Cost-effectiveness of on-demand removal of syndesmotic screws.

PURPOSE: Syndesmotic screw removal following acute syndesmotic injury is a commonly performed procedure. However, recent studies suggest that the removal does not result in improved patient reported outcome, while the procedure has proved not to be without complications. The aim of this study was to present a health-economic evaluation of on-demand removal (ODR) compared to routine removal (RR) of the syndesmotic screw. METHODS: Data were collected from the RODEO trial, a randomized controlled non-inferiority trial comparing functional outcome of ODR with RR. Economic evaluation resulted in total costs, costs (in Euro) per quality adjusted life year (QALY) and costs per point improvement on the Olerud Molander Ankle Score (OMAS). This included both direct and indirect costs. RESULTS: Total costs for ODR were significantly lower with a mean difference of 3160 euro compared to RR (p < 0.001). The difference in QALY was not significant. The difference in OMAS at 12 months was 1.79 with an incremental cost-effectiveness ratio (ICER) of €-1763 (p = 0.512). The ICER was well below the willingness to pay. Although unit costs might vary between hospitals and countries, these results provide relevant data of cost-effectiveness. CONCLUSION: The clinical effectiveness of both ODR and RR can be considered equal. The costs are lower for patients treated with ODR, which leads to the conclusion that ODR is cost-effective.

Effectiveness and cost-effectiveness of surgery versus casting for elderly patients with Displaced intra-Articular type C distal Radius fractures: protocol of a randomised controlled Trial with economic evaluation (the DART study).

INTRODUCTION: Current literature is inconclusive about the optimal treatment of elderly patients with displaced intra-articular distal radius fractures. Cast treatment is less invasive and less expensive than surgical treatment. Nevertheless, surgery is often the preferred treatment for this common type of distal radius fracture. Patients with a non-acceptable position after closed reduction are more likely to benefit from surgery than patients with an acceptable position after closed reduction. Therefore, this study aims to assess non-inferiority of functional outcomes after casting versus surgery in elderly patients with a non-acceptable position following a distal radius fracture. METHODS AND ANALYSIS: This study is a multicentre randomised controlled trial (RCT) with a non-inferiority design and an economic evaluation alongside. The population consists of patients aged 65 years and older with a displaced intra-articular distal radius fracture with non-acceptable radiological characteristics following either inadequate reduction or redisplacement after adequate reduction. Patients will be randomised between surgical treatment (open reduction and internal fixation) and non-operative treatment (closed reduction followed by cast treatment). We will use two age strata (65-75 and >75 years of age) and a web-based mixed block randomisation. A total of 154 patients will be enrolled and evaluated with the patient-rated wrist evaluation as the primary outcome at 1-year follow-up. Secondary outcomes include the Disabilities of the Arm, Shoulder and Hand questionnaire, quality of life (measured by the EQ-5D), wrist range of motion, grip strength and adverse events. In addition, we will perform a cost-effectiveness and cost-utility analysis from a societal and healthcare perspective. Incremental cost-effectiveness ratios, cost-effectiveness planes and cost-effectiveness acceptability curves will be presented. ETHICS AND DISSEMINATION: The Research and Ethics Committee approved this RCT (NL56858.100.16). The results of this study will be reported in a peer-reviewed journal. We will present the results of this study at (inter)national conferences and disseminate the results through guideline committees. TRIAL REGISTRATION NUMBER: Clinicaltrials.gov (NCT03009890). Dutch Trial Registry (NTR6365).

Direct discharge of patients with simple stable musculoskeletal injuries as an alternative to routine follow-up: a systematic review of the current literature.

PURPOSE: There is growing evidence that patients with certain simple stable musculoskeletal injuries can be discharged directly from the Emergency Department (ED), without compromising patient outcome and experience. This study aims to review the literature on the effects of direct discharge (DD) of simple stable musculoskeletal injuries, regarding healthcare utilization, costs, patient outcome and experience. METHODS: A systematic review was performed in Medline, Embase, CINAHL, Cochrane Library and Web of Science using PRISMA guidelines. Comparative and non-comparative studies on DD of simple stable musculoskeletal injuries from the ED in an adult/paediatric/mixed population were included if reporting ≥ 1 of: (1) logistic outcomes: DD rate (proportion of patients discharged directly); number of follow-up appointments; DD return rate; (2) costs; (3) patient outcomes/experiences: functional outcome; treatment satisfaction; adverse outcomes; other. RESULTS: Twenty-six studies were included (92% conducted in the UK). Seven studies (27%) assessed functional outcome, nine (35%) treatment satisfaction, and ten (38%) adverse outcomes. A large proportion of studies defined DD eligibility criteria as injuries being minor/simple/stable, without further detail. ED DD rate was 26.7-59.5%. Mean number of follow-up appointments was 1.00-2.08 pre-DD, vs. 0.00-0.33 post-DD. Return rate was 0.0-19.4%. Costs per patient were reduced by €69-€210 (ranging from - 38.0 to - 96.6%) post-DD. Functional outcome and treatment satisfaction levels were 'equal' or 'better' (comparative studies), and 'high' (non-comparative studies), post-DD. Adverse outcomes were low and comparable. CONCLUSIONS: This systematic review supports the idea that DD of simple stable musculoskeletal injuries from the ED provides an opportunity to reduce healthcare utilization and costs without compromising patient outcomes/experiences. To improve comparability and facilitate implementation/external validation of DD, future studies should provide detailed DD eligibility criteria, and use a standard set of outcomes. Systematic review registration number: 120779, date of first registration: 12/02/2019.

Cost Analysis of Volar Plate Fixation Versus Plaster Cast Immobilization for Intra-Articular Distal Radial Fractures.

BACKGROUND: The aim of this study was to compare the cost-effectiveness and cost-utility between plaster cast immobilization and volar plate fixation for acceptably reduced intra-articular distal radial fractures. METHODS: A cost-effectiveness analysis was conducted as part of a randomized controlled trial comparing operative (volar plate fixation) with nonoperative (plaster cast immobilization) treatment in patients between 18 and 75 years old with an acceptably reduced intra-articular distal radial fracture. Health-care utilization and use of resources per patient were documented prospectively and included direct medical costs, direct non-medical costs, and indirect costs. All analyses were performed according to the intention-to-treat principle. RESULTS: The mean total cost per patient was $291 (95% bias-corrected and accelerated confidence interval [bcaCI] = -$1,286 to $1,572) higher in the operative group compared with the nonoperative group. The mean total number of quality-adjusted life-years (QALYs) gained at 12 months was significantly higher in the operative group than in the nonoperative group (mean difference = 0.15; 95% bcaCI = 0.056 to 0.243). The difference in the cost per QALY (incremental cost-effectiveness ratio [ICER]) was $2,008 (95% bcaCI = -$9,608 to $18,222) for the operative group compared with the nonoperative group, which means that operative treatment is more effective but also more expensive. Subgroup analysis including only patients with a paid job showed that the ICER was -$3,500 per QALY for the operative group with a paid job compared with the nonoperative group with a paid job, meaning that operative treatment is more effective and less expensive for patients with a paid job. CONCLUSIONS: The difference in QALYs gained for the operatively treated group was equivalent to an additional 55 days of perfect health per year. In adult patients with an acceptably reduced intra-articular distal radial fracture, operative treatment is a cost-effective intervention, especially in patients with paid employment. Operative treatment is slightly more expensive than nonoperative treatment but provides better functional results and a better quality of life. LEVEL OF EVIDENCE: Economic and Decision Analysis Level I. See Instructions for Authors for a complete description of levels of evidence.

Volar Plate Fixation Versus Cast Immobilization in Acceptably Reduced Intra-Articular Distal Radial Fractures: A Randomized Controlled Trial.

BACKGROUND: The evidence for the treatment of acceptably reduced intra-articular distal radial fractures remains inconclusive. We therefore compared the functional outcomes of cast immobilization (nonoperative) and volar plate fixation (operative) for patients with these fractures. METHODS: This multicenter randomized controlled trial enrolled patients between 18 and 75 years old with an acceptably reduced intra-articular distal radial fracture. Patients were randomized to nonoperative treatment or to operative treatment. The primary outcome measure was the Patient-Rated Wrist Evaluation (PRWE) score after 12 months. Secondary outcome measures were the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire; the Short Form-36 (SF-36) questionnaire; a visual analog scale for pain; range of motion; grip strength; radiographic parameters; and complications. Analyses followed the intention-to-treat principle. RESULTS: A total of 96 patients were randomized, and 90 (46 in the nonoperative group and 44 in the operative group) were included in the analysis. Patients treated in the operative group had significantly better functional outcomes measured with the PRWE at 6 weeks, 3 months, 6 months, and 1 year. Additionally, a 28% rate of subsequent surgery was identified in the nonoperative group. CONCLUSIONS: Adult patients with an acceptably reduced intra-articular distal radial fracture have better functional outcomes for 12 months when treated operatively instead of nonoperatively. We therefore recommend surgical treatment for patients with these fractures. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Cost-effectiveness of immediate total-body CT in patients with severe trauma (REACT-2 trial).

BACKGROUND: The effect of immediate total-body CT (iTBCT) on health economic aspects in patients with severe trauma is an underreported issue. This study determined the cost-effectiveness of iTBCT compared with conventional radiological imaging with selective CT (standard work-up (STWU)) during the initial trauma evaluation. METHODS: In this multicentre RCT, adult patients with a high suspicion of severe injury were randomized in-hospital to iTBCT or STWU. Hospital healthcare costs were determined for the first 6 months after the injury. The probability of iTBCT being cost-effective was calculated for various levels of willingness-to-pay per extra patient alive. RESULTS: A total of 928 Dutch patients with complete clinical follow-up were included. Mean costs of hospital care were €25 809 (95 per cent bias-corrected and accelerated (bca) c.i. €22 617 to €29 137) for the iTBCT group and €26 155 (€23 050 to €29 344) for the STWU group, a difference per patient in favour of iTBCT of €346 (€4987 to €4328) (P = 0.876). Proportions of patients alive at 6 months were not different. The proportion of patients alive without serious morbidity was 61.6 per cent in the iTBCT group versus 66.7 per cent in the STWU group (difference -5.1 per cent; P = 0.104). The probability of iTBCT being cost-effective in keeping patients alive remained below 0.56 for the whole group, but was higher in patients with multiple trauma (0.8-0.9) and in those with traumatic brain injury (more than 0.9). CONCLUSION: Economically, from a hospital healthcare provider perspective, iTBCT should be the diagnostic strategy of first choice in patients with multiple trauma or traumatic brain injury.

Adoption of direct discharge of simple stable injuries amongst (orthopaedic) trauma surgeons.

INTRODUCTION: The importance of routine follow-up of several relatively simple stable injuries (SSIs) is questionable. Multiple studies show that direct discharge (DD) of patients with SSIs from the Emergency Department results in patient outcomes and experiences comparable to 'standard care' with outpatient follow-up. The purpose of this study was to evaluate to which extent DD of SSIs has been adopted amongst trauma and orthopedic surgeons internationally, and to assess the variation in the management of these common injuries. METHODS: An online survey was sent to members of an international trauma- and orthopaedic surgery collaboration. Participants, all trauma- or orthopaedic surgeons, were presented with eleven hypothetical cases of patients with simple stable injuries in which they were asked to outline their treatment plan regarding number of follow-up appointments and radiographs, physiotherapy and when to start functional movement. The primary outcome was the proportion of surgeons selecting direct discharge (i.e. zero scheduled appointments), per injury. Secondary outcomes included clinical agreement (>80% of respondents answering similarly) on total number of follow-up appointments (0, 1 or ≥2), radiographs (0, 1 or ≥2), routine physiotherapy referral (yes/no) and when to start functional movement (weeks). RESULTS: 138 of 667 (20.7%) surgeons completed the survey. Adoption of direct discharge ranged from 4-45% of case examples. In 10 out of 11 cases, less than 25% of surgeons selected direct discharge. Clinical agreement regarding number of appointments and when to start functional movement was not reached for any of the injuries. There was clinical agreement on number of radiographs for one injury and for four injuries regarding routine referral to a physiotherapist. DISCUSSION: Despite available evidence, DD of SSIs has not been widely adopted worldwide. Practice variation still exists even for these common injuries. This variation suggests inefficiency and consequently unnecessarily high healthcare costs. (Orthopaedic) trauma surgeons are encouraged to evaluate their current treatment protocols of SSIs.

Viscoelastic haemostatic assay augmented protocols for major trauma haemorrhage (ITACTIC): a randomized, controlled trial.

PURPOSE: Contemporary trauma resuscitation prioritizes control of bleeding and uses major haemorrhage protocols (MHPs) to prevent and treat coagulopathy. We aimed to determine whether augmenting MHPs with Viscoelastic Haemostatic Assays (VHA) would improve outcomes compared to Conventional Coagulation Tests (CCTs). METHODS: This was a multi-centre, randomized controlled trial comparing outcomes in trauma patients who received empiric MHPs, augmented by either VHA or CCT-guided interventions. Primary outcome was the proportion of subjects who, at 24 h after injury, were alive and free of massive transfusion (10 or more red cell transfusions). Secondary outcomes included 28-day mortality. Pre-specified subgroups included patients with severe traumatic brain injury (TBI). RESULTS: Of 396 patients in the intention to treat analysis, 201 were allocated to VHA and 195 to CCT-guided therapy. At 24 h, there was no difference in the proportion of patients who were alive and free of massive transfusion (VHA: 67%, CCT: 64%, OR 1.15, 95% CI 0.76-1.73). 28-day mortality was not different overall (VHA: 25%, CCT: 28%, OR 0.84, 95% CI 0.54-1.31), nor were there differences in other secondary outcomes or serious adverse events. In pre-specified subgroups, there were no differences in primary outcomes. In the pre-specified subgroup of 74 patients with TBI, 64% were alive and free of massive transfusion at 24 h compared to 46% in the CCT arm (OR 2.12, 95% CI 0.84-5.34). CONCLUSION: There was no difference in overall outcomes between VHA- and CCT-augmented-major haemorrhage protocols.

Correction to: Routine versus on demand removal of the syndesmotic screw; a protocol for an international randomised controlled trial (RODEO-trial).

An amendment to this paper has been published and can be accessed via the original article.

Detecting scaphoid fractures in wrist injury: a clinical decision rule.

INTRODUCTION: The aim of this study was to develop and validate an easy to use clinical decision rule, applicable in the ED that limits the number of unnecessary cast immobilizations and diagnostic follow-up in suspected scaphoid injury, without increasing the risk of missing fractures. METHODS: A prospective multicenter study was conducted that consisted of three components: (1) derivation of a clinical prediction model for detecting scaphoid fractures in adult patients following wrist trauma; (2) internal validation of the model; (3) design of a clinical decision rule. The predictors used were: sex, age, swelling of the anatomic snuffbox, tenderness in the anatomic snuffbox, scaphoid tubercle tenderness, painful ulnar deviation and painful axial thumb compression. The outcome measure was the presence of a scaphoid fracture, diagnosed on either initial radiographs or during re-evaluation after 1-2 weeks or on additional imaging (radiographs/MRI/CT). After multivariate logistic regression analysis and bootstrapping, the regression coefficient for each significant predictor was calculated. The effect of the rule was determined by calculating the number of missed scaphoid fractures and reduction of suspected fractures that required a cast. RESULTS: A consecutive series of 893 patients with acute wrist injury was included. Sixty-eight patients (7.6%) were diagnosed with a scaphoid fracture. The final prediction rule incorporated sex, swelling of the anatomic snuffbox, tenderness in the anatomic snuffbox, painful ulnar deviation and painful axial thumb compression. Internal validation of the prediction rule showed a sensitivity of 97% and a specificity of 20%. Using this rule, a 15% reduction in unnecessary immobilization and imaging could be achieved with a 50% decreased risk of missing a fracture compared with current clinical practice. CONCLUSIONS: This dataset provided a simple clinical decision rule for scaphoid fractures following acute wrist injury that limits unnecessary immobilization and imaging with a decreased risk of missing a fracture compared to current clinical practice. CLINICAL PREDICTION RULE: 1/(1 + EXP (-(0.649662618 × if man) + (0.51353467826 × if swelling anatomic snuffbox) + (-0.79038263985 × if painful palpation anatomic snuffbox) + (0.57681198857 × if painful ulnar deviation) + (0.66499549728 × if painful thumb compression)-1.685). TRIAL REGISTRATION: Trial register NTR 2544, www.trialregister.nl.

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.

Early detection of severe injuries after major trauma by immediate total-body CT scouts.

INTRODUCTION: Evaluation of immediate total-body CT (iTBCT) scouts during primary trauma care could be clinically relevant for early detection and treatment of specific major injuries. The aim of this study was to determine the diagnostic usefulness of TBCT scouts in detecting life-threatening chest and pelvic injuries. METHODS: All patients who underwent an iTBCT during their primary trauma assessment in one trauma center between April 2011 and November 2014 were retrospectively included. Two experienced trauma surgeons and two emergency radiologists evaluated iTBCT scouts with structured questionnaires. Inter-observer agreement and diagnostic properties were calculated for endotracheal tube position and identification of pneumo- and/or hemothorax and pelvic fractures. Diagnostic properties of iTBCT scouts for indication for chest tube placement and pelvic binder application were calculated in comparison to decision based on iTBCT. RESULTS: In total 220 patients with a median age of 37 years (IQR 26-59) were selected with a median Injury Severity Score of 18 (IQR 9-27). There was moderate to substantial inter-observer agreement and low false positive rates for pneumo- and/or hemothorax and for severe pelvic fractures by iTBCT scouts. For 19.8%-22.5% of the endotracheal intubated patients trauma surgeons stated that repositioning of the tube was indicated. Positive predictive value and sensitivity were respectively 100% (95%CI 52%-100%) and 50% (95%CI 22%-78%) for decisions on chest tube placement by trauma surgeon 1 and 67% (95%CI 13%-98%) and 22% (95%CI 4%-60%) for decisions by trauma surgeon 2. Only in one of 14 patients the pelvic binder was applied after iTBCT acquisition. CONCLUSIONS: iTBCT scouts can be useful for early detection of pneumo- and/or hemothorax and severe pelvic fractures. Decision for chest tube placement based on iTBCT scouts alone is not recommended.

Ultrasound guided supra-inguinal Fascia Iliaca Compartment Blocks in hip fracture patients: An alternative technique.

INTRODUCTION: In the Emergency Department, regional anesthesia is increasingly used in elderly patients with hip fractures. An example is a Fascia Iliaca Compartment Block (FICB). Traditionally, this block is administered below the inguinal ligament. There is no Emergency Department data regarding effectivity of an alternative, more cranial approach above the inguinal ligament. The objective was to determine analgesic effects of an ultrasound-guided supra-inguinal FICB in hip fracture patients in the Emergency Department. METHODS: This case series included all Emergency Department hip fracture patients who were treated with a supra-inguinal FICB during a period of 10 months. All data were recorded prospectively. Primary study outcome was decrease in Numerical Rating Scale (NRS) pain scores 60 min after the FICB. Secondary outcomes included the proportion of patients achieving 1.5 NRS points decrease at 60 min; NRS differences at 30 and 120 min compared to baseline; need for additional analgesia and occurrence of adverse events. RESULTS: A total of 22 patients were included in the study. At 60 min median NRS pain scores decreased from 6.0 to 3.0 (p < 0.001). Of all patients, a total of 59% achieved a decrease in 1.5 NRS points after 60 min. Median pain scores at 30 and 120 min were 4.0 (Interquartile Range (IQR) 2.0-5.0) and 2.5 (IQR 0.8-3.0). Seven patients (31.8%) required additional opioid analgesia after the FICB. No adverse events were recorded. CONCLUSION: An ultrasound-guided supra-inguinal FICB decreases NRS pain scores in hip fracture patients both clinically relevant and statistically significantly after 60 min. CLINICAL TRIAL REGISTRATION: The study was registered in the ISRCTN database (ISRCTN74920258).

Demographics, fracture patterns and treatment strategies following wrist trauma.

The objective of this study was to determine the percentage of radiographs which showed a fracture of the wrist. Secondary, the fracture characteristics and the received treatment were determined. Additionally, the percentage of operatively treated patients with a distal radius fracture was compared between the hospitals. A retrospective cohort study was performed in three Dutch hospitals in all consecutive adult patients with wrist trauma who presented at the ED. A fracture of the wrist was defined as a fracture of the distal one-third part of the radius, the distal one-third part of the ulna or any carpal bone. Fracture classification according to the AO/OTA classification, the amount of displaced fractures, and the received treatment were recorded. Out of 1740 patients with wrist trauma, 49% sustained one or more fractures of the wrist. The distal radius was most frequently fractured (61%). Almost half of the distal radius fractures was extra-articular (AO/OTA type A2-3) and 61% of fractures was displaced. Of all patients who sustained a distal radius fracture, 14% was treated operatively. Significantly more patients were treated operatively in the academic hospital in comparison to the teaching and non-teaching hospital.

Posterior malleolar fracture morphology determines outcome in rotational type ankle fractures.

INTRODUCTION: Rotational type ankle fractures with a concomitant fracture of the posterior malleolus are associated with a poorer clinical outcome as compared to ankle fractures without. However, clinical implications of posterior malleolar (PM) fracture morphology and pattern have yet to be established. Many studies on this subject report on fragment size, rather than fracture morphology based on computed tomography (CT). The overall purpose of the current study was to elucidate the correlation of PM fracture morphology and functional outcome, assessed with CT imaging and not with -unreliable- plain radiographs. METHODS: Between January 2010 and May 2014, 194 patients with an operatively (ORIF) treated ankle fracture, were prospectively included in the randomized clinical EF3X-trial at our Level-I trauma center. The current study retrospectively included 73 patients with rotational type ankle fractures and concomitant fractures of the posterior malleolus. According to the CT-based Haraguchi fracture morphology, all patients were divided into three groups: 20 Type I (large posterolateral-oblique), 21 Type II (transverse medial-extension) and 32 Type III (small-shell fragment). At 12 weeks, 1 year and 2 years postoperatively the Foot and Ankle Outcome Scores (FAOS) and SF-36 scores were obtained, with the FAOS domain scores at two years postoperative as primary study outcome. Statistical analysis included a multivariate regression and secondary a mixed model analysis. RESULTS: Haraguchi Type II PM ankle fractures demonstrated significantly poorer outcome scores at two years follow-up compared to Haraguchi Types I and III. Mean FAOS domain scores at two years follow-up showed to be significantly worse in Haraguchi Type II as compared to Type III, respectively: Symptoms 48.2 versus 61.7 (p = 0.03), Pain 58.5 versus 84.4 (p < 0.01), Activities of Daily Living (ADL) 64.1 versus 90.5 (p < 0.01). CONCLUSION: Posterior malleolar ankle fractures with medial extension of the fracture line (i.e. Haraguchi Type II) are associated with significantly poorer functional outcomes. The current dogma to fix PM fractures that involve at least 25-33% of the tibial plafond may be challenged, as posterior malleolar fracture pattern and morphology - rather than fragment size - seem to determine outcome.

Functional outcome of implant removal following fracture fixation below the level of the knee: a prospective cohort study.

AIMS: The aim of this study was to evaluate the functional outcome in patients undergoing implant removal (IR) after fracture fixation below the level of the knee. PATIENTS AND METHODS: All adult patients (18 to 75 years) undergoing IR after fracture fixation below the level of the knee between November 2014 and September 2016 were included as part of the WIFI (Wound Infections Following Implant Removal Below the Knee) trial, performed in 17 teaching hospitals and two university hospitals in The Netherlands. In this multicentre prospective cohort, the primary outcome was the difference in functional status before and after IR, measured by the Lower Extremity Functional Scale (LEFS), with a minimal clinically important difference of nine points. RESULTS: A total of 179 patients were included with a median age of 50 years (interquartile range (IQR) 37 to 60), of whom 71 patients (39.7%) were male. With a median score of 60 before IR (IQR 45 to 72) and 66 after IR (IQR 51 to 76) on the LEFS, there was a statistically significant improvement in functional outcome (p < 0 .001). A total of 31 surgical site infections (17.3%) occurred. CONCLUSION: Although IR led to a statistically significant improvement of functional outcome, the minimal clinically important difference was not reached. In conclusion, this study shows that IR does not result in a clinically relevant improvement in functional outcome. These results, in combination with the high complication rate, highlight the importance of carefully reviewing the indication for IR. Cite this article: Bone Joint J 2019;101-B:447-453.

Carpal Alignment: A New Method for Assessment.

Background Carpal alignment may be used as a tool to evaluate fracture reduction in patients with distal radius fractures. However, there is little consensus on how to measure and quantify carpal alignment. Purpose The aim of this study was to compare the inter- and intraobserver variability of a new perpendicular method with the existing method in fractured and unfractured wrists. Additionally, the normal distribution of carpal alignment in unfractured wrists was investigated. Patients and Methods Carpal alignment was assessed on lateral plain radiographs using two different methods, one described by Ng and McQueen and another newly proposed method, the perpendicular method. Using the perpendicular method, the observer draws one line along the inner rim of the volar cortex of the radius and one perpendicular line to the center of the capitate. The carpus is aligned when the line along the inner rim transects the center of the capitate. Three examiners measured the carpal alignment in 50 patients with nonfractured and 50 patients with fractured distal radius. Intra- and interobserver variability for both methods were determined. Results The interobserver coefficient for the perpendicular method was 0.98 and that for the Ng method was 0.86. The intraobserver coefficients for three examiners were 0.89, 0.62, and 0.63, respectively, for the Ng method. For the perpendicular method, the intraobserver variability was 0.96, 0.89, and 0.72, respectively. In patients with unfractured wrists, the mean perpendicular to the center of the capitate was 0.25 mm dorsally. Conclusion The new proposed method is a reproducible method for measuring carpal alignment with a high inter- and intraclass coefficient. Clinical Relevance This method of measurement allows for a reproducible technique for measuring carpal alignment.

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.

Non- or Minimally Displaced Distal Radial Fractures in Adult Patients: Three Weeks versus Five Weeks of Cast Immobilization-A Randomized Controlled Trial.

Background Patients with non- or minimally displaced distal radial fractures, that do not need repositioning, are mostly treated by a short-arm cast for a period of 4 to 6 weeks. A shorter period of immobilization may lead to a better functional outcome. Purpose We conducted a randomized controlled trial to evaluate whether the duration of cast immobilization for patients with non- or minimally displaced distal radial fractures can be safely shortened toward 3 weeks. Materials and Methods The primary outcomes were patient-reported outcomes measured by the Patient-Related Wrist Evaluation (PRWE) and Quick Disability of Arm, Shoulder and Hand (QuickDASH) score after 1-year follow-up. Secondary outcome measures were: PRWE and QuickDASH earlier in follow-up, pain (Visual Analog Scale), and complications like secondary displacement. Results Seventy-two patients (male/female, 23/49; median age, 55 years) were included and randomized. Sixty-five patients completed the 1-year follow-up. After 1-year follow up, patients in the 3 weeks immobilization group had significantly better PRWE (5.0 vs. 8.8 points, p = 0.045) and QuickDASH scores (0.0 vs. 12.5, p = 0.026). Secondary displacement occurred once in each group. Pain did not differ between groups ( p = 0.46). Conclusion Shortening the period of immobilization in adult patients with a non- or minimally displaced distal radial fractures seems to lead to equal patient-reported outcomes for both the cast immobilization groups. Also, there are no negative side effects of a shorter period of cast immobilization. Therefore, we recommend a period of 3 weeks of immobilization in patients with distal radial fractures that do not need repositioning.

Towards patient-specific management of trauma hemorrhage: the effect of resuscitation therapy on parameters of thromboelastometry.

Essentials The response of thromboelastometry (ROTEM) parameters to therapy is unknown. We prospectively recruited hemorrhaging trauma patients in six level-1 trauma centres in Europe. Blood products and pro-coagulants prevent further derangement of ROTEM results. ROTEM algorithms can be used to treat and monitor trauma induced coagulopathy. SUMMARY: Background Rotational thromboelastometry (ROTEM) can detect trauma-induced coagulopathy (TIC) and is used in transfusion algorithms. The response of ROTEM to transfusion therapy is unknown. Objectives To determine the response of ROTEM profiles to therapy in bleeding trauma patients. Patients/Methods A prospective multicenter study in bleeding trauma patients (receiving ≥ 4 red blood cell [RBC] units) was performed. Blood was drawn in the emergency department, after administration of 4, 8 and 12 RBC units and 24 h post-injury. The response of ROTEM to plasma, platelets (PLTs), tranexamic acid (TXA) and fibrinogen products was evaluated in the whole cohort as well as in the subgroup of patients with ROTEM values indicative of TIC. Results Three hundred and nine bleeding and shocked patients were included. A mean dose of 3.8 g of fibrinogen increased FIBTEM CA5 by 5.2 mm (IQR: 4.1-6.3 mm). TXA administration decreased lysis by 5.4% (4.3-6.5%). PLT transfusion prevented further derangement of parameters of clot formation. The effect of PLTs on EXTEM ca5 values was more pronounced in patients with a ROTEM value indicative of TIC than in the whole cohort. Plasma transfusion decreased EXTEM clotting time by 3.1 s (- 10 s to 3.9 s) in the whole cohort and by 10.6 s (- 45 s to 24 s) in the subgroup of patients with a ROTEM value indicative of TIC. Conclusion The effects of therapy on ROTEM values were small, but prevented further derangement of test results. In patients with ROTEM values indicative of TIC, the efficacy of PLTs and plasma in correcting deranged ROTEM parameters is possibly more robust.