Treatment of fracture-related infection of the lower extremity with antibiotic-eluting ceramic bone substitutes: case series of 35 patients and literature review.

INTRODUCTION: The current treatment concepts of fracture-related infection (FRI) [Consensus Conference (Anti-Infection Task Force (AITF)) on the definition of acute or chronic osteomyelitis (cOM)] are associated with unsolved challenges and problems, underlining the need for ongoing medical research. METHOD: Literature review of treatments for FRI and description of own cases. RESULTS: We could include eight papers with 394 patients reporting treatments and outcome in FRI. The infection was resolved in 92.9% (mean) of all treatments. The mean follow-up was 25 months with a persistent non-union in 7% of the patients. We diagnosed 35 (19f/16m; 56.4 ± 18.6 years) patients with bone infections anatomically allocated to the proximal and distal femur (12×), the pelvis (2×), distal tibia (3×), tibial diaphysis (11×), the ankle joint (4×) and calcaneus (3×). These 35 patients were treated (1) with surgical debridement; (2) with antibiotic-eluting ceramic bone substitutes; (3) bone stabilization (including nail fixation, arthrodesis nails, plates, or external ring fixation), (4) optionally negative pressure wound therapy (NPWT) and (5) optionally soft tissue closure with local or free flaps. The mean follow-up time was 14.9 ± 10.6 months (min/max: 2/40 month). The overall recurrence rate is low (8.5%, 3/35). Prolonged wound secretion was observed in six cases (17.1%, 6/35). The overall number of surgeries was a median of 2.5. CONCLUSION: The results in the literature and in our case series are explicitly promising regarding the treatment of posttraumatic fracture-related infection.

The influence of foehn winds on the incidence of severe injuries in southern Bavaria - an analysis of the TraumaRegister DGU®.

BACKGROUND: Foehn describes a wind which occurs in areas with close proximity to mountains. The presence of foehn wind is associated with worsening health conditions. This study analyzes the correlation between a foehn typical circulation and the incidence for suffering a severe trauma. METHODS: This is a retrospective, multicentre observational register study. The years from 2013 to 2016 were analyzed for the presence of foehn winds. A logistic regression analysis with the number of daily admitted trauma patients as the primary target value was performed in dependence of foehn winds. Southern Bavaria is a typical foehn wind region. Individuals were treated in 37 hospitals of Southern Bavaria which participate in the TraumaRegister DGU®, an international register that includes all severe trauma patients, mainly in Germany. We analyzed patients with an Injury Severity Score (ISS) of at least nine with admission to intensive care units or prior death in the emergency room. RESULTS: 6215 patients were enrolled in this study. A foehn-typical circulation was present on 65 days (4.5%). 301 patients (5%) suffered a trauma with an ISS ≥ 9 on a foehn day. The mean ISS was 20.2 (9-75). On average, 4.3 patients (0-15 patients) were admitted on a daily basis due to a severe trauma. The multivariate regression analysis revealed a daily increase of 0.87 individuals (p = 0.004; 95% CI 0.23-1.47) on foehn days. During spring 1.07 patients (p = < 0.001; 95% CI 0.72-1.42), in summer 1.98 patients (p = < 0.001; 95% CI 1.63-2.32), in fall 0.63 (p = < 0.001; 95% CI 0.28-0.97) and on Saturdays, 0.59 patients (p = < 0.001; 95% CI 0.24-0.93) were additionally admitted due to severe trauma. CONCLUSION: Foehn winds are significantly associated with severe trauma in trauma centers of the TraumaNetzwerk DGU®.

The posttraumatic activation of CD4+ T regulatory cells is modulated by TNFR2- and TLR4-dependent pathways, but not by IL-10.

Platelets modulate the immune system following injury by interacting with CD4+ T regulatory cells (CD4+ Tregs). The underlying mechanisms remain unsolved. We hypothesize paracrine interactions via Tumor necrosis factor-alpha (TNFα)-, Toll like receptor-4 (TLR4)-, and Interleukin-10 (IL-10). In the murine burn injury model, CD4+ Treg activation pathways were selectively addressed using TNFR2-, TLR4- and IL-10-deficient mice. The CD4+ Treg signalling molecule PKC-θ was analyzed using phospho-flow cytometry to detect rapid cell activation. Thromboelastometry (ROTEM®) was used to assess platelet activation. Injury induced significant early activation of CD4+ Tregs, disruption of TNFR2 and TLR4 activation pathways resulted in lower activity. The disruption of IL-10 crosstalk had no significant impact. Selective disruption of paracrine interactions is associated with changes in posttraumatic hemostasis parameters. TNFR2- and TLR4-dependent pathways modulate the activation of CD4+ Tregs following trauma. In contrast, we did not observe a role of IL-10 in the posttraumatic activation of CD4+ Tregs. ONE SENTENCE SUMMARY: TLR4- and TNFR2-dependent mechanisms, but not IL-10-dependent pathways, modulate the anti-inflammatory response of CD4+ Tregs following trauma.

Whole-body computed tomography in severely injured patients.

PURPOSE OF REVIEW: To provide an update on the relevant and recent studies on whole-body computed tomography (WBCT) imaging of severely injured patients. RECENT FINDINGS: The advantages of WBCT in time saving, diagnostic accuracy and even in survival have been proven in numerous studies. WBCT can also be beneficial in haemodynamically unstable major trauma patients. The CT scanner should be located close to the emergency department or even in the trauma room. The issue of radiation is still quite important, however, iterative as well as split-bolus protocols can nowadays reduce radiation significantly. The question: which trauma patient should receive WBCT and which not is not yet solved sufficiently. Postmortem WBCT has a promising potential to promptly define the definitive cause of death of trauma victims comparably to traditional autopsy. SUMMARY: On account of the recent advances, whole-body CT has become a crucial part of the initial in-hospital assessment of severely injured patients. It is recommended as the standard radiological tool for the emergency diagnostic work-up in major trauma patients.

Mid-term outcome following revision surgery of clavicular non- and malunion using anatomic locking compression plate and iliac crest bone graft.

BACKGROUND: Treatment of clavicular non- and malunion is still challenging. Current surgical procedures often result in frustrating functional outcome along with high-grade subjective impairment and increased rates of revision surgery. However, the combination of biological augmentation with vital bone graft and a biomechanically sufficient fixation system seems to be a promising concept of treatment. METHODS: In this retrospective study, 14 patients with a mean age of 44 years (26-67 years) suffering from non-union (n = 11) and/or malunion (n = 3) of the clavicle were enrolled. All patients were surgically treated using an anatomical precontoured locking compression plate (LCP) and autologous iliac crest bone graft. Functional outcome was assessed using the age- and sex-specific relative Constant Score. RESULTS: Mean follow-up was 27 months (range 12-44 months). The relative Constant Score significantly improved from preoperative 61 ± 8 (43-72) to 82 ± 10 (65-100) points at the final follow-up examination (p < 0.05). All patients showed bony union radiographically. One patient presented with a re-fracture of the clavicle nearly 3 years after revision surgery and 5 weeks after implant removal. Secondary fractures at the donor site of the anterior superior iliac spine were recorded in two patients. CONCLUSIONS: Iliac crest bone graft and anatomic locking plate fixation allow for a safe and adequate stabilization and radiographical bony union in non- and malunions of the clavicle with a high degree of patient satisfaction. However, secondary fractures of the anterior superior iliac spine constitute relevant complications and the time of hardware removal should be considered carefully.

Concomitant intra-articular glenohumeral injuries in displaced fractures of the lateral clavicle.

PURPOSE: To detect concomitant intra-articular glenohumeral injuries, in acute displaced fractures of the lateral clavicle, initially missed due to unfeasible clinical evaluation of the acutely injured shoulder. METHODS: All patients suffering from an acute displaced lateral clavicle fracture with indication to surgical treatment underwent diagnostic shoulder arthroscopy prior to open reduction and internal fixation. In case of therapy-relevant intra-articular glenohumeral injuries, subsequent surgical treatment was performed. RESULTS: Intra-articular injuries were found in 13 of 28 patients (46.4 %) with initially suspected isolated lateral clavicle fracture. Additional surgical treatment was performed in 8 of 28 cases (28.6 %). Superior labral anterior-posterior (SLAP) lesions were observed in 4 of 28 patients (14.3 %; SLAP II a: 1; II b: 1; III: 1; and IV: 1). Lesions of the pulley system were found in 3 of 28 patients (10.7 %; Habermeyer III°). One partial articular supraspinatus tendon avulsion lesion (3.6 %) and one lesion of the subscapularis tendon (3.6 %; Fox and Romeo II°) were observed. CONCLUSIONS: Traumatic concomitant glenohumeral injuries in lateral clavicle fractures seem to be more frequent than expected in general. Subsequent surgical treatment of these formerly missed but therapy-relevant injuries may increase functional outcome and reduce complication rate. LEVEL OF EVIDENCE: IV.

Evaluation of a new imaging tool for use with major trauma cases in the emergency department.

BACKGROUND: The aim of this study was to evaluate potential benefits of a new diagnostic software prototype (Trauma Viewer, TV) automatically reformatting computed tomography (CT) data on diagnostic speed and quality, compared to CT-image data evaluation using a conventional CT console. METHODS: Multiple trauma CT data sets were analysed by one expert radiology and one expert traumatology fellow independently twice, once using the TV and once using the secondary conventional CT console placed in the CT control room. Actual analysis time and precision of diagnoses assessment were evaluated. The TV and CT-console results were compared respectively, but also a comparison to the initial multiple trauma CT reports assessed by emergency radiology fellows considered as the gold standard was performed. Finally, design and function of the Trauma Viewer were evaluated in a descriptive manner. RESULTS: CT data sets of 30 multiple trauma patients were enrolled. Mean time needed for analysis of one CT dataset was 2.43 min using the CT console and 3.58 min using the TV respectively. Thus, secondary conventional CT console analysis was on average 1.15 min shorter compared to the TV analysis. Both readers missed a total of 11 diagnoses using the secondary conventional CT console compared to 12 missed diagnoses using the TV. However, none of these overlooked diagnoses resulted in an Abbreviated Injury Scale (AIS) > 2 corresponding to life threatening injuries. CONCLUSIONS: Even though it took the two expert fellows a little longer to analyse the CT scans on the prototype TV compared to the CT console, which can be explained by the new user interface of the TV, our preliminary results demonstrate that, after further development, the TV might serve as a new diagnostic feature in the trauma room management. Its high potential to improve time and quality of CT-based diagnoses might help in fast decision making regarding treatment of severely injured patients.

Does a minimal invasive approach reduce anterior chest wall numbness and postoperative pain in plate fixation of clavicle fractures?

BACKGROUND: Fractures of the clavicle present very common injuries with a peak of incidence in young active patients. Recently published randomized clinical trials demonstrated an improved functional outcome and a lower rate of nonunions in comparison to non-operative treatment. Anterior chest wall numbness due to injury of the supraclavicular nerve and postoperative pain constitute common surgery related complications in plate fixation of displaced clavicle fractures. We recently developed a technique for mini open plating (MOP) of the clavicle to reduce postoperative numbness and pain. The purpose of this study was to analyze the size of anterior chest wall numbness and the intensity of postoperative pain in MOP in comparison to conventional open plating (COP) of clavicle fractures. METHODS: 24 patients (mean age 38.2 ± 14.2 yrs.) with a displaced fracture of the clavicle (Orthopaedic Trauma Association B1.2-C1.2) surgically treated using a locking compression plate (LCP) were enrolled. 12 patients underwent MOP and another 12 patients COP. Anterior chest wall numbness was measured with a transparency grid on the second postoperative day and at the six months follow-up. Postoperative pain was evaluated using the Visual Analog Scale (VAS). RESULTS: Mean ratio of skin incision length to plate length was 0.61 ± 0.04 in the MOP group and 0.85 ± 0.06 in the COP group (p < 0.05). Mean ratio of the area of anterior chest wall numbness to plate length was postoperative 7.6 ± 5.9 (six months follow-up 4.7 ± 3.9) in the MOP group and 22.1 ± 19.1 (16.9 ± 14.1) in the COP group (p < 0.05). Mean VAS was 2.6 ± 1.4 points in the MOP group and 3.4 ± 1.6 points in the COP group (p = 0.20). CONCLUSIONS: In our study, MOP significantly reduced anterior chest wall numbness in comparison to a conventional open approach postoperative as well as at the six months follow-up. Postoperative pain tended to be lower in the MOP group, however this difference was not statistically significant. TRIAL REGISTRATION: ClinicalTrials.gov NCT02247778 . Registered 21 September 2014.

Update of the trauma risk adjustment model of the TraumaRegister DGU™: the Revised Injury Severity Classification, version II.

INTRODUCTION: The TraumaRegister DGU™ (TR-DGU) has used the Revised Injury Severity Classification (RISC) score for outcome adjustment since 2003. In recent years, however, the observed mortality rate has fallen to about 2% below the prognosis, and it was felt that further prognostic factors, like pupil size and reaction, should be included as well. Finally, an increasing number of cases did not receive a RISC prognosis due to the missing values. Therefore, there was a need for an updated model for risk of death prediction in severely injured patients to be developed and validated using the most recent data. METHODS: The TR-DGU has been collecting data from severely injured patients since 1993. All injuries are coded according to the Abbreviated Injury Scale (AIS, version 2008). Severely injured patients from Europe (ISS ≥ 4) documented between 2010 and 2011 were selected for developing the new score (n = 30,866), and 21,918 patients from 2012 were used for validation. Age and injury codes were required, and transferred patients were excluded. Logistic regression analysis was applied with hospital mortality as the dependent variable. Results were evaluated in terms of discrimination (area under the receiver operating characteristic curve, AUC), precision (observed versus predicted mortality), and calibration (Hosmer-Lemeshow goodness-of-fit statistic). RESULTS: The mean age of the development population was 47.3 years; 71.6% were males, and the average ISS was 19.3 points. Hospital mortality rate was 11.5% in this group. The new RISC II model consists of the following predictors: worst and second-worst injury (AIS severity level), head injury, age, sex, pupil reactivity and size, pre-injury health status, blood pressure, acidosis (base deficit), coagulation, haemoglobin, and cardiopulmonary resuscitation. Missing values are included as a separate category for every variable. In the development and the validation dataset, the new RISC II outperformed the original RISC score, for example AUC in the development dataset 0.953 versus 0.939. CONCLUSIONS: The updated RISC II prognostic score has several advantages over the previous RISC model. Discrimination, precision and calibration are improved, and patients with partial missing values could now be included. Results were confirmed in a validation dataset.

Clinical and radiological outcome following treatment of displaced lateral clavicle fractures using a locking compression plate with lateral extension: a prospective study.

BACKGROUND: Treatment of lateral fractures of the clavicle is challenging and has been controversially discussed for a long time due to high non-union rates in non-operative treatment and high complication rates in surgical treatment. Acromioclavicular joint instability due to the injury of the closely neighbored coraco-clavicular ligaments can result in a cranialization of the medial clavicle shaft. A recently developed implant showed a promising functional outcome in a small collective of patients. METHODS: In this prospective study, 20 patients with a mean age of 40.7 ± 11.3 years with a dislocated fracture of the lateral clavicle (Jäger&Breitner I-III, Neer I-III) were enrolled. All patients were surgically treated using the locking compression plate (LCP) for the superior anterior clavicle (Synthes®). Functional outcome was recorded using the Munich Shoulder Questionnaire (MSQ) allowing for qualitative self-assessment of the Shoulder Pain and Disability Index (SPADI), of the Disability of the Arm, Shoulder and Hand (DASH) score and of the Constant Score. Acromioclavicular joint stability was evaluated using the Taft-Score. RESULTS: The mean follow-up was 14.2 ± 4.0 months. The mean MSQ was 87.0 ± 7.4 points, the mean SPADI 91.1 ± 11.3 points, the mean DASH score 7.6 ± 7.3 points and the mean normative age- and sex-specific Constant Score 85.6 ± 8.0 points. The mean Taft Score resulted in 10.7 ± 1.0 points. The mean Taft Score in lateral clavicular fractures with fracture gap between the coracoclavicular ligaments in combination with a rupture of the conoid ligament (J&B II a, Neer II B; n =11) was with 10.3 ± 0.9 points significantly lower than the mean Taft Score of all other types of lateral clavicle fractures (J&B I, II b, III; n =9) which resulted in 11.3 ± 0.9 points (p<0.05). CONCLUSIONS: The Synthes® LCP superior anterior clavicle plate allows for a safe stabilization and good functional outcome with high patient satisfaction in fractures of the lateral clavicle. However, in fractures type Jäger&Breitner II a, Neer II B a significant acromioclavicular joint instability was observed and additional reconstruction of the coracoclavicular ligaments should be performed. TRIAL REGISTRATION: ClinicalTrials.gov NCT02256059. Registered 02 October 2014.

Emergency cesarean section due to acute aortic dissection type A (Debakey I) without Marfan syndrome: a case report and review of the literature.

BACKGROUND: Acute aortic dissection during pregnancy is an uncommon but important emergency due to its lethal risk to both mother and child. The dissection usually involves the ascending aorta or the aortic arch. Although additional affection of the descending aorta up to bifurcation is possible, further increasing the risk of organ malperfusion, full-length aortic dissection (DeBakey I) is known to be very rare. Dissection during pregnancy has been reported predominantly in combination with Marfan syndrome. Acute aortic dissection Stanford type A (AADA) DeBakey I during pregnancy without signs of Marfan syndrome as a warning signal is very uncommon in the current literature. OBJECTIVES: The etiology, diagnosis, differential diagnosis, and management of this rare disease are discussed in relation to the current literature. CASE REPORT: We report the case of an athletic 34-year-old woman in the third trimester of pregnancy, without history of previous diseases, who presented to our Emergency Department after collapsing. In the resuscitation department, an emergency cesarean section was performed due to the start of circulation failure in the mother. Computed tomography scan revealed a severe aortic dissection starting from 1 cm distal the aortic valve over the full length up to the iliac arteries, involving the brachiocephalic and carotid arteries up to the level of the larynx. Emergency replacement of the ascending aorta and the aortic arch was performed. Both the mother and baby survived and were doing well 1 year postoperatively. CONCLUSION: This alarming result of AADA (DeBakey I) in late pregnancy without obvious warnings such as Marfan syndrome illustrates the importance of performing early imaging in similar cases.

Incidence of delayed and missed diagnoses in whole-body multidetector CT in patients with multiple injuries after trauma.

BACKGROUND: Whole-body CT (WBCT) is the imaging modality of choice during the initial diagnostic work-up of multiple injured patients in order to identify serious injuries and initiate adequate treatment immediately. However, delayed diagnosed or even missed injuries have been reported frequently ranging from 1.3% to 47%. PURPOSE: To highlight commonly missed lesions in WBCT of patients with multiple injuries. MATERIAL AND METHODS: A total of 375 patients (age 42.8 ± 17.9 years, ISS 26.6 ± 17.0) with a WBCT (head to symphysis) were included. The final CT report was compared with clinical and operation reports. Discrepant findings were recorded and grouped as relevant and non-relevant to further treatment. In both groups, an experienced trauma radiologist read the CT images retrospectively, whether these lesions were missed or truly not detectable. RESULTS: In 336 patients (89.6%), all injuries in the regions examined were diagnosed correctly in the final reports of the initial CT. Forty-eight patients (12.8%) had injuries in regions of the body that were not included in the CT. Fourteen patients (3.7%) had injuries that did not require further treatment. Twenty-five patients (6.7%) had injuries that required further treatment. With secondary interpretation, 85.4% of all missed lesions could be diagnosed in retrospect from the primary CT data-set. Small pancreatic and bowel contusions were identified as truly non-detectable. CONCLUSION: In multiple traumas, only a few missed injuries in initial WBCT reading are clinically relevant. However, as the vast majority of these injuries are detectable, the radiologist has to be alert for commonly missed findings to avoid a delayed diagnosis.

Structural and Process Data on Radiological Imaging in the Treatment of Severely Injured Patients - Results of a Survey of Level I and II Trauma Centers in Germany. / Struktur- und Prozessdaten zur radiologischen Bildgebung bei Behandlung schwerstverletzter Patienten ­ Ergebnisse einer Befragung überregionaler und regionaler TraumaZentren in Deutschland.

PURPOSE: Systematic data collection regarding the integration of radiology as well as structural and process characteristics of radiological diagnostics of severely injured patients in Germany using a structured questionnaire. MATERIALS AND METHODS: Personal contact with all certified Level I and Level II Trauma Centers in Germany. Data on infrastructure, composition of the trauma room team, equipment, and data on the organization/performance of primary major trauma diagnostics were collected. RESULTS: With a participation rate of 46.9 % (n = 151) of all German trauma centers (N = 322), a solid database is available. There were highly significant differences in the structural characteristics incl. CT equipment between the level I and II centers: In 63.8 % of the level II centers, the CT unit was located more than 50 m away from the trauma room (34.2 % in the level I centers). A radiologist was part of the trauma room team in 59.5 % of level II centers (level I 88.1 %). Additionally, highly significant differences were found comparing 24-h provision of other radiologic examinations and interventions, such as MRI (level II 44.9 %, level I 92.8 %) and angiography (level II 69.2 %, level I 97.1 %). CONCLUSION: Heterogeneous structural and process characteristics of the diagnosis of severely injured patients in Germany were revealed, with highly significant differences between level I and level II centers. KEY POINTS: · This is the first study on the diagnostic reality of radiology in severely injured patients in Germany. Despite a high level of standardization, significant differences were observed.. CITATION FORMAT: · Ernstberger A, Reske SU, Brandl A et al. Structural and Process Data on Radiological Imaging in the Treatment of Severely Injured Patients - Results of a Survey of Level I and II Trauma Centers in Germany. Fortschr Röntgenstr 2022; 194: 505 - 514.

Cross-validation of two prognostic trauma scores in severely injured patients.

INTRODUCTION: Trauma scoring systems are important tools for outcome prediction and severity adjustment that informs trauma quality assessment and research. Discrimination and precision of such systems is tested in validation studies. The German TraumaRegister DGU® (TR-DGU) and the Trauma Audit and Research Network (TARN) from the UK agreed on a cross-validation study to validate their prediction scores (RISC II and PS14, respectively). METHODS: Severe trauma patients with an Injury Severity Score (ISS) ≥ 9 documented in 2015 and 2016 were selected in both registries (primary admissions only). The predictive scores from each registry were applied to the selected data sets. Observed and predicted mortality were compared to assess precision; area under the receiver operating characteristic curve was used for discrimination. Hosmer-Lemeshow statistic was calculated for calibration. A subgroup analysis including patients treated in intensive care unit (ICU) was also carried out. RESULTS: From TR-DGU, 40,638 patients were included (mortality 11.7%). The RISC II predicted mortality was 11.2%, while PS14 predicted 16.9% mortality. From TARN, 64,622 patients were included (mortality 9.7%). PS14 predicted 10.6% mortality, while RISC II predicted 17.7%. Despite the identical cutoff of ISS ≥ 9, patient groups from both registries showed considerable difference in need for intensive care (88% versus 18%). Subgroup analysis of patients treated on ICU showed nearly identical values for observed and predicted mortality using RISC II. DISCUSSION: Each score performed well within its respective registry, but when applied to the other registry a decrease in performance was observed. Part of this loss of performance could be explained by different development data sets: the RISC II is mainly based on patients treated in an ICU, while the PS14 includes cases mainly cared for outside ICU with more moderate injury severity. This is according to the respective inclusion criteria of the two registries. CONCLUSION: External validations of prediction models between registries are needed, but may show that prediction models are not fully transferable to other health-care settings.

Effect of whole-body CT during trauma resuscitation on survival: a retrospective, multicentre study.

BACKGROUND: The number of trauma centres using whole-body CT for early assessment of primary trauma is increasing. There is no evidence to suggest that use of whole-body CT has any effect on the outcome of patients with major trauma. We therefore compared the probability of survival in patients with blunt trauma who had whole-body CT during resuscitation with those who had not. METHODS: In a retrospective, multicentre study, we used the data recorded in the trauma registry of the German Trauma Society to calculate the probability of survival according to the trauma and injury severity score (TRISS), revised injury severity classification (RISC) score, and standardised mortality ratio (SMR, ratio of recorded to expected mortality) for 4621 patients with blunt trauma given whole-body or non-whole-body CT. FINDINGS: 1494 (32%) of 4621 patients were given whole-body CT. Mean age was 42.6 years (SD 20.7), 3364 (73%) were men, and mean injury-severity score was 29.7 (13.0). SMR based on TRISS was 0.745 (95% CI 0.633-0.859) for patients given whole-body CT versus 1.023 (0.909-1.137) for those given non-whole-body CT (p<0.001). SMR based on the RISC score was 0.865 (0.774-0.956) for patients given whole-body CT versus 1.034 (0.959-1.109) for those given non-whole-body CT (p=0.017). The relative reduction in mortality based on TRISS was 25% (14-37) versus 13% (4-23) based on RISC score. Multivariate adjustment for hospital level, year of trauma, and potential centre effects confirmed that whole-body CT is an independent predictor for survival (p

Autologous Iliac Bone Graft Compared with Biphasic Hydroxyapatite and Calcium Sulfate Cement for the Treatment of Bone Defects in Tibial Plateau Fractures: A Prospective, Randomized, Open-Label, Multicenter Study.

BACKGROUND: Bone-graft substitutes are commonly used for the augmentation of traumatic bone defects in tibial plateau fractures. However, their clinical performance compared with that of autologous bone-grafting, the gold standard in bone defect reconstruction, still remains under debate. This study investigates the differences in quality of life, pain, and radiographic outcomes in the treatment of tibial plateau fracture-associated bone defects with either autologous bone grafts or a bioresorbable hydroxyapatite and calcium sulfate cement (CERAMENT BONE VOID FILLER [CBVF]; BONESUPPORT). METHODS: In this study, 135 patients with acute depression and split-depression fractures of the proximal part of the tibia (OTA/AO types 41-B2 and 41-B3) were enrolled in a prospective, controlled, randomized, multicenter trial including 20 hospitals in Germany. Patients were randomized to receive either autologous iliac bone graft or CBVF for reconstruction of the bone defect. The primary outcome measures were the Short Form (SF)-12 version 2 Physical Component Summary (PCS) score at week 26 (the study was designed to show noninferiority of the CBVF with regard to the PCS with a prespecified margin of -5 points) and the pain level at 26 weeks postoperatively measured by a visual analog scale (VAS). The secondary outcomes were the SF-12 version 2 Mental Component Summary (MCS) and SF-12 PCS scores at weeks 1, 6, and 12 and bone-healing on radiographs. RESULTS: Age, sex, fixation methods, and fracture pattern were comparable in both groups. There were no significant differences (p > 0.05) in the SF-12 PCS or VAS scores at postoperative week 26. There was a significant reduction of blood loss (p = 0.007) and pain levels (p = 0.008) at postoperative day 1 in the CBVF group. The rates of fracture-healing, defect remodeling, and articular subsidence were not significantly different (p > 0.05) in both groups. CONCLUSIONS: Bioresorbable CBVF was noninferior to autologous bone graft with regard to both patient-reported and radiographic outcomes in tibial plateau fractures of OTA/AO types 41-B2 and 41-B3. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Evaluation of new quality indicators for the TraumaRegister DGU® using the systematic QUALIFY methodology.

BACKGROUND: The TraumaRegister DGU® (TR-DGU) of the German Trauma Society (Deutsche Gesellschaft für Unfallchirurgie, DGU) enables the participating hospitals to perform quality management. For that purpose, nine so-called audit filters have existed, since its foundation, which, inter alia, is listed in the Annual Report. The objective of this study effort is a revision of these quality indicators with the aim of developing pertinent new and reliable quality indicators for the management of severely injured patients. MATERIALS AND METHODS: Apart from indicators already used at national and international levels, a systematic review of the literature revealed further potential key figures for quality of the management of severely injured patients. The latter were evaluated by an interdisciplinary and interprofessional group of experts using a standardized QUALIFY process to assess their suitability as a quality indicator. RESULTS: By means of the review of the literature, 39 potential indicators could be identified. 9 and 14 indicators, respectively, were identified in existing trauma registries (TR-DGU and TARN), 17 in the ATLS® training concept, and 57 in the S3 guideline on the treatment of polytrauma/severe injuries. The exclusion of duplicates and the limitation to indicators that can be collected using the TR-DGU Version 2015 data set resulted in a total of 43 indicators to be reviewed. For each of the 43 indicators, 13 quality criteria were assessed. A consensus was achieved in 305 out of 559 individual assessments. With 13 quality criteria assessed and 43 indicators correspond this to a relative consensus value of 54.6%. None of the indicators achieved a consensus in all 13 quality criteria assessed. The following 13 indicators achieved a consensus in at least 9 quality criteria: time between hospital admission and WBCT, mortality, administration of tranexamic acid to bleeding patients, use of CCT with GCS <14, time until first emergency surgical intervention (7-item list in the TR-DGU), time until surgical intervention for penetrating trauma, application of pelvic sling belt (prehospital), capnometry (etCO2) in intubated patients, time until CCT with GCS < 15, time until surgery for hemorrhagic shock, time until craniotomy for severe TBI, prehospital airway management in unconscious patients (GCS < 9), and complete basic diagnostics available. Two indicators achieved a consensus in 11 criteria and thus represent the maximum consensus achieved within the group of experts. Four indicators only achieved a consensus in three quality criteria. 17 indicators had a mean value for the 3 relevance criteria of ≥ 3.5 and were, therefore, assessed by the group of experts as being highly relevant. CONCLUSION: Not all the key figures published for the management of severely injured patients are suitable for use as quality indicators. It remains to be seen whether the quality indicators identified by experts using the QUALIFY process will meet the requirements in practice. Prior to the implementation of the assessed quality indicators in standardized quality assurance programs, a scientific evaluation based on national data will be required.

Correction to: Evaluation of new quality indicators for the TraumaRegister DGU® using the systematic QUALIFY methodology.

The original version of this article unfortunately contained some mistakes.