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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.

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.

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).

Periprosthetic bone loss due to adaptive bone remodeling is an important unresolved issue in cementless total hip arthroplasty (THA). The use of porous tantalum on the proximal surface of the femoral stem is expected to decrease postoperative bone loss around the prosthesis through early fixation. We conducted a multicenter randomized controlled study to determine if porous tantalum could reduce periprosthetic bone loss after THA. From October 2012 to September 2014, 118 patients (mean age, 61.5 years; 107 females and 11 males) were prospectively enrolled and were randomly allocated at a ratio of 1:1 to either a metaphyseal filling stem with a proximal porous tantalum coating (Trabecular Metal) or a conventional metaphyseal filling stem with fiber mesh coating (VerSys). Patients underwent dual-energy x-ray absorptiometry scans within 1 week after surgery (baseline) and at 6, 12, and 24 months after surgery to assess periprosthetic bone mineral density (BMD) in the 7 Gruen zones. In addition, the Japanese Orthopaedic Association hip score was assessed before surgery and at 6, 12, and 24 months after surgery. In the proximal periprosthetic region (zones 1 and 7), the Trabecular Metal group had significantly smaller reductions in BMD than the VerSys group throughout the study period. In the VerSys group, significant reductions in BMD compared to baseline were seen at each measurement point in all regions, except in zone 6 at 24 months. In the Trabecular Metal group, no significant reductions in BMD relative to baseline were seen in zones 1, 5, or 6 throughout the study period. Both groups demonstrated similar improvement in Japanese Orthopaedic Association hip scores over the study period. This study demonstrated that a proximally coated stem with porous tantalum has superior results over a conventional stem with titanium fiber mesh in terms of periprosthetic bone remodeling.

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 The high failure rates of metal on metal (MoM) large diameter head total hip arthroplasty (LDH THA) and hip resurfacing (HR) prevented their long-term comparisons with regards to clinical outcome. Such knowledge would be important as ceramic LDH bearing is now available. With long-term follow-up, we investigated the difference in 1) patient-reported outcome measures (PROMs); 2) revision and adverse events rates, and 3) metal ion levels between MoM LDH THA and HR. Methods Forty-eight patients were randomized for LDH THA (24) or HR (24) with the same MoM articulation. At a mean follow-up of 14 years, we compared between groups different PROMs, the number of revisions and adverse events, whole blood Cobalt (Co) and Chromium (Cr) ion levels, and radiographic signs of implant dysfunction. Results LDH THA (all cases: revised and well-functioning) had significantly better WOMAC (94 versus 85, p  = 0.04), and more frequently reported having no limitation ( p  = 0.04). LDH THA revision rate was 20.8% (5/24) versus 8.3% (2/24) for HR ( p  = 0.4). Mean Co and Cr ion levels were higher in LDH THA compared to the HR (Co: 3.8 μg/L vs 1.7 μg/L; p = 0.04 and Cr: 1.9 μg/L vs 1.4 μg/L, p  = 0.1). On radiographic analyses, 2 LDH THAs showed signs of adverse reaction to metal debris, whereas 1 loose femoral HR component was documented. Conclusion In the long-term, MoM LDH THA had a high trunnion related revision rate but nonetheless showed better PROMs compared to HR. Provided with a well-functioning modular junction, non-MoM LDH THA would offer an appealing option. Trial registration ClinicalTrials.gov ( NCT04516239 ), August 18, 2020. Retrospectively registered.

Background Dislocation is a common complication after total hip arthroplasty (THA). This study aimed to compare the outcomes of mesh reconstruction versus conventional capsular repair in maintaining capsular integrity and preventing dislocation after THA. Methods This was a prospective, randomized controlled study of consecutive patients. A total of 124 high-dislocation-risk THAs were identified and randomized into two groups, one using mesh reconstruction and the other using the conventional capsular repair method. Perioperative data and radiological data were collected. Patients were followed up regularly. The main indices were the capsular integrity assessed by magnetic resonance imaging (MRI) and hip dislocation rate. The secondary indices included the Harris hip score (HHS), complications, and satisfaction. Results A total of 106 patients completed the follow-up and the average follow-up times were 19 ± 3.1 and 18 ± 3.3 months. The operation time of the mesh group was longer than that of the conventional group ( P  < 0.001). There were minor differences in acetabular anteversion and abduction angle, and the other data showed no differences. MRI results indicated that the success rate of capsular repair was higher in the mesh group (50 hips, 98%) than in the conventional group (37 hips, 67%) ( P  < 0.001), and the others failed the repair. Three dislocations occurred in the conventional group, while none occurred in the mesh group. The preoperative HHS (30 points) and postoperative HHS (82 points) of the mesh group were similar to those (35 points, 83 points) of the conventional group ( P  = 0.164, P  = 0.328). Satisfaction had no difference ( P  = 0.532). Conclusions Compared to conventional repair, mesh reconstruction can effectively maintain capsular integrity and decrease dislocation risk after THA without increasing complications. Level of evidence : Therapeutic study, Level IA.

Background Inferior placement of a femoral stem is predictive for early loosening and failure, but does restoration of the original hip anatomy benefit the function and survival of a total hip replacement? Methods Seventy-five patients with primary unilateral hip osteoarthritis operated with an uncemented anatomical stem were randomized for either standard or modular stems. We used 50 ABG II stems with modular necks and 25 standard stems (control group). We measured the symmetry in hip anatomy between healthy and operated side. The anatomical restoration variables were anteversion, global offset, and femoral offset/acetabular offset (FO/AO) quota. We performed measurements using a CT-based 3D templating and measuring software. Migratory behavior of the stems was then measured postoperatively with repeated radiostereometry (RSA) examinations over 5 years. Results Both stem types showed an early (within 3 months) good stabilization after an initial slight rotation into retroversion and subsidence. There were no significant differences in RSA migration between modular and standard stems. Postoperative anteversion and FO/AO quota had no impact on stem migration. The standard stem tended to result in insufficient global offset (GO), whereas the modular stem did not. Conclusions The modular stem gave good symmetrical anatomical restoration and, like the standard version, a benign migratory behavior. Anteversion, GO, and FO/AO quota had no significant impact on stem migration. It therefore seems to be of no importance whether we choose a modular or a standard stem with regard to postoperative stem migration for this stem type. We overestimated the effect anatomical parameters have on stem movement; hence, we believe the study to be underpowered. Trial registration ClinicalTrials.gov identifier: NCT01512550 . Registered 19 January 2012—retrospectively registered,