Effect of Antibiotic Prophylaxis on Surgical Site Infections Following Removal of Orthopedic Implants Used for Treatment of Foot, Ankle, and Lower Leg Fractures: A Randomized Clinical Trial.

Importance: Following clean (class I, not contaminated) surgical procedures, the rate of surgical site infection (SSI) should be less than approximately 2%. However, an infection rate of 12.2% has been reported following removal of orthopedic implants used for treatment of fractures below the knee. Objective: To evaluate the effect of a single dose of preoperative antibiotic prophylaxis on the incidence of SSIs following removal of orthopedic implants used for treatment of fractures below the knee. Design, Setting, and Participants: Multicenter, double-blind, randomized clinical trial including 500 patients aged 18 to 75 years with previous surgical treatment for fractures below the knee who were undergoing removal of orthopedic implants from 19 hospitals (17 teaching and 2 academic) in the Netherlands (November 2014-September 2016), with a follow-up of 6 months (final follow-up, March 28, 2017). Exclusion criteria were an active infection or fistula, antibiotic treatment, reimplantation of osteosynthesis material in the same session, allergy for cephalosporins, known kidney disease, immunosuppressant use, or pregnancy. Interventions: A single preoperative intravenous dose of 1000 mg of cefazolin (cefazolin group, n = 228) or sodium chloride (0.9%; saline group, n = 242). Main Outcomes and Measures: Primary outcome was SSI within 30 days as measured by the criteria from the US Centers for Disease Control and Prevention. Secondary outcome measures were functional outcome, health-related quality of life, and patient satisfaction. Results: Among 477 randomized patients (mean age, 44 years [SD, 15]; women, 274 [57%]; median time from orthopedic implant placement, 11 months [interquartile range, 7-16]), 470 patients completed the study. Sixty-six patients developed an SSI (14.0%): 30 patients (13.2%) in the cefazolin group vs 36 in the saline group (14.9%) (absolute risk difference, -1.7 [95% CI, -8.0 to 4.6], P = .60). Conclusions and Relevance: Among patients undergoing surgery for removal of orthopedic implants used for treatment of fractures below the knee, a single preoperative dose of intravenous cefazolin compared with saline did not reduce the risk of surgical site infection within 30 days following implant removal. Trial Registration: clinicaltrials.gov Identifier: NCT02225821.

Wound Infections Following Implant removal below the knee: the effect of antibiotic prophylaxis; the WIFI-trial, a multi-centre randomized controlled trial.

BACKGROUND: In the Netherlands about 18,000 procedures with implant removal are performed annually following open or closed reduction and fixation of fractures, of which 30-80% concern the foot, ankle and lower leg region. For clean surgical procedures, the rate of postoperative wound infections (POWI) should be less than ~2%. However, rates of 10-12% following implant removal have been reported, specifically after foot, ankle and lower leg fractures. Currently, surgeons individually decide if antibiotics prophylaxis is given, since no guideline exists. This leads to undesirable practice variation. The aim of the study is to assess the (cost-)effectiveness of a single intravenous gift of Cefazolin prior to implant removal following surgical fixation of foot, ankle and/or lower leg fractures. METHODS: This is a double-blind randomized controlled trial in patients scheduled for implant removal following a foot, ankle or lower leg fracture. Primary outcome is a POWI within 30 days after implant removal. Secondary outcomes are quality of life, functional outcome and costs at 30 days and 6 months after implant removal. With 2 x 250 patients a decrease in POWI rate from 10% to 3.3% (expected rate in clean-contaminated elective orthopaedic trauma procedures) can be detected (Power = 80%, 2-sided alpha = 5%, including 15% lost to follow up). DISCUSSION: If administration of prophylactic antibiotics prior to implant removal reduces the infectious complication rate, this will offer a strong argument to adopt this as standard practice of care. This will consequently lead to less physical and social disabilities and health care use. A preliminary, conservative estimation suggests yearly cost savings in the Netherlands of € 3.5 million per year. TRIAL REGISTRATION: This study is registered at Clinicaltrials.gov ( NCT02225821 ) and the Netherlands Trial Register ( NTR4393 ) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on October 7 2014.

Functional outcome of routine versus on-demand removal of the syndesmotic screw.

Aims: The primary aim of this study was to present the mid-term follow-up of a multicentre randomized controlled trial (RCT) which compared the functional outcome following routine removal (RR) to the outcome following on-demand removal (ODR) of the syndesmotic screw (SS). Methods: All patients included in the 'ROutine vs on DEmand removal Of the syndesmotic screw' (RODEO) trial received the Olerud-Molander Ankle Score (OMAS), American Orthopaedic Foot and Ankle Hindfoot Score (AOFAS), Foot and Ankle Outcome Score (FAOS), and EuroQol five-dimension questionnaire (EQ-5D). Out of the 152 patients, 109 (71.7%) completed the mid-term follow-up questionnaire and were included in this study (53 treated with RR and 56 with ODR). Median follow-up was 50 months (interquartile range 43.0 to 56.0) since the initial surgical treatment of the acute syndesmotic injury. The primary outcome of this study consisted of the OMAS scores of the two groups. Results: The median OMAS score was 85.0 for patients treated with RR, and 90.0 for patients treated with ODR (p = 0.384), indicating no significant difference between ODR and RR. The secondary outcome measures included the AOFAS (88.0 in the RR group and 90.0 for ODR; p = 0.722), FAOS (87.5 in the RR group and 92.9 for ODR; p = 0.399), and EQ-5D (0.87 in the RR group and 0.96 for ODR; p = 0.092). Conclusion: This study demonstrated no functional difference comparing ODR to RR in syndesmotic injuries at a four year follow-up period, which supports the results of the primary RODEO trial. ODR should be the standard practice after syndesmotic screw fixation.

Amsterdam wrist rules: a clinical decision aid.

BACKGROUND: Acute trauma of the wrist is one of the most frequent reasons for visiting the Emergency Department. These patients are routinely referred for radiological examination. Most X-rays however, do not reveal any fractures. A clinical decision rule determining the need for X-rays in patients with acute wrist trauma may help to percolate and select patients with fractures. METHODS/DESIGN: This study will be a multi-center observational diagnostic study in which the data will be collected cross-sectionally. The study population will consist of all consecutive adult patients (≥18 years) presenting with acute wrist trauma at the Emergency Department in the participating hospitals. This research comprises two components: one study will be conducted to determine which clinical parameters are predictive for the presence of a distal radius fracture in adult patients presenting to the Emergency Department following acute wrist trauma. These clinical parameters are defined by trauma-mechanism, physical examination, and functional testing. This data will be collected in two of the three participating hospitals and will be assessed by using logistic regression modelling to estimate the regression coefficients after which a reduced model will be created by means of a log likelihood ratio test. The accuracy of the model will be estimated by a goodness of fit test and an ROC curve. The final model will be validated internally through bootstrapping and by shrinking it, an adjusted model will be generated. In the second component of this study, the developed prediction model will be validated in a new dataset consisting of a population of patients from the third hospital. If necessary, the model will be calibrated using the data from the validation study. DISCUSSION: Wrist trauma is frequently encountered at the Emergency Department. However, to this date, no decision rule regarding this type of trauma has been created. Ideally, radiographs are obtained of all patients entering one of the participating hospitals with trauma to the wrist. However, this is ethically and logistically not feasible and one could argue that patients, for whom no radiography is required according to their physician, are not suspected of having a distal radius fracture and thus are not part of the domain. TRIAL REGISTRATION: This study is registered at the Netherlands Trial Register (NTR 2544) and was granted permission by the Medical Ethical Committee of the Academic Medical Center Amsterdam on 06-01-2011.

Displaced midshaft fractures of the clavicle: non-operative treatment versus plate fixation (Sleutel-TRIAL). A multicentre randomised controlled trial.

BACKGROUND: The traditional view that the vast majority of midshaft clavicular fractures heal with good functional outcomes following non-operative treatment may be no longer valid for all midshaft clavicular fractures. Recent studies have presented a relatively high incidence of non-union and identified speciic limitations of the shoulder function in subgroups of patients with these injuries. AIM: A prospective, multicentre randomised controlled trial (RCT) will be conducted in 21 hospitals in the Netherlands, comparing fracture consolidation and shoulder function after either non-operative treatment with a sling or a plate fixation. METHODS/DESIGN: A total of 350 patients will be included, between 18 and 60 years of age, with a dislocated midshaft clavicular fracture. The primary outcome is the incidence of non-union, which will be determined with standardised X-rays (Antero-Posterior and 30 degrees caudocephalad view). Secondary outcome will be the functional outcome, measured using the Constant Score. Strength of the shoulder muscles will be measured with a handheld dynamometer (MicroFET2). Furthermore, the health-related Quality of Life score (ShortForm-36) and the Disabilities of Arm, Shoulder and Hand (DASH) Outcome Measure will be monitored as subjective parameters. Data on complications, bone union, cosmetic aspects and use of painkillers will be collected with follow-up questionnaires. The follow-up time will be two years. All patients will be monitored at regular intervals over the subsequent twelve months (two and six weeks, three months and one year). After two years an interview by telephone and a written survey will be performed to evaluate the two-year functional and mechanical outcomes. All data will be analysed on an intention-to-treat basis, using univariate and multivariate analyses. DISCUSSION: This trial will provide level-1 evidence for the comparison of consolidation and functional outcome between two standardised treatment options for dislocated midshaft clavicular fractures. The gathered data may support the development of a clinical guideline for treatment of clavicular fractures. TRIAL REGISTRATION: Netherlands National Trial Register NTR2399.

Patient related functional outcome of glenoid rim fractures treated with open reduction and internal fixation.

The aim of this study was to evaluate patient related outcome and shoulder stability following open reduction and internal fixation (ORIF) in patients with glenoid rim fractures. After a median follow-up of four years, 14 patients completed the Rowe Shoulder Stability Score and Quick DASH questionnaire. The median Rowe score was 90 (Q1: 88, Q3: 100). Results were graded excellent in 11 patients and good in three. The median DASH score was 4.6 (Q1: 0, Q3: 32). In conclusion this study showed that ORIF of type la and 2 glenoid rim fractures provided satisfactory results with respect to prevention of instability. However, patient reported functional outcome was disappointing in 21% of the patients.

Plate Fixation Compared with Nonoperative Treatment for Displaced Midshaft Clavicular Fractures: A Multicenter Randomized Controlled Trial.

BACKGROUND: The use of operative treatment for clavicular fractures is increasing, despite varying results in previous studies. The aim of this study was to compare plate fixation and nonoperative treatment for displaced midshaft clavicular fractures with respect to nonunion, adverse events, and shoulder function. METHODS: In this multicenter, prospective, randomized controlled trial, patients between 18 and 60 years old with a displaced midshaft clavicular fracture were randomized between nonoperative treatment and open reduction with internal plate fixation. The primary outcome was evidence of nonunion at 1 year. Other outcomes were secondary operations, arm function as measured with the Constant shoulder score and Disabilities of the Arm, Shoulder and Hand (DASH) score, pain, cosmetic results, and general health status. Outcomes were recorded at 6 weeks, 3 months, and 1 year following trauma. RESULTS: One hundred and sixty patients were randomized. The rate of nonunion was significantly higher in the nonoperatively treated group than in the operatively treated group (23.1% compared with 2.4%; p < 0.0001), as was the rate of nonunion for which secondary plate fixation was performed (12.9% compared with 1.2%; p = 0.006). The rate of secondary operations was 27.4% in the operatively treated group (16.7% for elective plate removal) and 17.1% in the nonoperatively treated group (p = 0.18). Nineteen percent of the patients in the operatively treated group had persistent loss of sensation around the scar. No difference was found between the groups with respect to the Constant and DASH scores at all time points. CONCLUSIONS: For patients with a diaphyseal fracture of the clavicle displaced at least 1 shaft width, plate fixation improves the chances that the bone will heal; however, the rate of patients who need a second operation is considerable. In addition, the procedure does not improve shoulder function or general symptoms, and it does not decrease limitations compared with nonoperative treatment in a sling. LEVEL OF EVIDENCE: Therapeutic Level I. See Instructions for Authors for a complete description of levels of evidence.

Trauma surgery by general surgeons: Still an option for proximal femoral fractures?

INTRODUCTION: Surgery for proximal femoral fractures in the Netherlands is performed by trauma surgeons, general surgeons and orthopaedic surgeons. The aim of this study was to assess whether there is a difference in outcome for patients with proximal femoral fractures operated by trauma surgeons versus general surgeons. Secondly, the relation between hospital and surgeon volume and postoperative complications was explored. METHODS: Patients of 18 years and older were included if operated for a proximal femoral fracture by a trauma surgeon or a general surgeon in two academic, eight teaching and two non-teaching hospitals in the Netherlands from January 2010 until December 2013. The combined endpoint was defined as reoperation or surgical site infection. Multivariate analysis was used to adjust for patient and fracture characteristics and hospital and surgeon volume. Categories for hospital volume were>170/year (high volume), 96-170/year (medium volume) and <96/year (low volume). RESULTS: In 4552 included patients 2382 (52.3%) had surgery by a trauma surgeon. Postoperative complications occurred in 276 (11.6%) patients operated by a trauma surgeon and in 258 (11.9%) operated by a general surgeon (p=0.751). When considering confounders in a multivariate analysis, surgery by trauma surgeons was associated with less postoperative complications (OR 0.746; 95%CI 0.580-0.958; p=0.022). Surgery in high volume hospitals was also associated with less complications (OR 0.997; 95%CI 0.995-0.999; p=0.012). Surgeon volume was not associated with complications (OR 1.008; 95%CI 0.997-1.018; p=0.175). CONCLUSION: Surgery by trauma surgeons and high hospital volume are associated with less reoperations and surgical site infections for patients with proximal femoral fractures.

The role of plain radiography in paediatric wrist trauma.

OBJECTIVES: Acute wrist trauma in children is one of the most frequent reasons for visiting the emergency department (ED). Radiographic imaging in children with wrist trauma is mostly performed routinely to confirm or rule out a fracture. The aim of this study was to determine how many radiographs of the wrist show a fracture in children following wrist trauma. METHODS: A retrospective cohort study was performed in three Dutch hospitals from 2009-2010. Data were extracted from patient records and radiographic reports. RESULTS: Of the 1,223 children who presented at the ED after a wrist trauma, 51 % had a wrist fracture. The peak incidence of having a wrist fracture was at the age of 10 years; 65 % of the children younger than 10 years of age had a wrist fracture. Of all the patients without a wrist fracture, 74 % were older than 10 years of age. CONCLUSION: Almost half of the paediatric patients with a trauma of the wrist had normal radiographs. The development of a clinical decision rule to determine when a radiograph of the wrist is indicated following acute wrist trauma is needed. This could likely reduce the number of radiographs. MAIN MESSAGES: • Fifty-one percent of the children with wrist trauma have a wrist fracture. • Peak incidence of having a wrist fracture is at the age of 10 years. • Sixty-five percent of the children younger than 10 years of age had a wrist fracture. • Of all the patients without a wrist fracture, 74 % were older than 10 years of age. • The development of a clinical decision rule to reduce the number of radiographs is needed.