Background The Dynamic Locking Blade Plate (DLBP) was recently introduced for fixation of displaced femoral neck fractures (FNF) and has been well received. Although the results of this implant in... Show moreBackground The Dynamic Locking Blade Plate (DLBP) was recently introduced for fixation of displaced femoral neck fractures (FNF) and has been well received. Although the results of this implant in young patients are promising, the DLBP has not yet been compared to a standard device such as the Dynamic Hip Screw (DHS). The aim of this study is to compare the clinical outcome and costs of displaced FNF treated with internal fixation by means of either the DLBP or the DHS in patients up to 65 years of age. We hypothesize that the DLBP is superior compared to the DHS in terms of revision surgery rate, union rate, incidence of avascular necrosis and implant related failure. Methods The DEFENDD (DisplacEd Femoral Neck fractures Dlbp versus Dhs) trial is a multicentre randomized controlled trial that will include 266 patients of 18-65 years with a displaced FNF. Patients will be randomized to receive either a DLBP or a DHS with a 1:1 allocation using a random block size, stratified for centre. Clinical follow up will last 1 year and questionnaires will be obtained up to 2 years. The main outcome parameter is the incidence of revision surgery within 1 year, due to either non-union, avascular necrosis (AVN) or cut out of the implant. Secondary study parameters are the incidence of avascular necrosis, non-union, (implant related) complications, functional outcome, elective removal of the implant and health-related quality of life and costs. Discussion The outcome of the DEFENDD trial will provide high-level evidence of which implant is favourable for the treatment of femoral neck fractures in young patients (<= 65 years). Show less
Kalsbeek, J.H.; Walsum, A.D.P. van; Roerdink, W.H.; Vugt, A.B. van; Krol, H. van de; Schipper, I.B. 2020
Introduction: Posterior tilt of the femoral head in femoral neck fractures (FNF) may influence stability of the fracture and may therefore affect the treatment outcome. Posterior tilt can be... Show moreIntroduction: Posterior tilt of the femoral head in femoral neck fractures (FNF) may influence stability of the fracture and may therefore affect the treatment outcome. Posterior tilt can be measured with different methods. The Lateral Garden Angle (LGA) has been used for this purpose for decades and more recently the Posterior Tilt Measurement (PTM) was introduced. Despite the fact that both methods (LGA and PTM) are used in multiple studies, they have never been compared for reliability in a direct study. The aim of this study is to analyze the intra and inter observer reliability of the LGA described by Garden and the PTM according to Palm.Methods: Four observers measured the posterior tilt on the radiographs of 50 FNF two times with both methods. Intra and inter observer reliability were determined for the LGA and the PTM.Results: The intra observer reliability for both methods is substantial with an intra class coefficient of 0.75. The inter observer reliability of the PTM is also substantial with an intra class coefficient of 0.75 compared to a moderate reliability of the LGA with an intraclass coefficient of 0.60.Conclusion: Based on our results we believe the LGA and the PTM are both reliable methods to measure posterior tilt. Yet the Posterior Tilt Measurement seems to have a better inter observer reliability and therefore has a slight preference over the Lateral Garden Angle. (C) 2019 Elsevier Ltd. All rights reserved. Show less
Introduction The primary aim was to assess and compare the total costs (direct health care costs and indirect costs due to loss of production) after early mobilization versus plaster immobilization... Show moreIntroduction The primary aim was to assess and compare the total costs (direct health care costs and indirect costs due to loss of production) after early mobilization versus plaster immobilization in patients with a simple elbow dislocation. It was hypothesized that early mobilization would not lead to higher direct and indirect costs. Materials and methods This study used data of a multicenter randomized clinical trial (FuncSiE trial). From August 25, 2009 until September 18, 2012, 100 adult patients with a simple elbow dislocation were recruited and randomized to early mobilization (immediate motion exercises; n = 48) or 3 weeks plaster immobilization (n = 52). Patients completed questionnaires on health-related quality of life [EuroQoL-5D (EQ-5D) and Short Form-36 (SF-36 PCS and SF-36 MCS)], health care use, and work absence. Follow-up was 1 year. Primary outcome were the total costs at 1 year. Analysis was by intention to treat. Results There were no significant differences in EQ-5D, SF-36 PCS, and SF-36 MCS between the two groups. Mean total costs per patient were euro3624 in the early mobilization group versus euro7072 in the plaster group (p = 0.094). Shorter work absenteeism in the early mobilization group (10 versus 18 days; p = 0.027) did not lead to significantly lower costs for loss of productivity (euro1719 in the early mobilization group versus euro4589; p = 0.120). Conclusion From a clinical and a socio-economic point of view, early mobilization should be the treatment of choice for a simple elbow dislocation. Plaster immobilization has inferior results at almost double the cost. Show less
Haan, J. de; Hartog, D. den; Tuinebreijer, W.E.; Iordens, G.I.T.; Breederveld, R.S.; Bronkhorst, M.W.G.A.; ... ; Schep, N.W.L. 2010
Background: Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures.... Show moreBackground: Elbow dislocations can be classified as simple or complex. Simple dislocations are characterized by the absence of fractures, while complex dislocations are associated with fractures. After reduction of a simple dislocation, treatment options include immobilization in a static plaster for different periods of time or so-called functional treatment. Functional treatment is characterized by early active motion within the limits of pain with or without the use of a sling or hinged brace. Theoretically, functional treatment should prevent stiffness without introducing increased joint instability. The primary aim of this randomized controlled trial is to compare early functional treatment versus plaster immobilization following simple dislocations of the elbow. Methods/Design: The design of the study will be a multicenter randomized controlled trial of 100 patients who have sustained a simple elbow dislocation. After reduction of the dislocation, patients are randomized between a pressure bandage for 5-7 days and early functional treatment or a plaster in 90 degrees flexion, neutral position for prosupination for a period of three weeks. In the functional group, treatment is started with early active motion within the limits of pain. Function, pain, and radiographic recovery will be evaluated at regular intervals over the subsequent 12 months. The primary outcome measure is the Quick Disabilities of the Arm, Shoulder, and Hand score. The secondary outcome measures are the Mayo Elbow Performance Index, Oxford elbow score, pain level at both sides, range of motion of the elbow joint at both sides, rate of secondary interventions and complication rates in both groups (secondary dislocation, instability, relaxation), health-related quality of life (Short-Form 36 and EuroQol-5D), radiographic appearance of the elbow joint (degenerative changes and heterotopic ossifications), costs, and cost-effectiveness. Discussion: The successful completion of this trial will provide evidence on the effectiveness of a functional treatment for the management of simple elbow dislocations. Show less
