A randomized controlled trial of nonoperative treatment versus open reduction and internal fixation for stable, displaced, partial articular fractures of the radial head: The RAMBO trial

Background: The choice between operative or nonoperative treatment is questioned for partial articular fractures of the radial head that have at least 2 millimeters of articular step-off on at least one radiograph (defined as displaced), but less than 2 millimeter of gap between the fragments (defined as stable) and that are not associated with an elbow dislocation, interosseous ligament injury, or other fractures. These kinds of fractures are often classified as Mason type-2 fractures. Retrospective comparative studies suggest that operative treatment might be better than nonoperative treatment, but the long-term results of nonoperative treatment are very good. Most experts agree that problems like reduced range of motion, painful crepitation, nonunion or bony ankylosis are infrequent with both nonoperative and operative treatment of an isolated displaced partial articular fracture of the radial head, but determining which patients will have problems is difficult. A prospective, randomized comparison would help minimize bias and determine the balance between operative and nonoperative risks and benefits. Methods/Design. The RAMBO trial (Radial Head - Amsterdam - Amphia - Boston - Others) is an international prospective, randomized, multicenter trial. The primary objective of this study is to compare patient related outcome defined by the 'Disabilities of Arm, Shoulder and Hand (DASH) score' twelve months after injury between operative and nonoperative treated patients. Adult patients with partial articular fractures of the radial head that comprise at least 1/3rd of the articular surface, have ≥ 2 millimeters of articular step-off but less than 2 millimeter of gap between the fragments will be enrolled. Secondary outcome measures will be the Mayo Elbow Performance Index (MEPI), the Oxford Elbow Score (OES), pain intensity through the 'Numeric Rating Scale', range of motion (flexion arc and rotational arc), radiographic appearance of the fracture (heterotopic ossification, radiocapitellar and ulnohumeral arthrosis, fracture healing, and signs of implant loosening or breakage) and adverse events (infection, nerve injury, secondary interventions) after one year. Discussion. The successful completion of this trial will provide evidence on the best treatment for stable, displaced, partial articular fractures of the radial head. Trial registration. The trial is registered at the Dutch Trial Register: NTR3413

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)

Factors Associated with Revision Surgery after Internal Fixation of Hip Fractures

Background: Femoral neck fractures are associated with high rates of revision surgery after management with internal fixation. Using data from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial evaluating methods of internal fixation in patients with femoral neck fractures, we investigated associations between baseline and surgical factors and the need for revision surgery to promote healing, relieve pain, treat infection or improve function over 24 months postsurgery. Additionally, we investigated factors associated with (1) hardware removal and (2) implant exchange from cancellous screws (CS) or sliding hip screw (SHS) to total hip arthroplasty, hemiarthroplasty, or another internal fixation device. Methods: We identified 15 potential factors a priori that may be associated with revision surgery, 7 with hardware removal, and 14 with implant exchange. We used multivariable Cox proportional hazards analyses in our investigation. Results: Factors associated with increased risk of revision surgery included: female sex, [hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.25-2.50; P = 0.001], higher body mass index (fo

The impact of medical specialist staffing on emergency department patient flow and satisfaction

OBJECTIVE: The aim of this study was to describe the impact of additional medical specialists, non-emergency physicians (non-EPs), performing direct supervision or a combination of direct and indirect supervision at an EP-led emergency department (ED), on patient flow and satisfaction. PATIENTS AND METHODS: An observational, cross-sectional, three-part study was carried out including staff surveys (n=379), a before and after 16-week data collection using data of visits during the peak hours (n=5270), and patient questionnaires during 1 week before the pilot and during week 5 of the pilot. Content analysis and descriptive statistics were used for analyses. RESULTS: The value of being present at the ED was acknowledged by medical specialists in 49% of their surveys and 35% of the EPs' and ED nurses' surveys, especially during busy shifts. Radiologists were most often (67.3%) convinced of their value of being on-site, which was agreed upon by the ED professionals. Perceived improved quality of care, shortening of length of stay, and enhanced peer consultation were mentioned most often.During the pilot period, length of stay of boarded patients decreased from 197 min (interquartile range: 121 min) to 181 min (interquartile range: 113 min, P=0.006), and patient recommendation scores increased from -15 to +20. CONCLUSION: Although limited by the mix of direct and indirect supervision, our results suggest a positive impact of additional medical specialists during busy shifts. Throughput of admitted patients and patient satisfaction improved during the pilot period. Whether these findings differ between direct supervision and combination of direct and indirect supervision by the medical specialists requires further investigation

Early CT Compared With Bone Scintigraphy in Suspected Schapoid Fractures

Surger

Operative Treatment of Dislocated Midshaft Clavicular Fractures: Plate or Intramedullary Nail Fixation? A Randomized Controlled Trial

Background: Over the past decades, the operative treatment of displaced midshaft clavicular fractures has increased. The aim of this study was to compare short and midterm results of open reduction and plate fixation with those of intramedullary nailing for displaced midshaft clavicular fractures. Methods: A multicenter, randomized controlled trial was performed in four different hospitals. The study included 120 patients, eighteen to sixty-five years of age, treated with either open reduction and plate fixation (n = 58) or intramedullary nailing (n = 62). Preoperative and postoperative shoulder function scores and complications were documented until one year postoperatively. Significance was set at p <0.05. Results: No significant differences in the Disabilities of the Arm, Shoulder and Hand (DASH) or Constant-Murley score (3.0 and 96.0 points for the plate group and 5.6 and 95.5 points for the nailing group) were noted between the two surgical interventions at six months postoperatively. Until six months after the surgery, the plate-fixation group experienced less disability than the nailing group as indicated by the area under the curve of the DASH scores for this time period (p = 0.02). The mean numbers of complications per patient, irrespective of their severity, were similar between the plate-fixation (0.67) and nailing (0.74) groups (p = 0.65). Conclusions: The patients in the plate-fixation group recovered faster than the patients in the intramedullary nailing group, but the groups had similar results at six months postoperatively and the time of final follow-up. The rate of complications requiring revision surgery was low. Implant-related complications occurred frequently and could often be treated by implant remova

What Factors Are Associated With Implant Breakage and Revision After Intramedullary Nailing for Femoral Metastases?

Background Actual and impending pathologic fractures of the femur are commonly treated with intramedullary nails because they provide immediate stabilization with a minimally invasive procedure and enable direct weightbearing. However, complications and revision surgery are prevalent, and despite common use, there is limited evidence identifying those factors that are associated with complications. Questions/purposes Among patients treated with intramedullary nailing for femoral metastases, we asked the following questions: (1) What is the cumulative incidence of local complications? (2) What is the cumulative incidence of implant breakage and what factors are associated with implant breakage? (3) What is the cumulative incidence of revision surgery and what factors are associated with revision surgery? Methods Between January 2000 and December 2015, 245 patients in five centers were treated with intramedullary nails for actual and impending pathologic fractures of the femur caused by bone metastases. During that period, the general indications for intramedullary nailing of femoral metastases were impending fractures of the trochanter region and shaft and actual fractures of the trochanter region if sufficient bone stock remained; nails were used for lesions of the femoral shaft if they were large or if multiple lesions were present. Of those treated with intramedullary nails, 51% (117) were actual fractures and 49% (111) were impending fractures. A total of 60% (128) of this group were women; the mean age was 65 years (range, 29-93 years). After radiologic followup (at 4-8 weeks) with the orthopaedic surgeon, because of the palliative nature of these treatments, subsequent in-person followup was performed by the primary care provider on an as-needed basis (that is, as desired by the patient, without any scheduled visits with the orthopaedic surgeon) throughout each patient's remaining lifetime. However, there was close collaboration between the primary care providers and the orthopaedic team such that orthopaedic complications would be reported. A total of 67% (142 of 212) of the patients died before 1 year, and followup ranged from 0.1 to 175 months (mean, 14.4 months). Competing risk models were used to estimate the cumulative incidence of local complications (including persisting pain, tumor progression, and implant breakage), implant breakage separately, and revision surgery (defined as any reoperation involving the implant other than debridement with implant retention for infection). A cause-specific multivariate Cox regression model was used to estimate the association of factors (fracture type/preoperative radiotherapy and fracture type/use of cement) with implant breakage and revision, respectively. Results Local complications occurred in 12% (28 of 228) of the patients and 6-month cumulative incidence was 8% (95% confidence interval [CI], 4.7-11.9). Implant breakage occurred in 8% (18 of 228) of the patients and 6-month cumulative incidence was 4%(95% CI, 1.4-6.5). Independent factors associated with increased risk of implant breakage were an actual (as opposed to impending) fracture (cause-specific hazard ratio [HR_cs], 3.61; 95% CI, 1.23-10.53, p = 0.019) and previous radiotherapy (HR_cs, 2.97; 95% CI, 1.13-7.82, p = 0.027). Revisions occurred in 5% (12 of 228) of the patients and 6-month cumulative incidence was 2.2% (95% CI, 0.3-4.1). The presence of an actual fracture was independently associated with a higher risk of revision (HR_cs, 4.17; 95% CI, 0.08-0.82, p = 0.022), and use of cement was independently associated with a lower risk of revision (HR_cs, 0.25; 95% CI, 1.20-14.53, p = 0.025). Conclusions The cumulative incidence of local complications, implant breakage, and revisions is low, mostly as a result of the short survival of patients. Based on these results, surgeons should consider use of cement in patients with intramedullary nails with actual fractures and closer followup of patients after actual fractures and preoperative radiotherapy. Future, prospective studies should further analyze the effects of adjuvant therapies and surgery-related factors on the risk of implant breakage and revisions

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

Reliability, validity, responsiveness, and minimal important change of the Disablities of the Arm, Shoulder and Hand and Constant-Murley scores in patients with a humeral shaft fracture

The Disabilities of the Arm, Shoulder and Hand (DASH) and Constant-Murley scores are commonly used instruments. The DASH is patient-reported, and the Constant-Murley combines a clinician-reported and a patient-reported part. For patients with a humeral shaft fracture, their validity, reliability, responsiveness, and minimal important change (MIC) have not been published. This study evaluated the measurement properties of these instruments in patients who sustained a humeral shaft fracture. The DASH and Constant-Murley instruments were completed 5 times until 1 year after trauma. Pain score, Short Form 36, and EuroQol-5D were completed for comparison. Internal consistency was determined by the Cronbach α. Construct and longitudinal validity were evaluated by assessing hypotheses about expected Spearman rank correlations in scores and change scores, respectively, between patient-reported outcome measures (sub)scales. The smallest detectable change (SDC) was calculated. The MIC was determined using an anchor-based approach. The presence of floor and ceiling effects was determined. A total of 140 patients were included. Internal consistency was sufficient for DASH (Cronbach α = 0.96) but was insufficient for Constant-Murley (α = 0.61). Construct and longitudinal validity were sufficient for both patient-reported outcome measures (>75% of correlations hypothesized correctly). The MIC and SDC were 6.7 (95% confidence interval, 5.0-15.8) and 19.0 (standard error of measurement, 6.9), respectively, for DASH and 6.1 (95% CI -6.8 to 17.4) and 17.7 (standard error of measurement, 6.4), respectively, for Constant-Murley. The DASH and Constant-Murley are valid instruments for evaluating outcome in patients with a humeral shaft fracture. Reliability was only shown for the DASH, making this the preferred instrument. The observed MIC and SDC values provide a basis for sample size calculations for future researc