Clinical validation of the 'C-arm rotational view (CARV)': study protocol of a prospective randomised controlled trial.

INTRODUCTION: Rotational malalignment occurs in up to 30% of cases after intramedullary nailing of tibial shaft fractures. The aim of this study is to assess the clinical feasibility of a newly introduced standardised intraoperative fluoroscopy protocol coined 'C-arm rotational view (CARV)' in order to reduce the risk of rotational malalignment during intramedullary nailing of tibial shaft fractures. The CARV includes predefined fluoroscopy landmark views of the uninjured side to obtain correct alignment of the injured side with use of the rotation of the C-arm. METHODS AND ANALYSIS: This randomised controlled trial will be conducted in a level 1 trauma centre. Adult patients with an open or closed tibial fracture, eligible for intramedullary nailing, will be enrolled in the study. The interventional group will undergo intramedullary nailing guided by the CARV protocol to obtain accurate alignment. The control group is treated according to current clinical practice, in which alignment control of the tibia is based on clinical estimation of the treating surgeon. The primary endpoint is defined as the degree of rotation measured on low-dose postoperative CT scans. ETHICS AND DISSEMINATION: The study protocol will be performed in line with local ethical guidelines and the Declaration of Helsinki. The results of this trial will be disseminated in a peer-reviewed manuscript. Future patients are likely to benefit from this trial as it aims to provide a clinically feasible and easy-to-use standardised fluoroscopy protocol to reduce the risk for rotational malalignment during intramedullary nailing of tibial shaft fractures. TRIAL REGISTRATION NUMBER: NCT05459038.

Radiographic Predictors of Conversion to Total Knee Arthroplasty After Tibial Plateau Fracture Surgery: Results in a Large Multicenter Cohort.

BACKGROUND: Radiographic measurements of initial displacement of tibial plateau fractures and of postoperative reduction are used to determine treatment strategy and prognosis. We assessed the association between radiographic measurements and the risk of conversion to total knee arthroplasty (TKA) at the time of follow-up. METHODS: A total of 862 patients surgically treated for tibial plateau fractures between 2003 and 2018 were eligible for this multicenter cross-sectional study. Patients were approached for follow-up, and 477 (55%) responded. The initial gap and step-off were measured on the preoperative computed tomography (CT) scans of the responders. Condylar widening, residual incongruity, and coronal and sagittal alignment were measured on postoperative radiographs. Critical cutoff values for gap and step-off were determined using receiver operating characteristic curves. Postoperative reduction measurements were categorized as adequate or inadequate on the basis of cutoff values in international guidelines. Multivariable analysis was performed to assess the association between each radiographic measurement and conversion to TKA. RESULTS: Sixty-seven (14%) of the patients had conversion to TKA after a mean follow-up of 6.5 ± 4.1 years. Assessment of the preoperative CT scans revealed that a gap of >8.5 mm (hazard ratio [HR] = 2.6, p < 0.001) and step-off of >6.0 mm (HR = 3.0, p < 0.001) were independently associated with conversion to TKA. Assessment of the postoperative radiographs demonstrated that residual incongruity of 2 to 4 mm was not associated with increased risk of TKA compared with adequate fracture reduction of <2 mm (HR = 0.6, p = 0.176). Articular incongruity of >4 mm resulted in increased risk of TKA. Coronal (HR = 1.6, p = 0.05) and sagittal malalignment (HR = 3.7 p < 0.001) of the tibia were strongly associated with conversion to TKA. CONCLUSIONS: Substantial preoperative fracture displacement was a strong predictor of conversion to TKA. Postoperative gaps or step-offs of >4 mm as well as inadequate alignment of the tibia were strongly associated with an increased risk of TKA. LEVEL OF EVIDENCE: Therapeutic Level III . See Instructions for Authors for a complete description of levels of evidence.

Effectiveness and safety of catheter-directed thrombolysis in conjunction with percutaneous mechanical thrombectomy for acute iliofemoral deep vein thrombosis: A meta-analysis.

BACKGROUND: Patients with severe acute low iliofemoral deep vein thrombosis (DVT), such as phlegmasia cerulea dolens, benefit from catheter-directed thrombolysis (CDT). This meta-analysis investigated the effectiveness and safety of adjuvant percutaneous mechanical thrombectomy (PMT) during CDT compared with CDT alone in the treatment of acute iliofemoral DVT. METHODS: A meta-analysis was performed in accordance with the PRISMA guidelines. Medline, Embase, the Cochrane Library, China National Knowledge Internet, and Wanfang data were searched for studies on the management of acute iliofemoral DVT by means of CDT or CDT with adjuvant PMT. Randomized, controlled trials and nonrandomized studies were included. The primary outcomes were venous patency rate, major bleeding complications, and post-thrombotic syndrome occurrence within 2 years of the procedure. The secondary outcomes were thrombolytic time and volume, as well as the rates of thigh detumescence and iliac vein stenting. RESULTS: The meta-analysis included 20 eligible studies with a total of 1686 patients. The rates of venous patency (mean difference, 10.11; 95% confidence interval [CI], 5.59-14.62) and thigh detumescence (mean difference, 3.64; 95% CI, 1.10-6.18) of the adjuvant PMT group were higher than those of the CDT alone group. Compared with CDT alone, the adjuvant PMT group experienced fewer incidences of major bleeding complications (odds ratio, 0.45; 95% CI, 0.26-0.77) and occurrences of post-thrombotic syndrome within 2 years of the procedure (odds ratio, 0.55; 95% CI, 0.33-0.92). Furthermore, the duration of thrombolytic therapy was shorter, and the total dose of administered thrombolytics was lower with adjuvant PMT. CONCLUSIONS: Adjuvant PMT during CDT is associated with improved clinical outcomes and a lower incidence of major bleeding complications. The studies investigated were, however, single-center cohort studies, and future randomized controlled trials are needed to substantiate these findings.

3D assessment of initial fracture displacement of tibial plateau fractures is predictive for risk on conversion to total knee arthroplasty at long-term follow-up.

PURPOSE: Currently used classification systems and measurement methods are insufficient to assess fracture displacement. In this study, a novel 3D measure for fracture displacement is introduced and associated with risk on conversion to total knee arthroplasty (TKA). METHODS: A multicenter cross-sectional study was performed including 997 patients treated for a tibial plateau fracture between 2003 and 2018. All patients were contacted for follow-up and 534 (54%) responded. For all patients, the 3D gap area was determined in order to quantify the degree of initial fracture displacement. A cut-off value was determined using ROC curves. Multivariate analysis was performed to assess the association of 3D gap area with conversion to TKA. Subgroups with increasing levels of 3D gap area were identified, and Kaplan-Meier survival curves were plotted to assess survivorship of the knee free from conversion to TKA. RESULTS: A total of 58 (11%) patients underwent conversation to TKA. An initial 3D gap area ≥ 550 mm2 was independently associated with conversion to TKA (HR 8.4; p = 0.001). Four prognostic groups with different ranges of the 3D gap area were identified: excellent (0-150 mm2), good (151-550 mm2), moderate (551-1000 mm2), and poor (> 1000 mm2). Native knee survival at 10-years follow-up was 96%, 95%, 76%, and 59%, respectively, in the excellent, good, moderate, and poor group. CONCLUSION: A novel 3D measurement method was developed to quantify initial fracture displacement of tibial plateau fractures. 3D fracture assessment adds to current classification methods, identifies patients at risk for conversion to TKA at follow-up, and could be used for patient counselling about prognosis. LEVEL OF EVIDENCE: Prognostic Level III.

What are the long-term patient-reported and clinical outcomes after lateral clavicle fractures? A cross-sectional study of 619 patients.

BACKGROUND: Lateral clavicle fractures account for 17% of all clavicle fractures and large studies comparing nonoperative and operative treatment are lacking. Therefore, patients cannot be properly informed about different treatment options and prognosis. We assessed long-term patient-reported and clinical outcomes in patients with lateral clavicle fractures. METHODS: A multicenter cross-sectional study was performed in patients treated for lateral clavicle fractures between 2007 and 2016. Primary outcome included patient-reported outcome measures (PROMs) (DASH, EQ-5D, return to work, sports, cosmetics and satisfaction). Questionnaires were sent to 619 eligible patients, of which 353 (57%) responded after a mean follow-up of 7.4 ± 2.8 years. Secondary outcome included adverse events and secondary interventions. Outcomes after nonoperative vs. operative treatment (stratified by nondisplaced vs. displaced fractures) were compared using Student t tests and linear regression analysis. RESULTS: Nondisplaced lateral clavicle fractures were treated nonoperatively and resulted in excellent PROMs. Six patients (3%) developed a nonunion. For displaced lateral clavicle fractures, no differences were found between nonoperative and operative treatment with regard to DASH score (7.8 ± 12.5 vs 5.4 ± 8.6), EQ-5D (0.91 ± 0.13 vs 0.91 ± 0.09), pain (0.9 ± 1.7 vs. 0.8 ± 1.6), patient satisfaction (90.1 ± 25.5 vs. 86.3 ± 20.4), return to work (96.4% vs. 100%) and sports (61.4% vs. 62.3%). The absolute risk of nonunion in patients with a displaced fracture was higher after nonoperative than operative treatment (20.2% vs. 2.9%; p = 0.002), with six patients needing treatment to avoid one nonunion. CONCLUSIONS: Nondisplaced lateral clavicle fractures should be treated nonoperatively and result in good functional outcomes and high union rates. For displaced fractures, neither nonoperative nor operative treatment seems superior. Patients opting for nonoperative treatment should be informed that nonunion occurs in 20% of patients, but only half of these need additional operative treatment. Patients who opt for surgery should be told that nonunion occurs in only 3%; however, most patients (56%) will require secondary intervention for elective implant removal. Regardless of the type of treatment, no differences in functional outcome and PROMs should be expected at long-term follow-up.

Determining the Reliable Measurement Period for Preoperative Baseline Values With Telemonitoring Before Major Abdominal Surgery: Pilot Cohort Study.

BACKGROUND: Preoperative telemonitoring of vital signs, physical activity, and well-being might be able to optimize prehabilitation of the patient's physical and mental condition prior to surgery, support setting alarms during in-hospital monitoring, and allow personalization of the postoperative recovery process. OBJECTIVE: The primary aim of this study was to evaluate when and how long patients awaiting major abdominal surgery should be monitored to get reliable preoperative individual baseline values of heart rate (HR), daily step count, and patient-reported outcome measures (PROMs). The secondary aim was to describe the perioperative course of these measurements at home. METHODS: In this observational single-center cohort study, patients used a wearable sensor during waking hours and reported PROMs (pain, anxiety, fatigue, nausea) on a tablet twice a day. Intraclass correlation coefficients (ICCs) were used to evaluate the reliability of mean values on 2 specific preoperative days (the first day of telemonitoring and the day before hospital admission) and randomly selected preoperative periods compared to individual reference values. Mean values of HR, step count, and PROMs per day were visualized in a boxplot from 14 days before hospital admission until 30 days after surgery. RESULTS: A total of 16 patients were included in the data analyses. The ICCs of mean values on the first day of telemonitoring were 0.91 for HR, 0.71 for steps, and at least 0.86 for PROMs. The day before hospital admission showed reliability coefficients of 0.76 for HR, 0.71 for steps, and 0.92-0.99 for PROMs. ICC values of randomly selected measurement periods increased over the continuous period of time from 0.68 to 0.99 for HR and daily step counts. A lower bound of the 95% CI of at least 0.75 was determined after 3 days of measurements. The ICCs of randomly selected PROM measurements were 0.89-0.94. Visualization of mean values per day mainly showed variable preoperative daily step counts (median 2409, IQR 1735-4661 steps/day) and lower postoperative daily step counts (median 884, IQR 474-1605 steps/day). In addition, pain was visually reduced until 30 days after surgery at home. CONCLUSIONS: In this prospective pilot study, for patients awaiting major abdominal surgery, baseline values for HR and daily step count could be measured reliably by a wearable sensor worn for at least 3 consecutive days and PROMs during any preoperative day. No clear conclusions were drawn from the description of the perioperative course by showing mean values of HR, daily step count, and PROM values over time in the home situation.

Pre-operative Aortic Neck Characteristics and Post-operative Sealing Zone as Predictors of Type 1a Endoleak and Migration After Endovascular Aneurysm Repair: A Systematic Review and Meta-Analysis.

OBJECTIVE: Establishing the predictive value of neck characteristics and real achieved sealing zone is essential to foster risk stratified procedure selection and imaging surveillance. This systematic review provides an overview of pre-operative aortic neck characteristics and post-operative real achieved sealing zone and their respective risk of type 1a endoleak and migration after endovascular aneurysm repair (EVAR). METHODS: In agreement with PRISMA guidelines, MEDLINE, Embase, and Cochrane CENTRAL were searched. Data on neck characteristics, sealing zone, and EVAR outcome were extracted. Meta-analyses were performed to investigate the effect of neck diameter, angulation, and shape on type 1a endoleak (total, early ≤ 90 days, and late > 90 days) and migration in patients who underwent EVAR. A qualitative summary was also provided. RESULTS: Thirty-three studies were included. Patients with a larger neck diameter had an increased risk of total type 1a endoleak (nine studies: OR 3.32, 95% CI 2.38 - 4.63), early type 1a endoleak (six studies: OR 2.64, 95% CI 1.27 - 5.48), late type 1a endoleak (six studies: OR 3.26, 95% CI 2.12 - 5.03), and migration (seven studies: OR 2.88, 95% CI 1.32 - 6.26). An angulated neck increased the risk of total type 1a endoleak (seven studies: OR 4.27, 95% CI 1.55 - 11.78) and late type 1a endoleak (seven studies: OR 5.56, 95% CI 2.19 - 14.13). Neck shape was not associated with type 1a endoleak. Neck length and real achieved sealing zone on post-EVAR computed tomography were identified as risk factors for type 1a endoleak and migration through qualitative summary. CONCLUSION: There seems to be some consistent evidence that aortic neck diameter, angulation, and length are associated with the development of type 1a endoleak or migration. Real achieved sealing zone might be an important addition during follow up. However, a small number of studies, with serious limitations, could be included, and there was considerable variability in reporting patients and outcomes. A proposal for standardisation of aortic and EVAR data in future studies is provided.

Intraoperative fluoroscopic protocol to avoid rotational malalignment after nailing of tibia shaft fractures: introduction of the 'C-Arm Rotational View (CARV)'.

PURPOSE: Rotational malalignment (≥ 10°) is a frequent pitfall of intramedullary-nailing of tibial shaft fractures. This study aimed to develop an intraoperative fluoroscopy protocol, coined 'C-Arm Rotational View (CARV)', to significantly reduce the risk for rotational malalignment and to test its clinical feasibility. METHODS: A cadaver and clinical feasibility study was conducted to develop the CARV-technique, that included a standardized intraoperative fluoroscopy sequence of predefined landmarks on the uninjured and injured leg in which the rotation of the C-arm was used to verify for rotational alignment. A mid-shaft tibia fracture was simulated in a cadaver and an unlocked intramedullary-nail was inserted. Random degrees of rotational malalignment were applied using a hand-held goniometer via reference wires at the fracture site. Ten surgeons, blinded for the applied rotation, performed rotational corrections according to (1) current clinical practice after single-leg and dual-leg draping, and (2) according to the CARV-protocol. The primary outcome measure was the accuracy of the corrections relative to neutral tibial alignment. The CARV-protocol was tested in a small clinical cohort. RESULTS: In total, 180 rotational corrections were performed by 10 surgeons. Correction according to clinical practice using single-leg and dual-leg draping resulted in a median difference of, respectively, 10.0° (IQR 5.0°) and 10.0° (IQR 5.0°) relative to neutral alignment. Single-leg and dual-leg draping resulted in malalignment (≥10°) in, respectively, 67% and 58% of the corrections. Standardized correction using the CARV resulted in a median difference of 5.0° (IQR 5.0°) relative to neutral alignment, with only 12% categorized as malalignment (≥10°). The incidence of rotational malalignment after application of the CARV decreased from 67% and 58% to 12% (p = <0.001). Both consultants and residents successfully applied the CARV-protocol. Finally, three clinical patients with a tibial shaft fracture were treated according to the CARV-protocol, resulting all in acceptable alignment (<10°) based on postoperative CT-measurements. CONCLUSION: This study introduces an easy-to-use and clinically feasible standardized intraoperative fluoroscopy protocol coined 'C-arm rotational view (CARV)' to minimize the risk for rotational malalignment following intramedullary-nailing of tibial shaft fractures.

Functional Outcome After Nonoperative Management of Tibial Plateau Fractures in Skeletally Mature Patients: What Sizes of Gaps and Stepoffs Can be Accepted?

BACKGROUND: Gap and stepoff measurements provide information about fracture displacement and are used for clinical decision-making when choosing either operative or nonoperative management of tibial plateau fractures. However, there is no consensus about the maximum size of gaps and stepoffs on CT images and their relation to functional outcome in skeletally mature patients with tibial plateau fractures who were treated without surgery. Because this is important for patient counseling regarding treatment and prognosis, it is critical to identify the limits of gaps and stepoffs that are well tolerated. QUESTIONS/PURPOSES: (1) In patients treated nonoperatively for tibial plateau fractures, what is the association between initial fracture displacement, as measured by gaps and stepoffs at the articular surface on a CT image, and functional outcome? (2) What is the survivorship of the native joint, free from conversion to a total knee prosthesis, among patients with tibial plateau fractures who were treated without surgery? METHODS: A multicenter cross-sectional study was performed in all patients who were treated nonoperatively for a tibial plateau fracture between 2003 and 2018 in four trauma centers. All patients had a diagnostic CT scan, and a gap and/or stepoff more than 2 mm was an indication for recommending surgery. Some patients with gaps and/or stepoffs exceeding 2 mm might not have had surgery based on shared decision-making. Between 2003 and 2018, 530 patients were treated nonoperatively for tibial plateau fractures, of which 45 had died at follow-up, 30 were younger than 18 years at the time of injury, and 10 had isolated tibial eminence avulsions, leaving 445 patients for follow-up analysis. All patients were asked to complete the validated Knee Injury and Osteoarthritis Outcome Score (KOOS) questionnaire consisting of five subscales: symptoms, pain, activities of daily living (ADL), function in sports and recreation, and knee-related quality of life (QOL). The score for each subscale ranged from 0 to 100, with higher scores indicating better function. A total of 46% (203 of 445) of patients participated at a mean follow-up of 6 ± 3 years since injury. All knee radiographs and CT images were reassessed, fractures were classified, and gap and stepoff measurements were taken. Nonresponders did not differ much from responders in terms of age (53 ± 16 years versus 54 ± 20 years; p = 0.89), gender (70% [142 of 203] women versus 59% [142 of 242] women; p = 0.01), fracture classifications (Schatzker types and three-column concept), gaps (2.1 ± 1.3 mm versus 1.7 ± 1.6 mm; p = 0.02), and stepoffs (2.1 ± 2.2 mm versus 1.9 ± 1.7 mm; p = 0.13). In our study population, the mean gap was 2.1 ± 1.3 mm and stepoff was 2.1 ± 2.2 mm. The participating patients divided into groups with increasing fracture displacement based on gap and/or stepoff (< 2 mm, 2 to 4 mm, or > 4 mm), as measured on CT images. ANOVA was used to assess whether an increase in the initial fracture displacement was associated with poorer functional outcome. We estimated the survivorship of the knee free from conversion to total knee prosthesis at a mean follow-up of 5 years using a Kaplan-Meier survivorship estimator. RESULTS: KOOS scores in patients with a less than 2 mm, 2 to 4 mm, or greater than 4 mm gap did not differ (symptoms: 83 versus 83 versus 82; p = 0.98, pain: 85 versus 83 versus 86; p = 0.69, ADL: 87 versus 84 versus 89; p = 0.44, sport: 65 versus 64 versus 66; p = 0.95, QOL: 70 versus 71 versus 74; p = 0.85). The KOOS scores in patients with a less than 2 mm, 2 to 4 mm, or greater than 4 mm stepoff did not differ (symptoms: 84 versus 83 versus 77; p = 0.32, pain: 85 versus 85 versus 81; p = 0.66, ADL: 86 versus 87 versus 82; p = 0.54, sport: 65 versus 68 versus 56; p = 0.43, QOL: 71 versus 73 versus 61; p = 0.19). Survivorship of the knee free from conversion to total knee prosthesis at mean follow-up of 5 years was 97% (95% CI 94% to 99%). CONCLUSION: Patients with minimally displaced tibial plateau fractures who opt for nonoperative fracture treatment should be told that fracture gaps or stepoffs up to 4 mm, as measured on CT images, could result in good functional outcome. Therefore, the arbitrary 2-mm limit of gaps and stepoffs for tibial plateau fractures could be revisited. The survivorship of the native knee free from conversion to a total knee prosthesis was high. Large prospective cohort studies with high response rates are needed to learn more about the relationship between the degree of fracture displacement and functional recovery after tibial plateau fractures. LEVEL OF EVIDENCE: Level III, prognostic study.

A clinical decision aid to discern patients without and with midfacial and mandibular fractures that require treatment (the REDUCTION-II study): a prospective multicentre cohort study.

PURPOSE: To assess the diagnostic accuracy of physical examination findings and to construct clinical decision aids to discern emergency department patients without and with midfacial and mandibular fractures that require treatment. METHODS: A prospective multicentre cohort study was conducted in four hospitals in the Netherlands. Consecutive maxillofacial trauma patients were included whereupon each patient underwent a standardized physical examination consisting of 15 and 14 findings for midfacial and mandibular trauma, respectively. The primary outcome was the decision whether to treat during the emergency department stay or within 24 h of admission. The diagnostic accuracy was calculated for the individual physical examination findings and ensuing clinical decision aids with the focus being on detecting midfacial and mandibular fractures that require active treatment. RESULTS: A total of 766 midfacial trauma patients were identified of whom 339 (44.3%) had midfacial fractures. Of those, 74 (21.8%) required active treatment. A total of 280 mandibular trauma patients were identified of whom 66 (23.6%) had mandibular fractures. Of those, 37 (56.0%) required active treatment. The decision aid for midfacial trauma consisting of facial depression, epistaxis, ocular movement limitation, palpable step-off, objective malocclusion and tooth mobility or avulsion had a sensitivity of 97.3 (90.7-99.3), a specificity of 38.6 (35.0-42.3), and a negative predictive value of 99.3 (97.3-99.8). The decision aid for mandibular trauma consisting of mouth opening limitation, jaw movement pain, objective malocclusion and tooth mobility or avulsion resulted in a sensitivity of 100.0 (90.6-100.0), a specificity of 39.1 (33.2-45.4), and a negative predictive value of 100.0 (96.1-100.0). CONCLUSION: The clinical decision aids successfully identified midfacial and mandibular trauma patients requiring active fracture treatment and so may be useful in preventing unnecessary radiological procedures in the future. TRIAL REGISTRATION: The study was registered at ClinicalTrials.gov with the identifier NCT03314480.

A Systematic Review and Critical Appraisal of Peri-Procedural Tissue Perfusion Techniques and their Clinical Value in Patients with Peripheral Arterial Disease.

OBJECTIVE: Many techniques have been introduced to enable quantification of tissue perfusion in patients with peripheral arterial disease (PAD). Currently, none of these techniques is widely used to analyse real time tissue perfusion changes during endovascular or surgical revascularisation procedures. The aim of this systematic review was to provide an up to date overview of the peri-procedural applicability of currently available techniques, diagnostic accuracy of assessing tissue perfusion and the relationship with clinical outcomes. DATA SOURCES: MEDLINE, Embase, CINAHL, and the Cochrane Central Register of Controlled Trials. REVIEW METHODS: This systematic review was conducted in accordance with the Preferred Reporting Items for Systematic review and Meta-Analysis (PRISMA) guidelines. Four electronic databases were searched up to 31 12 2020 for eligible articles: MEDLINE, Embase, CINAHL and the Cochrane Central Register of Controlled Trials. Eligible articles describing a perfusion measurement technique, used in a peri-procedural setting before and within 24 hours after the revascularisation procedure, with the aim of determining the effect of intervention in patients with PAD, were assessed for inclusion. The QUADAS-2 tool was used to assess the risk of bias and applicability of the studies. RESULTS: An overview of 10 techniques found in 26 eligible articles focused on study protocols, research goals, and clinical outcomes is provided. Non-invasive techniques included laser speckle contrast imaging, micro-lightguide spectrophotometry, magnetic resonance imaging perfusion, near infrared spectroscopy, skin perfusion pressure, and plantar thermography. Invasive techniques included two dimensional perfusion angiography, contrast enhanced ultrasound, computed tomography perfusion imaging, and indocyanine green angiography. The results of the 26 eligible studies, which were mostly of poor quality according to QUADAS-2, were without exception, not sufficient to substantiate implementation in daily clinical practice. CONCLUSION: This systematic review provides an overview of 10 tissue perfusion assessment techniques for patients with PAD. It seems too early to appoint one of them as a reference standard. The scope of future research in this domain should therefore focus on clinical accuracy, reliability, and validation of the techniques.

Does 3D-Assisted Operative Treatment of Pelvic Ring Injuries Improve Patient Outcome?-A Systematic Review of the Literature.

Background: There has been an exponential growth in the use of advanced technologies for three-dimensional (3D) virtual pre- and intra-operative planning of pelvic ring injury surgery but potential benefits remain unclear. The purpose of this study was to evaluate differences in intra- and post-operative results between 3D and conventional (2D) surgery. Methods: A systematic review was performed including published studies between 1 January 2010 and 22 May 2020 on all available 3D techniques in pelvic ring injury surgery. Studies were assessed for their methodological quality according to the Modified McMaster Critical Review form. Differences in operation time, blood loss, fluoroscopy time, screw malposition rate, fracture reduction and functional outcome between 3D-assisted and conventional (2D) pelvic injury treatment were evaluated and a best-evidence synthesis was performed. Results: Eighteen studies fulfilled the inclusion criteria, evaluating a total of 988 patients. Overall quality was moderate. Regarding intra-operative results of 3D-assisted versus conventional surgery: The weighted mean operation time per screw was 43 min versus 52 min; for overall operation time 126 min versus 141 min; blood loss 275 ± 197 mL versus 549 ± 404 mL; fluoroscopy time 74 s versus 125 s and fluoroscopy frequency 29 ± 4 versus 63 ± 3. In terms of post-operative outcomes of 3D-assisted versus conventional surgery: weighted mean screw malposition rate was 8% versus 18%; quality of fracture reduction measured by the total excellent/good rate by Matta was 86% versus 82% and Majeed excellent/good rate 88% versus 83%. Conclusion: The 3D-assisted surgery technologies seem to have a positive effect on operation time, blood loss, fluoroscopy dose, time and frequency as well as accuracy of screw placement. No improvement in clinical outcome in terms of fracture reduction and functional outcome has been established so far. Due to a wide range of methodological quality and heterogeneity between the included studies, results should be interpreted with caution.

Clinical selection strategy for and evaluation of intra-operative brachytherapy in patients with locally advanced and recurrent rectal cancer.

BACKGROUND AND PURPOSE: A radical resection of locally advanced rectal cancer (LARC) or recurrent rectal cancer (RRC) can be challenging. In case of increased risk of an R1 resection, intra-operative brachytherapy (IOBT) can be applied. We evaluated the clinical selection strategy for IOBT. MATERIALS AND METHODS: Between February 2007 and May 2018, 132 LARC/RRC patients who were scheduled for surgery with IOBT standby, were evaluated. By intra-operative inspection of the resection margin and MR imaging, it was determined whether a resection was presumed to be radical. Frozen sections were taken on indication. In case of a suspected R1 resection, IOBT (1 × 10 Gy) was applied. Histopathologic evaluation, treatment and toxicity data were collected from medical records. RESULTS: Tumour was resected in 122 patients. IOBT was given in 42 patients of whom 54.8% (n = 23) had a histopathologically proven R1 resection. Of the 76 IOBT-omitted R0 resected patients, 17.1% (n = 13) had a histopathologically proven R1 resection. In 4 IOBT-omitted patients, a clinical R1/2 resection was seen. In total, correct clinical judgement occurred in 72.6% (n = 88) of patients. In LARC, 58.3% (n = 14) of patients were overtreated (R0, with IOBT) and 10.9% (n = 5) were undertreated (R1, without IOBT). In RRC, 26.5% (n = 9) of patients were undertreated. CONCLUSION: In total, correct clinical judgement occurred in 72.6% (n = 88). However, in 26.5% (n = 9) RRC patients, IOBT was unjustifiedly omitted. IOBT is accompanied by comparable and acceptable toxicity. Therefore, we recommend IOBT to all RRC patients at risk of an R1 resection as their salvage treatment.

Frailty leads to poor long-term survival in patients undergoing elective vascular surgery.

OBJECTIVE: Frailty has persistently been associated with unfavorable short-term outcomes after vascular surgery, including an increased complication risk, greater readmission rate, and greater short-term mortality. However, a knowledge gap remains concerning the association between preoperative frailty and long-term mortality. In the present study, we aimed to determine this association in elective vascular surgery patients. METHODS: The present study was a part of a large prospective cohort study initiated in 2010 in our tertiary referral teaching hospital to study frailty in elderly elective vascular surgery patients (Vascular Ageing Study). A total of 639 patients with a minimal follow-up of 5 years, who had been treated from 2010 to 2014, were included in the present study. The Groningen Frailty Indicator, a 15-item self-administered questionnaire, was used to determine the presence and degree of frailty. RESULTS: Of the 639 patients, 183 (28.6%) were considered frail preoperatively. For the frail patients, the actuarial survival after 1, 3, and 5 years was 81.4%, 66.7%, and 55.7%, respectively. For the nonfrail patients, the corresponding survival was 93.6%, 83.3%, and 75.2% (log-rank test, P < .001). Frail patients had a significantly greater risk of 5-year mortality (unadjusted hazard ratio, 2.09; 95% confidence interval, 1.572-2.771; P < .001). After adjusting for surgical- and patient-related risk factors, the hazard ratio was 1.68 (95% confidence interval, 1.231-2.286; P = .001). CONCLUSIONS: The results of our study have shown that preoperative frailty is associated with significantly increased long-term mortality after elective vascular surgery. Knowledge of a patient's preoperative frailty state could, therefore, be helpful in shared decision-making, because it provides more information about the procedural benefits and risks.

Is reduction of routine radiograph use in patients with distal radius fractures cost effective? Analysis of data from the multicentre, randomised controlled WARRIOR trial.

OBJECTIVE: To assess the cost effectiveness of a reduced imaging follow-up protocol of distal radius fractures compared with usual care. DESIGN: An economical evaluation conducted alongside a multicentre randomised controlled trial (RCT). SETTING: Four level-one trauma centres in the Netherlands. PARTICIPANTS: 341 patients participated (usual care (n=172), reduced imaging (n=169)). INTERVENTIONS: Patients were randomised to usual care (routine radiography at 1, 2, 6 and 12 weeks) or a reduced imaging strategy (radiographs at 6 and 12 weeks only for a clinical indication). OUTCOME MEASURES: Functional outcome was assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire and quality-adjusted life years (QALYs) using the EuroQol-5Dimensions-3 Levels (EQ-5D-3L). Costs were measured using self-reported questionnaires and medical records, and analysed from a societal perspective. Multiple imputation, seemingly unrelated regression analysis and bootstrapping were used to analyse the data. RESULTS: Clinical overall outcomes of both groups were comparable. The difference in DASH was -2.03 (95% CI -4.83 to 0.77) and the difference in QALYs was 0.025 (95% CI -0.01 to 0.06). Patients in the reduced imaging group received on average 3.3 radiographs (SD: 1.9) compared with 4.2 (SD: 1.9) in the usual care group. Costs for radiographic imaging were significantly lower in the reduced imaging group than in the usual care group (€-48 per patient, 95% CI -68 to -27). There was no difference in total costs between groups (€-401 per patient, 95% CI -2453 to 1251). The incremental cost-effectiveness ratio (ICER) for QALYs was -15 872; the ICER for the DASH was 198. The probability of reduced imaging being cost effective compared with usual care ranged from 0.8 to 0.9 at a willingness to pay of €20 000/QALY to €80 000/QALY. CONCLUSIONS: Implementing a reduced imaging strategy in the follow-up of distal radius fractures has a high probability of being cost effective for QALYs, without decreasing functional outcome. We, therefore, recommend imaging only when clinically indicated. TRIAL REGISTRATION NUMBER: The Netherlands trial register (NL4477).

Transitions in frailty state after kidney transplantation.

PURPOSE: Frailty is the body's failure to return to homeostasis after every day or acute stressful events, causing adverse outcomes. To study its dynamics in kidney transplant recipients (KTR), we determined whether the degree of frailty and its domains are affected by kidney transplantation (KT). METHODS: Between 2015 and 2017, 176 KTR were included. Frailty scores were measured using the Groningen Frailty Indicator (GFI), assessed preoperatively and during follow-up. Transitions in frailty state and changes in the individual domains were determined. RESULTS: Mean age (±SD) was 51.8 (± 14.1) years, and 63.1% of KTR were male. Thirty patients were considered frail (GFI ≥ 4) at baseline. After a mean follow-up of 22.8 ± 8.3 months, 34 non-frail patients (19.3%) became frail, 125 patients (71.0%) remained the same, and 17 frail patients (9.7%) became non-frail (GFI < 4). In the domain psychosocial functioning, 28.4% of the patients had an increase in GFI score after follow-up. Patients who scored a point in the domain cognition at baseline had a greater chance of becoming frail (OR 4.38, 95% CI 0.59-32.24). CONCLUSION: In conclusion, almost one-fifth of non-frail KTR transitioned to a frail state after their transplantation. These results could be used to predict the impact of KT on frailty course and help with implementing prehabilitation for patients at risk.

Transition in Frailty State Among Elderly Patients After Vascular Surgery.

BACKGROUND: Frailty in the vascular surgical ward is common and predicts poor surgical outcomes. The aim of this study was to analyze transitions in frailty state in elderly patients after vascular surgery and to evaluate influence of patient characteristics on this transition. METHODS: Between 2014 and 2018, 310 patients, ≥65 years and scheduled for elective vascular surgery, were included in this cohort study. Transition in frailty state between preoperative and follow-up measurement was determined using the Groningen Frailty Indicator (GFI), a validated tool to measure frailty in vascular surgery patients. Frailty is defined as a GFI score ≥4. Patient characteristics leading to a transition in frailty state were analyzed using multivariable Cox regression analysis. RESULTS: Mean age was 72.7 ± 5.2 years, and 74.5% were male. Mean follow-up time was 22.7 ± 9.5 months. At baseline measurement, 79 patients (25.5%) were considered frail. In total, 64 non-frail patients (20.6%) shifted to frail and 29 frail patients (9.4%) to non-frail. Frail patients with a high Charlson Comorbidity Index (HR = 0.329 (CI: 0.133-0.812), p = 0.016) and that underwent a major vascular intervention (HR = 0.365 (CI: 0.154-0.865), p = 0.022) had a significantly higher risk to remain frail after the intervention. CONCLUSIONS: The results of this study, showing that after vascular surgery almost 21% of the non-frail patients become frail, may lead to a more effective shared decision-making process when considering treatment options, by providing more insight in the postoperative frailty course of patients.

Reducing the negative appendectomy rate with the laparoscopic appendicitis score; a multicenter prospective cohort and validation study.

BACKGROUND: Approximately nine percent of all acute appendectomies are unintentionally performed on a normal appendix. Failure of treatment (negative appendectomy or missed appendicitis) is associated with higher morbidity and mortality when compared to appendectomy for uncomplicated appendicitis. The Laparoscopic APPendicitis (LAPP) score was developed in order to systematically evaluate the appendix for the presence of inflammation. This study aims to determine whether the LAPP score reduces the negative appendectomy rate without missing appendicitis. METHODS: From September 2013 through May 2016, 322 adult patients presenting with a clinical suspicion of acute appendicitis and an indication for diagnostic laparoscopy were included and analyzed in this multicenter prospective validation study. Depending on the LAPP score, the appendix was either removed (n = 300) or left in situ (n = 22). These patients were compared to a historical control group of 584 patients treated at the same hospitals. The appendix was examined by a pathologist and the negative appendectomy rate was calculated. RESULTS: The negative appendectomy rate was significantly lower when the LAPP score was used (4,7% vs. 8,4%; P = 0,034). None of the patients with a negative LAPP score, in which the appendix remained in situ, developed acute appendicitis within three months. There were no significant differences in operation time, complications, or readmissions. Using the LAPP score was associated with significantly higher rates of preoperative radiological imaging (98% vs. 70%; P < 0,001). After adjusting for covariables, including radiological imaging, use of the LAPP score led to fewer treatment failures when compared to not using the LAPP score (OR: 0,48, 95% C.I. 0,251 to 0,914; P = 0,025). CONCLUSION: The LAPP score is a safe and simple tool to reduce the negative appendectomy rate during laparoscopic surgery without missing cases of acute appendicitis.