakage varies considerably with both non-surgical and surgical treatment modalities. There is a definite need for evidence concerning the best way to treat prolonged wound leakage after joint arthroplasty.\n                    <\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Methods and analysis<\/jats:title>\n                    <jats:p>A prospective nationwide randomised controlled trial will be conducted in 35 hospitals in the Netherlands. The goal is to include 388 patients with persistent wound leakage 9\u201310 days after THA or TKA. These patients will be randomly allocated to non-surgical treatment (pressure bandages, (bed) rest and wound care) or surgical treatment (debridement, antibiotics and implant retention (DAIR)). DAIR will also be performed on all non-surgically treated patients with persistent wound leakage at day 16\u201317 after index surgery, regardless of amount of wound leakage, other clinical parameters or C reactive protein. Clinical data are entered into a web-based database. Patients are asked to fill in questionnaires about disease-specific outcomes, quality of life and cost effectiveness at 3, 6 and 12 months after surgery. Primary outcome is the number of revision surgeries due to infection within a year of arthroplasty.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Ethics and dissemination<\/jats:title>\n                    <jats:p>The Review Board of each participating hospital has approved the local feasibility. The results will be published in peer-reviewed scientific journals.<\/jats:p>\n                  <\/jats:sec>\n                  <jats:sec>\n                    <jats:title>Trial registration number<\/jats:title>\n                    <jats:p>NTR5960;Pre-results.<\/jats:p>\n                  <\/jats:sec>","DOI":"10.1136\/bmjopen-2017-018673","type":"journal-article","created":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T21:11:52Z","timestamp":1765833112000},"page":"e018673","update-policy":"https:\/\/doi.org\/10.1136\/crossmarkpolicy","source":"Crossref","is-referenced-by-count":22,"title":["LEAK study: design of a nationwide randomised controlled trial to find the best way to treat wound leakage after primary hip and knee arthroplasty"],"prefix":"10.1136","volume":"7","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-3532-537X","authenticated-orcid":false,"given":"Claudia A M","family":"L\u00f6wik","sequence":"first","affiliation":[{"name":"Department of Orthopaedic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Frank-Christiaan","family":"Wagenaar","sequence":"additional","affiliation":[{"name":"OCON, Center for Orthopaedic Surgery, Hengelo, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Walter","family":"van der Weegen","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Sint Anna Ziekenhuis, Geldrop, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rudolf W","family":"Poolman","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Onze Lieve Vrouwe Gasthuis, Amsterdam, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Rob G H H","family":"Nelissen","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, Leiden University Medical Center, Leiden, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Sjoerd K","family":"Bulstra","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yvette","family":"Pronk","sequence":"additional","affiliation":[{"name":"Research Department, Kliniek Viasana, Mill, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Karin M","family":"Vermeulen","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Marjan","family":"Wouthuyzen-Bakker","sequence":"additional","affiliation":[{"name":"Department of Medical Microbiology and Infection Prevention, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Inge","family":"van den Akker-Scheek","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Martin","family":"Stevens","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Paul C","family":"Jutte","sequence":"additional","affiliation":[{"name":"Department of Orthopaedic Surgery, University of Groningen, University Medical Center Groningen, Groningen, The Netherlands"}],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"239","published-online":{"date-parts":[[2017,12,28]]},"reference":[{"key":"2025121513114043000_7.12.e018673.1","doi-asserted-by":"publisher","DOI":"10.1016\/j.semarthrit.2013.07.003"},{"key":"2025121513114043000_7.12.e018673.2","unstructured":"LROI-rapportage. Blikop uitkomsten. Jaarrapportage uit de landelijke registratieorthopedische implantaten 2015, 2015."},{"key":"2025121513114043000_7.12.e018673.3","first-page":"1","article-title":"Hospitalization for total hip replacement among inpatients aged 45 and over: United States, 2000-2010","volume":"186","author":"Wolford","year":"2015","journal-title":"NCHS Data Brief"},{"key":"2025121513114043000_7.12.e018673.4","first-page":"1","article-title":"Hospitalization for total knee replacement among inpatients aged 45 and over: United States, 2000-2010","volume":"210","author":"Williams","year":"2015","journal-title":"NCHS Data Brief"},{"key":"2025121513114043000_7.12.e018673.5","doi-asserted-by":"publisher","DOI":"10.1016\/j.arth.2007.10.017"},{"key":"2025121513114043000_7.12.e018673.6","doi-asserted-by":"crossref","first-page":"541","DOI":"10.1097\/BCO.0b013e3181a0a7fb","article-title":"Timing of open debridement for suspected infection of joint prosthesis: a report on 551 patients","volume":"20","author":"Maathuis","year":"2009","journal-title":"Curr Orthop Pract"},{"key":"2025121513114043000_7.12.e018673.7","doi-asserted-by":"publisher","DOI":"10.1016\/S0883-5403(06)80091-4"},{"key":"2025121513114043000_7.12.e018673.8","doi-asserted-by":"publisher","DOI":"10.1302\/0301-620X.94B5.27073"},{"issue":"Suppl 1","key":"2025121513114043000_7.12.e018673.9","doi-asserted-by":"crossref","first-page":"39","DOI":"10.1016\/j.arth.2007.03.014","article-title":"Wound complications after total knee arthroplasty","volume":"22","author":"Vince","year":"2007","journal-title":"J Arthroplasty"},{"key":"2025121513114043000_7.12.e018673.10","doi-asserted-by":"publisher","DOI":"10.1016\/j.arth.2013.09.041"},{"key":"2025121513114043000_7.12.e018673.11","doi-asserted-by":"crossref","first-page":"202","DOI":"10.7150\/jbji.22327","article-title":"Managing persistent wound leakage after total knee and hip arthroplasty. Results of a nationwide survey among Dutch orthopaedic surgeons","volume":"\u00a02","author":"Wagenaar","year":"\u00a02017","journal-title":"J Bone Joint Infect"},{"key":"2025121513114043000_7.12.e018673.12","doi-asserted-by":"publisher","DOI":"10.1016\/j.arth.2010.01.104"},{"key":"2025121513114043000_7.12.e018673.13","doi-asserted-by":"publisher","DOI":"10.3109\/17453674.2013.858288"},{"key":"2025121513114043000_7.12.e018673.14","doi-asserted-by":"publisher","DOI":"10.3109\/17453674.2013.823589"},{"key":"2025121513114043000_7.12.e018673.15","doi-asserted-by":"crossref","first-page":"649","DOI":"10.1016\/j.arth.2014.10.026","article-title":"Periprosthetic knee infections treated with irrigation and debridement: outcomes and preoperative predictive factors","volume":"30","author":"Triantafyllopoulos","year":"2015","journal-title":"J Arthroplasty"},{"key":"2025121513114043000_7.12.e018673.16","doi-asserted-by":"publisher","DOI":"10.2106\/JBJS.L.00251"},{"key":"2025121513114043000_7.12.e018673.17","unstructured":"ZorginstituutNederland. Kostenhandleiding: methodologie van kostenonderzoek en referentieprijzen voor economische evaluaties in de gezondheidszorg: Geactualiseerde versie, 2015."},{"key":"2025121513114043000_7.12.e018673.18","doi-asserted-by":"publisher","DOI":"10.1016\/j.joca.2006.06.014"},{"key":"2025121513114043000_7.12.e018673.19","doi-asserted-by":"publisher","DOI":"10.1186\/1477-7525-6-16"},{"key":"2025121513114043000_7.12.e018673.20","doi-asserted-by":"crossref","first-page":"347","DOI":"10.1080\/00016470510030814","article-title":"Translation and validation of the Dutch version of the Oxford 12-item knee questionnaire for knee arthroplasty","volume":"76","author":"Haverkamp","year":"2005","journal-title":"Acta Orthop"},{"key":"2025121513114043000_7.12.e018673.21","doi-asserted-by":"publisher","DOI":"10.1080\/00016470510030580"},{"key":"2025121513114043000_7.12.e018673.22","doi-asserted-by":"publisher","DOI":"10.1007\/s11136-012-0322-4"},{"key":"2025121513114043000_7.12.e018673.23","doi-asserted-by":"crossref","first-page":"343","DOI":"10.1016\/j.jval.2016.01.003","article-title":"Dutch tariff for the five-level version of EQ-5D","volume":"19","author":"M Versteegh","year":"2016","journal-title":"Value Health"},{"key":"2025121513114043000_7.12.e018673.24","doi-asserted-by":"crossref","unstructured":"Bouwmans C , Hakkaart-van Roijen M , Koopmanschap M , et al . Handleiding iMTA medical cost questionnaire (iMCQ). Rotterdam: iMTA, Erasmus Universiteit, 2013. www.imta.nl","DOI":"10.1016\/j.jval.2014.08.1791"},{"key":"2025121513114043000_7.12.e018673.25","doi-asserted-by":"crossref","unstructured":"Bouwmans C , Hakkaart-van Roijen M , Koopmanschap M , et al . \u00a0Handleiding iMTA productivity cost questionnaire (iPCQ). Rotterdam: iMTA, Erasmus Universiteit, 2013. www.imta.nl","DOI":"10.1016\/j.jval.2014.08.1791"},{"key":"2025121513114043000_7.12.e018673.26","doi-asserted-by":"crossref","first-page":"753","DOI":"10.1016\/j.jval.2015.05.009","article-title":"The iMTA productivity cost questionnaire: a standardized instrument for measuring and valuing health-related productivity losses","volume":"18","author":"Bouwmans","year":"2015","journal-title":"Value Health"}],"container-title":["BMJ Open"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/syndication.highwire.org\/content\/doi\/10.1136\/bmjopen-2017-018673","content-type":"unspecified","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,12,15]],"date-time":"2025-12-15T21:11:52Z","timestamp":1765833112000},"score":1,"resource":{"primary":{"URL":"https:\/\/bmjopen.bmj.com\/lookup\/doi\/10.1136\/bmjopen-2017-018673"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2017,12]]},"references-count":26,"journal-issue":{"issue":"12","published-online":{"date-parts":[[2017,12,28]]},"published-print":{"date-parts":[[2017,12]]}},"alternative-id":["10.1136\/bmjopen-2017-018673"],"URL":"https:\/\/doi.org\/10.1136\/bmjopen-2017-018673","relation":{},"ISSN":["2044-6055","2044-6055"],"issn-type":[{"value":"2044-6055","type":"print"},{"value":"2044-6055","type":"electronic"}],"subject":[],"published":{"date-parts":[[2017,12]]}}}