Effect of music on clinical outcome after hip fracture operations (MCHOPIN): study protocol of a multicentre randomised controlled trial.

BACKGROUND: Patients undergoing proximal femur fracture surgery are at high risk of postoperative complications, with postoperative delirium occurring in 25%-40% of patients. Delirium has profound effects on patient outcome and recovery, the patient's family, caregivers and medical costs. Perioperative music has a beneficial effect on eliciting modifiable risk factors of delirium. Therefore, the aim of this trial was to evaluate the effect of perioperative recorded music on postoperative delirium in patients with proximal femur fracture undergoing surgery. METHODS AND ANALYSIS: The Music on Clinical Outcome after Hip Fracture Operations study is an investigator-initiated, multicentre, randomised controlled, open-label, clinical trial. Five hundred and eight patients with proximal femur fracture meeting eligibility criteria will be randomised to the music intervention or control group with concealed allocation in a 1:1 ratio, stratified by hospital site. The perioperative music intervention consists of preselected lists totalling 30 hours of music, allowing participants to choose their preferred music from these lists (classical, jazz and blues, pop and Dutch). The primary outcome measure is postoperative delirium rate. Secondary outcome measures include pain, anxiety, medication requirement, postoperative complications, hospital length of stay and 30-day mortality. A 90-day follow-up will be performed in order to assess nursing home length of stay, readmission rate and functional ability to perform daily living activities. Furthermore, the cost and cost-effectiveness of the music intervention will be assessed. Data will be analysed according to an intention-to-treat principle. ETHICS AND DISSEMINATION: The study protocol has been approved by the Medical Research Ethics Committee Erasmus MC on 8 October 2018 (MEC-2018-110, NL64721.078.18). The trial will be carried out following the Declaration of Helsinki principles, Good Clinical Practice guidelines and Dutch Medical Research Involving Human Subjects Act. Research data will be reported following Consolidated Standards of Reporting Trials guidelines and study results will be published in a peer-reviewed journal. TRIAL REGISTRATION NUMBER: NTR7036.

Cost-effectiveness of direct discharge from the emergency department of patients with simple stable injuries in the Netherlands.

BACKGROUND: Approximately one-third of musculoskeletal injuries are simple stable injuries (SSIs). Direct discharge (DD) from the emergency department (ED) of patients with SSIs reduces healthcare utilization, without compromising patient outcome and experience, when compared with "traditional" care with routine follow-up. This study aimed to determine the cost-effectiveness of DD compared with traditional care from a societal perspective. METHODS: Societal costs, including healthcare, work absenteeism, and travel costs, were calculated for patients with an SSI, 6 months before (pre-DD cohort) and after implementation of DD (DD cohort). The pre-DD cohort was treated according to local protocols. The DD cohort was treated using orthoses, discharge leaflet, smartphone application, and telephone helpline, without scheduling routine follow-up. Effect measures included generic health-related quality of life (HR-QoL; EuroQol Five-Dimensional Questionnaire); disease-specific HR-QoL (functional outcome, different validated questionnaires, converted to 0-100 scale); treatment satisfaction (Visual Analog Scale (VAS), 1-10); and pain (VAS, 1-10). All data were assessed using a 3-month postinjury survey and electronic patient records. Incremental cost-effectiveness ratios were calculated and uncertainty was assessed using bootstrapping techniques. RESULTS: Before DD, 144 of 348 participants completed the survey versus 153 of 371 patients thereafter. There were no statistically significant differences between the pre-DD cohort and the DD cohort for generic HR-QoL (0.03; 95% CI -0.01 to 0.08), disease-specific HR-QoL (4.4; 95% CI -1.1 to 9.9), pain (0.08; 95% CI -0.37 to 0.52) and treatment satisfaction (-0.16; 95% CI -0.53 to 0.21). Total societal costs were lowest in the DD cohort (-€822; 95% CI -€1719 to -€67), including healthcare costs (-€168; 95% CI -€205 to -€131) and absenteeism costs (-€645; 95% CI -€1535 to €100). The probability of DD being cost-effective was 0.98 at a willingness-to-pay of €0 for all effect measures, remaining high with increasing willingness-to-pay for generic HR-QoL, disease-specific HR-QoL, and pain, and decreasing with increasing willingness-to-pay for treatment satisfaction. DISCUSSION: DD from the ED of patients with SSI seems cost-effective from a societal perspective. Future studies should test generalizability in other healthcare systems and strengthen findings in larger injury-specific cohorts. LEVEL OF EVIDENCE: II.

Optimizing orthopedic trauma care delivery during the COVID-19 pandemic. A closed-loop audit of implementing a virtual fracture clinic and fast-track pathway in a Dutch level 2 trauma center.

BACKGROUND: Guidelines concerning outpatient management of patients during the coronavirus pandemic required minimized face-to-face follow-up and increased remote care. In response, we established a virtual fracture clinic (VFC) review for emergency department (ED) patients with musculoskeletal injuries, meaning patients are reviewed 'virtually' the next workday by a multidisciplinary team, instead of routine referral for face-to-face fracture clinic review. Patients wait at home and are contacted afterwards to discuss treatment. Based on VFC review, patients with minor injuries are discharged, while for other patients an extensive treatment plan is documented using injury-specific care pathways. Additionally, we established an ED orthopedic trauma fast-track to reduce waiting time. This study aimed to evaluate the extent to which our workflow supported adherence to national coronavirus-related guidelines and effects on ED waiting time. METHODS: A closed-loop audit was performed during two 4-week periods using predefined standards: (1) all eligible ED orthopedic trauma patients are referred for VFC review; (2) reached afterwards; and follow-up is (3) patient initiated, or (4) performed remotely, whenever possible. Total ED waiting time, time to review, time for review, and time after review were assessed during both audit periods and compared with previous measurements. RESULTS: During both audits, the majority of eligible ED patients were referred for VFC review (1st: n=162 (88.0%); 2nd: n=302 (98.4%)), and reached afterwards (1st: 98.1%; 2nd: 99.0%). Of all referred patients, 17.9% and 13.6% were discharged 'virtually' during first and second audits, respectively, while 45.0% and 41.1% of scheduled follow-up appointments were remote. Median total ED waiting time was reduced (1st: -36 minutes (p<0.001); 2nd: -33 minutes (p<0.001)). During the second audit, median ED time to review was reduced by -13 minutes (p<0.001), as well as time for review: -10 minutes (p=0.019). DISCUSSION: In line with national guidelines, our VFC review allowed time-effective review and triage of the majority of ED orthopedic trauma patients, supporting patient-initiated and remote follow-up, whenever possible. ED waiting time was reduced after implementing the VFC review and orthopedic trauma fast-track. LEVEL OF EVIDENCE: IV.

Direct discharge from the emergency department of simple stable injuries: a propensity score-adjusted non-inferiority trial.

BACKGROUND: Recent studies suggest a large proportion of musculoskeletal injuries are simple stable injuries (SSIs). The aim of this study was to evaluate whether direct discharge (DD) from the emergency department (ED) of SSIs is non-inferior to 'traditional care' regarding treatment satisfaction and functional outcome, and to compare other patient-reported outcomes (PROMs), patient-reported experiences (PREMs), resource utilization, and adverse outcomes before and after DD. METHODS: This trial compared outcomes for 11 SSIs 6 months before and after the implementation of DD protocols. Pre-DD, patients were treated according to local protocols. Post-DD, patients were discharged directly using removable orthoses, discharge leaflets, smartphone application, and telephone helpline. Participants received a 3-month postinjury PROM/PREM survey to assess treatment satisfaction (Visual Analog Scale, VAS), pain (VAS), functional outcome (four validated questionnaires), and health-related quality of life (HR-QoL; EuroQol-5D). Resource utilization included general practitioner (GP) visit (yes/no), physiotherapist visit (yes/no), return to work/school/sports (days), work/school absenteeism to visit hospital (yes/no), number of hospital visits, and follow-up X-rays. Other outcomes included missed injuries (additionally to SSI) and adverse outcomes (delayed union, non-union). Between-group differences were assessed using propensity score-adjusted regression analyses. Non-inferiority was assessed for satisfaction and functional outcome using predefined margins. RESULTS: 348 (pre-DD) and 371 (post-DD) patients participated; 144 (41.4%) and 153 (41.2%) patients completed the survey. Satisfaction and functional outcome post-DD were non-inferior to traditional care. Mean satisfaction was 8.13 pre-DD and 7.95 post-DD (mean difference: -0.16, p=0.408). Pain, HR-QoL, GP/physiotherapist visits, and return to work/school/sports were comparable before and after DD. Work absenteeism was higher pre-DD (OR 0.110, p<0.001), as well as school absenteeism (OR 0.084, p<0.001). Post-DD, the mean number of hospital visits and X-rays reduced: -1.68 (p<0.001) and -0.26 (p<0.001). Missed injuries occurred once pre-DD versus twice post-DD. There were no adverse outcomes. DISCUSSION: The results of this study confirm several SSIs can be discharged directly from the ED without compromising patient outcome/experience. Future injury-specific trials are needed to conclusively assess non-inferiority of DD. LEVEL OF EVIDENCE: II.

Long-term Outcome After Nonoperative Treatment for Rockwood I and II Acromioclavicular Joint Injuries.

BACKGROUND: Rockwood I and II acromioclavicular joint injuries are generally treated nonoperatively. The long-term outcome is considered to be good but has not yet been properly investigated. PURPOSE: To assess the long-term outcome after nonoperative therapy for Rockwood I and II acromioclavicular joint injuries regarding functional and radiologic outcome. STUDY DESIGN: Cohort study; Level of evidence, 3. METHODS: Eligible patients visited the emergency department between January 2003 and December 2015 and were ≥16 years old at the time of presentation. The main study parameters were the Constant score, the Disabilities of the Arm, Shoulder and Hand score, and the Simple Shoulder Test. The Constant score was measured in the injured and contralateral shoulders. Radiologic outcomes in both shoulders included joint displacement, joint space, degenerative changes, osteolysis of the distal clavicle, and ossification of the ligaments. RESULTS: A total of 75 patients were included for follow-up. After a median follow-up of 85 months (interquartile range [IQR], 68.0-100.0), the mean Constant score in the injured shoulder for the total sample was 88.6 (SD, 12.7) as compared with 93.3 (SD, 8.7) in the contralateral shoulder, with a significant difference of 4.7 points between shoulders. The median Disabilities of the Arm, Shoulder and Hand score was 4.2 (IQR, 0.0-10.8), and the median Simple Shoulder Test was 100 (IQR, 91.7-100.0). The median patient satisfaction for the injured shoulder was 83 (IQR, 70.0-95.0). Regarding radiologic outcomes, for the injured shoulder versus the contralateral shoulder, patients had similar rates of degeneration (44% vs 46%) but more frequent osteolysis of the distal clavicle (31% vs 0%), ossification of the ligaments (29% vs 7%), and deformity of the distal clavicle (19% vs 0%). CONCLUSION: Despite the frequent occurrence of radiographic changes, long-term functional outcome after Rockwood I and II acromioclavicular joint injuries is good, with only clinically nonrelevant functional differences between the injured and contralateral shoulders.

[Direct discharge from the ED for patients with simple stable injuries: a Dutch pilot study]. / Direct ontslag vanaf de SEH voor patiënten met simpele en stabiele letsels.

OBJECTIVE: To describe and study (a) the implementation of direct discharge from a Dutch Emergency Department (ED) for patients with relatively simple stable injuries (SSIs), (b) preliminary logistical and financial effects, and (c) patients' experiences. DESIGN: Prospective cohort study. METHOD: Following the example of a healthcare reorganisation in the United Kingdom, in May 2019 we changed the treatment protocols of eleven SSIs. Since that time, no standard follow-up appointment has been scheduled for these patients. Patients are given information about treatment and the recovery period, and a form of immobilization is applied which can easily be removed at home. This information is summarised in a discharge leaflet and a smartphone application. A telephone helpline is available for any concerns or questions. During the implementation phase we determined compliance with, and deviation from, the protocol daily for 3 months. To determine the logistical and financial effects we compared the healthcare utilization of all patients with SSIs three months before and after implementation. Patient satisfaction and the shift in treatment towards primary care were determined by means of questionnaires. RESULTS: In the three months before implementation 275 patients with an SSI presented to our ED, compared with 318 in the same period after implementation; 304 of the 318 patients were directly discharged (protocol compliance 95.6%). We found a significant reduction in follow-up appointments (-91%), radiological imaging (-72%), and costs. Patient satisfaction was comparable. There was no shift towards primary care in healthcare utilisation. CONCLUSION: In the Netherlands, direct discharge from the ED seems to be an effective and safe alternative to traditional treatment with outpatient follow-up. Further studies on patient-reported outcomes should determine if this process is in concordance with the principle of Value Based Health Care.

Predictors for losing reduction after reposition in conservatively treated both-bone forearm fractures in 38 children.

BACKGROUNDS: Alignment loss after reduction and cast immobilisation of angulated and/or complete displaced forearm fractures is challenging. Many authors have tried to describe risk factors and create indices (initial angulation, initial complete displacement, lack of anatomic reduction, cast and padding index) in order to identify those fractures that are prone to losing their alignment during treatment. METHODS: This retrospective case-control study included children sustaining both-bone forearm fractures treated by closed reduction and cast immobilisation. Basic characteristics were recorded and radiographs evaluated to measure displacement and angulation before and after reduction, cast index and padding index. The primary outcome was loss of reduction during the immobilisation period. RESULTS: Group A consisted of 22 patients in whom >5° reduction loss was seen during cast immobilisation. Group B consisted of 16 patients with <5° reduction loss. After multivariate analyses we found group A included more broken cortices, with a statistically significant higher number of initial displaced fractures (p < 0.001 and p = 0.010) and residual displacement (p = 0.022). The cast and padding index did not differ significantly between groups (p = 0.77 and 0.15 respectively). CONCLUSIONS: Cast and padding index did not correlate well as predictor of alignment loss, although in this study cortical stability seemed more important towards predicting alignment loss.

Femoral Neck Shortening After Hip Fracture Fixation Is Associated With Inferior Hip Function: Results From the FAITH Trial.

OBJECTIVE: To describe the distribution of femoral neck shortening after internal fixation and to determine whether shortening is associated with inferior hip function at 24 months after a hip fracture in patients 50 years of age or older. DESIGN: Retrospective cohort study. SETTING: A secondary analysis of data from 81 clinical centers included in the Fixation using Alternative Implants for the Treatment of Hip Fractures (FAITH) trial. PARTICIPANTS: Three hundred fifty patients, 50 years of age or older, who had an isolated femoral neck fracture and underwent timely operative fixation of the fracture. INTERVENTION: Femoral neck shortening was measured as a categorical variable and classified into one of the following groups, as determined by the Central Adjudication Committee: no shortening, mild shortening (≤5 mm), moderate shortening (6-10 mm), or severe shortening (>10 mm). MAIN OUTCOME MEASUREMENT: The primary outcome for the current analysis was hip function, as measured by the Western Ontario & McMaster Universities Osteoarthritis Index questionnaire, at 24 months after injury. RESULTS: Two-thirds of patients had no or mild shortening (≤5 mm), whereas one-third of patients had moderate or severe shortening (>5 mm). After adjusting for surgical treatment, a greater amount of femoral neck shortening was found to be associated with poorer hip function (P < 0.01). CONCLUSIONS: We found that increasing femoral neck shortening was associated with inferior hip function. Although internal fixation often results in successful union, patients who heal in a shortened position report poorer functional outcomes. LEVEL OF EVIDENCE: Prognostic Level II. See Instructions for Authors for a complete description of levels of evidence.

Direct and indirect costs associated with nonoperative treatment for shoulder instability: an observational study in 132 patients.

BACKGROUND: Shoulder instability is associated with decreased functioning. The associated costs could be substantial and interesting to clinicians, researchers, and policy makers. This prospective observational study aims to (1) estimate productivity losses and healthcare expenses following the nonoperative treatment of shoulder instability and (2) identify patient characteristics that influence societal costs. METHODS: One hundred and thirty-two patients completed a questionnaire regarding production losses and healthcare utilization following consecutive episodes of shoulder instability. Productivity losses were calculated using the friction cost approach. Healthcare utilization was evaluated using standard costs. analysis of variance test was used to assess which patient characteristics are related to productivity losses and healthcare expenses. Societal costs were assessed using multilevel analyses. Bootstrapping was used to estimate statistical uncertainty. RESULTS: Mean productivity losses are €1469, €881, and €728 and mean healthcare expenses are €3759, €3267, and €2424 per patient per dislocation for the first, second, and third dislocation. Productivity losses decrease significantly after the second (mean difference €-1969, 95%CI= -3680 to -939) and third (mean difference €-2298, 95%CI= -4092 to -1288) compared to the first dislocation. CONCLUSIONS: Nonoperative treatment of shoulder instability has substantial societal costs. LEVEL OF EVIDENCE: III, economic analysis.

Functional outcome in patients who underwent distal biceps tendon repair.

INTRODUCTION: To asses physical function and quality of life after distal biceps tendon repair and compare suture anchor and cortical button fixation. Secondarily, we assessed the impact of other factors: acute repair, graft use, concomitant arm conditions, contralateral rupture, and complications. METHODS: We approached all 50 patients that underwent distal biceps tendon rupture repair (2009-2016) to participate in our study and complete a questionnaire including: patient demographics, QuickDASH, Quality of life EQ-5D-5L, pain score, and Mayo Elbow Performance score (MEPS). RESULTS: In total, 37 (76%) of 49 alive patients participated in our study. All were men, with a median age of 47 years. Median follow-up was 34 months (range 8-100 months). On average, we found perfect upper extremity (QuickDASH, median: 0, IQR 0-7.9; 53% had no [QuickDASH = 0] upper extremity disability) and elbow function (MEPS, median: 100, IQR 100-100; 83% had perfect [MEPS > 90] clinical elbow function), perfect quality of life (EQ-5D-5L, median: 1, IQR 0.85-1; 59% had perfect [EQ-5D-5L = 1] quality of life), and no pain (median 0, IQR 0-0; 68% had no pain). We found no difference in upper extremity (QuickDASH: anchor, median 1.1, IQR 0-6.8; endobutton, median 0, IQR 0-9.1, p = 0.972) and elbow (MEPS: anchor, median 100, IQR 100-100; endobutton, median 100, IQR 100-100, p = 0.895) function, quality of life (EQ-5D-5L: anchor, median 1, IQR 0.85-1; endobutton, median 1, IQR 0.84-1, p = 0.507), and pain score (anchor, median 0, IQR 0-0.5; endobutton, median 0, IQR 0-0, p = 0.742) when comparing the anchor to endobutton fixation technique. CONCLUSIONS: Overall, patients have excellent outcome after distal biceps tendon rupture repair. There was no difference in patient-reported outcome measures between suture anchor and endobutton fixation. LEVEL OF EVIDENCE: Level III, retrospective comparative study.

Classification systems for distal radius fractures.

Background and purpose - The reliability of conventional radiography when classifying distal radius fractures (DRF) is fair to moderate. We investigated whether reliability increases when additional computed tomography scans (CT) are used. Patients and methods - In this prospective study, we performed pre- and postreduction posterior-anterior and lateral radiographs of 51 patients presenting with a displaced DRF. The case was included when there was a (questionable) indication for surgical treatment and an additional CT was conducted within 5 days. 4 observers assessed the cases using the Frykman, Fernández, Universal, and AO classification systems. The first 2 assessments were performed using conventional radiography alone; the following 2 assessments were performed with an additional CT. We used the intraclass correlation coefficient (ICC) to evaluate reliability. The CT was used as a reference standard to determine the accuracy. Results - The intraobserver ICC for conventional radiography alone versus radiography and an additional CT was: Frykman 0.57 vs. 0.51; Fernández 0.53 vs. 0.66; Universal 0.57 vs. 0.64; AO 0.59 vs. 0.71. The interobserver ICC was: Frykman: 0.45 vs. 0.28; Fernández: 0.38 vs. 0.44; Universal: 0.32 vs. 0.43; AO: 0.46 vs. 0.40. Interpretation - The intraobserver reliability of the classification systems was fair but improved when an additional CT was used, except for the Frykman classification. The interobserver reliability ranged from poor to fair and did not improve when using an additional CT. Additional CT scanning has implications for the accuracy of scoring the fracture types, especially for simple fracture types.

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.

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.

Coverage of Exposed Bone of the Lateral Malleolus With a Proximally Based Lateral Malleolar Perforator Flap.

The treatment of soft tissue defects of the ankle, combined with an implant-related infection, remains a challenge. The present case report illustrates the use of a pedicled perforator flap for soft tissue reconstruction to cover a postoperative defect at the lateral malleolus after an ankle fracture.

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.

Surgery versus conservative treatment in patients with type A distal radius fractures, a randomized controlled trial.

BACKGROUND: Fractures of the distal radius are common and account for an estimated 17% of all fractures diagnosed. Two-thirds of these fractures are displaced and require reduction. Although distal radius fractures, especially extra-articular fractures, are considered to be relatively harmless, inadequate treatment may result in impaired function of the wrist. Initial treatment according to Dutch guidelines consists of closed reduction and plaster immobilisation. If fracture redisplacement occurs, surgical treatment is recommended. Recently, the use of volar locking plates has become more popular. The aim of this study is to compare the functional outcome following surgical reduction and fixation with a volar locking plate with the functional outcome following closed reduction and plaster immobilisation in patients with displaced extra-articular distal radius fractures. DESIGN: This single blinded randomised controlled trial will randomise between open reduction and internal fixation with a volar locking plate (intervention group) and closed reduction followed by plaster immobilisation (control group). The study population will consist of all consecutive adult patients who are diagnosed with a displaced extra-articular distal radius fracture, which has been adequately reduced at the Emergency Department. The primary outcome (functional outcome) will be assessed by means of the Disability Arm Shoulder Hand Score (DASH). Secondary outcomes comprise the Patient-Rated Wrist Evaluation score (PRWE), quality of life, pain, range of motion, radiological parameters, complications and cross-overs. Since the treatment allocated involves a surgical procedure, randomisation status will not be blinded. However, the researcher assessing the outcome at one year will be unaware of the treatment allocation. In total, 90 patients will be included and this trial will require an estimated time of two years to complete and will be conducted in the Academic Medical Centre Amsterdam and its partners of the regional trauma care network. DICUSSION: Ideally, patients would be randomised before any kind of treatment has been commenced. However, we deem it not patient-friendly to approach possible participants before adequate reduction has been obtained. TRIAL REGISTRATION: This study is registered at the Netherlands Trial Register (NTR3113) and was granted permission by the Medical Ethical Review Committee of the Academic Medical Centre on 01-10-2012.

HUMeral shaft fractures: measuring recovery after operative versus non-operative treatment (HUMMER): a multicenter comparative observational study.

BACKGROUND: Fractures of the humeral shaft are associated with a profound temporary (and in the elderly sometimes even permanent) impairment of independence and quality of life. These fractures can be treated operatively or non-operatively, but the optimal tailored treatment is an unresolved problem. As no high-quality comparative randomized or observational studies are available, a recent Cochrane review concluded there is no evidence of sufficient scientific quality available to inform the decision to operate or not. Since randomized controlled trials for this injury have shown feasibility issues, this study is designed to provide the best achievable evidence to answer this unresolved problem. The primary aim of this study is to evaluate functional recovery after operative versus non-operative treatment in adult patients who sustained a humeral shaft fracture. Secondary aims include the effect of treatment on pain, complications, generic health-related quality of life, time to resumption of activities of daily living and work, and cost-effectiveness. The main hypothesis is that operative treatment will result in faster recovery. METHODS/DESIGN: The design of the study will be a multicenter prospective observational study of 400 patients who have sustained a humeral shaft fracture, AO type 12A or 12B. Treatment decision (i.e., operative or non-operative) will be left to the discretion of the treating surgeon. Critical elements of treatment will be registered and outcome will be monitored at regular intervals over the subsequent 12 months. The primary outcome measure is the Disabilities of the Arm, Shoulder, and Hand score. Secondary outcome measures are the Constant score, pain level at both sides, range of motion of the elbow and shoulder joint at both sides, radiographic healing, rate of complications and (secondary) interventions, health-related quality of life (Short-Form 36 and EuroQol-5D), time to resumption of ADL/work, and cost-effectiveness. Data will be analyzed using univariate and multivariable analyses (including mixed effects regression analysis). The cost-effectiveness analysis will be performed from a societal perspective. DISCUSSION: Successful completion of this trial will provide evidence on the effectiveness of operative versus non-operative treatment of patients with a humeral shaft fracture. TRIAL REGISTRATION: The trial is registered at the Netherlands Trial Register (NTR3617).

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).

Complete Avulsion of the Pectoralis Major Tendon: a Case Report.

Rupture of the pectoralis major muscle is a rare injury, usually occurring during sports activities or after direct trauma. This article describes the clinical presentation, diagnostic tools and treatment of a patient with a complete avulsion of the pectoralis major tendon.