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

IntroductionTotal 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 analysisA 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 disseminationThe 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.

Fabricating Laser-Induced Periodic Surface Structures on Medical Grade Cobalt–Chrome–Molybdenum: Tribological, Wetting and Leaching Properties

“…The influence of the surface roughness on the contact angle can be described by either Wenzel [38], where it is assumed that the total surface will be in contact with the liquid, or by Cassie [39], where different materials or a combination of trapped air and a solid will be in contact with the liquid. In case of Wenzel the relation between the apparent contact angle (CA) θ a and the intrinsic CA θ i is given by cos(θ a ) = σ(cos θ i ), (1) where σ is the ratio between the true surface area and the projected area. In case of hydrophilic surfaces an increase of the roughness will result in a decrease of the CA and in the case of hydrophobic surfaces an increase of the roughness will result in an increase of the CA.…”

“…At least 3% of the patients that require primary total hip arthroplasty surgery need a revision due to severe prosthetic joint infections [1]. This leads to additional hospitalizations, costs and compromises the patient's health.…”

Persistent Wound Leakage After Total Knee And Hip Arthroplasty

“…The Dutch Arthoplasty Register reports a total of 3809 THA and 2667 TKA revision surgeries performed in 2015. Revision surgery within 1 year of index surgery was necessary in more than 600 patients and at least 30% of these were PJI related [36]. Persistent wound leakage can be treated by non-surgical and surgical treatment modalities.…”

Preoperative bacteriuria positivity on urinalysis increases wound complications in primary total hip arthroplasty regardless of the urine culture result

“…Wound complications are common after THA surgery [ 6 , 7 ]. Postoperative wound complications, including superficial wound infection and wound leakage, may increase the risk of subsequent prosthetic joint infection (PJI) by up to 35-fold [ 8 – 10 ].…”