A hinged external fixator for complex elbow dislocations: A multicenter prospective cohort study

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 of the radial head, olecranon, or coronoid process. The majority of patients with these complex dislocations are treated with open reduction and internal fixation (ORIF), or arthroplasty in case of a non-reconstructable radial head fracture. If the elbow joint remains unstable after fracture fixation, a hinged elbow fixator can be applied. The fixator provides stability to the elbow joint, and allows for early mobilization. The latter may be important for preventing stiffness of the joint. The aim of this study is to determine the effect of early mobilization with a hinged external elbow fixator on clinical outcome in patients with complex elbow dislocations with residual instability following fracture fixation. Methods/Design. The design of the study will be a multicenter prospective cohort study of 30 patients who have sustained a complex elbow dislocation and are treated with a hinged elbow fixator following fracture fixation because of residual instability. Early active motion exercises within the limits of pain will be started immediately after surgery under supervision of a physical therapist. Outcome will be evaluated at regular intervals over the subsequent 12 months. The primary outcome 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, radiographic healing of the fractures and formation of periarticular ossifications, rate of secondary interventions and complications, and health-related quality of life (Short-Form 36). Discussion. The outcome of this study will yield quantitative data on the functional outcome in patients with a complex elbow dislocation and who are treated with ORIF and additional stabilization with a hinged elbow fixator. Trial Registration. The trial is registered at the Netherlands Trial Register (NTR1996)

Functional treatment versus plaster for simple elbow dislocations (FuncSiE): a randomized trial

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. 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 pro-supination 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. Trial Registration. The trial is registered at the Netherlands Trial Register (NTR2025)

The economic burden of the postoperative management in surgically treated trauma patients with peri- and/or intra-articular fractures of the lower extremities:A prospective multicenter cohort study

OBJECTIVES: To estimate the economic burden expressed in costs and quality of life of the post-surgical treatment of peri‑ and/or intra-articular fractures in the lower extremity from a societal perspective. DESIGN: This is a quantitative study as it aims to find averages and generalize results to wider populations. The design is a cost-of-illness and quality of life study focusing on costs (in euros), Activities of Daily Living (ADL) and Quality of Life (Qol) in patients with peri‑ and/or intra-articular fractures of the lower extremities. SETTING: Surgically treated trauma patients with peri‑ and/or intra-articular fractures of the lower extremities during 26 weeks follow-up. Patients were included from 4 hospitals in the Netherlands. MAIN OUTCOME MEASURES: Costs, ADL and Quality Adjusted Life Years (QALY). METHODS: Cost of illness was estimated through a bottom-up method. The Dutch Eq-5D-5 L questionnaire was used to calculate utilities while Lower Extremity Functional Scale (LEFS) scores were used as a measure of ADL. Non-parametric bootstrapping was used to test for statistical differences in costs. Subgroup analyses were performed to determine the influence of work status and further sensitivity analyses were performed to test the robustness of the results. RESULTS: Total average societal costs were € 9836.96 over six months. Unexpectedly, total societal and healthcare costs were lower for patients with a paid job relative to patients without. Sensitivity analyses showed that our choice of a societal perspective and the EuroQol as our primary utility measurement tool had a significant effect on the outcomes. The ADL at baseline was respectively; 10.4 and at 26 weeks post-surgery treatment 49.5. The QoL was at baseline respectively; 0.3 and at 26 weeks post-surgery treatment 0.7. These findings are indicative of a significantly improved ADL and QoL (p ≤ 0.05) over time. CONCLUSIONS: This study reveal a substantial economic burden in monetary terms and effect on QoL of patients with peri‑ and/or intra-articular fractures of the lower extremities during 26 weeks follow-up. REGISTRATION: This study was registered in the Dutch Trial Register (NTR6077). Date of registration: 01-09-2016

Early mobilization versus plaster immobilization of simple elbow dislocations: a cost analysis of the FuncSiE multicenter randomized clinical trial

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 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 €3624 in the early mobilization group versus €7072 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 (€1719 in the early mobilization group versus €4589; 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

Publisher Correction: Economic evaluation of operative versus nonoperative treatment of a humeral shaft fracture: economic analyses alongside a multicenter prospective cohort study (HUMMER) (European Journal of Trauma and Emergency Surgery, (2022), 10.1007/s00068-022-02160-1)

In this article, the order that the authors appeared in the author list was incorrect. The correct order is: Saskia H. Van Bergen1 · Esther M. M. Van Lieshout1 · Kiran C. Mahabier1 · Alexandra J. L. M. Geraerds2 · Suzanne Polinder2 · Dennis Den Hartog1 · Michael H. J. Verhofstad1 · on behalf of the HUMMER Investigators