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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.

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).

BackgroundProximal femur replacements in patients with sarcoma are associated with high rates of infection. This study is the largest one comparing infection rates with titanium versus silver-coated megaprostheses in sarcoma patients.MethodsInfection rates were assessed in 99 patients with proximal femur sarcoma who underwent placement of a titanium (n = 35) or silver-coated (n = 64) megaprosthesis. Treatments administered for infection were also analyzed.ResultsInfections occurred in 14.3% of patients in the titanium group, in comparison with 9.4% of those in the silver group, when the development of infection was the primary end point. The 5- and 10-year event-free survival rates for the prosthesis relative to the parameter of infection were 90% in the silver group and 83% in the titanium group. The overall infection rates were 10.9% in the silver group and 20% in the titanium group. Two patients each in the silver and titanium groups ultimately had to undergo amputation. The need for two-stage prosthesis exchanges (57.1% in the titanium group) declined to 14.3% in the silver group.ConclusionUsing a silver-coated proximal femoral replacement nearly halved the overall infection rate. When infections occurred, it was usually possible to avoid two-stage prosthesis exchanges in the silver group.

Background A two-stage prosthesis exchange procedure has been the gold standard in surgical treatment of the chronically infected knee arthroplasty so far. This includes 2 surgeries/hospitalizations and an interim period of 2–3 months between surgeries with impaired health, functional status and quality of life of the patients. A one-stage exchange procedure holds many obvious advantages compared to the two-stage approach, but outcomes of a one-stage versus two-stage procedures have never been investigated in a randomized clinical trial. The purpose of this study is primarily to investigate time-adjusted differences in functional status of patients after one-stage versus two-stage revision. Secondary, to report time-adjusted differences in quality of life, complications (including re-revisions due to infection) and mortality. Methods This study is a pragmatic, multi-center, randomized, non-inferiority trial comparing one-stage versus two-stage revision of the infected knee arthroplasty. Seven Danish hospitals are currently participating in the study, but additional hospitals can enter the study if adhering to protocol. Ninety-six patients will be included prospectively. Follow-up will be with PROM-questionnaires and clinical controls up to 10 years. The patients who are not able to participate in the randomized trial are followed in a parallel cohort study. PROM’s Oxford Knee Score and EQ5D + EQ5D VAS questionnaires are completed preoperatively and sent out to the study participants at 6 weeks, 3, 6, 9, 12, 18 and 24 months as well as 5 and 10 years postoperatively. In addition a tailor made cost questionnaire on the non-treating hospital resource use, community health and social service use, travel costs, time off work and informal care are sent out. Discussion If one of the two treatment alternatives is found superior in both domains of quality of life (both knee-specific and generic) and health economics, that treatment should be promoted. Other outcomes will open informed discussions about treatment strategies for periprosthetic knee infections. Trial registration The randomized trial is registered on ClinicalTrials.gov with ID NCT03435679 , initial release date January 31, 2018 and the cohort study is registered with ID NCT04427943 , submitted January 8, 2020 and posted June 11, 2020.

Background Periprosthetic joint infections (PJIs) represent one of the most serious complications associated with joint replacement surgeries, a complication also of modern orthopedic surgery despite the efforts that occurred in this field. Frequently PJIs lead to prolonged morbidity, increased costs and mortality. Methods We are conducting a single-center observational cohort ongoing study in the Academic Emergency Hospital Sibiu, Romania, study in which sonication of the retrieved and as a rapid method of bacteria detection, molecular identification of bacteria by 16S rRNA beacon-based fluorescent in situ hybridization (bbFISH) are used. Results A total of 61 patients were enrolled in this study. The diagnosis of aseptic loosening was established in 30 cases (49.1%) and the diagnosis of periprosthetic joint infection was established at 31 patients (50.8%). The mean follow-up period in the subgroup of patients diagnosed with periprosthetic joint infections was 36.06 ± 12.59 months (range: 1–54). The 25-months Kaplan-Meier survival rate as the end point, as a consequence of the period of enrollment and a different follow-up period for each type of surgical procedure, was 75% after debridement and implant retention, 91.7% after one-stage exchange, 92.3% after two-stage exchange, and 100% after three-stage exchange. There were no significant differences in survival percentage. Conclusions Our study has good results similar to previously published data. We cannot recommend one strategy of managing prosthetic joint infections over the other. Definitely, there is a need for prospective randomized controlled trials.

Objective The prevailing treatment for chronic periprosthetic joint infection (PJI) is a two‐stage exchange, yet the optimal duration of antibiotic therapy following this procedure remains a topic of debate. This study aimed to determine whether a short course of postoperative antibiotic therapy can maintain infection control rates following a long interval two‐stage exchange (LITE) for PJI. Methods We conducted a prospective study enrolling patients with chronic PJI who underwent the LITE procedure at our institution from April 2018 to November 2021. Patients were randomly assigned to receive either a long course (12 weeks) or short course (2 weeks) of postoperative antibiotics. The pathogens, antibiotics, inflammatory markers, antibiotic‐related complications, cases of reinfection, or re‐operation were recorded. Continuous variables were analyzed using the two‐sample t‐test or Mann–Whitney U test, and categorical variables were analyzed using Fisher's exact tests. Kaplan–Meier survival analysis was used to compare infection control rates. Results A total of 60 patients with chronic PJI who completed the LITE procedure were included in the study (30 patients per group). All patients were followed for a minimum of 24 months (mean 39.2 ± 13.0 months). We observed that the infection control rate in the short‐course group was not inferior to that in the long‐course group (96.7% vs. 96.7%, p = 1.000). Conclusions For patients with chronic PJI undergoing the LITE procedure, a 2‐week course of postoperative antibiotics suffices to maintain infection control rates. Trial Registration Chinese Clinical Trial Registry: ChiCTR1900027089 For patients with chronic PJI undergoing the long interval two‐stage exchange (LITE) procedure, a 2‐week course of postoperative antibiotics suffices to maintain infection control rates.

ObjectivesUnderstanding patients’ preferences for treatment is crucial to provision of good care and shared decisions, especially when more than one treatment option exists for a given condition. One such condition is infection of the area around the prosthesis after hip replacement, which affects between 0.4% and 3% of patients. There is more than one treatment option for this major complication, and our study aimed to assess the value that patients place on aspects of revision surgery for periprosthetic hip infection.DesignWe identified four attributes of revision surgery for periprosthetic hip infection. Using a discrete choice experiment (DCE), we measured the value placed on each attribute by 57 people who had undergone either one-stage or two-stage revision surgery for infection.SettingThe DCE was conducted with participants from nine National Health Service hospitals in the UK.ParticipantsAdults who had undergone revision surgery for periprosthetic hip infection (N=57).ResultsOverall, the strongest preference was for a surgical option that resulted in no restrictions on engaging in valued activities after a new hip is fitted (β=0.7). Less valued but still important attributes included a shorter time taken from the start of treatment to return to normal activities (6 months; β=0.3), few or no side effects from antibiotics (β=0.2), and having only one operation (β=0.2).ConclusionsThe results highlight that people who have had revision surgery for periprosthetic hip infection most value aspects of care that affect their ability to engage in normal everyday activities. These were the most important characteristics in decisions about revision surgery.

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.)

Background Approximately 88,000 primary hip replacements are performed in England and Wales each year. Around 1% go on to develop deep prosthetic joint infection. Between one-stage and two-stage revision arthroplasty best treatment options remain unclear. Our aims were to characterise consultant orthopaedic surgeons’ decisions about performing either one-stage or two-stage revision surgery for patients with deep prosthetic infection (PJI) after hip arthroplasty, and to identify whether a randomised trial comparing one-stage with two-stage revision would be feasible. Methods Semi-structured interviews were conducted with 12 consultant surgeons who perform revision surgery for PJI after hip arthroplasty at 5 high-volume National Health Service (NHS) orthopaedic departments in England and Wales. Surgeons were interviewed before the development of a multicentre randomised controlled trial. Data were analysed using a thematic approach. Results There is no single standardised surgical intervention for the treatment of PJI. Surgeons balance multiple factors when choosing a surgical strategy which include multiple patient-related factors, their own knowledge and expertise, available infrastructure and the infecting organism. Surgeons questioned whether it was appropriate that the two-stage revision remained the best treatment, and some surgeons' willingness to consider more one-stage revisions had increased over recent years and were influenced by growing evidence showing equivalence between surgical techniques, and local observations of successful one-stage revisions. Custom-made articulating spacers was a practice that enabled uncertainty to be managed in the absence of definitive evidence about the superiority of one surgical technique over the other. Surgeons highlighted the need for research evidence to inform practice and thought that a randomised trial to compare treatments was needed. Most surgeons thought that patients who they treated would be eligible for trial participation in instances where there was uncertainty about the best treatment option. Conclusions Surgeons highlighted the need for evidence to support their choice of revision. Some surgeons' willingness to consider one-stage revision for infection had increased over time, largely influenced by evidence of successful one-stage revisions. Custom-made articulating spacers also enabled surgeons to manage uncertainty about the superiority of surgical techniques. Surgeons thought that a prospective randomised controlled trial comparing one-stage with two-stage joint replacement is needed and that randomisation would be feasible.

Although the design features of the Medial Pivot fixed-bearing prosthesis reportedly improve kinematics compared with TKAs using fixed-bearings, clinical improvements have not been reported. We asked whether the clinical and radiographic outcomes, ranges of motion of the knee, patient satisfaction, and complication rates would be better in knees with a Medial Pivot fixed-bearing prosthesis than in those with a PFC Sigma mobile-bearing prosthesis. We compared the results of 92 patients who had a Medial Pivot fixed-bearing prosthesis implanted in one knee and a PFC Sigma mobile-bearing prosthesis implanted in the other. There were 85 women and seven men with a mean age of 69.5 years (range, 55–81 years). The minimum followup was 2 years (mean, 2.6 years; range, 2–3 years). The patients were assessed clinically and radiographically using the rating systems of the Hospital for Special Surgery and the Knee Society at 3 months, 1 year, and annually thereafter. Contrary to expectations, we found worse early clinical outcomes, smaller ranges of knee motion, less patient satisfaction, and a higher complication rate for the Medial Pivot fixed-bearing prosthesis than for the PFC Sigma mobile-bearing prosthesis. Level of Evidence: Level I, therapeutic study. See the Guidelines for Authors for a complete description of levels of evidence.