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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.

Purpose Surgeons want to achieve native kinematics in primary total knee arthroplasty (TKA). Cruciate-substituting (CS) implants could restore the knee kinematics more efficiently than posterior-stabilised (PS) TKA. This study aimed to compare gait patterns in patients with CS or PS TKA at 6 months. The hypothesis was that CS implants would demonstrate comparable gait parameters to PS implants at 6 months. Methods In this prospective case–control study, 38 primary TKA without coronal laxity were divided into 2 groups: 19 cruciate-substituting (CS) and 19 posterior-stabilised (PS) implants. The type of prosthesis was determined according to the surgical period. Exclusion criteria were TKA revision, associated procedures and inability to walk on a treadmill. Gait analysis was conducted on a treadmill 6 months postoperatively for each patient with a knee assessment device (KneeKG®). Gait characteristics included analysis in three spatial dimensions (flexion–extension, abduction–adduction, internal–external rotation, anterior–posterior translation). Clinical outcomes (Knee Society Score and Forgotten Joint Score) were compared between both groups at 6 months postoperatively. Results At 6 months, the gait analysis did not demonstrate any significant difference between CS and PS implants. The range and the maximum anteroposterior translation were similar in both groups (9.2 ± 6.5 mm in CS group vs. 8.1 ± 3 mm in PS group (n.s.); and − 5.2 ± 5 mm in CS group vs. − 6.3 ± 5.9 mm in PS group (n.s.), respectively). The internal/external rotation, the flexion, and the varus angle were similar between CS and PS implants. The KSS Knee score was higher at 6 months in the CS group than in the PS group (92.1 ± 5.6 vs. 84.8 ± 8.9 ( p  < 0.01)). Conclusion Cruciate-substituting and posterior-stabilised TKA had similar gait patterns at 6 months postoperatively, despite a non-equivalent posterior stabilisation system. CS prostheses were an interesting option for primary TKA for knee kinematics restoration without requiring a femoral box. Level of evidence Prospective, case–control study; Level II.

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.

Purpose Research has shown that a cemented mobile-bearing component has a favorable effect on the bone mineral density (BMD) of the distal femur at 2 years after total knee arthroplasty (TKA). This study was performed to determine whether the advantage on BMD of a cemented mobile-bearing TKA over a conventional cemented fixed-bearing TKA changes with time. This report is an update of a matched cohort study initiated in 2004 and for which the 2-year results have been published. Methods Twenty-eight knees that were treated with a fixed-bearing posterior stabilized (PS) prosthesis and 28 matched knees from a database of 76 knees that were treated with a mobile-bearing PS prosthesis in the same period were investigated. All knees underwent dual-energy X-ray absorptiometry (DEXA) scans around the femoral component preoperatively, 2 weeks postoperatively, 5 years postoperatively, and annually thereafter. Eighteen knees with a cemented mobile-bearing PS prosthesis and 20 knees with a cemented fixed-bearing PS prosthesis were investigated for more than 6 years. The mean follow-up period was 11 years. Results The range of motion, Knee Society Score, BMD of the lumbar spine, and follow-up period were not significantly different preoperatively and postoperatively in the two groups. In the fixed-bearing group, the BMD of the anterior part of the femoral condyle decreased postoperatively. In the mobile-bearing group, the BMD of the posterior part of the femoral condyle increased postoperatively. The postoperative change in the BMD at 5 years and the latest follow-up period was statistically significant in the two groups. Conclusions This DEXA study revealed that a cemented mobile-bearing component had a favorable effect on the BMD of the distal femur after TKA even at a mean of 11 years postoperatively. Level of evidence Therapeutic study, level II, prospective comparative study.

Periprosthetic joint infection (PJI) is a serious complication of total knee arthroplasty. Two-stage revision is the most widely used technique and considered as the most effective for treating periprosthetic knee infection. The one-stage revision strategy is an emerging alternative option, however, its performance in comparison to the two-stage strategy is unclear. We therefore sought to ask if there was a difference in re-infection rates and other clinical outcomes when comparing the one-stage to the two-stage revision strategy. Our first objective was to compare re-infection (new and recurrent infections) rates for one- and two-stage revision surgery for periprosthetic knee infection. Our second objective was to compare between the two revision strategies, clinical outcomes as measured by postoperative Knee Society Knee score, Knee Society Function score, Hospital for Special Surgery knee score, WOMAC score, and range of motion. Systematic review and meta-analysis. MEDLINE, EMBASE, Web of Science, Cochrane Library, reference lists of relevant studies to August 2015, and correspondence with investigators. Longitudinal (prospective or retrospective cohort) studies conducted in generally unselected patients with periprosthetic knee infection treated exclusively by one- or two-stage revision and with re-infection outcomes reported within two years of revision surgery. No clinical trials comparing both revision strategies were identified. Two independent investigators extracted data and discrepancies were resolved by consensus with a third investigator. Re-infection rates from 10 one-stage studies (423 participants) and 108 two-stage studies (5,129 participants) were meta-analysed using random-effect models after arcsine transformation. The rate (95% confidence intervals) of re-infection was 7.6% (3.4-13.1) in one-stage studies. The corresponding re-infection rate for two-stage revision was 8.8% (7.2-10.6). In subgroup analyses, re-infection rates remained generally similar for several study-level and clinically relevant characteristics. Postoperative clinical outcomes of knee scores and range of motion were similar for both revision strategies. Potential bias owing to the limited number of one-stage revision studies and inability to explore heterogeneity in greater detail. Available evidence from aggregate published data suggest the one-stage revision strategy may be as effective as the two-stage revision strategy in treating infected knee prostheses in generally unselected patients. Further investigation is warranted. PROSPERO 2015: CRD42015017327.

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 . . .

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 Allergies against implant materials are still not fully understood. Despite controversies about its relevance, some patients need treatment with hypoallergenic implants. This study compared coated and standard total knee arthroplasty (TKA) regarding inflammatory response and patient-reported outcome measures (PROMs). Methods 76 patients without self-reported allergies against implant materials were included in a RCT and received a coated or standard TKA of the same cemented posterior-stabilized knee system. 73 patients completed the 3-year follow-up. Two patients died and there was one revision surgery. Serum levels of cytokines with a possible role in implant allergy were measured in patient`s serum (IL-1beta, IL-5, IL-6, IL-8, IL-10, IFN γ, TNF α) prior to, one and three years after surgery. Furthermore, PROMs including knee function (Oxford Knee Score, Knee Society Score) and health-related quality of life (QoL, EuroQuol questionnaire) were assessed. Additionally, 8 patients with patch-test proven skin allergy against implant materials who received the coated implant were assessed similarly and compared to a matched-pair group receiving the same implant. Results There were no differences in function and QoL between the assessed groups at any follow-up. The majority of patients demonstrated no elevation of the measured blood cytokines. Cytokine patterns showed no differences between study groups at any follow-up. The allergy patients demonstrated slower functional improvement and minor differences in cytokine pattern. Yet these results were not significant. There were no differences in the matched-pair analysis. Conclusion We observed no relevant increase in serum cytokine levels in any group. The inflammatory response measured seems limited, even in allergy patients. Furthermore, there were no differences between coated and standard TKA in non-allergy patients in the 3-year Follow-Up period. Trial registration The study protocol was registered in the US National Institutes of Health’s database ( http://www.clinicaltrials.gov ) registry under NCT03424174 on 03/17/2016.

Background Antibiotic-impregnated bone cement has increased in popularity as an effort to reduce the risk of infection in high-risk TKAs. However, limited data has been reported regarding antibiotic levels achieved when using tobramycin-impregnated bone cement after implanting total knee components. Questions/Purposes We asked: (1) What is the tobramycin serum and knee intraarticular levels in patients undergoing primary TKA using tobramycin cement? (2) What is the intraarticular tobramycin level for patients receiving only intravenous tobramycin? Methods All patients undergoing primary TKA by one of the two study surgeons (GV, JP) during a 6-month period were evaluated for inclusion and invited to participate. The study enrolled 15 patients undergoing primary TKA by one of two surgeons (GV, JP) who met inclusion criteria; treatment allocation was assigned randomly through blinded envelope. The study group consisted of 10 patients whose components were implanted using a commercially prepared low-dose tobramycin bone cement mixture (1 g/40 g). The control group consisted of five patients who received standard weight-based dose intravenous tobramycin. Samples of serum and Hemovac ® drain-collected intraarticular hematoma were analyzed at 6, 24, and 48 hours postoperatively. Tobramycin levels were measured using an immunoassay technique with a low-end sensitivity of 0.28 μg/mL. Mann-Whitney U tests were performed to compare the serum and intraarticular tobramycin concentrations at each time in the independent variable of group (Control and Study). Results The median (interquartile range [IQR]) intraarticular tobramycin concentrations for the study group, with tobramycin-impregnated bone cement, was 31.8 (29.0) μg/mL at 6 hours, 17.1 (13.1) μg/mL at 24 hours, and 6.8 (6.8) μg/mL at 48 hours. The intraarticular tobramycin concentrations of this study group were larger than those for the control group at 6 hours (median = 1.3; IQR = 0.7; p = 0.002), 24 hours (median = 1.3, IQR = 1.0; p = 0.002), and 48 hours (median = 1.4; IQR = 1.0; p = 0.02). The serum concentrations for the tobramycin-impregnated bone cement group were 0.3 μg/mL or less for all samples whereas serum concentrations and median (IQR) for the control group were 1.2 (2.6) μg/mL, 1.6 (4.4) μg/mL, and 2.0 (3.3) μg/mL at 6, 24, and 48 hours respectively. The serum levels for the tobramycin-impregnated cement group were less than those for the control group at 6 hours (p = 0.001), 24 (p = 0.001), and 48 hours (p < 0.001). Conclusions Tobramycin-impregnated bone cement provides a way to deliver antibiotics in patients undergoing TKA. This supratherapeutic short-term prophylactic perioperative antibiotic local delivery can be achieved with limited systemic absorption, whereas joint tobramycin levels were less than therapeutic levels when given intravenously alone. In the control group, with only intravenous tobramycin, a subtherapeutic (< 2.0 μg/mL) level of tobramycin was found in all the intraarticular samples at 6, 24, and 48 hours. Based on the evidence obtained in this study, commercially prepared low-dose tobramycin bone cement can be used to obtain short-term supratherapeutic local concentrations in the knee while maintaining serum tobramycin levels at a minimum. Level of Evidence Level II, therapeutic study.