The Value of Intraoperative 3-Dimensional Fluoroscopy in the Treatment of Distal Radius Fractures: A Randomized Clinical Trial.

PURPOSE: This study attempted to determine the clinical effectiveness of the intraoperative use of 3-dimensional fluoroscopy compared with conventional 2-dimensional fluoroscopy in patients with distal radius fractures. METHODS: We performed a multicenter randomized clinical trial in which 206 patients were randomized between the use of 3-dimensional fluoroscopy or not during operative treatment of the distal radius fracture. The primary outcome was the quality of fracture reduction and fixation assessed on a postoperative computed tomography scan with a dichotomous outcome: indication for revision, yes or no. RESULTS: There was no significant difference in whether the fracture required revision surgery: 31% (2-dimensional group) versus 24% (3-dimensional group). In 11% of distal radius fractures allocated to the 3-dimensional group, additional intraoperative corrections (screw replacements) were performed. CONCLUSIONS: Compared with 2-dimensional fluoroscopy, the use of intraoperative 3-dimensional fluoroscopy does not appear to improve the quality of reduction and fixation in the management of patients with a distal radius fracture. However, the use of 3-dimensional fluoroscopy appears to have advantages such as more intraoperative revisions and less revision surgeries that this study could not clearly demonstrate. TYPE OF STUDY/LEVEL OF EVIDENCE: Diagnostic II.

Systematic CT evaluation of reduction and hardware positioning of surgically treated calcaneal fractures: a reliability analysis.

INTRODUCTION: Up to date, there is a lack of reliable protocols that systematically evaluate the quality of reduction and hardware positioning of surgically treated calcaneal fractures. Based on international consensus, we previously introduced a 23-item scoring protocol evaluating the reduction and hardware positioning in these fractures based on postoperative computed tomography. The current study is a reliability analysis of the described scoring protocol. METHODS: Three raters independently and systematically evaluated anonymized postoperative CT scans of 102 surgically treated calcaneal fractures. A selection of 25 patients was scored twice by all individual raters to calculate intra-rater reliability. The scoring protocol consisted of 23 items addressing quality of reduction and hardware positioning. Each of these four-option questions was answered as: 'optimal', 'suboptimal (but not needing revision)', 'not acceptable (needing revision)' or 'not judgeable'. We used intraclass correlation coefficients (ICC's) to calculate inter- and intra-rater reliability. RESULTS: Inter-rater reliability of the overall 23-item protocol was good (ICC 0.66, 95% CI 0.64-0.69). Individual items that scored an inter-rater ICC ≥0.60 included evaluation of the calcaneocuboid joint, the posterior talocalcaneal joint, the anterior talocalcaneal joint, the position of the plate and sustentaculum screws and screws protruding the tuber and medial wall. The intra-rater reliability for the overall protocol was good for all three individual raters with ICC's between 0.60 and 0.70. CONCLUSION: Our scoring protocol for the radiological evaluation of operatively treated calcaneal fractures is reliable in terms of inter- and intra-rater reliability.

Effects of intra-operative fluoroscopic 3D-imaging on peri-operative imaging strategy in calcaneal fracture surgery.

INTRODUCTION: Previous studies demonstrated that intra-operative fluoroscopic 3D-imaging (3D-imaging) in calcaneal fracture surgery is promising to prevent revision surgery and save costs. However, these studies limited their focus to corrections performed after 3D-imaging, thereby neglecting corrections after intra-operative fluoroscopic 2D-imaging (2D-imaging). The aim of this study was to assess the effects of additional 3D-imaging on intra-operative corrections, peri-operative imaging used, and patient-relevant outcomes compared to 2D-imaging alone. PATIENTS AND METHODS: In this before-after study, data of adult patients who underwent open reduction and internal fixation (ORIF) of a calcaneal fracture between 2000 and 2014 in our level-I Trauma center were collected. 3D-imaging (BV Pulsera with 3D-RX, Philips Healthcare, Best, The Netherlands) was available as of 2007 at the surgeons' discretion. Patient and fracture characteristics, peri-operative imaging, intra-operative corrections and patient-relevant outcomes were collected from the hospital databases. Patients in whom additional 3D-imaging was applied were compared to those undergoing 2D-imaging alone. RESULTS: A total of 231 patients were included of whom 107 (46%) were operated with the use of 3D-imaging. No significant differences were found in baseline characteristics. The median duration of surgery was significantly longer when using 3D-imaging (2:08 vs. 1:54 h; p = 0.002). Corrections after additional 3D-imaging were performed in 53% of the patients. However, significantly fewer corrections were made after 2D-imaging when 3D-imaging was available (Risk difference (RD) -15%; 95% Confidence interval (CI) -29 to -2). Peri-operative imaging, besides intra-operative 3D-imaging, and patient-relevant outcomes were similar between groups. CONCLUSION: Intra-operative 3D-imaging provides additional information resulting in additional corrections. Moreover, 3D-imaging probably changed the surgeons' attitude to rely more on 3D-imaging, hence a 15%-decrease of corrections performed after 2D-imaging when 3D imaging was available. No substantiation for cost reduction was found through reduction in peri-operative imaging or in terms of improved patient-relevant outcomes.

Evaluation of reduction and fixation of calcaneal fractures: a Delphi consensus.

BACKGROUND: Postoperative radiological assessment of the quality of reduction and fixation of calcaneal fractures is essential when evaluating treatment success. However, a universally accepted radiological evaluation protocol is currently unavailable. The aim of this study was to obtain an expert-based consensus on the most important criteria for the radiological assessment of the quality of reduction and fixation of calcaneal fractures. METHODS: The Delphi method, consisting of three rounds, was used to obtain consensus. Each round focused on four main topics of calcaneal fracture evaluation: imaging technique (38 items), anatomical landmarks (21 items), fracture reduction (16 items) and position of the fixation material (9 items). We invited ten radiologists and 44 surgeons from the USA and Europe (all calcaneus experts) to complete online questionnaires. They were asked which aspects require evaluation to determine the quality of fracture reduction and fixation. Agreement was expressed as the percentage of respondents with identical answers. Consensus was defined as an agreement of at least 80 %. RESULTS: All experts were invited for the three Delphi rounds and 16, 18, and 15 specialists responded per round, respectively. Agreement was reached for 23/38 (60 %) items regarding imaging techniques, 20/21 (95 %) anatomical landmarks, 13/16 (81 %) items regarding fracture reduction and 8/9 items (89 %) regarding fracture fixation. CONCLUSION: This Delphi consensus shows that more aspects require evaluation than currently used in radiological evaluation protocols. With this consensus, we provide the basis for a universal evaluation protocol to assess the radiological outcome of calcaneal fracture treatment.

The correlation between intra-operative 2D- and 3D fluoroscopy with postoperative CT-scans in the treatment of calcaneal fractures.

OBJECTIVES: The aim of this study was to determine the correlation of the intra-operative fluoroscopic 2D- and 3D-images compared with a postoperative CT-scan, in terms of quality of reduction and fixation of calcaneal fractures. METHODS: Patients requiring open reduction and internal fixation (ORIF) of a calcaneal fracture were recruited as part of the EF3X-trial. During surgery, intra-operative images of fluoroscopic 2D- and 3D-imaging were obtained to assess the quality of the reduction and implant position. All patients received a postoperative CT-scan within one week. The operating surgeon evaluated intra-operatively both 2D- and 3D-images according to a 23-item scoring protocol on a 3-point Likert scale. A scoring panel, consisting of three clinical experts, evaluated all images in a blinded and independent fashion. Intraclass correlation coefficients (ICC) with their 95% confidence intervals (CI) were calculated using a two-way-random model with absolute agreement. RESULTS: A total of 102 calcaneal fractures were included. Agreement of 3D-imaging for the quality of reduction was better than 2D-imaging, although still fair, but for fixation moderate to good. Agreement between the 2D-images and the CT-scans was poor to fair. Intra-operative 2D-imaging received the highest ratings for image quality and interpretability, followed by CT-scanning. CONCLUSION: Implant position can be evaluated satisfactory with the aid of intra-operative 3D imaging. Although intra-operative 3D imaging had a better agreement with postoperative CT-scanning than 2D-imaging, there is a need to improve image quality and suppress scattering from implants to improve the additional value of intra-operative 3D imaging in calcaneal fracture reduction and fixation.

Epidemiology of extremity fractures in the Netherlands.

INTRODUCTION: Insight in epidemiologic data of extremity fractures is relevant to identify people at risk. By analyzing age- and gender specific fracture incidence and treatment patterns we may adjust future policy, take preventive measures and optimize health care management. Current epidemiologic data on extremity fractures and their treatment are scarce, outdated or aiming at a small spectrum of fractures. The aim of this study was to assess trends in incidence and treatment of extremity fractures between 2004 and 2012 in relation to gender and age. METHODS: We used a combination of national registries of patients aged ≥ 16 years with extremity fractures. Fractures were coded by the International Classification of Diseases (ICD) 10, and allocated to an anatomic region. ICD-10 codes were used for combining the data of the registries. Absolute numbers, incidences, number of patients treated in university hospitals and surgically treated patients were reported. A binary logistic regression was used to calculate trends during the study period. RESULTS: From 2004 to 2012 the Dutch population aged ≥16 years grew from 13,047,018 to 13,639,412 inhabitants, particularly in the higher age groups of 46 years and older. The absolute number of extremity fractures increased significantly from 129,188 to 176,129 (OR 1.308 [1.299-1.318]), except for forearm and lower leg fractures. Incidences increased significantly (3-4%) for wrist, hand/finger, hip/upper leg, ankle and foot/toe fractures. In contrast to the older age categories from 66 years and older, in younger age categories from 16 to 35 years, fractures of the extremities were more frequent in men than in women. Treatments gradually moved towards non-university hospitals for all except forearm fractures. Both relative and absolute numbers increased for surgical treatments of clavicle/shoulder, forearm, wrist and hand/finger fractures. Contrarily, lower extremity fractures showed an increase in non-surgical treatment, except for lower leg fractures. CONCLUSION: During the study period, we observed an increasing incidence of extremity fractures and a shift towards surgical treatment. Patient numbers in university hospitals declined. If these trends continue, policy makers would be well advised to consider the changing demands in extremity fracture treatment and pro-actively increase capacity and resources.

[The Amsterdam wrist rules: the multicenter prospective derivation and external validation of a clinical decision rule for the use of radiography in acute wrist trauma]. / De Amsterdam Wrist Rules: Een klinische beslisregel voor polstrauma op de SEH.

BACKGROUND: Although only 39% of patients with wrist trauma have sustained a fracture, the majority of patients is routinely referred for radiography. The purpose of this study was to derive and externally validate a clinical decision rule that selects patients with acute wrist trauma in the Emergency Department (ED) for radiography. METHOD: This multicenter prospective study consisted of three components: (1) derivation of a clinical prediction model for detecting wrist fractures in patients following wrist trauma; (2) external validation of this model; and (3) design of a clinical decision rule. The study was conducted in the EDs of five Dutch hospitals: one academic hospital (derivation cohort) and four regional hospitals (external validation cohort). We included all adult patients with acute wrist trauma. The main outcome was fracture of the wrist (distal radius, distal ulna or carpal bones) diagnosed on conventional X-rays. RESULTS: A total of 882 patients were analyzed; 487 in the derivation cohort and 395 in the validation cohort. We derived a clinical prediction model with eight variables: age; sex, swelling of the wrist; swelling of the anatomical snuffbox, visible deformation; distal radius tender to palpation; pain on radial deviation and painful axial compression of the thumb. The Area Under the Curve at external validation of this model was 0.81 (95% CI: 0.77-0.85). The sensitivity and specificity of the Amsterdam Wrist Rules (AWR) in the external validation cohort were 98% (95% CI: 95-99%) and 21% (95% CI: 15%-28). The negative predictive value was 90% (95% CI: 81-99%). CONCLUSION: The Amsterdam Wrist Rules is a clinical prediction rule with a high sensitivity and negative predictive value for fractures of the wrist. Although external validation showed low specificity and 100 % sensitivity could not be achieved, the Amsterdam Wrist Rules can provide physicians in the Emergency Department with a useful screening tool to select patients with acute wrist trauma for radiography. The upcoming implementation study will further reveal the impact of the Amsterdam Wrist Rules on the anticipated reduction of X-rays requested, missed fractures, Emergency Department waiting times and health care costs.

Accuracy and consequences of 3D-fluoroscopy in upper and lower extremity fracture treatment: a systematic review.

OBJECTIVES: The aim of this systematic review was to compare the diagnostic accuracy, subjective image quality and clinical consequences of 3D-fluoroscopy with standard imaging modalities (2D-fluoroscopy, X-ray or CT) during reduction and fixation of intra-articular upper and lower extremity fractures. METHODS: A systematic literature search was performed in MEDLINE, EMBASE and the Cochrane library. In total 673 articles were identified (up to March 2012). The 19 included studies described patients/cadavers with intra-articular upper/lower extremity fractures and compared 3D-fluoroscopy to standard imaging. The study was performed in accordance with the Quality Assessment of Diagnostic Accuracy Studies (QUADAS) guidelines. Diagnostic accuracy was defined by the quality of fracture reduction or implant position and, if possible, expressed as sensitivity and specificity; subjective image quality was determined by the quality of depiction of bone or implants; clinical consequences were defined as corrections in reduction or implant position following 3D-fluoroscopy. RESULTS: Ten cadaver- and nine clinical studies were included. A meta-analysis was not possible, because studies used different scoring protocols to express diagnostic accuracy and reported incomplete data. Based on the individual studies, diagnostic accuracy of 3D-fluoroscopy was better than 2D-fluoroscopy and X-ray, but similar to CT-scanning. Subjective image quality of 3D-fluoroscopy was inferior compared to all other imaging modalities. In 11-40% of the operations additional corrections were performed after 3D-fluoroscopy, while the necessity for these corrections were not recognized based on 2D-fluoroscopic images. CONCLUSIONS: Although subjective image quality is rated inferior compared to other imaging modalities, intra-operative use of 3D-fluoroscopy is a helpful diagnostic tool for improving the quality of reduction and implant position in intra-articular fractures.

[Perioperative 3D fluoroscopy of intra-articular fractures of the extremities]. / Peroperatieve 3D-doorlichting bij intra-articulaire fracturen aan de extremiteiten.

During operative treatment of intra-articular fractures of the extremities, 2D fluoroscopy is often used for assessing the quality of fracture reduction and fixation and for making any necessary corrections. Post-operative radiographs or CT scans, however, frequently reveal suboptimal reduction or fixation of the fracture. To help prevent this, a 3D-fluoroscopy technique that can be used during surgery has been developed. The radiation exposure from intra-operative 3D fluoroscopy is higher than that from 2D fluoroscopy, but significantly lower than exposure resulting from CT scanning. The diagnostic value of 3D fluoroscopy is comparable to that of CT scanning. Extra corrections were performed during a considerably high percentage of operations (11-39%) using 3D fluoroscopy; it is unknown, however, whether corrections are required of all the defects detected. In a randomised clinical trial, we are currently investigating the added value of 3D fluoroscopy in terms of the quality of procedures involving the reduction and fixation, as well as patient-relevant outcomes such as pain and joint function in the long term.