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LEAK study: design of a nationwide randomised controlled trial to find the best way to treat wound leakage after primary hip and knee arthroplasty.

ABSTRACT: INTRODUCTION: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 porte d'entrée 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. METHODS AND ANALYSIS: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 9-10 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 16-17 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. ETHICS AND DISSEMINATION:The Review Board of each participating hospital has approved the local feasibility. The results will be published in peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER:NTR5960;Pre-results.

SUBMITTER: Lowik CAM

PROVIDER: S-EPMC5770823 | biostudies-other | 2017 Dec

REPOSITORIES: biostudies-other

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LEAK study: design of a nationwide randomised controlled trial to find the best way to treat wound leakage after primary hip and knee arthroplasty.

Löwik Claudia A M CAM Wagenaar Frank-Christiaan FC van der Weegen Walter W Poolman Rudolf W RW Nelissen Rob G H H RGHH Bulstra Sjoerd K SK Pronk Yvette Y Vermeulen Karin M KM Wouthuyzen-Bakker Marjan M van den Akker-Scheek Inge I Stevens Martin M Jutte Paul C PC

BMJ open 20171228 12

<h4>Introduction</h4>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 <i>porte d'entrée</i> for micro-organisms. On the other hand, prolonged wound leakage can be a ...[more]

PMID: 29288184

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Project description:Background: Persistent wound leakage after joint arthroplasty is a scantily investigated topic, despite the claimed relation with a higher risk of periprosthetic joint infection. This results in a lack of evidence-based clinical guidelines for the diagnosis and treatment of persistent wound leakage after joint arthroplasty. Without such guideline, clinical practice in orthopaedic hospitals varies widely. In preparation of a nationwide multicenter randomized controlled trial on the optimal treatment of persistent wound leakage, we evaluated current Dutch orthopaedic care for persistent wound leakage after joint arthroplasty. Methods: We conducted a questionnaire-based online survey among all 700 members of the Netherlands Orthopaedic Association, consisting of 23 questions on the definition, classification, diagnosis and treatment of persistent wound leakage after joint arthroplasty. Results: The questionnaire was completed by 127 respondents, representing 68% of the Dutch hospitals that perform orthopaedic surgery. The results showed wide variation in the classification, definition, diagnosis and treatment of persistent wound leakage among Dutch orthopaedic surgeons. 56.7% of the respondents used a protocol for diagnosis and treatment of persistent wound leakage, but only 26.8% utilized the protocol in every patient. Most respondents (59.1%) reported a maximum period of persistent wound leakage before starting non-surgical treatment of 3 to 7 days after index surgery and 44.1% of respondents reported a maximum period of wound leakage of 10 days before converting to surgical treatment. Conclusions: The wide variety in clinical practice underscores the importance of developing an evidence-based clinical guideline for the diagnosis and treatment of persistent wound leakage after joint arthroplasty. To this end, a nationwide multicenter randomized controlled trial will be conducted in the Netherlands, which may provide evidence on this important and poorly understood topic.

Project description:Arthrofibrosis is characterized by excessive extracellular matrix (ECM) deposition that results in restricted joint motion after total knee arthroplasty (TKA). Current surgical and pharmacologic treatment options are limited. Therefore, an in vitro model for joint myofibroblastogenesis is valuable to investigate the arthrofibrotic process and identify diagnostic biomarkers and treatment options. In this study, we obtained intraoperative posterior capsule (PC), quadriceps tendon (QT), and suprapatellar pouch (SP) tissue from knees of four patients undergoing primary TKA for osteoarthritis and characterized primary outgrowth cells from these tissues in the absence and presence of transforming growth factor beta 1 (TGFβ1), a pro-myofibroblastic cytokine. Light microscopy of knee outgrowth cells revealed spindle-shaped cells while immunofluorescence (IF) established staining for the fibroblast-specific antigen TE-7 and Vimentin, which are characteristics of fibroblasts. These fibroblasts differentiate readily into myofibroblasts as highlighted by enhanced alpha smooth muscle actin (ACTA2) mRNA and protein expression and increased collagen mRNA (i.e., collagen type 1 (COL1A1) and collagen type 3 (COL3A1)) expression and collagenous matrix deposition in the presence of TGFβ1. Of note, these studies also revealed that knee-derived fibroblasts are more sensitive to TGFβ1-mediated myofibroblastogenesis than adipose-derived mesenchymal stem cells. Importantly, while outgrowth fibroblasts isolated from four patients and three anatomical regions exhibit similar gene expression profiles, these knee fibroblasts form a unique gene expression cluster within the fibroblast niche as revealed by RNA-sequencing analysis. In conclusion, our study provides a fibroblast/myofibroblast model of outgrowth knee cells derived from patients undergoing primary TKA that can be employed to assess myofibroblast-related processes and test novel pharmacological strategies in vitro for arthrofibrosis.

Dataset Information

LEAK study: design of a nationwide randomised controlled trial to find the best way to treat wound leakage after primary hip and knee arthroplasty.

Publications

LEAK study: design of a nationwide randomised controlled trial to find the best way to treat wound leakage after primary hip and knee arthroplasty.

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