Reliability and reproducibility analysis of the AOSpine Sacral Fractures Classification System by spinal and pelvic surgeons.

STUDY DESIGN: Retrospective Cohort Study OBJECTIVES: The AOSpine Sacral Classification System was proposed as a comprehensive and universally accepted new classification for Sacral Fractures, and was recently internally validated. However, an external, independent and multidisciplinary reports on validation of this classification is lacking. Aim of the present study is to analyze the interobserver reliability and intraobserver reproducibility of the AOSpine Sacral Classification System for Sacral Fractures between orthopedic spinal and pelvic surgeons with different levels of experience. METHODS: Our institutional database was searched to retrieve patients with acute, traumatic sacral injury admitted from June 2017 to June 2020. For each patients, X-Rays and CT scans were collected. Three Orthopedic Pelvic Surgeons (Group A) and three Spine Surgeons (Group B), with different level of experience (Junior, 〈 5 years; Middle, 5-10 years; Expert 〉 10 years) independently classified all the sacral fractures included in the dataset, with two separate evaluation three weeks apart. Both intra and interobserver reliability were calculated with k-coefficient. RESULTS: Overall, 150 patients were included in the final dataset, for a total of 1800 different assessments, with all the subtypes reported. The intraobserver reproducibility for the whole group was substantial (κ=0.72). Overall, the interobserver reliability was moderate, with a κ=0.57. When only fracture type was taken in account, the κ value became substantial (κ=0.62). No significant differences were found comparing group A and group B (0.55 vs κ 0.55, p>0.05). No significant differences according to surgeon's experience were found; however, the κ value was slightly lower among the junior surgeons. CONCLUSIONS: Our findings confirmed the reliability and reproducibility of this classification in clinical practice. In the current study the surgeon's expertise (pelvic and spinal trauma) and the level of experience does not influence the reliability of the classification system.

The management of emergency spinal surgery during the COVID-19 pandemic in Italy.

AIMS: The current pandemic caused by COVID-19 is the biggest challenge for national health systems for a century. While most medical resources are allocated to treat COVID-19 patients, several non-COVID-19 medical emergencies still need to be treated, including vertebral fractures and spinal cord compression. The aim of this paper is to report the early experience and an organizational protocol for emergency spinal surgery currently being used in a large metropolitan area by an integrated team of orthopaedic surgeons and neurosurgeons. METHODS: An organizational model is presented based on case centralization in hub hospitals and early management of surgical cases to reduce hospital stay. Data from all the patients admitted for emergency spinal surgery from the beginning of the outbreak were prospectively collected and compared to data from patients admitted for the same reason in the same time span in the previous year, and treated by the same integrated team. RESULTS: A total of 19 patients (11 males and eight females, with a mean age of 49.9 years (14 to 83)) were admitted either for vertebral fracture or spinal cord compression in a 19-day period, compared to the ten admitted in the previous year. No COVID-19 patients were treated. The mean time between admission and surgery was 1.7 days, significantly lower than 6.8 days the previous year (p < 0.001). CONCLUSION: The structural organization and the management protocol we describe allowed us to reduce the time to surgery and ultimately hospital stay, thereby maximizing the already stretched medical resources available. We hope that our early experience can be of value to the medical communities that will soon be in the same emergency situation. Cite this article: Bone Joint J 2020;102-B(6):671-676.

Can leucocyte esterase replace frozen sections in the intraoperative diagnosis of prosthetic hip infection?

AIMS: Leucocyte esterase (LE) has been shown to be an accurate marker of prosthetic joint infection (PJI), and has been proposed as an alternative to frozen section (FS) histology for intraoperative diagnosis. In this study, the intraoperative assessment of LE was compared with FS histology for the diagnosis of prosthetic hip infection. PATIENTS AND METHODS: A total of 119 patients undergoing revision total hip arthroplasty (THA) between June 2015 and December 2017 were included in the study. There were 56 men and 63 women with a mean age of 66.2 years (27 to 88). Synovial fluid was collected before arthrotomy for the assessment of LE using enzymatic colourimetric strips. Between five and six samples were stained with haematoxylin and eosin for FS histology, and considered suggestive of infection when at least five polymorphonuclear leucocytes were found in five high-power fields. RESULTS: The sensitivity and specificity of the LE assay were 100% and 93.8%, respectively; the positive (PPV) and the negative (NPV) predictive values were 79.3% and 100%, respectively. The mean time between the collection of the sample and the result being known was 20.1 minutes (sd 4.4). The sensitivity and specificity of FS histology were 78.3% and 96.9%, respectively; the PPV and the NPV were 85.7% and 94.9%, respectively. The mean time between the collection of the sample and the result being known was 27.2 minutes (sd 6.9). CONCLUSION: The sensitivity of LE assay was higher, with similar specificity and diagnostic accuracy, compared with FS histology. The faster turnaround time, its ease of use, and low costs make LE assay a valuable alternative to FS histology. We now use it routinely for the intraoperative diagnosis of PJI. Cite this article: Bone Joint J 2019;101-B:372-377.

Calcium-Based, Antibiotic-Loaded Bone Substitute as an Implant Coating: A Pilot Clinical Study.

Background: Implant-related infections remain a major complication after orthopaedic surgery. Antibacterial coating of implants may prevent bacterial adhesion and biofilm formation. However, in spite of extensive preclinical research in the field, antibacterial coatings to protect orthopaedic implants in the clinical setting remain particularly few. The aim of the present study is to evaluate the safety of a calcium-based, antibiotic-loaded bone substitute as an antibacterial coating of cementless joint prosthesis. Methods: From March 2013 to August 2015, 20 consecutive patients scheduled for cementless or hybrid two-stage revision surgery for peri-prosthetic joint infection were included in this prospective, observational, pilot study. Cerament G or Cerament V, a gentamicin or vancomycin-loaded calcium-based resorbable bone substitute (60% calcium sulphate, 40% hydroxyapatite), was applied at surgery on the stem surface of hip (n=7) or knee (n=13) revision prosthesis. After surgery, all patients underwent clinical (HHS or KSS and SF-12 score), laboratory and radiographic evaluation at 3, 6 and 12 months and yearly thereafter. Results: At a minimum of 12 months follow-up, 19/20 (95%) patients showed no recurrence of infection and no signs of radiographic loosening of the stem. No adverse events were associated with the use of Cerament G or V. Conclusions: This is the first pilot clinical study on the short-term safety of using a calcium-based, gentamicin or vancomycin-loaded bone substitute as a surface coating on cementless prosthetic implants. If confirmed by larger studies and at longer follow-ups, these findings may open a new prospective to protect intra-operatively orthopedic implants from bacterial adhesion, through the use of resorbable, osteoconductive, antibiotic carriers.

ANTIBIOTIC-LOADED REGENOSS FOR THE TREATMENT OF SEPTIC BONE DEFECTS: IN VITRO STUDY AND PRELIMINARY CLINICAL EXPERIENCE.

Bone and joint infections are a difficult to treat condition, often associated with bone loss. Although the management of septic bone defects may currently be achieved through various treatment modalities, there is a continuous need for bone substitutes able at the same time to favour bone repair and to provide local antibacterial protection. RegenOss, a biomimetic and resorbable bone substitute, has been previously shown to be highly biocompatible and osteoconductive. Aims of the present study were to test the in vitro ability of RegenOss to act as a local carrier of antibiotics and to investigate its clinical safety and efficacy in a continuous series of patients, affected by bone loss in active or previous infection. In vitro study was performed by adding vancomycin, levofloxacin or meropenem and assessing elution properties of RegenOss at fixed time intervals by means of a microbiological assay. At 48 hours, 98.5% of meropenem, 94.1% of levofloxacin and 76.3% of vancomycin were recovered in the medium, while all antibiotics were completely eluted at seven days. Clinical safety and efficacy of vancomicyn- or vancomicyn and meropenem-loaded RegenOss had been tested in 13 consecutive patients. After the surgical procedure, each patient underwent clinical, laboratory and radiographic evaluation at 3, 6, 12, 18 and 24 months. No adverse events associated with the use of RegenOss were observed. Twelve patients showed no infection recurrence and ten satisfactory bone healing at follow-up. In conclusion, this study shows the ability of RegenOss to act as local carrier when loaded with three different antibiotics with a complete elution in one week. The clinical use of antibiotic-loaded RegenOss appears safe in this preliminary clinical series, while larger studies are needed to confirm the efficacy of the intra-operative combination of this biomimetic bone substitute with various antibacterials in the treatment of septic bone defects.

Target organ damage in hypertensive patients: correlation between retinal arteriovenular ratio and left ventricular geometric patterns.

Early evaluation of cardiovascular (CV) risk in hypertensive patients is of primary importance and studies of retinal vessels can be helpful. The aim of this study is to assess the correlation between retinal vessel changes and target organ damage (TOD), expressed as left ventricular remodelling (LVR) or hypertrophy (LVH). We evaluated 60 treated hypertensive individuals (mean age 60.9±13.3 years). On the basis of echocardiographic results, we divided the subjects showing the presence of TOD and subjects without TOD into Groups A and B, respectively. Both groups underwent a non-mydriatic digital retinography. The obtained vessel images were analysed using dedicated software in order to calculate AVR (arteriovenular ratio), index of the retinal arteriolar narrowing. The data analyses confirmed a mean AVR value of 0.86 in Group B and a mean value of 0.77 in Group A. AVR index was also analysed in a subgroup of A with evidence of LVR, and mean value was 0.76. The same procedure was carried out with subgroup of A with LVH and AVR index resulted 0.77. In all comparisons, P-value was statistically significant (P<0.05). Our findings provide evidence that in hypertensive patients retinal AVR correlates with the presence of TOD, in this study in the context of LVR and LVH. In conclusion, AVR offers a direct vision retinal microcirculation and, also, indirectly, provides information of the left ventricular geometric pattern in hypertensive patients; thus, AVR may have an important role in global CV risk stratification and could possibly be used for optimising the hypertensive patient management.

A validation study of a new nasogastric polyfunctional catheter.

PURPOSE: Pleural and abdominal pressure are clinically estimated by measuring the esophageal and bladder or intragastric pressure (IGP), respectively. A new nasogastric polyfunctional catheter is now commercially available, equipped with two balloons in the lower and distal part; this catheter allows simultaneous esophageal pressure (Pes) and IGP measurements and can be also used to feed the patient. We compared the Pes and IGP measured using this new device with those obtained with a standard balloon catheter taken as gold standard. METHODS: Twenty-four intubated patients requiring ventilator support (mean age 64.3 ± 16.8 years, body mass index 25.3 ± 3.0 kg/m(2), and PaO(2)/FiO(2) 280.8 ± 123.4 mmHg) were enrolled. Esophageal pressure and IGP were measured with the new nasogastric polyfunctional catheter (Nutrivent, Sidam, Italy) and with a standard balloon catheter (Smart Cath Viasys, USA). The Smart Cath was first inserted in the stomach and then retracted to the esophagus to measure IGP and Pes, respectively. In each patient two paired measurements were averaged. RESULTS: In the Bland-Altman analysis, the bias and agreement bands for Pes, ΔPes (computed as the difference of esophageal pressure between end-inspiration and expiration), and IGP were -0.25 (-2.65 to +2.15), 0.0 (-0.9 to +0.9), and -0.45 (-2.85 to + 1.95) cmH(2)O, respectively. No side effects or complications were recorded. CONCLUSIONS: The new polyfunctional catheter showed a clinically acceptable validity in recording esophageal and intragastric pressure. This device should help physicians to better individualize the clinical patient management.