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.

Early mobilisation versus plaster immobilisation of simple elbow dislocations: results of the FuncSiE multicentre randomised clinical trial.

BACKGROUND/AIM: To compare outcome of early mobilisation and plaster immobilisation in patients with a simple elbow dislocation. We hypothesised that early mobilisation would result in earlier functional recovery. METHODS: From August 2009 to September 2012, 100 adult patients with a simple elbow dislocation were enrolled in this multicentre randomised controlled trial. Patients were randomised to early mobilisation (n=48) or 3 weeks plaster immobilisation (n=52). Primary outcome measure was the Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score. Secondary outcomes were the Oxford Elbow Score, Mayo Elbow Performance Index, pain, range of motion, complications and activity resumption. Patients were followed for 1 year. RESULTS: Quick-DASH scores at 1 year were 4.0 (95% CI 0.9 to 7.1) points in the early mobilisation group versus 4.2 (95% CI 1.2 to 7.2) in the plaster immobilisation group. At 6 weeks, early mobilised patients reported less disability (Quick-DASH 12 (95% CI 9 to 15) points vs 19 (95% CI 16 to 22); p<0.05) and had a larger arc of flexion and extension (121° (95% CI 115° to 127°) vs 102° (95% CI 96° to 108°); p<0.05). Patients returned to work sooner after early mobilisation (10 vs 18 days; p=0.020). Complications occurred in 12 patients; this was unrelated to treatment. No recurrent dislocations occurred. CONCLUSIONS: Early active mobilisation is a safe and effective treatment for simple elbow dislocations. Patients recovered faster and returned to work earlier without increasing the complication rate. No evidence was found supporting treatment benefit at 1 year. TRIAL REGISTRATION NUMBER: NTR 2025.

The reliability and reproducibility of the Hertel classification for comminuted proximal humeral fractures compared with the Neer classification.

INTRODUCTION: The Neer classification is the most commonly used fracture classification system for proximal humeral fractures. Inter- and intra-observer agreement is limited, especially for comminuted fractures. A possibly more straightforward and reliable classification system is the Hertel classification. The aim of this study was to compare the inter- and intra-observer variability of the Hertel with the Neer classification in comminuted proximal humeral fractures. MATERIALS AND METHODS: Four observers evaluated blinded radiographic images (X-rays, CT-scans, and CT-scans with 3D-reconstructions) of 60 patients. After at least two months classification was repeated. RESULTS: Inter-observer agreement on plain X-rays was fair for both Hertel (κ = 0.39; 95% CI 0.23-0.62) and Neer (κ = 0.29; 0.09-0.42). Inter-observer agreement on CT-scans was substantial (κ = 0.63; 0.56-0.72) for Hertel and moderate for Neer (κ = 0.51; 0.29-0.68). Inter-observer agreement on 3D-reconstructions was moderate for both Hertel (κ = 0.60; 0.53-0.72) and Neer (κ = 0.51; 0.39-0.58). Intra-observer agreement on plain X-rays was fair for both Hertel (κ = 0.38; 0.27-0.59) and Neer (κ = 0.40; 0.15-0.52). Intra-observer agreement on CT-scans was moderate for both Hertel (κ = 0.50; 0.38-0.66) and Neer (κ = 0.42; 0.35-0.52). Intra-observer agreement on 3D-reconstructions was moderate for Hertel (κ = 0.55; 0.45-0.64) and substantial for Neer (κ = 0.63; 0.48-0.79). CONCLUSIONS: The Hertel and Neer classifications showed a fair to substantial inter- and intra-observer agreement on the three diagnostic modalities used. Although inter-observer agreement was highest for Hertel classification on CT-scans, Neer classification had the highest intra-observer agreement on 3D-reconstructions. Data of this study do not confirm superiority of either classification system for the classification of comminuted proximal humeral fractures.

Good functional recovery of complex elbow dislocations treated with hinged external fixation: a multicenter prospective study.

BACKGROUND: After a complex dislocation, some elbows remain unstable after closed reduction or fracture treatment. Function after treatment with a hinged external fixator theoretically allows collateral ligaments to heal without surgical reconstruction. However, there is a lack of prospective studies that assess functional outcome, pain, and ROM. QUESTIONS/PURPOSES: We asked: (1) In complex elbow fracture-dislocations, does treatment with a hinged external fixator result in reduction of disability and pain, and in improvement in ROM, function, and quality of life? (2) Does delayed treatment (7 days or later) have a negative effect on ROM after 1 year? (3) What are the complications seen after external fixator treatment? METHODS: During a 2-year period, 11 centers recruited 27 patients 18 years or older who were included and evaluated at 2 and 6 weeks and at 3, 6, and 12 months after surgery as part of this prospective case series. During the study period, the participating centers agreed on general indications for use of the hinged external fixator, which included persistent instability after closed reduction alone or closed reduction combined with surgical treatment of associated fracture(s), when indicated. Functional outcome was evaluated using the Quick Disabilities of the Arm, Shoulder and Hand (QuickDASH; primary outcome) score, the Mayo Elbow Performance Index (MEPI), the Oxford Elbow Score, and the level of pain (VAS). ROM, adverse events, secondary interventions, and radiographs also were evaluated. A total of 26 of the 27 patients (96%) were available for followup at 1 year. RESULTS: All functional and pain scores improved. The median QuickDASH score decreased from 30 (25(th)-75(th) percentiles [P25-P75], 23-40) at 6 weeks to 7 (P25-P75, 2-12) at 1 year with a median difference of -25 (p < 0.001). The median MEPI score increased from 80 (P25-P75, 64-85) at 6 weeks to 100 (P25-P75, 85-100) at 1 year with a median difference of 15 (p < 0.001). The median Oxford Elbow Score increased from 60 (P25-P75, 44-68) at 6 weeks to 90 (P25-P75, 73-96) at 1 year with a median difference of 29 (p < 0.001). The median VAS decreased from 2.8 (P25-P75, 1.0-5.0) at 2 weeks to 0.5 (P25-P75, 0.0-1.9) at 1 year with a median difference of -2.1 (p = 0.001). ROM also improved. The median flexion-extension arc improved from 50° (P25-P75, 33°-80°) at 2 weeks to 118° (P25-P75, 105°-138°) at 1 year with a median difference of 63° (p < 0.001). Similarly, the median pronation-supination arc improved from 90° (P25-P75, 63°-124°) to 160° (P25-P75, 138°-170°) with a median difference of 75° (p < 0.001). At 1 year, the median residual deficit compared with the uninjured side was 30° (P25-P75, 5°-35°) for the flexion-extension arc, and 3° (P25-P75, 0°-25°) for the pronation-supination arc. Ten patients (37%) experienced a fixator-related complication, and seven patients required secondary surgery (26%). One patient reported recurrent instability. CONCLUSIONS: A hinged external elbow fixator provides enough stability to start early mobilization after an acute complex elbow dislocation and residual instability. This was reflected in good functional outcome scores and only slight disability despite a relatively high complication rate.

Trends in incidence and costs of injuries to the shoulder, arm and wrist in The Netherlands between 1986 and 2008.

BACKGROUND: Upper extremity injuries account for a large proportion of attendances to the Emergency Department. The aim of this study was to assess population-based trends in the incidence of upper extremity injuries in the Dutch population between 1986 and 2008, and to give a detailed overview of the associated health care costs. METHODS: Age-standardized incidence rates of upper extremity injuries were calculated for each year between 1986 and 2008. The average number of people in each of the 5-year age classes for each year of the study was calculated and used as the standard (reference) population. Injury cases were extracted from the National Injury Surveillance System (non-hospitalized patients) and the National Medical Registration (hospitalized patients). An incidence-based cost model was applied in order to estimate associated direct health care costs in 2007. RESULTS: The overall age-adjusted incidence of upper extremity injuries increased from 970 to 1,098 per 100,000 persons (13%). The highest incidence was seen in young persons and elderly women. Total annual costs for all injuries were 290 million euro, of which 190 million euro were paid for injuries sustained by women. Wrist fractures were the most expensive injuries (83 million euro) due to high incidence, whereas upper arm fractures were the most expensive injuries per case (4,440 euro). Major cost peaks were observed for fractures in elderly women due to high incidence and costs per patient. CONCLUSIONS: The overall incidence of upper extremity injury in the Netherlands increased by 13% in the period 1986-2008. Females with upper extremity fractures and especially elderly women with wrist fractures accounted for a substantial share of total costs.

How to train surgical residents to perform laparoscopic Roux-en-Y gastric bypass safely.

BACKGROUND: As a result of increasing numbers of patients with morbid obesity there is a worldwide demand for bariatric surgeons. The Roux-en-Y gastric bypass, nowadays performed mostly laparoscopically (LRYGB), has been proven to be a highly effective surgical treatment for morbid obesity. This procedure is technically demanding and requires a long learning curve. Little is known about implementing these demanding techniques in the training of the surgical resident. The aim of this study was to evaluate the safety and feasibility of the introduction of LRYGB into the training of surgical residents. METHODS: All patients who underwent LRYGB between March 2006 and July 2010 were retrospectively analyzed. The procedure was performed by a surgical resident under strict supervision of a bariatric surgeon (group I) or by a bariatric surgeon (group II). The primary end point was the occurrence of complications. Secondary end points included operative time, days of hospitalization, rate of readmission, and reappearance in the emergency department (ED) within 30 days. RESULTS: A total of 409 patients were found eligible for inclusion in the study: 83 patients in group I and 326 in group II. There was a significant difference in operating time (129 min in group I vs. 116 min in group II; p < 0.001) and days of hospitalization. Postoperative complication rate, reappearance in the ED, and rate of readmission did not differ between the two groups. CONCLUSIONS: Our data suggest that under stringent supervision and with sufficient laparoscopic practice, implementation of LRYGB as part of surgical training is safe and results in only a slightly longer operating time. Complication rates, days of hospitalization, and the rates of readmission and reappearance in the ED within 30 days were similar between the both groups. These results should be interpreted by remembering that all procedures in group I were performed in a training environment so occasional intervention by a bariatric surgeon, when necessary, was inevitable.

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).

Minimal important change and other measurement properties of the Oxford Elbow Score and the Quick Disabilities of the Arm, Shoulder, and Hand in patients with a simple elbow dislocation; validation study alongside the multicenter FuncSiE trial.

STUDY DESIGN: Validation study using data from a multicenter, randomized, clinical trial (RCT). OBJECTIVES: To evaluate the reliability, validity, responsiveness, and minimal important change (MIC) of the Dutch version of the Oxford Elbow Score (OES) and the Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) in patients with a simple elbow dislocation. BACKGROUND: Patient-reported outcome measures are increasingly important for assessing outcome following elbow injuries, both in daily practice and in clinical research. However measurement properties of the OES and Quick-DASH in these patients are not fully known. METHODS: OES and Quick-DASH were completed four times until one year after trauma. Mayo Elbow Performance Index, pain (VAS), Short Form-36, and EuroQol-5D were completed for comparison. Data of a multicenter RCT (n = 100) were used. Internal consistency was determined using Cronbach's alpha. Construct and longitudinal validity were assessed by determining hypothesized strength of correlation between scores or changes in scores, respectively, of (sub)scales. Finally, floor and ceiling effects, MIC, and smallest detectable change (SDC) were determined. RESULTS: OES and Quick-DASH demonstrated adequate internal consistency (Cronbach α, 0.882 and 0.886, respectively). Construct validity and longitudinal validity of both scales were supported by >75% correctly hypothesized correlations. MIC and SDC were 8.2 and 12.0 point for OES, respectively. For Quick-DASH, these values were 11.7 and 25.0, respectively. CONCLUSIONS: OES and Quick-DASH are reliable, valid, and responsive instruments for evaluating elbow-related quality of life. The anchor-based MIC was 8.2 points for OES and 11.7 for Quick-DASH.

Outcome after modified Putti-Platt procedure for recurrent traumatic anterior shoulder dislocations.

Most recent studies on procedures for stabilizing the glenohumeral joint focus on arthroscopic techniques. A relatively simple open procedure is the modified Putti-Platt procedure. The aim of these retrospective case series was to evaluate the functional outcome, patient satisfaction, and quality of life of patients who underwent this procedure. After a median follow-up time of 4.7 (P25-P75 1.7-6.8) years, fifty-one patients could be enrolled with a mean age of 25 (21-39) years. Five patients (10 %) reported re-dislocations. The median Constant score for the affected side was 84 (P25-P75 75-91). Median loss of motion in abduction, elevation, external rotation, and external rotation in 90° of abduction did not exceed 10° when compared to the healthy shoulder. A median Rowe score of 92 (P25-P75 75-95) was measured. The WOSI score and SF-36 showed excellent quality of life. The VAS proved high patient satisfaction with the outcome; 7.9 (6.8-9.5). We concluded that the modified Putti-Platt procedure leads to excellent outcome scores and only marginal restriction in range of motion combined with a high patient satisfaction. Our data prove that excellent results can be obtained with a relatively simple open procedure.