High variability in Factor IX one-stage assay in samples spiked with nonacog beta pegol among different pairs of reagent/detection system.

INTRODUCTION: Haemophilia B (HB) is an X-linked hereditary bleeding disorder characterized by coagulation factor IX (FIX) deficiency. To improve the quality of life of patients and adherence to treatment, recombinant factor concentrates modified to extend their half-life have been developed, called extended half-life factors (EHL: extended half-life). Nonacog beta pegol (N9-GP) is a glycopegylated recombinant human FIX molecule that has a half-life of 93 h with a single dose and has shown a higher recovery percentage than other molecules. To diagnose and monitor the treatment of haemophiliac patients, FIX activity is determined with the one-stage clotting assay (OSA) and/or the chromogenic assay. The objective of this work, carried out in three centres, was to measure the recovery of N9-PG with 10 different activated partial thromboplastin time (APTT) reagents on three platforms, in samples spiked in vitro with N9-GP, at four different concentration levels. METHODS: It was measured the recovery of N9-GP with 10 different APTT reagents (polyphenol, ellagic acid, silice dioxide, colloidal silica as APTT activator on three platforms, in sample spiked in vitro with N9-GP. RESULTS: The results show heterogeneity in the activity of N9-GP measured by OSA with the different APTT reagents when the calibrations were performed with the specific calibrator of each coagulometer. A recovery percentage between 87% and 108% was obtained only with polyphenol and ellagic acid as activator in the three platforms evaluated. The other reagents studied overestimate or underestimate, with no clear profile. When a calibration curve was performed with a calibrator prepared from the N9-GP vial, all APTT reagents met the established recovery requirement. CONCLUSION: APTT reagents with polyphenol or ellagic acid as activator would be the only ones appropriate when using the commercially available OSA with specific calibrator to monitor patients treated with N9-GP.

A Retrospective Observational Cohort Study of Periprosthetic Hip Infection Treated by one-stage Method Including Cases With Bone Graft Reconstruction.

Purpose: Prosthetic joint infection (PJI) is a devastating complication that can affect hip arthroplasty. Its treatment is extremely difficult, and issues regarding the optimal treatment remain unanswered. This study intended to show the effectiveness of the one-stage treatment of PJI. Materials and Methods: A retrospective observational cohort study performed from July 2014- August 2018. All patients with suspected PJI were included. Major and minor criteria developed by the International Consensus on Periprosthetic Joint Infection (ICPJI) was used to define infection. Laboratory tests and image exams were performed, and all patients were followed for at least 2 years. Outcomes: Success rate (2018 ICPJI definition to success) in treatment of PJI using one-stage revision method. Clinical and functional outcomes defined by Harris Hip Score (HHS). Results: Thirty-one patients were screened and 18 analyzed. 69.85 ± 9.76 years was the mean age. Mean follow-up time was 63.84 ± 18.55 months. Ten patients had acetabular defects and required bone graft reconstruction. Sixteen patients were classified as Tier 1, 1 as Tier 3D, and as 1 Tier 3E. Almost 90% of patients submitted to one-stage revision with acetabulum graft reconstruction were free of infection. The overall infection survival rate was 78.31±6.34 months. Candida albicans and sinus tract were statistically significant in univariate Cox's analysis. The predictor of one-stage revision surgery failure that remained final Cox's regression model was C. albicans (hazard ratio [HR]: 4.47). Conclusion: Treatment through one-stage revision surgery associated with 6 months of antimicrobial is a viable option with acceptable results even when bone graft reconstruction is necessary. C. albicans was a strong predictor of failure in this cohort.

One-stage exchange should be avoided in periprosthetic joint infection cases with massive femoral bone loss or with history of any failed revision to treat periprosthetic joint infection.

AIMS: There is a paucity of long-term studies analyzing risk factors for failure after single-stage revision for periprosthetic joint infection (PJI) following total hip arthroplasty (THA). We report the mid- to long-term septic and non-septic failure rate of single-stage revision for PJI after THA. METHODS: We retrospectively reviewed 88 cases which met the Musculoskeletal Infection Society (MSIS) criteria for PJI. Mean follow-up was seven years (1 to 14). Septic failure was diagnosed with a Delphi-based consensus definition. Any reoperation for mechanical causes in the absence of evidence of infection was considered as non-septic failure. A competing risk regression model was used to evaluate factors associated with septic and non-septic failures. A Kaplan-Meier estimate was used to analyze mortality. RESULTS: The cumulative incidence of septic failure was 8% (95% confidence interval (CI) 3.5 to 15) at one year, 13.8% (95% CI 7.6 to 22) at two years, and 19.7% (95% CI 12 to 28.6) at five and ten years of follow-up. A femoral bone defect worse than Paprosky IIIA (hazard ratio (HR) 13.58 (95% CI 4.86 to 37.93); p < 0.001) and obesity (BMI ≥ 30 kg/m2; HR 3.88 (95% CI 1.49 to 10.09); p = 0.005) were significantly associated with septic failure. Instability and periprosthetic fracture were the most common reasons for mechanical failure (5.7% and 4.5%, respectively). The cumulative incidence of aseptic failure was 2% (95% CI 0.4 to 7) at two years, 9% (95% CI 4 to 17) at five years, and 12% (95% CI 5 to 22) at ten years. A previous revision to treat PJI was significantly associated with non-septic failure (HR 9.93 (95% CI 1.77 to 55.46); p = 0.009). At the five-year timepoint, 93% of the patients were alive (95% CI 84% to 96%), which fell to 86% (95% CI 75% to 92%) at ten-year follow-up. CONCLUSION: Massive femoral bone loss was associated with greater chances of developing a further septic failure. All septic failures occurred within the first five years following the one-stage exchange. Surgeons should be aware of instability and periprosthetic fracture being potential causes of further aseptic revision surgery. Cite this article: Bone Joint J 2021;103-B(7):1247-1253.

One-Stage Hip Revision Arthroplasty Using Megaprosthesis in Severe Bone Loss of The Proximal Femur Due to Radiological Diffuse Osteomyelitis.

Managing substantial proximal and/or distal femoral bone defects is one of the biggest challenges in chronic hip periprosthetic joint infection. Most authors use two-stage arthroplasty with a temporary antibiotic-loaded cement spacer for the management of these patients. In this study, we show our experience with one-stage exchange arthroplasty in managing severe bone defects due to radiological-extensive proximal femoral osteomyelitis. Two patients were included in the study. They showed radiological-extensive proximal femoral osteomyelitis, and they were treated with one-stage exchange arthroplasty using megaprosthesis. Diffuse osteomyelitis was confirmed in both cases; in one case, the histology was compatible with osteomyelitis, and the other case had a positive culture identified in a bone sample. At a minimum of a four-year follow-up, the patients did not reveal any clinical, radiological or laboratory signs of infection. In conclusion, one-stage exchange arthroplasty and megaprosthesis is an option for the treatment of chronic hip periprosthetic joint infection associated with radiological-diffuse proximal femoral osteomyelitis.

Simultaneous Bilateral Femoral Neck Fracture Due to a Tonic-Clonic Seizure and High-Dose Steroid Therapy.

Simultaneous bilateral femoral neck fractures (FNFs) are extremely rare and usually associated with an underlying condition affecting the bone quality and mineralization. Convulsions have also been described as a possible cause, mostly as a consequence of epilepsy, hyponatremia, and hypocalcemia. We present a 52-year-old female patient, with bilateral displaced FNFs due to a tonic-clonic seizure and high-dose steroid therapy related to a frontal lobe anaplastic oligodendroglioma brain tumor resection. Two days after admission, bilateral one-stage uncemented total hip arthroplasty (THA) under general anesthesia and through a posterolateral approach was performed using a metal-on-polyethylene bearing surface. Several risk factors can be identified in this unique case, such as the high-dose steroid therapy, the low-demand activity of the patient due to her functional sequelae, and finally, the convulsive episode. Surgeons should be aware of this uncommon injury to ensure early diagnosis and treatment in all patients with a previous history of seizures, chronic steroid use, severe hip pain, and inability to walk. For bone metabolic diseases, preventive measures should be indicated to avoid these complications. Bilateral one-stage uncemented THA represents an effective procedure with a low complication rate allowing early rehabilitation.

Infección periprotésica de rodilla ¿influye la estrategia quirúrgica en el resultado funcional? / Total knee arthroplasty infection, what is the best strategy for better functional outcomes?

Resumen: Introducción: La estrategia quirúrgica al enfrentarnos a las infecciones periprotésicas de rodilla sigue siendo controvertida. Los objetivos del tratamiento son la erradicación de la infección, la mejoría del dolor y de la función articular. El manejo quirúrgico incluye el desbridamiento y retención del implante, el recambio protésico en un tiempo o el recambio en dos tiempos. Esta última estrategia quirúrgica se considera el «gold standard¼, alcanzando unas tasas de curación hasta de 80%-100%, aunque poco se ha publicado acerca de los resultados funcionales. Material y métodos: Estudio retrospectivo de 65 pacientes, con infección periprotésica de rodilla. En 20 pacientes se realizó un recambio en un tiempo y en 45 pacientes fueron recambios en dos tiempos. Evaluación pre- y postoperatoriamente con la escala modificada HSS. Todos los pacientes fueron tratados con antibioterapia intravenosa, evaluamos la respuesta analítica y clínica para confirmar la erradicación o no de la infección. Resultados: La infección se resolvió en 39 de 65 pacientes, 12 en el grupo de recambio en un tiempo y 27 para el grupo de dos tiempos. Sin diferencia significativa entre los grupos en relación con curación ni resultado funcional. Sin embargo, hay una diferencia estadísticamente significativa entre aquellos pacientes que recibieron tratamiento antibiótico vía oral antes del diagnóstico y aquéllos que no lo recibieron. Conclusión: La tasa de curación es similar en los tratados con recambio en un tiempo y recambio en dos tiempos. No pudimos demostrar superioridad en los resultados funcionales entre los dos grupos.

Abstract: Introduction: Surgical strategy in dealing with periprosthetic knee infections remains controversial. The goals of treatment are to eradicate infection, improve pain and joint function. Surgical management includes implant debridement and retention, prosthetic replacement in one-time, or two-stage replacement. This latest surgical strategy is considered the «gold standard¼, reaching healing rates up to 80%-100%, although little has been published about functional results. Material and methods: Retrospective study of 65 patients with periprosthetic knee infection. In 20 patients a replacement was made in a time and in 45 patients were in two stages. Pre- and post-operative evaluation with the modified HSS scale. All patients were treated with intravenous antibiotherapy, we evaluated the analytical and clinical response to confirm the eradication or not of the infection. Results: The infection was resolved in 39 out of 65 patients, 12 in the replacement group in a time and 27 for the two-stages group. No significant difference between the groups in relation to healing or functional result. However, there is a statistically significant difference between those patients who received oral antibiotic treatment prior to diagnosis and those who did not. Conclusions: The healing rate is similarly treated with replacement in a time and replacement in two times. We were unable to demonstrate superiority in the functional results between the two groups.

Unusual Listeria monocytogenes hematogenous infection in total knee replacement treated with one-stage revision surgery.

Septic arthritis due to Listeria monocytogenes (LM) is extremely rare and most infections due to this organism are seen in immunocompromised patients. We describe a patient without immunological compromise, with a late total knee arthroplasty infection caused by LM treated with one-stage revision surgery. She had an elevated erythrocyte sedimentation rate (79 mm/h) and C-reactive protein (13 mg/dL). Aspiration of the knee joint yielded purulent fluid; cultures showed LM. The patient was given 6 weeks of intravenous ampicillin, followed by trimethoprim/sulfamethoxazole, and finally amoxicillin orally for 7 months. Two years after revision surgery, radiographs showed no evidence of implant loosening. This is a single case and although one-stage approach seemed to have worked, it should not be recommended on the basis of a single report.

Primary Total Knee Arthroplasty Implants as Functional Prosthetic Spacers for Definitive Management of Periprosthetic Joint Infection: A Multicenter Study.

BACKGROUND: There are limited data on the utility of a standard primary total knee arthroplasty (TKA) femoral component with an all polyethylene tibia as a functional prosthetic spacer in place of a conventional all cement spacer for the management of periprosthetic joint infection (PJI). The aim of this multicenter study was to retrospectively review (1) ultimate treatment success; (2) reimplantation rates; (3) reoperation rates; and (4) change in knee range of motion in patients managed with functional prosthetic spacers following TKA PJI. METHODS: A retrospective review was performed for patients at 2 tertiary care centers who underwent a functional prosthetic spacer implantation as part of a functional single-stage (n = 57) or all cement spacer conventional two-stage (n = 137) revision arthroplasty protocol over a 5-year period. Outcomes including reinfection, reimplantation, and reoperation rates, success rate as defined by the Delphi criteria, and final range of motion were compared between the 2 cohorts at a minimum of 2-year follow-up. RESULTS: There was no significant difference in reinfection (14.0 vs 24.1%), reoperation (19.3 vs 27.7%), or success rates (78.9 vs 70.8%; P > .05 for all) between the one-stage and two-stage revision TKA cohorts. Mean final total arc of motion was also similar between the 2 groups (105.8 vs 101.8 degrees, respectively). CONCLUSION: Functional prosthetic spacers offer the advantage of a single procedure with decreased overall hospitalization and improved cost-effectiveness with analogous success rates (78.9%) compared with two-stage exchange (70.8%) at mid-term follow-up. Although long-term data are required to determine its longevity and efficacy, the outcomes in this study are encouraging. LEVEL OF EVIDENCE: 3.

[Total knee arthroplasty infection, what is the best strategy for better functional outcomes?] / Infección periprotésica de rodilla ¿influye la estrategia quirúrgica en el resultado funcional?

INTRODUCTION: Surgical strategy in dealing with periprosthetic knee infections remains controversial. The goals of treatment are to eradicate infection, improve pain and joint function. Surgical management includes implant debridement and retention, prosthetic replacement in one-time, or two-stage replacement. This latest surgical strategy is considered the «gold standard¼, reaching healing rates up to 80%-100%, although little has been published about functional results. MATERIAL AND METHODS: Retrospective study of 65 patients with periprosthetic knee infection. In 20 patients a replacement was made in a time and in 45 patients were in two stages. Pre- and post-operative evaluation with the modified HSS scale. All patients were treated with intravenous antibiotherapy, we evaluated the analytical and clinical response to confirm the eradication or not of the infection. RESULTS: The infection was resolved in 39 out of 65 patients, 12 in the replacement group in a time and 27 for the two-stages group. No significant difference between the groups in relation to healing or functional result. However, there is a statistically significant difference between those patients who received oral antibiotic treatment prior to diagnosis and those who did not. CONCLUSIONS: The healing rate is similarly treated with replacement in a time and replacement in two times. We were unable to demonstrate superiority in the functional results between the two groups.

INTRODUCCIÓN: La estrategia quirúrgica al enfrentarnos a las infecciones periprotésicas de rodilla sigue siendo controvertida. Los objetivos del tratamiento son la erradicación de la infección, la mejoría del dolor y de la función articular. El manejo quirúrgico incluye el desbridamiento y retención del implante, el recambio protésico en un tiempo o el recambio en dos tiempos. Esta última estrategia quirúrgica se considera el «gold standard¼, alcanzando unas tasas de curación hasta de 80%-100%, aunque poco se ha publicado acerca de los resultados funcionales. MATERIAL Y MÉTODOS: Estudio retrospectivo de 65 pacientes, con infección periprotésica de rodilla. En 20 pacientes se realizó un recambio en un tiempo y en 45 pacientes fueron recambios en dos tiempos. Evaluación pre- y postoperatoriamente con la escala modificada HSS. Todos los pacientes fueron tratados con antibioterapia intravenosa, evaluamos la respuesta analítica y clínica para confirmar la erradicación o no de la infección. RESULTADOS: La infección se resolvió en 39 de 65 pacientes, 12 en el grupo de recambio en un tiempo y 27 para el grupo de dos tiempos. Sin diferencia significativa entre los grupos en relación con curación ni resultado funcional. Sin embargo, hay una diferencia estadísticamente significativa entre aquellos pacientes que recibieron tratamiento antibiótico vía oral antes del diagnóstico y aquéllos que no lo recibieron. CONCLUSIÓN: La tasa de curación es similar en los tratados con recambio en un tiempo y recambio en dos tiempos. No pudimos demostrar superioridad en los resultados funcionales entre los dos grupos.

Quiste pilonidal abscedado: tratamiento definitivo en un solo tiempo durante el episodio agudo, resultados a corto plazo / Pilonidal cyst abscess: definitive treatment in a single time during the acute, short-term results

Sacrococcigeal Pilonidal disease (EPSC) is a chronic inflammatory disease with intercurrent periods of abscess formation. Habitual behavior is the management in two stages, characterized by drainage and delayed management using different techniques. Objective: To show the treatment in a single time (definitive) of the EPSC abscessed with the technique of Mc Fee. Materials and Methods: Prospective study. 20 patients with abscessed EPSC were admitted in the Hospital of Los Angeles, between april 2009 - april 2010, who underwent Mc Fee technique as definitive treatment. Average follow up of 197 days. Results: Of 20 patients, 11 were females. Average age 28.2 years. BMI 27.5. The average hospital stay was 1.7 days. The average time walk without pain was of 6.6 days. Postoperative pain was low in most subjects. The total healing time was 34.9 days on average. The satisfaction with the scar was high in 90 percent. Discussion and Conclusion: In this study the technique of Mc Fee is presented as an alternative for definitive treatment in a single time. Success in all areas, such pain, postoperative recovery, complications and cosmetic out come. The follow up must be longer to determine the existence of long term recurrences.

La enfermedad pilonidal sacrococcigea (EPSC) es una enfermedad inflamatoria crónica que cursa con períodos intercurrentes de abscedación. La conducta habitual es el manejo en dos tiempos, caracterizado por drenaje y manejo diferido mediante distintas técnicas. Objetivo: Mostrar los resultados del tratamiento definitivo en un tiempo en la EPSC abscedada mediante la técnica de Mc Fee. Materiales y Métodos: Estudio transversal con recolección prospectiva de datos. 20 pacientes con EPSC abscedada en el Hospital de Los Ángeles, entre abril de 2009 - abril de 2010, sometidos a técnica de Mc Fee como tratamiento definitivo. Seguimiento promedio de 197 días. Resultados: Total 20 pacientes, 11 de sexo femenino. Edad promedio 28,2 años. IMC 27,5. La hospitalización promedio fue de 1,7 días. El tiempo promedio de caminata sin dolor 6,6 días. El dolor postoperatorio fue bajo en la mayoría de los sujetos. El tiempo de curación total 34,9 días promedio. La satisfacción con la cicatriz, alta en 90 por ciento. Discusión y Conclusión: En este trabajo la técnica de Mc Fee se presenta como una alternativa para el tratamiento definitivo en un solo tiempo mostrando resultados satisfactorios en todos los ámbitos, como son dolor, recuperación posoperatoria, complicaciones y resultado estético. El seguimiento debe prolongarse para determinar la existencia de recidivas.