Bernard G. Francq

Surgical inaccuracy of tumor resection and reconstruction within the pelvis: an experimental study.

Background and purpose Osseous pelvic tumors can be resected and reconstructed using massive bone allografts. Geometric accuracy of the conventional surgical procedure has not yet been documented. The aim of this experimental study was mainly to assess accuracy of tumoral resection with a 10-mm surgical margin, and also to evaluate the geometry of the host-graft reconstruction. Methods An experimental model on plastic pelvises was designed to simulate tumor resection and reconstruction. 4 experienced surgeons were asked to resect 3 different tumors and to reconstruct pelvises. 24 resections and host-graft junctions were available for evaluation. Resection margins were measured. Several methods were created to evaluate geometric properties of the host-graft junction. Results The probability of a surgeon obtaining a 10-mm surgical margin with a 5-mm tolerance above or below, was 52% (95% CI: 37–67). Maximal gap, gap volume, and mean gap between host and graft was 3.3 (SD 1.9) mm, 2.7 (SD 2.1) cm3 and 3.2 (SD 2.1) mm, respectively. Correlation between these 3 reconstruction measures and the degree of contact at the host-graft junction was poor. Interpretation 4 experienced surgeons did not manage to consistently respect a fixed surgical margin under ideal working conditions. The complex 3-dimensional architecture of the pelvis would mainly explain this inaccuracy. Solutions to this might be to increase the surgical margin or to use computer- and robotic-assisted technologies in pelvic tumor resection. Furthermore, our attempt to evaluate geometry of the pelvic reconstruction using simple parameters was not satisfactory. We believe that there is a need to define new standards of evaluation.

Computer-assisted planning and navigation improves cutting accuracy during simulated bone tumor surgery of the pelvis

Background: Resection of bone tumors within the pelvis requires good cutting accuracy to achieve satisfactory safe margins. Manually controlled bone cutting can result in serious errors, especially due to the complex three-dimensional geometry, limited visibility, and restricted working space of the pelvic bone. This experimental study investigated cutting accuracy during navigated and non-navigated simulated bone tumor cutting in the pelvis. Methods: A periacetabular tumor resection was simulated using a pelvic bone model. Twenty-three operators (10 senior and 13 junior surgeons) were asked to perform the tumor cutting, initially according to a freehand procedure and later with the aid of a navigation system. Before cutting, each operator used preoperative planning software to define four target planes around the tumor with a 10-mm desired safe margin. After cutting, the location and flatness of the cut planes were measured, as well as the achieved surgical margins and the time required for each cutting procedure. Results: The location of the cut planes with respect to the target planes was significantly improved by using the navigated cutting procedure, averaging 2.8 mm as compared to 11.2 mm for the freehand cutting procedure (p < 0.001). There was no intralesional tumor cutting when using the navigation system. The maximum difference between the achieved margins and the 10-mm desired safe margin was 6.5 mm with the navigated cutting process (compared to 13 mm with the freehand cutting process). Conclusions: Cutting accuracy during simulated bone cuts of the pelvis can be significantly improved by using a freehand process assisted by a navigation system. When fully validated with complementary in vivo studies, the planning and navigation-guided technologies that have been developed for the present study may improve bone cutting accuracy during pelvic tumor resection by providing clinically acceptable margins.

Natural progression of blood-induced joint damage in patients with haemophilia: clinical relevance and reproducibility of three-dimensional gait analysis.

Summary.  A major complication in haemophilia is the destruction of joint cartilage because of recurrent intraarticular and intramuscular bleeds. Therefore, joint assessment is critical to quantify the extent of joint damage, which has traditionally been evaluated using both radiological and clinical joint scores. Our study aimed to evaluate the natural progression of haemophilic arthopathy using three‐dimensional gait analysis (3DGA) and to assess the reproducibility of this technique. We hypothesized that the musculoskeletal function was relatively stable in patients with haemophilia. Eighteen adults with established haemophilic arthropathies were evaluated twice by 3DGA (mean follow‐up: 18 ± 5 weeks). Unexpectedly, our findings revealed infraclinical deterioration of gait pattern, characterized by a 3.2% decrease in the recovery index, which is indicative of the subject’s ability to save energy while walking. A tendency towards modification of segmental joint function was also observed. Gait analysis was sufficiently reproducible with regards to spatiotemporal parameters as well as kinetic, mechanical and energetic gait variables. The kinematic variables were reproducible in both the sagittal and frontal planes. In conclusion, 3DGA is a reproducible tool to assess abnormal gait patterns and monitor natural disease progression in haemophilic patients.

Efficacy and safety of ivabradine in patients with chronic systolic heart failure and diabetes: an analysis from the SHIFT trial

To evaluate clinical profiles and outcomes in patients with systolic heart failure (HF) with or without diabetes, and the efficacy and safety of ivabradine (heart rate‐lowering agent) with respect to diabetic status.

Diagnostic accuracy of the Thessaly test, standardised clinical history and other clinical examination tests (Apley’s, McMurray’s and joint line tenderness) for meniscal tears in comparison with magnetic resonance imaging diagnosis

BACKGROUND Reliable non-invasive diagnosis of meniscal tears is difficult. Magnetic resonance imaging (MRI) is often used but is expensive and incidental findings are problematic. There are a number of physical examination tests for the diagnosis of meniscal tears that are simple, cheap and non-invasive. OBJECTIVES To determine the diagnostic accuracy of the Thessaly test and to determine if the Thessaly test (alone or in combination with other physical tests) can obviate the need for further investigation by MRI or arthroscopy for patients with a suspected meniscal tear. DESIGN Single-centre prospective diagnostic accuracy study. SETTING Although the study was performed in a secondary care setting, it was designed to replicate the results that would have been achieved in a primary care setting. PARTICIPANTS Two cohorts of patients were recruited: patients with knee pathology (n = 292) and a control cohort with no knee pathology (n = 75). MAIN OUTCOME MEASURES Sensitivity, specificity and diagnostic accuracy of the Thessaly test in determining the presence of meniscal tears. METHODS Participants were assessed by both a primary care clinician and a musculoskeletal clinician. Both clinicians performed the Thessaly test, McMurrays test, Apleys test, joint line tenderness test and took a standardised clinical history from the patient. RESULTS The Thessaly test had a sensitivity of 0.66, a specificity of 0.39 and a diagnostic accuracy of 54% when utilised by primary care clinicians. This compared with a sensitivity of 0.62, a specificity of 0.55 and diagnostic accuracy of 59% when used by musculoskeletal clinicians. The diagnostics accuracy of the other tests when used by primary care clinicians was 54% for McMurrays test, 53% for Apleys test, 54% for the joint line tenderness test and 55% for clinical history. For primary care clinicians, age and past history of osteoarthritis were both significant predictors of MRI diagnosis of meniscal tears. For musculoskeletal clinicians age and a positive diagnosis of meniscal tears on clinical history taking were significant predictors of MRI diagnosis. No physical tests were significant predictors of MRI diagnosis in our multivariate models. The specificity of MRI diagnosis was tested in subgroup of patients who went on to have a knee arthroscopy and was found to be low [0.53 (95% confidence interval 0.28 to 0.77)], although the sensitivity was 1.0. CONCLUSIONS The Thessaly test was no better at diagnosing meniscal tears than other established physical tests. The sensitivity, specificity and diagnostic accuracy of all physical tests was too low to be of routine clinical value as an alternative to MRI. Caution needs to be exercised in the indiscriminate use of MRI scanning in the identification of meniscal tears in the diagnosis of the painful knee, due to the low specificity seen in the presence of concomitant knee pathology. Further research is required to determine the true diagnostic accuracy and cost-effectiveness of MRI for the detection of meniscal tears. TRIAL REGISTRATION Current Controlled Trial ISRCTN43527822. FUNDING The National Institute for Health Research Health Technology Assessment programme.

A Randomized, Single-Blind, Crossover Trial of Recovery Time in High-Flux Hemodialysis and Hemodiafiltration

Background The choice between hemodiafiltration (HDF) or high-flux hemodialysis (HD) to treat end-stage kidney disease remains a matter of debate. The duration of recovery time after treatment has been associated with mortality, affects quality of life, and may therefore be important in informing patient choice. We aimed to establish whether recovery time is influenced by treatment with HDF or HD. Study Design Randomized patient-blinded crossover trial. Settings & Participants 100 patients with end-stage kidney disease were enrolled from 2 satellite dialysis units in Glasgow, United Kingdom. Intervention 8 weeks of HD followed by 8 weeks of online postdilution HDF or vice versa. Outcomes Posttreatment recovery time, symptomatic hypotension events, dialysis circuit clotting events, and biochemical parameters. Measurements Patient-reported recovery time in minutes, incidence of adverse events during treatments, hematology and biochemistry results, quality-of-life questionnaire. Results There was no overall difference in recovery time between treatments (medians for HDF vs HD of 47.5 [IQR, 0-240] vs 30 [IQR, 0-210] minutes, respectively; P = 0.9). During HDF treatment, there were significant increases in rates of symptomatic hypotension (8.0% in HDF vs 5.3% in HD; relative risk [RR], 1.52; 95% CI, 1.2-1.9; P < 0.001) and intradialytic tendency to clotting (1.8% in HDF vs 0.7% in HD; RR, 2.7; 95% CI, 1.5-5.0; P = 0.002). Serum albumin level was significantly lower during HDF (3.2 vs 3.3 g/dL; P < 0.001). Health-related quality-of-life scores were equivalent. Limitations Single center; mean achieved HDF convection volume, 20.6 L. Conclusions Patients blinded to whether they were receiving HD or HDF in a randomized controlled crossover study reported similar posttreatment recovery times and health-related quality-of-life scores.

How to regress and predict in a Bland–Altman plot? Review and contribution based on tolerance intervals and correlated-errors-in-variables models

Two main methodologies for assessing equivalence in method-comparison studies are presented separately in the literature. The first one is the well-known and widely applied Bland-Altman approach with its agreement intervals, where two methods are considered interchangeable if their differences are not clinically significant. The second approach is based on errors-in-variables regression in a classical (X,Y) plot and focuses on confidence intervals, whereby two methods are considered equivalent when providing similar measures notwithstanding the random measurement errors. This paper reconciles these two methodologies and shows their similarities and differences using both real data and simulations. A new consistent correlated-errors-in-variables regression is introduced as the errors are shown to be correlated in the Bland-Altman plot. Indeed, the coverage probabilities collapse and the biases soar when this correlation is ignored. Novel tolerance intervals are compared with agreement intervals with or without replicated data, and novel predictive intervals are introduced to predict a single measure in an (X,Y) plot or in a Bland-Atman plot with excellent coverage probabilities. We conclude that the (correlated)-errors-in-variables regressions should not be avoided in method comparison studies, although the Bland-Altman approach is usually applied to avert their complexity. We argue that tolerance or predictive intervals are better alternatives than agreement intervals, and we provide guidelines for practitioners regarding method comparison studies. Copyright

Accuracy of a new intraoperative cone beam CT imaging technique (Artis zeego II) compared to postoperative CT scan for assessment of pedicle screws placement and breaches detection

PurposeThe goal of this study was to compare the accuracy of a novel intraoperative cone beam computed tomography (CBCT) imaging technique with that of conventional computed tomography (CT) scans for assessment of pedicle screw placement and breach detection.MethodsThree hundred and forty-eight pedicle screws were inserted in 58 patients between October 2013 and March 2016. All patients had an intraoperative CBCT scan and a conventional CT scan to verify the placement of the screws. The CBCT and CT images were reviewed by two surgeons to assess the accuracy of screw placement and detect pedicle breaches using two established classification systems. Agreement on screw placement between intraoperative CBCT and postoperative CT was assessed using Kappa and Gwet’s coefficients. Using CT scanning as the gold standard, the sensitivity, specificity, positive predictive value, and negative predictive value were calculated to determine the ability of CBCT imaging to accurately evaluate screw placement.ResultsThe Kappa coefficient was 0.78 using the Gertzbein classification and 0.80 using the Heary classification, indicating a substantial agreement between the intraoperative CBCT and postoperative CT images. Gwet’s coefficient was 0.94 for both classifications, indicating almost perfect agreement. The sensitivity, specificity, positive predictive value and negative predictive value of the CBCT images were 77, 98, 86, and 96%, respectively, for the Gertzbein classification and 79, 98, 88, and 96%, respectively, for the Heary classification.ConclusionsIntraoperative CBCT provides accurate assessment of pedicle screw placement and enables intraoperative repositioning of misplaced screws. This technique may make postoperative CT imaging unnecessary.

Delta method and bootstrap in linear mixed models to estimate a proportion when no event is observed: application to intralesional resection in bone tumor surgery

Resecting bone tumors requires good cutting accuracy to reduce the occurrence of local recurrence. This issue is considerably reduced with a navigated technology. The estimation of extreme proportions is challenging especially with small or moderate sample sizes. When no success is observed, the commonly used binomial proportion confidence interval is not suitable while the rule of three provides a simple solution. Unfortunately, these approaches are unable to differentiate between different unobserved events. Different delta methods and bootstrap procedures are compared in univariate and linear mixed models with simulations and real data by assuming the normality. The delta method on the z-score and parametric bootstrap provide similar results but the delta method requires the estimation of the covariance matrix of the estimates. In mixed models, the observed Fisher information matrix with unbounded variance components should be preferred. The parametric bootstrap, easier to apply, outperforms the delta method for larger sample sizes but it may be time costly. Copyright

Pedicle screw insertion accuracy in terms of breach and reposition using a new intraoperative cone beam computed tomography imaging technique and evaluation of the factors associated with these parameters of accuracy: a series of 695 screws

PurposeThe goals of this study were to assess the accuracy of pedicle screw insertion using an intraoperative cone beam computed tomography (CBCT) system, and to analyze the factors potentially influencing this accuracy.MethodsSix hundred and ninety-five pedicle screws were inserted in 118 patients between October 2013 and March 2016. Screw insertion was performed using 2D-fluoroscopy or CBCT-based navigation. Accuracy was assessed in terms of breach and reposition. All the intraoperative CBCT scans, done after screw insertion, were reviewed to assess the accuracy of screw placement using two established classification systems: Gertzbein and Heary. Generalized linear mixed models were used to model the odds (95% CI) for a screw to lead to a breach according to the independent variables.ResultsThe breach rate was 11.7% using the Gertzbein classification and 15.4% using the Heary classification. Seventeen screws (2.4%) were repositioned intraoperatively. The only factor affecting statistically the odds to have a breach was the indication of surgery. The patients with non-degenerative disease had a significantly higher risk of breach than those with degenerative disease.ConclusionUse of intraoperative CBCT as 2D-fluoroscopy or coupled with a navigation system for pedicle screw insertion is accurate in terms of breach occurrence and reposition. However, these rates depend on the classification or grading system used. Use of a navigation system does not decrease the risk of breach significantly. And the risk of breach is higher in non-degenerative conditions (trauma, scoliosis, infection, and malignancy disease) than in degenerative diseases.