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The appropriate duration of antimicrobial therapy for bacterial prosthetic joint infection is debated. In this open-label, randomized, controlled, noninferiority trial involving 410 patients with prosthetic joint infection at 28 centers across France, antimicrobial therapy for 6 weeks was compared with therapy for 12 weeks and was not found to be noninferior.

Background Despite significant progress in orthopaedic surgery, the prevalence of periprosthetic joint infections (PJIs) remains persistent, and future increases are expected due to the increasing number of joint arthroplasties. PJIs are intricately connected to biofilm-producing bacteria, which encase infected prostheses, impairing the effectiveness of antibiotics and the immune system. Acute PJIs with immature biofilms are traditionally managed with debridement, antibiotics, and implant retention (DAIR). However, to date, there has not been a conclusive direct clinical comparison (in vivo) demonstrating the superiority of one irrigation solution over others. Recently, there has been a growing interest in irrigation solutions with antibiofilm properties demonstrated in in vitro studies, exemplified by the preformulated Bactisure® irrigation solution, which contains ethanol, acetic acid, sodium acetate, benzalkonium chloride, and sterile water. The main objective of this study was to evaluate the effectiveness (infection cure rate) of preformulated Bactisure® irrigation solution in vivo compared with saline solution in a control group of patients with acute knee and/or hip periprosthetic infections treated with DAIR. Methods Prospective single-centre randomized controlled trial involving patients with acute or haematogenous PJI who received standard DAIR surgery from December 2022 to December 2024. The type of irrigation solution used during surgery will include two groups allocated at a 1:1 ratio: a control group ( n  = 25) with saline solution and an experimental group ( n  = 25) receiving the Bactisure® preformulated solution. The sample size was calculated based on an expected reduction in reinfection rates from 45% in the control group to 10% in the experimental group. Data on baseline patient characteristics, clinical and radiological information, and healthcare questionnaires will be recorded. All patients will be followed for minimum of 12 months. The infection cure rate at 1 year will be the primary outcome. Discussion This study is the first to compare the effectiveness of preformulated Bactisure® irrigation solution with that of saline solution in real clinical practice (in vivo) in patients with acute knee and/or hip periprosthetic infections treated with DAIR. Our main hypothesis is that, compared with saline solution, Bactisure® provides a better infection cure rate at 1 year post-DAIR. Trial registration International Standard Randomized Controlled Trial Number (ISRCTN): https://doi.org/10.1186/ISRCTN10873696 . Registered on December 19, 2023.

Background There is a concern regarding the use of a closed-suction drain (CSD) in two-stage exchange arthroplasty for periprosthetic joint infection as it may decrease the antibiotic concentrations in the joint fluids. The purpose of this study was to identify whether the use of a CSD could reduce local antibiotic concentrations following spacer implantation. Methods A prospective, randomized, controlled trial was conducted at our institution between January 2018 and November 2018. We enrolled 32 patients undergoing two-stage exchange arthroplasty for periprosthetic hip infection with an interim cement spacer containing 4-g vancomycin and 2-g meropenem per 40-g methyl-methacrylate cement polymer. Patients were randomized and evenly divided into the study group (non-CSD) and control group (CSD group) by sealed envelopes. Drainage samples of joint fluids ( n  = 160) were collected every 24 h for the first five days following spacer implantation. The antibiotic concentrations of drainage samples were measured by high-performance liquid chromatography, and the bioactivities of the drainage samples against methicillin-sensitive and methicillin-resistant Staphylococcus aureus (MSSA and MRSA) and E. coli were assessed. Results There was no significant difference in the decrease of vancomycin (study group vs. control group: 163.20 ± 77.05 vs. 162.39 ± 36.31; p  = 0.917) and meropenem concentration (123.78 ± 21.04 vs. 117.27 ± 19.38; P  = 0.548) between the two groups during the first five days following spacer implantation. All joint drainage samples in each group exhibited antibacterial activity against MSSA, MRSA and E. coli . Conclusions The use of CSD following the implantation of an antibiotic-loaded cement spacer does not reduce the effectiveness of such a spacer in two-stage exchange arthroplasty. (Chinese Clinical Trial Registry, ChiCTR-INR-17014162. Registered 26 December 2017.)

The two-stage revision strategy has been claimed as being the \"gold standard\" for treating prosthetic joint infection. The one-stage revision strategy remains an attractive alternative option; however, its effectiveness in comparison to the two-stage strategy remains uncertain. To compare the effectiveness of one- and two-stage revision strategies in treating prosthetic hip infection, using re-infection as an outcome. Systematic review and meta-analysis. MEDLINE, EMBASE, Web of Science, Cochrane Library, manual search of bibliographies to March 2015, and email contact with investigators. Cohort studies (prospective or retrospective) conducted in generally unselected patients with prosthetic hip infection treated exclusively by one- or two-stage revision and with re-infection outcomes reported within two years of revision. No clinical trials were identified. Data were extracted by two independent investigators and a consensus was reached with involvement of a third. Rates of re-infection from 38 one-stage studies (2,536 participants) and 60 two-stage studies (3,288 participants) were aggregated using random-effect models after arcsine transformation, and were grouped by study and population level characteristics. In one-stage studies, the rate (95% confidence intervals) of re-infection was 8.2% (6.0-10.8). The corresponding re-infection rate after two-stage revision was 7.9% (6.2-9.7). Re-infection rates remained generally similar when grouped by several study and population level characteristics. There was no strong evidence of publication bias among contributing studies. Evidence from aggregate published data suggest similar re-infection rates after one- or two-stage revision among unselected patients. More detailed analyses under a broader range of circumstances and exploration of other sources of heterogeneity will require collaborative pooling of individual participant data. PROSPERO 2015: CRD42015016559.

The studyBlom AW, Lenguerrand, Strange S, et al. Clinical and cost effectiveness of single stage compared with two stage revision for hip prosthetic joint infection (INFORM): pragmatic, parallel group, open label, randomised controlled trial. BMJ 2022;379:e071281.To read the full NIHR Alert, go to: https://evidence.nihr.ac.uk/alert/one-stage-hip-revisions-are-as-good-as-2-stage-surgery-to-replace-infected-artificial-hips/

Introduction Debridement, Antibiotics and Implant Retention (DAIR) has been the mainstay of treatment for early onset periprosthetic joint infection in spite of variable results. Modular component exchange is a widely recommended strategy to improve success rates with DAIR though very strong evidence to support its practice is still lacking. Materials and methods Eighty six patients underwent DAIR for early onset PJI following primary hip and knee arthroplasty were divided into two groups for this retrospective review. 45 patients (group 1) underwent DAIR with modular component exchange and 41 patients without exchange (group 2). We compared success rates based on infection eradication (primary outcome variable) and need for revision surgical procedures between these two groups. We also assessed differences in primary outcome based on type of arthroplasty, timing of DAIR and addition of local antibiotics. Results The overall success rate after DAIR was 71%. The outcome was similar in both groups (69% vs 74%, P = 0.66). The need for revision surgical procedures was 27% which was similar in both groups (P = 0.98) with 23% needing revision of prosthetic components. Type of arthroplasty (hip or knee) and addition of local antibiotics had no bearing on infection eradication after DAIR with or without modular component exchange. DAIR with in 45 days of primary arthroplasty had significantly higher success rate compared to DAIR after 45 days in both groups. Conclusions We observed that modular component exchange did not improve infection eradication after DAIR for early onset PJI following hip and knee arthroplasty. Reasonable success rates can be expected after DAIR especially if the patient develops early clinical signs and the procedure is carried out as early as possible.

With the increasing success of hip joint replacements, the average age of patients has decreased, patients have become more active and their expectations of the implant durability have risen. Thus, pre-clinical endurance tests on hip implants require defining realistic in vivo loads from younger and more active patients. These loads require simplifications to be applicable for simulator tests and numerical analyses. Here, the contact forces in the joint were measured with instrumented hip implants in ten subjects during nine of the most physically demanding and frequent activities of daily living. Typical levels and directions of average and high joint loads were extracted from the intra- and inter-individually widely varying individual data. These data can also be used to analyse bone remodelling at the implant-bone interface, evaluate tissue straining in finite element studies or validate analytical loading predictions, among other uses. The current ISO standards for endurance tests of implant stems and necks are based on historic analytical data from the 1970s. Comparisons of these test forces with in vivo loads unveiled that their unidirectional orientations deviate from the time-dependent in vivo directions during walking and most other activities. The ISO force for testing the stem is substantially too low while the ISO force for the neck better matches typical in vivo magnitudes. Because the magnitudes and orientations of peak forces substantially vary among the activities, load scenarios that reflect a collection of time-dependent high forces should be applied rather than using unidirectional forces. Based on data from ten patients, proposals for the most demanding activities, the time courses of the contact forces and the required cycle numbers for testing are given here. Friction moments in the joint were measured in addition to the contact forces. The moment data were also standardized and can be applied to wear tests of the implant. It was shown that friction only very slightly influences the stresses in the implant neck and shaft.

ObjectivesTo investigate the relative performance of hip prosthesis constructs as compared with the best performing prosthesis constructs and illustrate the substantial variability in performance of currently used prostheses.DesignA non-inferiority study.SettingThe National Joint Registry for England, Wales, Northern Ireland and the Isle of Man (NJR).ParticipantsAll patients with a primary total hip replacement registered in the NJR between 1 April 2003 and 31 December 2016.Main outcome measuresKaplan-Meier failure function for hip prosthesis constructs. Failure difference between best performing construct and remaining constructs.MethodsUsing a non-inferiority analysis, the performance of hip prosthesis constructs by brand were compared with the best performing contemporary construct. Construct failure was estimated using the 1-Kaplan-Meier survival function method, that is, an estimate of net failure. The difference in failure between the contemporary benchmark and all other constructs was tested.ResultsOf the 4442 constructs used, only 134 had ≥500 procedures at risk at 3 years postprimary, 89 of which were not demonstrated to be inferior to the benchmark by at least 100% relative risk. By 10 years postprimary, there were 26 constructs with ≥500 at risk, 13 of which were not demonstrated to be inferior by at least 20% relative risk.Even fewer constructs were not inferior to the benchmark when analysed by age and gender. At 5 years postprimary, there were 15 constructs in males and 11 in females, aged 55–75 years, not shown to be inferior.ConclusionsThere is great variability in construct performance and the majority of constructs have not been demonstrated to be non-inferior to contemporary benchmarks. These results can help to inform patients, clinicians and commissioners when considering hip replacement surgery.

Current techniques for the identification of the infecting organism in prosthetic-joint (e.g., hip or knee) infection remain insensitive. In this study of 331 surgeries involving prosthetic joint replacement, a new technique that sonicates the removed artificial joint is found to be more sensitive in identifying the infecting organism than are standard culture techniques. In surgeries involving prosthetic joint replacement, a new technique that sonicates the removed artificial joint is found to be more sensitive in identifying the infecting organism than are standard culture techniques. In the United States, 638,000 patients underwent hip or knee replacement in 2003. 1 Although they may improve the quality of life, these procedures are associated with complications, including aseptic failure and prosthetic-joint infection. 2 It is important to distinguish prosthetic-joint infection from other causes of joint failure, because its management is different. 3 Nonmicrobiologic methods developed for diagnosing native-joint infection use different criteria from those used to diagnose prosthetic-joint infection. 4 Microbiologic diagnosis of prosthetic-joint infection may also require different criteria from those used for the microbiologic diagnosis of native-joint infection. Most clinicians and laboratory workers culture periprosthetic tissue (hereafter referred to as . . .

IntroductionChronic hip prosthetic joint infection (PJI) treatment needs non-conservative surgery. The recommended treatment follows a two-stage protocol. Between the two surgeries, full-weight bearing is prohibited, and joint stiffness and pain are rather usual complications. The single-stage procedure is thought to be less susceptible to late functional complications with a shorter, single hospital stay. However, infection control could be less efficient; the protocol highly relies on antibiotics and has a list of contra-indications. Most of these contra-indications are directly related to the biofilm formation. As no randomised control trial has ever compared single-stage versus two-stage surgery on infection treatment, the level of evidence for recommending one procedure over the other is low. An antibiotic-loaded hydrogel coating (Defensive Antiadhesive Coating (DAC), Novagenit SRL) has been proven to mechanically prevent biofilm formation while allowing a prolonged intra-articular antibiotic release. The addition of this biofilm inhibitor to a single-stage surgery might stand as a promising strategy for PJI. Moreover, using this device to prevent biofilm formation could expand one-stage surgery to patients who are in theory contra-indicated to one-stage surgery.Methods and analysisSINBIOSE-H is a Prospective Randomized Open, Blinded End-point clinical trial that will include patients with a chronic hip PJI as defined by the Musculoskeletal Infection Society (MSIS), with at least one theoretical contra-indication for single-stage surgery. Patients needing a cemented implant will not be included. 440 patients will be randomised in two groups: the experimental group is composed of single-stage procedure associated with the use of biofilm inhibitor (DAC) loaded with topical antibiotics, and the control group is composed of two-stage procedure without biofilm inhibitor. The primary objective will be to demonstrate that single-stage surgery with antibiotic-loaded hydrogel-coated implants is non-inferior to two-stage surgery for chronic hip PJI treatment. The secondary objectives will be to demonstrate that single-stage surgery with antibiotic-loaded hydrogel-coated implants is superior to two-stage surgery on the prevention of functional complications, patient satisfaction scores, death rate, postoperative complications or early revision surgery for any cause other than infection. Based on a failure rate of two-stage surgery of 20% and a reduction of the infection rate using the DAC biofilm inhibitor from 3 to 0.7%, with a non-inferiority margin of 1.35 and power set at 90%, we estimated to enrol 420 patients.Ethics and disseminationThe protocol is in accordance with ethical principles established by the Helsinki World Medical Assembly and its amendments and will be conducted in accordance with the recommendations of International Conference on Harmonisation Good Clinical Practice. A core information and informed consent form will be provided. The written approval of the Ethics Committee (EC)/Institutional Review Board (IRB) together with the approved subject information/informed consent forms must be filed in the study files. Written informed consent must be obtained before any study-specific procedure takes place. The data will be saved on the internal network in a secured directory, dedicated to the study. At the end of the research, all documents (case report files, investigator files, etc) will be archived and stored for 15 years in each centre. Data on SAEs will be included in the study documentation file. All data and documents will be made available if requested by relevant authorities. The EC and IRB were submitted and approved in France (CPP Ile De France X, 93 602 AULNAY-SOUS-BOIS). Ethics approval covers all centres.Trial registration numberThe study is registered on clinicaltrials.org under NCT04251377 (EUDRACT NUMBER, 2019-A01491-56; trial sponsor, St Etienne University Hospital Center; date of the last version, 24 February 2006).