[Perceived utility of the inclusion of physician assistants in the surgical process quality and continuing education in Germany : Results of an interprofessional online survey]. / Empfundener Nutzen der Einbindung von Physician Assistants in die chirurgische Prozessqualität und Weiterbildung in Deutschland : Ergebnisse einer interprofessionellen Online-Umfrage.

BACKGROUND: Compared to Anglo-American countries, physician assistants (PA) remain an underrepresented professional group within the German healthcare system. In the surgical disciplines, PAs may relieve the administrative burden of doctors by taking on delegable routine tasks, thus creating time and resources for advanced surgical training. OBJECTIVE: According to interprofessional experts, can the use of PA lead to an optimization of surgical training and a gain in time for surgical qualification in Germany? MATERIAL AND METHODS: After searching for systematic reviews of the current state of knowledge, an online survey was initiated among surgeons and PAs via social networks to determine current and desired clinical areas of activity for PAs in surgery and their future influence on specialist training in Germany. RESULTS: A total of nine systematic reviews were identified, suggesting a beneficial impact of PAs on length of stay, direct costs, and treatment outcomes in surgical scenarios. The online survey included 234 surgeons and 114 PAs. Hospitals with ≥ 90 surgical beds employed PAs far more frequently (65%) than smaller institutions (40%). Although both professional groups are generally highly satisfied with the integration of PAs into clinical workflows, there are gradually different opinions about the preferred spectrum of tasks and duties. DISCUSSION: PAs would like to have greater responsibility in ordering and interpreting diagnostic tests, communicating with patients, and working in the operating theater. Surgeons are concerned that PAs could replace surgical interns and residents. PAs may enrich healthcare in Germany on various levels and can also improve surgical training. The voice and needs of all professional groups must be considered and respected during the upcoming health system reform.

In-hospital mortality after prehospital endotracheal intubation versus alternative methods of airway management in trauma patients. A cohort study from the TraumaRegister DGU®.

PURPOSE: Prehospital airway management in trauma is a key component of care and is associated with particular risks. Endotracheal intubation (ETI) is the gold standard, while extraglottic airway devices (EGAs) are recommended alternatives. There is limited evidence comparing their effectiveness. In this retrospective analysis from the TraumaRegister DGU®, we compared ETI with EGA in prehospital airway management regarding in-hospital mortality in patients with trauma. METHODS: We included cases only from German hospitals with a minimum Abbreviated Injury Scale score ≥ 2 and age ≥ 16 years. All patients without prehospital airway protection were excluded. We performed a multivariate logistic regression to adjust with the outcome measure of hospital mortality. RESULTS: We included n = 10,408 cases of whom 92.5% received ETI and 7.5% EGA. The mean injury severity score was higher in the ETI group (28.8 ± 14.2) than in the EGA group (26.3 ± 14.2), and in-hospital mortality was comparable: ETI 33.0%; EGA 30.7% (27.5 to 33.9). After conducting logistic regression, the odds ratio for mortality in the ETI group was 1.091 (0.87 to 1.37). The standardized mortality ratio was 1.04 (1.01 to 1.07) in the ETI group and 1.1 (1.02 to 1.26) in the EGA group. CONCLUSIONS: There was no significant difference in mortality rates between the use of ETI or EGA, or the ratio of expected versus observed mortality when using ETI.

[Evidence-based versus expertise-based medicine in orthopedic and trauma surgery : There is nothing more practical than a good theory]. / Evidenzbasierte Medizin versus Erfahrungsmedizin in Orthopädie und Unfallchirurgie : Es gibt nichts Praktischeres als eine gute Theorie.

About a quarter of a century after the introduction of the concept and principles of evidence-based medicine (EbM), some healthcare providers are still adamant that these are incompatible with knowledge gained through experience. Across the surgical disciplines, it is often argued EbM underestimates or neglects the importance of intuition and surgical skills. To put it bluntly, these assumptions are wrong and often characterized by a misunderstanding of the methodology of EbM. Even the best controlled trial cannot be properly interpreted or implemented without clinical reasoning; furthermore, clinicians of all disciplines are obligated to provide care according to the current state of scientific knowledge. In an era of revolutionary biomedical developments, exponential increase of research but incremental innovations, they must become familiar with pragmatic tools to appraise the validity and relevance of clinical study results, and to decide whether there is a need to adapt current beliefs and practices based on the new information. We herein use the recent example of a new medical device for the surgical treatment of rotator cuff tears and subacromial impingement syndrome to illustrate how important it is to interpret data in the context of a precise, answerable question and to combine clinical expertise with methodological principles offered by EbM.

Large-scale, pragmatic randomized trials in the era of big data, precision medicine and machine learning. Valid and necessary, or outdated and a waste of resources?

During the past decade, more and more large-scale pragmatic clinical trials have been carried out in orthopedic trauma surgery. This trend is fueled by the common belief that the larger the numbers in a trial, the broader the eligibility criteria, and the less strict the regimentation of local treatment standards by protocol, the more trustworthy the findings would be. However, it must also be taken into account that the precision of an outcome measurement does not depend on the sample size alone, but the homogeneity of the studied population. Consequently, a small trial with stringent entry and assessment criteria may offer similarly precise answers as a large trial with less strict entry and assessment criteria because of the basic mathematical correlation between standard deviation and standard error of the mean. There is now a lively and controversial debate about the role of randomized controlled trials (RCT) in an era of stratified medicine driven by the ever increasing understanding and clinical measurability of molecular pathways, making a certain intervention more effective in patients who show a distinct genetic variant. Cluster and pattern recognition by artificial intelligence (AI) and its methodological variety applied to huge datasets and population-based cohorts further propel the spiral of knowledge. Advanced adaptive RCT concepts like enrichment designs, basket and bucket trials, master protocols etc. were developed to combine classic principles of the scientific method with big data, the latter of which have not arrived yet in trauma care. In spite of all biomedical and methodological achievements made, surprisingly such key questions remain unanswered as a) is a certain treatment causally responsible for making a difference in patient-centered outcomes compared to placebo, a control treatment, or the standard of care, b) do the results of a controlled experiment are relevant enough to change clinical practice, and c) under which conditions and assumptions shall we conduct large-scale pragmatic RCTs, focused confirmatory RCTs, or personalized analyses with or without AI support.

[Interpretation of systematic review articles and meta-analyses : Clinical trials in trauma surgery and orthopedics]. / Interpretation von systematischen Übersichtsarbeiten und Metaanalysen : Klinische Studien in Unfallchirurgie und Orthopädie.

Clinical trials must be planned and interpreted in the context of current best clinical and scientific evidence, undoubtedly provided by systematic reviews and meta-analyses, especially Cochrane Reviews. While many clinicians feel overwhelmed by this complex data source, few visualElements (e.g., the traffic light system of the Cochrane risk of bias [RoB­2] tool, forest plots, etc.), together with indices such as the I2 heterogeneity statistic, allow for a quick appraisal of all critical and necessary qualitative and quantitative information. The effectiveness of different treatment options can indirectly be assessed by methodological advancements like network meta-analyses.Point estimates of percentages are insufficient to describe the utility and value of a proposed novel intervention, which, in orthopedic and trauma surgery, often represents a step innovation. 95% confidence intervals and the so-called fragility index are helpful in determining the ultimate patient benefit.

Middle Meningeal Artery Embolization Minimizes Burdensome Recurrence Rates After Newly Diagnosed Chronic Subdural Hematoma Evacuation (MEMBRANE): study protocol for a randomized controlled trial.

BACKGROUND: Chronic subdural hematoma (cSDH) is the most common complication of mild traumatic brain injury demanding neurosurgery in high-income countries. If undetected and untreated, cSDH may increase intracranial pressure and cause neurological deficiencies. The first-line intervention of choice is burr hole trepanation and hematoma evacuation. However, any third patient may experience rebleeding, demanding craniotomy with excess morbidity. Adjunct endovascular embolization of the frontal and parietal branches of the middle meningeal artery (MMA) is a promising approach to avoid relapse and revision but was hitherto not studied in a randomized trial. METHODS: MEMBRANE is an investigator-initiated, single-center, randomized controlled trial. Male, female, and diverse patients older than 18 years scheduled for surgical evacuation of a first cSDH will be assigned in a 1:1 fashion by block randomization to the intervention (surgery plus endovascular MMA embolization) or the control group (surgery alone). The primary trial endpoint is cSDH recurrence within 3 months of follow-up after surgery. Secondary endpoints comprise neurological deficits assessed by the modified Rankin Scale (mRS) and recurrence- or intervention-associated complications during 3 months of follow-up. Assuming a risk difference of 20% of rebleeding and surgical revision, a power of 80%, and a drop-out rate of 10%, 154 patients will be enrolled onto this trial, employing an adaptive O'Brien-Fleming approach with a planned interim analysis halfway. DISCUSSION: The MEMBRANE trial will provide first clinical experimental evidence on the effectiveness of endovascular embolization of the MMA as an adjunct to surgery to reduce the risk of recurrence after the evacuation of cSDH. TRIAL REGISTRATION: German Clinical Trials Registry (Deutsches Register Klinischer Studien [DRKS]) DRKS00020465. Registered on 18 Nov 2021. CLINICALTRIALS: gov NCT05327933 . Registered on 13 Apr 2022.

[Clinical studies in trauma surgery and orthopedics: read, interpret and implement]. / Klinische Studien in Unfallchirurgie und Orthopädie: lesen, interpretieren und umsetzen.

Informative, participatory clinical decision-making needs to combine both skills and expertise as well as current scientific evidence. The flood of digital information makes it difficult in everyday clinical practice to keep up to date with the latest publications. This article provides assistance for coping with this problem. A basic understanding of prior and posterior probabilities as well as systematic error (bias) makes it easier to weigh up the benefits and risks, e.g. of a (surgical) intervention compared to a nonsurgical treatment. Randomized controlled trials (RCT, with all modern modifications) deliver undistorted results but in orthopedic and trauma surgery can lead to a heavily selected nonrepresentative sample and the results must be confirmed or refuted by further, independent RCTs. Large-scale observational data (e.g. from registries) can be modelled in a quasi-experimental manner and accompany RCTs in health technology assessment.

What Is the Diagnostic Accuracy of Flat-panel Cone-beam CT Arthrography for Diagnosis of Scapholunate Ligament Tears?

BACKGROUND: Cone beam CT (CBCT) is a widely available technique with possible indications in carpal ligament injuries. The accuracy of CBCT arthrography in diagnosing traumatic tears of the scapholunate ligament has not been reported. QUESTIONS/PURPOSES: (1) What is the diagnostic accuracy of CBCT and how does it relate to the accuracy of multislice CT arthrography and conventional arthrography in diagnosing scapholunate ligament tears? (2) What is the estimated magnitude of skin radiation doses of each method? METHODS: This secondary analysis of a previous prospective study included 71 men and women with suspected scapholunate ligament tears and indications for arthroscopy. Preoperative imaging was conventional arthrography and either MSCT arthrography for the first half of patients to be included (n = 36) or flat-panel CBCT arthrography for the remaining patients (n = 35). Index tests identified therapy-relevant SLL tears with dorsal or complete SLL ruptures, and these tears were compared with relevant SLL tears which were determined through arthroscopy as Geissler Stadium III and IV by probing the instable SL joint with a microhook or arthroscope. These injuries were treated by open ligament repair and Kirschner wire fixation. Accuracy values and 95% confidence intervals were calculated. Additional estimates of the radiation skin doses of each CBCT exam and two MSCT protocols were subsequently calculated using dose area products, dose length products, and CT dose indices. RESULTS: The diagnostic accuracy was high for all imaging methods. 95% CIs were broadly overlapping and therefore did not indicate differences between the diagnostic groups: Sensitivity of CBCT arthrography was 100% (95% CI 77 to 100), specificity was 95% (95% CI 76 to 99.9), positive predictive value was 93% (95% CI 68 to 99.8), and negative predictive value was 100% (95% CI 83 to 100). For MSCT arthrography, the sensitivity was 92% (95% CI 64 to 99.8), specificity was 96% (95% CI 78 to 99.9), positive predictive value was 92% (95% CI 64 to 99.8), and negative predictive value was 96% (95% CI 78 to 99.9). For conventional arthrography, the sensitivity was comparably high: 96% (95% CI 81 to 99.9). Specificity was (81% [95% CI 67 to 92]); the positive predictive value was 77% (95% CI 59 to 89) and negative predictive value was 97% (95% CI 86 to 99.9). Estimated mean (range) radiation skin doses were reported in a descriptive fashion and were 12.9 mSv (4.5 to 24.9) for conventional arthrography, and 3.2 mSv (2.0 to 4.8) for CBCT arthrography. Estimated radiation skin doses were 0.2 mSv and 12 mSv for MSCT arthrography, depending on the protocol. CONCLUSION: Flat-panel CBCT arthrography can be recommended as an accurate technique to diagnose scapholunate ligament injuries after wrist trauma. Estimated skin doses are low for CBCT arthrography and adapted MSCT arthrography protocols. LEVEL OF EVIDENCE: Level III, diagnostic study.

Association of Low-Dose Whole-Body Computed Tomography With Missed Injury Diagnoses and Radiation Exposure in Patients With Blunt Multiple Trauma.

Importance: Initial whole-body computed tomography (WBCT) for screening patients with suspected blunt multiple trauma remains controversial and a source of excess radiation exposure. Objective: To determine whether low-dose WBCT scanning using an iterative reconstruction algorithm does not increase the rate of missed injury diagnoses at the point of care compared with standard-dose WBCT with the benefit of less radiation exposure. Design, Setting, and Participants: This quasi-experimental, prospective time-series cohort study recruited 1074 consecutive patients admitted for suspected blunt multiple trauma to an academic metropolitan trauma center in Germany from September 3, 2014, through July 26, 2015, for the standard-dose protocol, and from August 7, 2015, through August 20, 2016, for the low-dose protocol. Five hundred sixty-five patients with suspected blunt multiple trauma prospectively received standard-dose WBCT, followed by 509 patients who underwent low-dose WBCT. Confounding was controlled by segmented regression analysis and a secondary multivariate logistic regression model. Data were analyzed from January 16, 2017, through October 14, 2019. Interventions: Standard- or low-dose WBCT. Main Outcomes and Measures: The primary outcome was the incidence of missed injury diagnoses at the point of care, using a synopsis of clinical, surgical, and radiological findings as an independent reference test. The secondary outcome was radiation exposure with either imaging strategy. Results: Of 1074 eligible patients, 971 (mean [SD] age, 52.7 [19.5] years; 649 men [66.8%]) completed the study. A total of 114 patients (11.7%) had multiple trauma, as defined by an Injury Severity Score of 16 or greater. The proportion of patients with any missed injury diagnosis at the point of care was 109 of 468 (23.3%) in the standard-dose and 107 of 503 (21.3%) in the low-dose WBCT groups (risk difference, -2.0% [95% CI, -7.3% to 3.2%]; unadjusted odds ratio, 0.89 [95% CI, 0.66-1.20]; P = .45). Adjustments for autocorrelation and multiple confounding variables did not alter the results. Radiation exposure, measured by the volume computed tomography dose index, was lowered from a median of 11.7 (interquartile range, 11.7-17.6) mGy in the standard-dose WBCT group to 5.9 (interquartile range, 5.9-8.8) mGy in the low-dose WBCT group (P < .001). Conclusions and Relevance: Low-dose WBCT using iterative image reconstruction does not appear to increase the risk of missed injury diagnoses at the point of care compared with standard-dose protocols while almost halving the exposure to diagnostic radiation.

Single versus dual Kirschner wires for closed reduction and intramedullary nailing of displaced fractures of the fifth metacarpal neck (1-2 KiWi): a randomized controlled trial.

AIMS: The aim of this study was to investigate whether clinical and radiological outcomes after intramedullary nailing of displaced fractures of the fifth metacarpal neck using a single thick Kirschner wire (K-wire) are noninferior to those of technically more demanding fixation with two thinner dual wires. PATIENTS AND METHODS: This was a multicentre, parallel group, randomized controlled noninferiority trial conducted at 12 tertiary trauma centres in Germany. A total of 290 patients with acute displaced fractures of the fifth metacarpal neck were randomized to either intramedullary single-wire (n = 146) or dual-wire fixation (n = 144). The primary outcome was the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire six months after surgery, with a third of the minimal clinically important difference (MCID) used as the noninferiority threshold. Secondary outcomes were pain, health-related quality of life (EuroQol five-dimensional questionnaire (EQ-5D)), radiological measures, functional deficits, and complications. RESULTS: Overall, 151/290 of patients (52%) completed the six months of follow-up, leaving 83 patients in the single-wire group and 68 patients in the dual-wire group. In the modified intention-to-treat analysis set, mean DASH scores six months after surgery were 3.8 (sd 7.0) and 4.4 (sd 9.4), respectively. With multiple imputation (n = 288), mean DASH scores were estimated at 6.3 (sd 8.7) and 7.0 (sd 10.0). Upper (1 - 2α)) confidence limits consistently remained below the noninferiority margin of 3.0 points in the DASH instrument. While there was a statistically nonsignificant trend towards a higher rate of shortening and rotational malalignment in the single wire group, no statistically significant differences were observed across groups in any secondary outcome measure. CONCLUSION: A single thick K-wire is sufficient for intramedullary fixation of acute displaced subcapital fractures of the fifth metacarpal neck. The less technically demanding single-wire technique produces noninferior clinical and radiological outcomes compared with the dual-wire approach. Cite this article: Bone Joint J 2019;101-B:1263-1271.

Duration of antibiotic treatment and risk of recurrence after surgical management of orthopaedic device infections: a multicenter case-control study.

BACKGROUND: Device-related infections in orthopaedic and trauma surgery are a devastating complication with substantial impact on morbidity and mortality. Systemic suppressive antibiotic treatment is regarded an integral part of any surgical protocol intended to eradicate the infection. The optimal duration of antimicrobial treatment, however, remains unclear. In a multicenter case-control study, we aimed at analyzing the influence of the duration of antibiotic exposure on reinfection rates 1 year after curative surgery. METHODS: This investigation was part of a federally funded multidisciplinary network project aiming at reducing the spread of multi-resistant bacteria in the German Baltic region of Pomerania. We herein used hospital chart data from patients treated for infections of total joint arthroplasties or internal fracture fixation devices at three academic referral institutions. Subjects with recurrence of an implant-related infection within 1 year after the last surgical procedure were defined as case group, and patients without recurrence of an implant-related infection as control group. We placed a distinct focus on infection of open reduction and internal fixation (ORIF) constructs. Uni- and multivariate logistic regression analyses were employed for data modelling. RESULTS: Of 1279 potentially eligible patients, 269 were included in the overall analysis group, and 84 contributed to an extramedullary fracture-fixation-device sample. By multivariate analysis, male sex (odds ratio [OR] 2.06, 95% confidence interval [CI] 1.08 to 3.94, p = 0.029) and facture fixation device infections (OR 2.05, 95% CI 1.05 to 4.02, p = 0.036) remained independent predictors of reinfection. In the subgroup of infected ORIF constructs, univariate point estimates suggested a nearly 60% reduced odds of reinfection with systemic fluoroquinolones (OR 0.42, 95% CI 0.04 to 2.46) or rifampicin treatment (OR 0.41, 95% CI 0.08 to 2.12) for up to 31 days, although the width of confidence intervals prohibited robust statistical and clinical inferences. CONCLUSION: The optimal duration of systemic antibiotic treatment with surgical concepts of curing wound and device-related orthopaedic infections is still unclear. The risk of reinfection in case of infected extramedullary fracture-fxation devices may be reduced with up to 31 days of systemic fluoroquinolones and rifampicin, although scientific proof needs a randomized trial with about 1400 subjects per group. Concerted efforts are needed to determine which antibiotics must be applied for how long after radical surgical sanitation to guarantee sustainable treatment success.

Efficacy and safety of programmable compared with fixed anti-siphon devices for treating idiopathic normal-pressure hydrocephalus (iNPH) in adults - SYGRAVA: study protocol for a randomized trial.

BACKGROUND: Idiopathic normal-pressure hydrocephalus (iNPH) is a distinct form of dementia, characterized by gait ataxia, cognitive impairment and urinary incontinence. In contrast to all other causes of dementia (e.g., Alzheimer-type and others), ventriculoperitoneal (VP) shunt surgery may offer a curative treatment option to patients. While being a rather low-risk type of surgery, it may cause significant over- or underdrainage complications (e.g., headaches, dizziness, vomiting, intracerebral bleeding, etc.) during posture change. Anti-siphon devices (ASDs) are a group of technically different additional valves used in shunt surgery. They are designed to maintain intraventricular pressure within a normal physiological range regardless of patient position. Fixed ASDs proved to substantially lower the rate of overdrainage complications. No significant differences, however, were noted regarding underdrainage complications. Technical successors of fixed ASDs are programmable ASDs. The aim of this study is to evaluate whether programmable ASDs compared to fixed ASDs are able to avoid both over- and underdrainage complications. METHODS/DESIGN: In this investigator-initiated, multicenter randomized trial, 306 patients are planned to be recruited. Male and female patients aged ≥18 years with iNPH who are eligible for VP shunt surgery and meet all other entry criteria can participate. Patients will be randomized in a balanced 1: 1 fashion to a VP shunt with a programmable valve either supplemented with a fixed ASD, or a programmable ASD. Patients will be followed-up 3, 6 and, on an optional basis, 12 months after surgery. The primary outcome measure is the cumulative incidence of over- or underdrainage 6 months post surgery, as defined by clinical and imaging parameters. DISCUSSION: SYGRAVA is the first randomized trial to determine whether programmable ASDs reduce complications of drainage compared to fixed ASDs in patients with iNPH. The results of this study may contribute to health-technology assessment of different valve systems used for VP-shunt surgery, and determination of the future standard of care. TRIAL REGISTRATION: International Standard Randomised Controlled Trial Number: ISRCTN13838310 . Registered on 10 November 2016.

Pediatric out-of-hospital cardiac arrest caused by left coronary-artery agenesis with primary shockable rhythm.

BACKGROUND: To illustrate a rare cause of out-of-hospital cardiac arrest in children, its differential diagnoses, emergency and subsequent treatment at various steps in the rescue chain, and potential outcomes. CASE PRESENTATION: A 4-year-old boy with unknown agenesis of the left coronary ostium sustained out-of-hospital cardiac arrest. Bystander cardio-pulmonary resuscitation was initiated and defibrillation was performed via an automated external defibrillator (AED) shortly after paramedics arrived at the scene, restoring sinus rhythm and spontaneous circulation. After admission to the intensive care unit the child was intubated for airway and seizure control. Further diagnostic work-up by angiography revealed agenesis of the left coronary artery. After initial seizures, the boy's neurological recovery was complete. He subsequently underwent successful internal mammary artery in-situ bypass surgery to the trunk of the left coronary artery. One year after cardiac arrest, the patient had completely recovered with no physical or intellectual sequelae. A catheter examination proved excellent growth of the bypass and good cardiac function. CONCLUSIONS: This case illustrates the long term outcome after agenesis of the LCA while reiterating that prompt access to pediatric defibrillation may be lifesaving-albeit in a minority of pediatric OHCA.

Nationwide Incidence of Normal Pressure Hydrocephalus (NPH) Assessed by Insurance Claim Data in Germany.

BACKGROUND: The purpose of this study is to investigate the epidemiology of the idiopathic normal pressure hydrocephalus (iNPH) in Germany. METHODS: The database of the nationwide Barmer Health Insurance was queried for specific combinations of corresponding International Classification of Diseases, Ninth Revision (ICD-9) codes and OPS codes (German modification of the ICPM and official classification of surgical procedures) in order to assess the number of patients treated for iNPH and the number surgical procedures associated with the disease in a 10 years period between 2003 and 2012. RESULTS: Between 2003 and 2012, the incidence of iNPH increased from zero to 1.36/100.000/year. CONCLUSION: This is the first population-based epidemiologic study on iNPH in Germany covering a ten year period.

The treatment of displaced intra-articular distal radius fractures in elderly patients.

BACKGROUND: From 2000 to 2012, the annual incidence of inpatient treatment for distal radius fracture in Germany rose from 65 to 86 per 100 000 persons. It is unclear whether open reduction and volar angle-stable plate osteosynthesis (ORIF), a currently advocated treatment, yields a better functional outcome or quality of life than closed reposition and casting. METHODS: In the ORCHID multi-center trial, 185 patients aged 65 and older with an AO type C distal radial fracture were randomly assigned to ORIF or closed reposition and casting. Their health-related quality of life and hand/arm function were assessed 3 and 12 months afterward with the Short Form 36 (SF-36) questionnaire and the Disability of the Arm, Shoulder and Hand (DASH) questionnaire. The radiological findings, range of movement of the wrist, and EuroQol-5D (EQ-5D) scores were documented as well. RESULTS: Among the 149 patients in the intention-to-treat-analysis, there was no significant difference in SF-36 scores between the two treatment groups at one year (mean difference, 3.3 points in favor of ORIF; 95% confidence interval, -0.2 +6.8 points; p = 0.058). The DASH scores showed moderately strong, but clinically unimportant effects in favor of ORIF, and there was no difference in EQ-5D scores. ORIF led to better radiological results and wrist mobility at 3 months, with comparable results at 12 months. 37 of the patients initially allotted to nonsurgical treatment underwent secondary surgery due to significant loss of reduction. CONCLUSION: The findings with respect to mobility, functionality, and quality of life at 12 months provide marginal and inconsistent evidence for the superiority of volar angle-stable plate osteosynthesis over closed reduction and casting in the treatment of intra-articular distal radius fractures. Primary nonsurgical management is also effective in suitable patients.

Dose reduction in whole-body computed tomography of multiple injuries (DoReMI): protocol for a prospective cohort study.

BACKGROUND: Single-pass, contrast-enhanced whole body multidetector computed tomography (MDCT) emerged as the diagnostic standard for evaluating patients with major trauma. Modern iterative image algorithms showed high image quality at a much lower radiation dose in the non-trauma setting. This study aims at investigating whether the radiation dose can safely be reduced in trauma patients without compromising the diagnostic accuracy and image quality. METHODS/DESIGN: Prospective observational study with two consecutive cohorts of patients. SETTING: A high-volume, academic, supra-regional trauma centre in Germany. STUDY POPULATION: Consecutive male and female patients who 1. had been exposed to a high-velocity trauma mechanism, 2. present with clinical evidence or high suspicion of multiple trauma (predicted Injury Severity Score [ISS] ≥16) and 3. are scheduled for primary MDCT based on the decision of the trauma leader on call.Imaging protocols: In a before/after design, a consecutive series of 500 patients will undergo single-pass, whole-body 128-row multi-detector computed tomography (MDCT) with a standard, as low as possible radiation dose. This will be followed by a consecutive series of 500 patients undergoing an approved ultra-low dose MDCT protocol using an image processing algorithm. DATA: Routine administrative data and electronic patient records, as well as digital images stored in a picture archiving and communications system will serve as the primary data source. The protocol was approved by the institutional review board. MAIN OUTCOMES: (1) incidence of delayed diagnoses, (2) diagnostic accuracy, as correlated to the reference standard of a synopsis of all subsequent clinical, imaging, surgical and autopsy findings, (3) patients' safety, (4) radiation exposure (e.g. effective dose), (5) subjective image quality (assessed independently radiologists and trauma surgeons on a 100-mm visual analogue scale), (6) objective image quality (e.g., contrast-to-noise ratio). ANALYSIS: Multivariate regression will be employed to adjust and correct the findings for time and cohort effects. An exploratory interim analysis halfway after introduction of low-dose MDCT will be conducted to assess whether this protocol is clearly inferior or superior to the current standard. DISCUSSION: Although non-experimental, this study will generate first large-scale data on the utility of imaging-enhancing algorithms in whole-body MDCT for major blunt trauma. TRIAL REGISTRATION: Current Controlled Trials ISRCTN74557102.