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.

Detecting Changes in Tissue Perfusion With Hyperspectral Imaging and Thermal Imaging Following Endovascular Treatment for Peripheral Arterial Disease.

PURPOSE: Hyperspectral imaging (HSI) and thermal imaging allow contact-free tissue perfusion measurements and may help determine the effect of endovascular treatment (EVT) in patients with peripheral arterial disease. This study aimed to detect changes in perfusion with HSI and thermal imaging peri-procedurally and determine whether these changes can identify limbs that show clinical improvement after 6 weeks. METHODS: Patients with Rutherford class 2-6 scheduled for EVT were included prospectively. Hyperspectral imaging and thermal imaging were performed directly before and after EVT. Images were taken from the lateral side of the calves and plantar side of the feet. Concentrations of (de)oxyhemoglobin, oxygen saturation, and skin temperature were recorded. Angiographic results were determined on completion angiogram. Clinical improvement 6 weeks after EVT was defined as a decrease ≥ one Rutherford class. Peri-procedural changes in perfusion parameters were compared between limbs with and without good angiographic results or clinical improvement. To identify limbs with clinical improvement, receiver operating characteristic (ROC) curves were used to determine cutoff values for change in HSI. RESULTS: Included were 23 patients with 29 treated limbs. Change in HSI values and temperature was not significantly different between limbs with good and poor angiographic results. Change in peri-procedural deoxyhemoglobin, determined by HSI, at the calves and feet was significantly different between limbs with and without clinical improvement at 6 week follow-up (p=0.027 and p=0.017, respectively). The ROC curve for change in deoxyhemoglobin at the calves showed a cutoff value of ≤1.0, and ≤-0.5 at the feet, which were discriminative for clinical improvement (sensitivity 77%; specificity 75% and sensitivity 62%; specificity 88%, respectively). CONCLUSIONS: HSI can detect changes in perfusion at the calves after EVT in patients with Rutherford class 2-6. Peri-procedural deoxyhemoglobin changes at the calves and feet are significantly different between limbs with and without clinical improvement. Decrease in deoxyhemoglobin directly after EVT may identify limbs that show clinical improvement 6 weeks after EVT.

Differences in shuntflow (Qa), cardiac function and mortality between hemodialysis patients with a lower-arm fistula, an upper-arm fistula, and an arteriovenous graft.

BACKGROUND: High-flow vascular accesses may contribute to cardiovascular morbidity and mortality in hemodialysis patients. Since shuntflow (Qa) varies between vascular access types, the current study aims to investigate differences in left ventricular hypertrophy (LVH), systolic and diastolic function parameters, and all-cause mortality between patients with a lower-arm arteriovenous fistula (AVF), an upper-arm AVF, and an arteriovenous graft (AVG). METHODS: A post hoc analysis of 100 patients was performed in a single-center, prospective observational study. Echocardiography examinations were performed prior to the dialysis session. Qa measurements were performed using ultrasound dilution. Patient groups were categorized by vascular access type. Cox proportional hazards models were used to investigate the association of shunt type with all-cause mortality with adjustment for potential confounders including, amongst others, age, sex, diabetes, the duration of hemodialysis treatment, shunt vintage, and Qa. RESULTS: Patients with an upper-arm AVF had significantly (p < 0.001) higher Qa (median 1902, IQR 1223-2508 ml/min) compared to patients with a lower-arm AVF (median 891, IQR 696-1414 ml/min) and patients with an AVG (median 881, IQR 580-1157 ml/min). The proportion of patients with LVH and systolic and diastolic echocardiographic parameters did not differ significantly between groups. Survival analysis showed that an upper-arm AVF was associated with a significantly lower all-cause mortality (p = 0.04) compared to a lower-arm AVF. CONCLUSIONS: Patients with an upper-arm fistula had a higher Qa but similar systolic and diastolic cardiac function. Patients with an upper-arm fistula had a significantly lower risk of all-cause mortality compared with patients with a lower-arm fistula.

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.

Determination of Changes in Tissue Perfusion at Home with Hyperspectral and Thermal Imaging in the First Six Weeks after Endovascular Therapy in Patients with Peripheral Arterial Disease.

The aims of this study were to assess changes in tissue perfusion up to 6 weeks after endovascular therapy (EVT), in hospital and at home, and to determine differences in tissue perfusion between patients with and without clinical improvement or good angiographic result. This single-center prospective cohort study included patients undergoing EVT for Rutherford stages two to six. Hyperspectral and thermal imaging were performed at the dorsal and plantar sides of the foot. These measurements consisted of a baseline measurement pre-EVT, and six follow-up measurements obtained at 1 and 4 h and 6 weeks in hospital, and 1 day, 7 days, and 14 days at home. Clinical improvement was defined as a decrease of one or more Rutherford class or decrease in the wound surface area and a good angiographic result was accomplished when a Transatlantic Inter-Society Consensus for the Management of PAD II C or D lesion was treated and uninterrupted flow continued in at least one below-the-knee artery in continuation with the inframalleolar arteries. The study included 34 patients with 41 treated limbs. Deoxyhemoglobin values were lower 1 h post-EVT compared with baseline and increased over time up to 6 weeks post-EVT. Significant differences in deoxyhemoglobin levels at 7 and 14 days post-EVT were determined between patients with and without clinical or angiographic success. This prospective pilot study shows the feasibility of hyperspectral imaging and thermal imaging post-EVT at home, which may decrease the need for hospital visits.

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.

Comparing a non-removable total contact cast with a non-removable softcast in diabetic foot ulcers: A retrospective study of a prospective database.

OBJECTIVE: Diabetic foot ulcers (DFUs) are mostly cured by an off-loading cast. Healing ratios of a non-removable Total Contact Softcast (TCS) were compared to a conventional Total Contact Cast (TCC), the latter reporting negative effects on lifestyle and transportation. METHODS: Analysis of prospectively collected data for 2010-2017. Included were patients with a neuropathic DFU. Ischemic ulcers were excluded, as were Charcot arthropathy, non-plantar/non-forefoot ulcer location, and compliance issues. Patients with TCS were compared to TCC. Primary and secondary outcomes were healing ratio and healing time of DFU. RESULTS: 50 patients with 61 cast periods were included. Mean age was 63.7 ± 10.1 years. Overall successful ulcer healing was 71% (43/61). Except for depth of the DFUs, between-group patient characteristics were comparable; deeper DFUs were reported in the TCC group. This group reported 65% healed DFU (22/34), the TCS group 74% (20/27). Mean healing time was 8.4 weeks (95 %CI 5.9-10.8) for TCC and 5.5 weeks (95 %CI 4.2-6.9) for TCS (p = 0.052). Depth of the wound was a confounder. CONCLUSIONS: TCS had a similar DFU healing ratio and a potentially clinically relevant effect (HR 1.47, 95 %CI 0.64-3.38) on healing time (ns). Ulcer depth is important for time to ulcer healing. A randomized study is recommended.

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.

Laser Doppler Flowmetry Combined with Spectroscopy to Determine Peripheral Tissue Perfusion and Oxygen Saturation: A Pilot Study in Healthy Volunteers and Patients with Peripheral Arterial Disease.

BACKGROUND: In this study, we assessed the ability of the EPOS system (Perimed AB, Järfälla, Stockholm, Sweden) to detect differences in tissue perfusion between healthy volunteers and patients with peripheral arterial disease (PAD) with different severity of disease. METHODS: This single-center prospective pilot study included 10 healthy volunteers and 20 patients with PAD scheduled for endovascular therapy (EVT). EPOS measurements were performed at rest at 32 °C and 44 °C, followed by transcutaneous oxygen pressure (TcPo2) measurements. The measurements were performed on the dorsal and medial side of the foot, as well as the lateral side of the calf. EPOS parameters included hemoglobin oxygen saturation (HbSo2) and speed-resolved red blood cell (RBC) perfusion. RESULTS: HbSo2 at 44 °C was significantly different between the three groups for all measurement locations. The overall speed-resolved RBC perfusion at 44 °C was statistically significant between the groups on the dorsal and medial side of the foot but not on the calf. TcPo2 values were not significantly different between the three groups. CONCLUSIONS: This study demonstrates that the EPOS system can depict differences in tissue perfusion between healthy volunteers, patients with Fontaine class IIb PAD, and those with Fontaine class III or IV PAD but only after heating to 44 °C.

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.

Reliability assessment of hyperspectral imaging with the HyperView™ system for lower extremity superficial tissue oxygenation in young healthy volunteers.

PURPOSE: Hyperspectral imaging (HSI) is a noninvasive spectroscopy technique for determining superficial tissue oxygenation. The HyperView™ system is a hand-held camera that enables perfusion image acquisition. The evaluation of superficial tissue oxygenation is warranted in the evaluation of patients with peripheral arterial disease. The aim was to determine the reliability of repeated HSI measurements. METHODS: In this prospective cohort study, HSI was performed on 50 healthy volunteers with a mean age of 26.4 ± 2.5 years, at the lower extremity. Two independent observers performed HSI during two subsequent measurement sessions. Short term test-retest reliability and intra- and inter-observer reliability were determined, and generalizability and decision studies were performed. Transcutaneous oxygen pressure (TcPO2) measurements were also performed. RESULTS: The short term test-retest reliability was good for the HSI values determined at the lower extremity, ranging from 0.72 to 0.90. Intra- and inter-observer reliability determined at different days were poor to moderate for both HSI (0.24 to 0.71 and 0.30 to 0.58, respectively) and TcPO2 (0.54 and 0.56, and 0.51 and 0.31, respectively). Reliability can be increased to >0.75 by averaging two measurements on different days. CONCLUSION: This study showed good short term test-retest reliability for HSI measurements, however low intra- and inter-observer reliability was observed for tissue oxygenation measurements with both HSI and TcPO2 performed at separate days in young healthy volunteers. Reliability of HSI can be improved when determined as a mean of two measurements taken on different days.

Continuous monitoring of vital signs with the Everion biosensor on the surgical ward: a clinical validation study.

BACKGROUND: Wearable sensors enable continuous vital sign monitoring, although information about their performance on nursing wards is scarce. Vital signs measured by telemonitoring and nurse measurements on a surgical ward were compared to assess validity and reliability. METHODS: In a prospective observational study, surgical patients wore a wearable sensor (Everion, Biovotion AG, Zürich, Switzerland) that continuously measured heart rate (HR), respiratory rate (RR), oxygen saturation (SpO2), and temperature during their admittance on the ward. Validity was evaluated using repeated-measures correlation and reliability using Bland-Altman plots, mean difference, and 95% limits of agreement (LoA). RESULTS: Validity analyses of 19 patients (median age, 68; interquartile range, 62.5-72.5 years) showed a moderate relationship between telemonitoring and nurse measurements for HR (r = 0.53; 95% confidence interval, 0.44-0.61) and a poor relationship for RR, SpO2, and temperature. Reliability analyses showed that Everion measured HR close to nurse measurements (mean difference, 1 bpm; LoA, -16.7 to 18.7 bpm). Everion overestimated RR at higher values, whereas SpO2 and temperature were underestimated. CONCLUSIONS: A moderate relationship was determined between Everion and nurse measurements at a surgical ward in this study. Validity and reliability of telemonitoring should also be assessed with gold standard devices in future clinical trials.

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.