single-stage surgery with antibiotic-loaded hydrogel coated implants versus two stage surgery for secondary prevention of complex chronic periprosthetic hip joint infection

Conditions: Hip Prosthesis Infection

Summary: each year, around 1500 infected total hip arthroplasties (tha) need non-conservative surgery, remaining an issue for patients and healthcare units. the recommended treatment, relying on cohort reviews and international consensus follows a two-stage protocol. this protocol implies a first surgery to remove all infected implants and at least 6 weeks of antibiotic treatment without implant, then usually an antibiotic-free period and only then a second surgery to put back new implants and start the rehabilitation protocol, with usually more than a week of a second hospital stay. between both surgeries, full-weight bearing is prohibited and joint stiffness and/or pain are rather usual complications. failure rate is estimated at 10% in this two-stage strategy. the single-stage procedure (i.e. implanting back a new prosthesis during the same surgery after implant removal, synovectomy and lavage) is thought to be less susceptible to late functional complications (i.e. pain, stiffness and muscle deficiency) with a shorter, single hospital stay. although, with single-stage surgery, infection control could be less efficient because most pathogens produce during the first hours of infection an antibiotic-resistant layer called biofilm, allowing them to colonize and adhere to foreign objects like implants. this single-surgery protocol thus highly relies on antibiotics and has a list of contra-indications (based on experts' consensus): the presence of damaged soft tissues or a sinus tract, unknown pathogens, difficult to treat micro-organisms, severe immunosuppression and for many surgeons, each time a bone graft is necessary. most of these contra-indications are directly related to the biofilm. as no randomized control trial has ever compared single-stage versus two-stage surgery, the level of evidence for recommending one procedure over the other is low. we conducted a survey that showed that most of the french reference centers have already switched to single stage surgery for single-stage non contra-indicated cases. an antibiotic-loaded hydrogel coating (defensive antiadhesive coating®, novagenit srl), has been proven to mechanically prevent the biofilm formation, while allowing a prolonged intraarticular antibiotic release, in a randomized controlled trial in primary prevention of infection in tha. the addition of this biofilm inhibitor to a single-stage surgery might stand as a promising strategy for secondary prevention of peri-prosthetic hip joint infection. moreover, using this device to prevent biofilm formation could expand one stage surgery to patients that are "normally" contra-indicated to one stage surgery.


Eligibility criteria:
inclusion criteria: * social security affiliation * signed informed consent * chronic periprosthetic hip joint infection defined according to the musculoskeletal infection society criteria : * two positive periprosthetic cultures with phenotypically identical organisms * or a sinus tract communicating with the joint, * or having 3 of 5 minor criteria: * elevated serum c-reactive protein (crp) and erythrocyte sedimentation rate (esr); * elevated synovial fluid white blood cell (wbc) count or change of ++ on leukocyte esterase test strip; * elevated synovial fluid polymorphonuclear neutrophil percentage (pmn%); * positive histological analysis of periprosthetic tissue; * a single positive culture. exclusion criteria: * patients with hypersensitivity to hydrogel components (hyaluronic acid and/or poly-lactic acid) known of defensive antibacterial coating (dac)® * pregnancy or positive pregnancy test (performed in women of childbearing age before inclusion) * life expectancy \< 3 months * expected use of a cemented implant by the surgical team (for the treatment surgical protocol) * unable to give informed consent * patients under guardianship or curators * refusal to participate

Keywords: surgery biofilm inhibitor chronic infections total hip arthroplasties (tha) defensive antibacterial coating (dac®) novagenit® hip prosthesis