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Purpose: Fracture-related infection (FRI) is an important complication related to orthopaedic trauma. Although the scientific interest with respect to the diagnosis and treatment of FRI is increasing, data on the microbiological epidemiology remains limited. Therefore, the primary aim of this study was to evaluate the microbiological epidemiology related to FRI, including the association with clinical symptoms and antimicrobial susceptibility data. The secondary aim was to analyze whether there was a relationship between the time to onset of infection and the microbiological etiology of FRI. Methods: FRI patients treated at the University Hospitals of Leuven, Belgium, between January 1st 2015 and November 24th 2019 were evaluated retrospectively. The microbiological etiology and antimicrobial susceptibility data were analyzed. Patients were classified as having an early (<2 weeks after implantation), delayed (2-10 weeks) or late-onset (> 10 weeks) FRI. Results: One hundred ninety-one patients with 194 FRIs, most frequently involving the tibia (23.7%) and femur (18.6%), were included. Staphylococcus aureus was the most frequently isolated pathogen, regardless of time to onset (n=61; 31.4%), followed by S. epidermidis (n=50; 25.8%) and non-epidermidis coagulase-negative staphylococci (n=35; 18.0%). Polymicrobial infections (n=49; 25.3%), mainly involving Gram negative bacilli (GNB) (n=32; 65.3%), were less common than monomicrobial infections (n=138; 71.1%). Virulent pathogens in monomicrobial FRIs were more likely to cause pus or purulent discharge (n=45;54.9%; p=0.002) and fistulas (n=21;25.6%; p=0.030). Susceptibility to piperacillin/tazobactam for GNB was 75.9%. Vancomycin covered 100% of Gram positive cocci. Conclusion: This study revealed that in early FRIs, polymicrobial infections and infections including Enterobacterales and enterococcal species were more frequent. A time-based FRI classification is not meaningful to estimate the microbiological epidemiology and cannot be used to guide empiric antibiotic therapy. Large multicenter prospective studies are necessary to gain more insight into the added value of (broad) empirical antibiotic therapy. [ABSTRACT FROM AUTHOR]

Fracture‐related infection (FRI) is a serious complication following musculoskeletal trauma. Accurate diagnosis and appropriate treatment depend on retrieving adequate deep tissue biopsies for bacterial culture. The aim of this cohort study was to compare intraoperative tissue cultures obtained by the Reamer‐Irrigator‐Aspirator system (RIA)‐system against standard tissue cultures obtained during the same surgical procedure. All patients had long bone fractures of the lower limbs and were assigned to the FRI or Control group based on the FRI consensus definition. The FRI group consisted of 24 patients with confirmed FRI and the Control group consisted of 21 patients with aseptic nonunion or chronic pain (in the absence of other suggestive/confirmatory criteria). Standard tissue cultures and cultures harvested by the RIA‐system showed similar results. In the FRI group, standard tissue cultures and RIA cultures revealed relevant pathogens in 67% and 71% of patients, respectively. Furthermore, in four FRI patients, cultures obtained by the RIA‐system revealed additional relevant pathogens that were not found by standard tissue culturing, which contributed to the optimization of the treatment plan. In the Control group, there were no false‐positive RIA culture results. As a proof‐of‐concept, this cohort study showed that the RIA‐system could have a role in the diagnosis of FRI as an adjunct to standard tissue cultures. Since scientific evidence on the added value of the RIA‐system in the management of FRI is currently limited, further research on this topic is required before its routine application in clinical practice. [ABSTRACT FROM AUTHOR]

Background: Tibial shaft fractures (TSFs) are among the most common long bone injuries often resulting from high-energy trauma. To date, musculoskeletal complications such as fracture-related infection (FRI) and compromised fracture healing following fracture fixation of these injuries are still prevalent. The relatively high complication rates prove that, despite advances in modern fracture care, the management of TSFs remains a challenge even in the hands of experienced surgeons. Therefore, the Fracture-Related Outcome Study for operatively treated Tibia shaft fractures (F.R.O.S.T.) aims at creating a registry that enables data mining to gather detailed information to support future clinical decision-making regarding the management of TSF's.Methods: This prospective, international, multicenter, observational registry for TSFs was recently developed. Recruitment started in 2019 and is planned to take 36 months, seeking to enroll a minimum of 1000 patients. The study protocol does not influence the clinical decision-making procedure, implant choice, or surgical/imaging techniques; these are being performed as per local hospital standard of care. Data collected in this registry include injury specifics, treatment details, clinical outcomes (e.g., FRI), patient-reported outcomes, and procedure- or implant-related adverse events. The minimum follow up is 12 months.Discussion: Although over the past decades, multiple high-quality studies have addressed individual research questions related to the outcome of TSFs, knowledge gaps remain. The scarcity of data calls for an international high-quality, population-based registry. Creating such a database could optimize strategies intended to prevent severe musculoskeletal complications. The main purpose of the F.R.O.S.T registry is to evaluate the association between different treatment strategies and patient outcomes. It will address not only operative techniques and implant materials but also perioperative preventive measures. For the first time, data concerning systemic perioperative antibiotic prophylaxis, the influence of local antimicrobials, and timing of soft-tissue coverage will be collected at an international level and correlated with standardized outcome measures in a large prospective, multicenter, observational registry for global accessibility.Trial Registration: ClinicalTrials.gov : NCT03598530 . [ABSTRACT FROM AUTHOR]

Introduction: Fracture-related infection (FRI) is a serious complication related to orthopedic trauma, both from an infectious disease and a surgical point of view. The lack of scientific data with respect to diagnostic criteria and treatment principles of this entity has hampered efforts for an evidence-based approach and, as such, practices to prevent and treat FRI are often extrapolated from peri-prosthetic joint infection (PJI) literature. Recently, consensus guidelines were developed with respect to prevention, diagnosis and treatment of FRI.Areas covered: This review will define FRI and approaches to prevent and treat this complication will be discussed, with an emphasis on antimicrobial and surgical considerations. Guidelines focusing on FRI will be highlighted and aspects of pre-clinical research with imminent translational potential described.Expert opinion: New strategies are currently under investigation to improve the outcome of this sometimes-devastating complication. Local delivery of antimicrobials seems to be a promising approach; however, further high-quality clinical research is necessary to demonstrate efficacy. Delivery mechanisms for local antimicrobials include polymethyl methacrylate, implant coatings, collagen fleece, hydrogels and ceramics. The reintroduction of antimicrobials such as bacteriophage therapy has demonstrated promise in the management of drug-resistant organisms. [ABSTRACT FROM AUTHOR]

To identify the most relevant factors with respect to the management of fracture-related infection (FRI) and to develop a comprehensive FRI classification that guides decision-making and allows scientific comparison. An international group of FRI experts determined the preconditions, purpose, primary factors for inclusion, format and detailed description of the elements of an FRI classification through a consensus driven process. Three major elements were identified and grouped together in the FRI Classification: Fracture (F), Related patient factors (R) and Impairment of soft tissues (I). Each element was divided into five levels of complexity. Fractures can be healed (F1) or unhealed (F2–5). Patients may be fully healthy (R1) or have 4 levels of compromise, with and without end-organ damage (R2–5). Soft tissue condition ranges from well vascularized and easily closed (I1) to major skin defects requiring free flaps (I4). In all three elements, the fifth level (F5, R5 or I5) describes a patient who has an unreconstructible bone, soft tissue envelope or is not fit for surgery. The FRI classification, which is based on the three major elements Fracture (F), Related patient factors (R) and Impairment of soft tissues (I) is intended to guide decision-making and improve the quality of scientific reporting for FRIs in the future. The proposed classification is based on expert opinion and therefore an essential next step is clinical validation, in order to realize the ultimate goal of improving outcomes in the management of FRI. [ABSTRACT FROM AUTHOR]

Purpose: Fracture-related infection (FRI) is one of the most serious complications in orthopedic trauma surgery. Despite its widespread use, the role of Negative Pressure Wound Therapy (NPWT) remains controversial in the management pathway of FRI. The aim of this study was to assess the relationship between the application of NPWT and its duration and recurrence of infection in operatively treated FRI patients.Patients and Methods: This is a retrospective cohort study based on the FRI database of three level 1 Trauma Centres. Included patients had to be at least 16 years of age and surgically treated for FRI between January 1st 2015 and September 1st 2020. Patients were subdivided in either the NPWT group, when NPWT was applied as part of the FRI treatment, or in the control group, when no NPWT had been applied. To limit confounding, patients were excluded if they (also) underwent NPWT prior to the diagnosis of FRI. The relation between the duration of NPWT during FRI treatment and the recurrence rate of infection was analyzed using a multivariable logistic regression model.Results: A total of 263 patients were included, 99 in the NPWT group and 164 in the control group. The median duration of NPWT was 18.0 (IQR 15.8) days. In the NPWT group, 28 patients (28.3%) developed a recurrent FRI. In the control group, 19 patients (11.6%) had a recurrent FRI (p = 0.001, 95% CI [0.174 - 0.635]). In the NPWT group there were no significant differences in baseline characteristics between the recurrence and non-recurrence group. The duration of NPWT was associated with a higher risk of recurrence of infection (p = 0.013, OR 1.036, 95% CI [1.008 - 1.066]).Conclusion: Delayed wound closure with the application of NPWT increased the risk of recurrence of infection in patients with soft tissue defects after FRI treatment. Therefore, it is advised to consider NPWT only as a short-term (e.g. few days) necessity to bridge the period until definitive wound closure can be established. [ABSTRACT FROM AUTHOR]

Background: Fracture-related infection (FRI) after the operative management of patella fractures is a serious complication that can result in prolonged hospitalization, multiple revision procedures and permanent functional impairment. Till today, treatment modalities and outcome of FRI of the patella are not well described. Therefore, the main objective of this retrospective cohort study was to evaluate treatment options, functional outcome and healthcare costs related to FRI of the patella.Methods: This study evaluated 111 consecutive patients that were surgically treated for patella fractures, at the department of trauma surgery of the University Hospitals Leuven (Belgium), between January 2015 and April 2020. Patients were excluded if they (1) were younger than 18 years at the time of injury or (2) died during follow up. The minimal follow-up for all patients was 18 months.Results: During the 5-year study period, 107 patients with 108 patella fractures were included. A total of 10 patients were diagnosed with an FRI (9.3%). Four of these were treated with a DAIR approach and three patients underwent implant removal or exchange. Finally, three patients were treated with total patellectomy. Out of the 10 patients, two were diagnosed with a recurrence of infection. Overall, we observed substantial lower scores for all Knee Injury and Osteoarthritis Outcome Score subscales in the FRI group, compared to a reference population. Moreover, our study shows that direct hospital-related healthcare costs of FRI of the patella were nine times higher compared to non-FRI cases.Conclusions: FRI of the patella is a challenging complication and recurrence of infection not uncommon. Although multiple treatment modalities exist, a multidisciplinary patient-specific approach is crucial. An early or delayed onset infection can be managed with a DAIR approach, but only when the construct is stable and the soft tissue coverage adequate. In patients with an FRI, implant removal is preferred when the fracture has healed. A total patellectomy can be used as a salvage procedure in complex cases with acceptable functional results. Overall, FRI of the patella leads to both a negative impact on the functional status of the patient and a ninefold increase in total healthcare costs. [ABSTRACT FROM AUTHOR]

Background: The recently developed fracture-related infection (FRI) consensus definition, which is based on specific diagnostic criteria, has not been fully validated in clinical studies. We aimed to determine the diagnostic performance of the criteria of the FRI consensus definition and evaluated the effect of the combination of certain suggestive and confirmatory criteria on the diagnostic performance.Methods: A multicenter, multi-national, retrospective cohort study was performed. Patients were subdivided into an FRI or a control group, according to the treatment they received and the recommendations from a multidisciplinary team ('intention to treat'). Exclusion criteria were patients with an FRI diagnosed outside the study period, patients younger than 18 years of age, patients with pathological fractures or patients with fractures of the skull, cervical, thoracic and lumbar spine. Minimum follow up for all patients was 18 months.Results: Overall, 637 patients underwent revision surgery for suspicion of FRI. Of these, 480 patients were diagnosed with FRI, treated accordingly, and included in the FRI group. The other 157 patients were included in the control group. The presence of at least one confirmatory sign was associated with a sensitivity of 97.5%, a specificity of 100% and a high discriminatory value (AUROC 0.99, p < 0.001). The presence of a clinical confirmatory criterion or, if not present, at least one positive culture was associated with the highest diagnostic performance (sensitivity: 98.6%, specificity: 100%, AUROC: 0.99 (p < 0.001)). In the subgroup of patients without clinical confirmatory signs at presentation, specificities of at least 95% were found for the clinical suggestive signs of fever, wound drainage, local warmth and redness.Conclusions: The presence of at least one confirmatory criterion identifies the vast majority of patients with an FRI and was associated with an excellent diagnostic discriminatory value. Therefore, our study validates the confirmatory criteria of the FRI consensus definition. Infection is highly likely in case of the presence of a single positive culture with a virulent pathogen. When certain clinical suggestive signs (e.g., wound drainage) are observed (individually or in combination and even without a confirmatory criterion), it is more likely than not, that an infection is present. [ABSTRACT FROM AUTHOR]

Objectives: Fracture-related infection (FRI) is a feared complication with substantial clinical and economic consequences. The main objective of this study was to compare direct and indirect healthcare costs related to long bone fractures in patients with and without FRI and to assess its impact on the patient's quality of life (QoL).Patients and Methods: Between January 2015 and March 2019, 175 patients with FRI were treated at the University Hospitals Leuven (Belgium). Using a matched-pair analysis, patients with an FRI were matched by age, sex, and fracture location (humeral, femoral, or tibial shaft) to a non-FRI cohort treated during the same time period. Clinical and process-related variables, direct hospital-related healthcare costs, and indirect costs due to absenteeism were compared between the two groups. Furthermore, the patient's QoL was evaluated using Patient-Reported Outcomes Measurement Information System (PROMIS) physical function and pain interference.Results: After matched-pair analysis, 15 patients in both the FRI and non-FRI group were included. FRI was associated with direct hospital-related costs being eight times that of non-FRI patients (€ 47,845 [€ 43,072-€ 82,548] vs. € 5,983 [€ 4,519-€ 8,428], p < 0.001). Furthermore, FRI was associated with prolonged absenteeism (340 [340-676] vs. 86 [65-216] days, p = 0.007) and a median indirect cost that was nearly four times that of patients without FRI (€ 77,909 vs. € 19,706). Lastly, FRI patients showed significantly poorer outcomes on both physical function (33 [19-41] vs. 46 [43-44], p < 0.001) and pain interference (24 [13-34] vs. 8 [8-12], p < 0.001) PROMIS scales.Conclusion: Direct hospital-related healthcare costs of FRI are eight times that of non-FRI long bone fractures. Total healthcare costs are mainly driven by hospitalisation costs, wherein FRI is associated with prolonged length of stay. To the best of our knowledge, this study is the first to demonstrate that FRI is also associated with substantial absenteeism, which is almost four times higher compared to non-FRI patients. In addition to this economic impact, FRI significantly deteriorates QoL. Generalizing the outcome of this study should be done cautiously due to the small sample size of 15 patients in both the FRI and non-FRI group after matched-pair analysis. [ABSTRACT FROM AUTHOR]

Background: Fracture-related infection (FRI) remains one of the most challenging complications in orthopaedic trauma surgery. An early diagnosis is of paramount importance to guide treatment. The primary aim of this study was to compare the Centers for Disease Control and Prevention (CDC) criteria for the diagnosis of organ/space surgical site infection (SSI) to the recently developed diagnostic criteria of the FRI consensus definition in operatively treated fracture patients.Methods: This international multicenter retrospective cohort study evaluated 257 patients with 261 infections after operative fracture treatment. All patients included in this study were considered to have an FRI and treated accordingly ('intention to treat'). The minimum follow-up was one year. Infections were scored according to the CDC criteria for organ/space SSI and the diagnostic criteria of the FRI consensus definition.Results: Overall, 130 (49.8%) FRIs were captured when applying the CDC criteria for organ/space SSI, whereas 258 (98.9%) FRIs were captured when applying the FRI consensus criteria. Patients could not be classified as having an infection according to the CDC criteria mainly due to a lack of symptoms within 90 days after the surgical procedure (n = 96; 36.8%) and due to the fact that the surgery was performed at an anatomical localization not listed in the National Healthcare Safety Network (NHSN) operative procedure code mapping (n = 37; 14.2%).Conclusion: This study confirms the importance of standardization with respect to the diagnosis of FRI. The results endorse the recently developed FRI consensus definition. When applying these diagnostic criteria, 98.9% of the infections that occured after operative fracture treatment could be captured. The CDC criteria for organ/space SSI captured less than half of the patients with an FRI requiring treatment, and seemed to have less diagnostic value in this patient population. [ABSTRACT FROM AUTHOR]

• The applicability of the fracture-related infection (FRI) consensus definition has not been examined in LMICs. • A five-question telephone questionnaire was developed using the FRI consensus definition in open tibia fracture patients. • The overall sensitivity of the questionnaire was 71.4 % and the specificity was 93.0 %. • Drainage was the most sensitive criteria and fever was the most specific in predicting FRI. • Conducting telephone questionnaires to diagnose FRIs is promising and feasible in LMICs. Fracture-related infections (FRIs) are a major cause of trauma-associated morbidity worldwide. In 2018, an expert group supported by the AO Foundation, European Bone and Joint Infection Society developed a consensus definition of FRI. Still, there is limited knowledge on the applicability of this definition in low- and middle-income countries (LMICs). Given the unique barriers that cause low follow-up rates for orthopaedic trauma patients in LMICs, this study aims to evaluate the diagnostic performance of a telephone questionnaire in identifying patients with FRIs after open tibia fracture fixation in Tanzania. Patients from a randomized controlled trial investigating the infection prevention benefit of locally applied gentamycin for open tibial fractures were included. Patients completed FRI based telephone questionnaires 7–10 days prior to scheduled follow-ups at 6 weeks, 3 months, 6 months, 9 months, and 1 year. The questionnaire included two "confirmatory" criteria questions for FRI (i.e., open wound and purulent drainage) and three "suggestive" criteria questions (i.e., wound drainage, fever, and warmth). Contingency tests were performed to identify the sensitivity and specificity between answers and adjudicated FRI diagnoses at the corresponding in-person follow-up. Data was analysed using STATA version 15.0 and MedCalc's online diagnostic test calculator. There were a total of 234 complete questionnaires and 85 unique patients included. The sensitivity and specificity of having any positive answer in the questionnaire was highest at 6 months (100 % and 92.5 %, respectively). For all time-points pooled, sensitivity was 71.4 % and specificity was 93.0 %. Drainage had the highest sensitivity (71.4 %) while fever had the highest specificity (99.6 %). For confirmatory criteria, sensitivity was 14.3 % and specificity was 96.0 %. Contrastingly, the sensitivity for suggestive criteria was higher (71.4 %), with a similar specificity (93.8 %). Our study indicates that telephone questionnaires have adequate diagnostic performance when assessing FRIs. The presence of drainage identified the majority of patients with FRI, and specificities were high across confirmatory and suggestive criteria. Our study is one of the first to evaluate telephone questionnaires as a diagnostic tool for FRIs in patients with open tibia fractures in a LMIC hospital and validates the FRI consensus definition criteria. [ABSTRACT FROM AUTHOR]

• FRI of the clavicle is a challenging complication especially in the case of a bone defect. • In our institution, a patient-specific multidisciplinary approach for treatment of clavicular FRI leads to good clinical and radiological outcomes. • Surgical decisions are guided by the bone defect size, soft tissue status and patient demand. • Fracture (construct) stability is one of the most important aspects in the management of FRI of the clavicle. • Healthcare costs are up to 3.5 times higher compared to non-infected surgically treated clavicle fractures. The number of operatively treated clavicle fractures has increased over the past decades. Consequently, this has led to an increase in secondary procedures required to treat complications such as fracture-related infection (FRI). The primary objective of this study was to assess the clinical and functional outcome of patients treated for FRI of the clavicle. The secondary objectives were to evaluate the healthcare costs and propose a standardized protocol for the surgical management of this complication. All patients with a clavicle fracture who underwent open reduction and internal fixation (ORIF) between 1 January 2015 and 1 March 2022 were retrospectively evaluated. This study included patients with an FRI who were diagnosed and treated according to the recommendations of a multidisciplinary team at the University Hospitals Leuven, Belgium. We evaluated 626 patients with 630 clavicle fractures who underwent ORIF. In total, 28 patients were diagnosed with an FRI. Of these, eight (29%) underwent definitive implant removal, five (18%) underwent debridement, antimicrobial treatment and implant retention, and fourteen patients (50%) had their implant exchanged in either a single-stage procedure, a two-stage procedure or after multiple revisions. One patient (3.6%) underwent resection of the clavicle. Twelve patients (43%) underwent autologous bone grafting (tricortical iliac crest bone graft (n = 6), free vascularized fibular graft (n = 5), cancellous bone graft (n = 1)) to reconstruct the bone defect. The median follow-up was 32.3 (P 25 -P 75 : 23.9–51.1) months. Two patients (7.1%) experienced a recurrence of infection. The functional outcome was satisfactory, with 26 out of 28 patients (93%) having full range of motion. The median healthcare cost was € 11.506 (P 25 -P 75 : € 7.953–23.798) per patient. FRI is a serious complication that can occur after the surgical treatment of clavicle fractures. In our opinion, when treated adequately using a multidisciplinary patient-specific approach, the outcome of patients with an FRI of the clavicle is good. The median healthcare costs of these patients are up to 3.5 times higher compared to non-infected operatively treated clavicle fractures. Although not studied individually, we consider factors such as the size of the bone defect, condition of the soft tissue, and patient demand important when it comes to guiding our surgical decision making in cases of osseous defects. [ABSTRACT FROM AUTHOR]