Investigation of the Impact of Defective Ultrasound Transducers on Clinical Image Quality in Grayscale 2-D Still Images.

OBJECTIVE: There are several studies that show high defect rates of transducers in clinical use. The purpose of the present study was to investigate whether image quality and the risk for misdiagnosis is affected by using defective transducers. METHODS: Four defective transducers with varying degrees of defect severity, still in clinical use, were selected. Forty artifact-affected clinical images from each transducer were compared with images acquired from fully functional transducers, of the same model, in an observer study where four experienced radiologists rated each of the 320 images. The rating tasks included if the artifacts were detectable, if the possible artifacts might affect the diagnosis, how well structural details were reproduced and, finally, an assessment of overall image quality. RESULTS: The artifacts in the images were detectable for three of the four transducers (p < 0.05), and in 121 of 640 assessments of the images from the defective transducers the observers were confident that the artifacts could affect the diagnosis. All four faulty transducers were assessed to have decreased ability to resolve structural details (p < 0.05), and three of the four transducers were assessed to have worse overall image quality (p < 0.05). CONCLUSION: The present study shows that image quality and the risk of misdiagnosis can be affected by using defective transducers. This highlights the importance of frequent quality control of the transducers to avoid decreased image quality and even misdiagnosis.

MTL-CEBPA, a Small Activating RNA Therapeutic Upregulating C/EBP-α, in Patients with Advanced Liver Cancer: A First-in-Human, Multicenter, Open-Label, Phase I Trial.

PURPOSE: Transcription factor C/EBP-α (CCAAT/enhancer-binding protein alpha) acts as a master regulator of hepatic and myeloid functions and multiple oncogenic processes. MTL-CEBPA is a first-in-class small activating RNA oligonucleotide drug that upregulates C/EBP-α. PATIENTS AND METHODS: We conducted a phase I, open-label, dose-escalation trial of MTL-CEBPA in adults with advanced hepatocellular carcinoma (HCC) with cirrhosis, or resulting from nonalcoholic steatohepatitis or with liver metastases. Patients received intravenous MTL-CEBPA once a week for 3 weeks followed by a rest period of 1 week per treatment cycle in the dose-escalation phase (3+3 design). RESULTS: Thirty-eight participants have been treated across six dose levels (28-160 mg/m2) and three dosing schedules. Thirty-four patients were evaluable for safety endpoints at 28 days. MTL-CEBPA treatment-related adverse events were not associated with dose, and no maximum dose was reached across the three schedules evaluated. Grade 3 treatment-related adverse events occurred in nine (24%) patients. In 24 patients with HCC evaluable for efficacy, an objective tumor response was achieved in one patient [4%; partial response (PR) for over 2 years] and stable disease (SD) in 12 (50%). After discontinuation of MTL-CEBPA, seven patients were treated with tyrosine kinase inhibitors (TKIs); three patients had a complete response with one further PR and two with SD. CONCLUSIONS: MTL-CEBPA is the first saRNA in clinical trials and demonstrates an acceptable safety profile and potential synergistic efficacy with TKIs in HCC. These encouraging phase I data validate targeting of C/EBP-α and have prompted MTL-CEBPA + sorafenib combination studies in HCC.

Outcome of hip arthroscopy in patients with mild to moderate osteoarthritis-A prospective study.

Osteoarthritis (OA) of the hip is a common cause of hip pain. The arthroscopic management of patients with femoro-acetabular impingement (FAI) has been reported to yield good outcomes. The purpose of this study was to report on outcome following the arthroscopic treatment of patients with FAI in the presence of mild to moderate OA. Seventy-five patients undergoing arthroscopic surgery for FAI, all with preoperative radiological signs of mild to moderate OA were prospectively included in this study. A 2-year follow-up, using web-based patient-reported outcome measures, including the International Hip Outcome Tool (iHOT-12), Copenhagen Hip and Groin Outcome (HAGOS), EQ-5D, Hip Sports Activity Scale (HSAS) for physical activity level and a visual analogue scale (VAS) for overall hip function, was performed, complemented by a radiographic evaluation. At follow-up (mean 26 months, SD 5), five patients (7%) had undergone total hip arthroplasty, leaving 70 patients for the analysis. Preoperative scores compared with those obtained at the 2-year follow-up revealed significant improvements (P < 0.0001) for all measured outcomes; the iHOT-12 (42 versus 65), VAS for global hip function (48 versus 68), HSAS (2.5 versus 3), EQ5D index (0.62 versus 0.76), EQ VAS (69 versus 75) and different HAGOS subscales (54 versus 72, 47 versus 67, 56 versus 75, 40 versus 61, 33 versus 56, 31 versus 55). At follow-up, 56 (82%) patients reported that they was satisfied with the outcome of surgery. Arthroscopic treatment for patients with FAI in the presence of mild to moderate OA resulted in statistically significant and clinically relevant improvements in outcome measures related to pain, symptoms, function, physical activity level and quality of life in the majority of patients.

Added value of interpreter experience in occult and suspect hip fractures: a retrospective analysis of 254 patients.

The influence of experience in categorizing suspect and occult fractures on radiography compared to MRI and clinical outcome has not been studied. The aim of this study is to evaluate the importance of experience in diagnosing normal or suspect hip radiographs compared to MRI. Primarily reported normal or suspect radiography in 254 patients with low-energy hip trauma and subsequent MRI was re-evaluated by two experienced reviewers. Primary readings and review were compared. The prevalence of fractures among normal and suspect radiographic studies was assessed. Clinical outcome was used as reference. At review of radiography, 44 fractures (17 %) were found. Significantly more fractures were found among suspect cases than among normal cases. At MRI, all 44 fractures were confirmed, and further 64 fractures were detected (25 %). MRI detected all fractures with no missed fractures revealed at follow-up. There were a significantly higher proportion of fractures at MRI among the suspect radiographic diagnoses for both the primary report and at review than among occult cases. The more experienced reviewers classified radiography examinations with higher accuracy than primary reporting general radiologists. There was almost complete agreement on MRI diagnoses.

Computed tomography compared to magnetic resonance imaging in occult or suspect hip fractures. A retrospective study in 44 patients.

BACKGROUND: Computed tomography (CT) for evaluation of occult and suspect hip fractures has been proposed as a good second-line investigation. The diagnostic precision compared to magnetic resonance imaging (MRI) is unclear. PURPOSE: To compare the diagnostic performance of CT and MRI in a retrospective study on patients with suspect and occult hip fractures. MATERIAL AND METHODS: Forty-four elderly consecutive patients with low-energy trauma to the hip were identified where negative or suspect CT was followed by MRI. Primary reporting and review by two observers as well as the diagnostic performance of the two modalities were compared. Surgical treatment and clinical course were used as outcomes. RESULTS: Compared to the primary reports, the CT reviewers found fewer normal and no suspect cases. MRI changed the primary diagnoses in 27 cases, and in 14 and 15 cases, respectively, at review. There was no disagreement on MRI diagnoses. CONCLUSION: In our patient population, MRI was deemed a more reliable modality for hip fracture diagnosis in comparison to CT. For clinical decision making, MRI seems to have a higher accuracy than CT. A negative CT finding cannot completely rule out a hip fracture in patients where clinical findings of hip fracture persevere. KEY POINTS: • Experience is highly influential in diagnosing occult or suspect hip fractures at CT • Inconclusive hip CT shows high inter-rater reliability at experienced review • There was low diagnostic accuracy via CT compared to MRI for all interpreters • Hip fractures can readily be diagnosed at MRI regardless of radiological experience.

Prevalence of exclusively and concomitant pelvic fractures at magnetic resonance imaging of suspect and occult hip fractures.

Pelvic fractures may occur together with hip fractures as a result of low energy trauma. It is unclear whether they do require special attention. There are conflicting results in the literature about the prevalence of both concomitant hip and pelvic fractures as well as exclusive pelvic fractures. It has been reported that hip fractures and obturator ring fractures are mutually exclusive. To retrospectively analyze the prevalence of exclusively pelvic as well as concomitant hip and pelvic fractures in patients examined with MRI after low-energy trauma in elderly. During 9 years, 316 elderly patients had been examined with MRI for suspected or occult hip fracture after a fall. A fracture was diagnosed when MRI showed focal signal abnormalities in the subcortical bone marrow, with or without disruption of adjacent cortices. One observer reviewed all studies. A second observer verified all studies with hip fractures. Follow-up was available for all but two patients that died prior to hip surgery. The prevalence of concomitant pelvic and femoral neck or trochanteric fractures was statistically compared using chi-squared test for categorical variables. Hip fractures were found in 161 (51 %) patients of which 29 (9 %) had concomitant pelvic fractures. There were exclusively pelvic fractures in 82 (26 %) patients of which 65 (79 %) were on the traumatized side only. In 73 patients, there were no fractures. Occult or suspected hip fractures are not infrequently associated with pelvic fractures. Exclusively pelvic fractures are not uncommon.

Critical factors in cut-out complication after Gamma Nail treatment of proximal femoral fractures.

BACKGROUND: The most common mechanical failure in the internal fixation of trochanteric hip fractures is the cut-out of the sliding screw through the femoral head. Several factors that influence this complication have been suggested, but there is no consensus as to the relative importance of each factor. The purpose of this study was to analyse the cut-out complication with respect to the following variables: patients' age, fracture type, fracture reduction, implant positioning and implant design. METHODS: 3066 consecutive patients were treated for trochanteric fractures with Gamma Nails between 1990 and 2002 at the Centre de Traumatologie et de l'Orthopedie (CTO), Strasbourg, France. Cut-out complications were identified by reviewing all available case notes and radiographs. Subsequently, the data were analysed by a single reviewer (AJB) with focus on the studied factors. RESULTS: Seventy-one cut-out complications were found (2.3%) of the 3066 trochanteric fractures. Cut-out failure associated with avascular head necrosis, pathologic fracture, deep infection or secondary to prior failure of other implants were excluded from the study (14 cases). The remaining 57 cases (1.85%, median age 82.6, 79% females) were believed to have a biomechanical explanation for the cut-out failure. 41 patients had a basicervical or complex fracture type. A majority of cut-outs (43 hips, 75%) had a combination of the critical factors studied; non-anatomical reduction, non-optimal lag screw position and the characteristic fracture pattern found. CONCLUSIONS: The primary cut-out rate of 1.85% was low compared with the literature. A typical cut-out complication in our study is represented by an unstable fracture involving the trochanteric and cervical regions or the combination of both, non-anatomical reduction and non-optimal screw position. Surgeons confronted with proximal femoral fractures should carefully scrutinize preoperative radiographs to assess the primary fracture geometry and fracture classification. To reduce the risk of a cut-out it is important to achieve both anatomical reduction and optimal lag screw position as these are the only two factors that can be controlled by the surgeon.

Bone bruise, lipohemarthrosis, and joint effusion in CT of non-displaced hip fracture.

BACKGROUND: A suspected occult hip fracture after normal radiography is not uncommon in an elderly person after a fall. Despite a lack of robust validation in the literature, computed tomography (CT) is often used as secondary imaging. PURPOSE: To assess the frequency and clinical utility of non-cortical skeletal and soft tissue lesions as ancillary fracture signs in CT diagnosis of occult hip fractures. MATERIAL AND METHODS: All fracture signs (cortical and trabecular fractures, bone bruise, joint effusion, and lipohemarthrosis) were recorded in 231 hip low-energy trauma cases with CT performed after normal or equivocal radiography in two trauma centers. RESULTS: There were no fracture signs in 110 patients. Twelve of these had a joint effusion. In 121 patients with 46 cervical hip fractures and 75 trochanteric fractures one or more fracture signs were present. Cortical fractures were found in 115 patients. Bone bruise was found in 119 patients, joint effusion in 35, and lipohemarthrosis in 20 patients. CONCLUSION: Ancillary signs such as bone bruise and lipohemarthrosis can strengthen and sometimes indicate the diagnosis in CT of occult hip fractures. Joint effusion is a non-specific sign.

High clinical utility of computed tomography compared to radiography in elderly patients with occult hip fracture after low-energy trauma.

To evaluate the clinical utility of computed tomography (CT) compared to radiography in evaluating suspect or missed hip fractures in elderly after low-energy trauma. One hundred ninety-three hip CT examinations performed in two trauma centers during 3 years of evaluation of clinically suspect or occult hip fracture within 24 h of negative or suspect radiography were retrospectively reviewed. Consensus CT diagnosis by three observers was compared to clinical outcome and in some cases also further imaging. All patients were elderly and had sustained a low-energy trauma. Eighty-four examinations revealed no fracture. Follow-up was uneventful but for two patients who had been operated. Thirty-nine of 41 cervical hip fractures were surgically or otherwise confirmed, two cases were not operated due to week-old trauma and moderate symptoms. Twenty-nine of 68 trochanteric fractures or avulsions were confirmed surgically. Computed tomography has a high clinical utility as it can detect nearly all clinically suspect but radiographically negative cervical hip fractures as well as most trochanteric fractures and avulsions. A negative CT is near-perfect in ruling out a hip fracture requiring surgery.

Observer variation for radiography, computed tomography, and magnetic resonance imaging of occult hip fractures.

BACKGROUND: Conventional radiography is insufficient for diagnosis in a small but not unimportant number of hip fractures, and secondary imaging with computed tomography (CT) or magnetic resonance imaging (MRI) is warranted. There are no convincing observer variation studies performed for conventional radiography or CT in occult fractures, and no large materials for MRI. PURPOSE: To assess observer variation in radiography, CT and MRI of suspected occult, non-displaced hip fractures, and to evaluate to what extent observer experience or patient age may influence observer performance. MATERIAL AND METHODS: A total of 375 patients after hip trauma where radiography was followed by CT or MRI to evaluate a suspected occult hip fracture were collected retrospectively from two imaging centers. After scoring by three observers with varying degrees of radiologic experience, observer variation was assessed by using linear weighted kappa statistics. RESULTS: For radiography, agreements between the three observers were moderate to substantial for intracapsular fractures, with kappa values in the ranges of 0.56-0.66. Kappa values were substantial for extracapsular fractures, in the ranges of 0.69-0.72. With increasing professional experience, fewer fractures were classified as equivocal at radiography. For CT and MRI, observer agreements were similar and almost perfect, with kappa values in the ranges of 0.85-0.97 and 0.93-0.97. CONCLUSION: There were almost perfect observer agreements for CT and MRI in diagnosing non-displaced, occult hip fractures. Observer agreements for radiography were moderate to substantial, and observer experience influenced agreement only at radiography.