Ultrasound-Guided Nerve Blocks as Analgesia for Nonoperative Management of Distal Radius Fractures-Two Consecutive Randomized Controlled Trials.

OBJECTIVES: To investigate whether a conventional fracture hematoma block (FHB) or an ultrasound-guided peripheral nerve block has more superior analgesic effect during nonoperative management of distal radius fractures in an emergency department setting. Two peripheral nerve block types were investigated, one at the level of the elbow, or cubital nerve block (CNB), and another an axillary nerve block (ANB). DESIGN: Two prospective randomized controlled studies were performed to compare the difference in pain intensity during closed reduction of a distal radius fracture between FHB-, CNB-, and, ANB-treated patients. SETTING: Level 2 trauma center. PATIENTS: One hundred ten patients with radiographic displaced distal radius fractures were randomized. Fifty patients were randomized between FHB and CNB, and 60 patients were randomized between CNB and ANB. INTERVENTION: FHB, CNB, or ANB. These were performed by 3 physicians new to ultrasound-guided peripheral nerve blocks and trained before onset of this study. MAIN OUTCOME MEASUREMENT: Pain was sequentially measured using an NRS during closed distal radius fracture reduction. RESULTS: CNB patients experienced less pain during block procedure (P = 0.002), finger trap traction (P = 0.007), fracture reduction (P = 0.00001), after plaster cast application (P = 0.01), and after control radiography (P = 0.01). In our second study, ANB-treated patients reported less pain during block procedure (P = 0.04), during finger trap traction (P < 0.0001), fracture reduction (P < 0.0001), after plaster cast application (P = 0.0001), and after control radiography (P = 0.0005). CONCLUSIONS: Although participating clinicians had minimal expertise using ultrasound-guided peripheral nerve blocks, nonoperative management of distal radius fracture using an ANB was less painful. These block types are expected to completely eradicate sensation the best. Future studies should address technical factors including adequate placement and time to let the block set up, as well as issues such as resource utilization including time and clinician availability to better determine the relative advantages and disadvantages to other analgesia techniques such as the FHB. LEVEL OF EVIDENCE: Therapeutic Level II. See Instructions for Authors for a complete description of levels of evidence.

Case report of nail bed injury after blunt trauma; what lies beneath the nail?

INTRODUCTION: A stable, mobile and sensate fingertip is of paramount importance to perform daily tasks and sense dangerous situations. Unfortunately, fingertips are easily injured with various extents of soft tissue damage. Delayed and inadequate treatment of nail bed injuries may cause substantial clinical problems. The aim is to increase awareness about nail bed injuries among physicians who often treat these patients. PRESENTATION OF CASE: We present a 26-year-old male with blunt trauma to a distal phalanx. Conventional radiographs showed an intra-articular, multi-fragmentary fracture of the distal phalanx. At the outpatient department the nail was removed and revealed a lacerated nail bed, more than was anticipated upon during the first encounter at the emergency department. DISCUSSION: Blunt trauma to the fingertip occurs frequently and nail bed injuries are easy to underestimate. An adequate emergency treatment of nail bed injuries is needed to prevent secondary deformities and thereby reduce the risk of secondary reconstruction of the nail bed, which often gives unpredictable results. CONCLUSION: However, adequate initial assessment and treatment are important to achieve the functional and cosmetic outcomes. Therefore awareness of physicians at the emergency department is essential.

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.

Which factors affect limitation of pronation/supination after forearm fractures in children? A prospective multicentre study.

INTRODUCTION: Both-bone forearm fractures in children frequently result in a limitation of pronation/supination, which hinders daily activities. The purpose of this prospective multicentre study was to investigate which clinical factors are related to the limitation of pronation/supination in children with a both-bone forearm fracture. METHODS: In four Dutch hospitals, consecutive children (<16 years) who sustained a both-bone forearm fracture were included. Children were followed up for 6-9 months and data from questionnaires, physical examination and X-rays were collected. Univariate and multivariate logistic regression analyses were used to assess the relationship between limitation of pronation/supination (≥20°) and several clinical factors. RESULTS: A group of 410 children with both-bone forearm fractures were included, of which 10 children missed the final examination (follow-up rate of 97.6%). We found that a re-fracture (odds ratio (OR) 11.7, 95% confidence interval (CI) 1.2; 118.5), a fracture in the diaphysis (OR 3.3, 95% CI 1.4; 7.9) and less physiotherapy during follow-up (OR 0.90, 95% CI 0.82; 0.98) were independently associated with a limitation of pronation/supination of 20° or more. CONCLUSIONS: These findings imply that a re-fracture and a diaphyseal located fracture were associated independently of each other with a limitation of pronation/supination in children with a both-bone forearm fracture. Furthermore, in children with severe limitation extensive physiotherapy is associated with better functional outcome.

Conversion to below-elbow cast after 3 weeks is safe for diaphyseal both-bone forearm fractures in children.

BACKGROUND: It is unclear whether it is safe to convert above-elbow cast (AEC) to below-elbow cast (BEC) in a child who has sustained a displaced diaphyseal both-bone forearm fracture that is stable after reduction. In this multicenter study, we wanted to answer the question: does early conversion to BEC cause similar forearm rotation to that after treatment with AEC alone? CHILDREN AND METHODS: Children were randomly allocated to 6 weeks of AEC, or 3 weeks of AEC followed by 3 weeks of BEC. The primary outcome was limitation of pronation/supination after 6 months. The secondary outcomes were re-displacement of the fracture, limitation of flexion/extension of the wrist and elbow, complication rate, cast comfort, complaints in daily life, and cosmetics of the fractured arm. RESULTS: 62 children were treated with 6 weeks of AEC, and 65 children were treated with 3 weeks of AEC plus 3 weeks of BEC. The follow-up rate was 60/62 and 64/65, respectively with a mean time of 6.9 (4.7-13) months. The limitation of pronation/supination was similar in both groups (18 degrees for the AEC group and 11 degrees for the AEC/BEC group). The secondary outcomes were similar in both groups, with the exception of cast comfort, which was in favor of the AEC/BEC group. INTERPRETATION: Early conversion to BEC cast is safe and results in greater cast comfort.

Early conversion to below-elbow cast for non-reduced diaphyseal both-bone forearm fractures in children is safe: preliminary results of a multicentre randomised controlled trial.

INTRODUCTION: This multicentre randomised controlled trial was designed to explore whether 6 weeks above-elbow cast (AEC) or 3 weeks AEC followed by 3 weeks below-elbow cast (BEC) cause similar limitation of pronation and supination in non-reduced diaphyseal both-bone forearm fractures in children. MATERIALS AND METHODS: Children were randomly allocated to 6 weeks AEC or to 3 weeks AEC followed by 3 weeks BEC. The primary outcome was limitation of pronation and supination after 6 months. The secondary outcomes were re-displacement of the fracture, complication rate, limitation of flexion and extension of wrist and elbow, cast comfort, cosmetics, complaints in daily life and assessment of radiographs. RESULTS: A group of 23 children was treated with 6 weeks AEC and 24 children with 3 weeks AEC and 3 weeks BEC. The follow-up rate was 98 % with a mean follow-up of 7.0 months. The mean limitation of pronation and supination was 23.3 ± 22.0 for children treated with AEC and 18.0 ± 16.9 for children treated with AEC and BEC. The other study outcomes were similar in both groups. CONCLUSIONS: Early conversion to BEC is safe in the treatment of non-reduced diaphyseal both-bone forearm fractures in children. LEVEL OF EVIDENCE: Multicentre randomised controlled trial, Level II.

The timing of ankle fracture surgery and the effect on infectious complications; a case series and systematic review of the literature.

PURPOSE: Information about the influence of delayed surgery on infectious wound complications is ambiguous. A clinical audit was performed to test the hypothesis that early surgery lowers the rate of infectious wound complications. Secondly we looked at the influence of surgical delay and complications on patient reported functional outcome. METHODS: All consecutive, closed distal fibular fractures treated surgically with a plate were included and retrospectively analysed for the delay in operation and wound complications. In a second cohort of patients with a AO-Weber B-type ankle fracture outcome was measured using the Olerud-Molander ankle score (OMAS), the American Orthopaedic Foot and Ankle Society score (AOFAS) and a visual analog score (VAS) for overall satisfaction. RESULTS: Patients treated within one day experienced no wound complications (zero out of 60), whereas in the delayed group 11% (16/145) did (p = 0.004). A similar significant difference was found for the patients treated within one week (2/98) versus after one week (14/107). A systematic review of the literature showed a difference in wound complications of 3.6% (early) versus 12.9% (late) (p < 0.0001). After 43 months, the median AOFAS was 11.5 points lower in the complication group, the OMAS 10 points, and the VAS 0.5 points, with all differences being statistically significant. CONCLUSIONS: Every effort should be made to operate on closed ankle fractures as soon as reasonably possible. A delay in surgery is associated with a significant rise in infectious wound complications, which significantly lowers outcome and patient satisfaction. These fractures should preferably be treated within the first day.

Do clinical characteristics and outcome in nonagenarians with a hip fracture differ from younger patients?

AIM: To compare clinical characteristics and outcome of nonagenarian hip fracture patients with younger patients aged 65-89 years. METHODS: This was a cohort follow-up study of admissions for a hip fracture between 2005-2010 (mean follow up of 3.5 years) in two teaching hospitals in The Netherlands; 230 nonagenarians and 1014 patients aged 65-89 years were included. Clinical characteristics, adverse events, mobility and mortality were compared. RESULTS: Nonagenarians were more likely to be female and anemic (both P<0.001), and had more trochanteric fractures (P=0.005). The number of American Society of Anesthesiologists III/VI classified patients did not differ between the two groups. During the hospital stay, adverse events were more frequently observed in nonagenarians compared with younger patients (P<0.001). The length of stay was significantly longer in nonagenarians (P<0.001), and the 90-day readmission rate was similar. Absolute mortality was higher in nonagenarians (P<0.001), excess mortality, however, was comparable. Before admission, 40.0% of the nonagenarians lived in their own home, and 40.9% had returned 3 months postfracture. The rate of returning to their own home was lower compared with younger patients (P<0.001). Prefracture mobility was worse in nonagenarians compared with the younger group, but 3 months after discharge, the number of patients that regained prefracture mobility was comparable in both age groups. CONCLUSIONS: Nonagenarian hip fracture patients differ significantly from younger patients aged 65-89 years with respect to clinical characteristics and long-term outcome. However, almost half of the nonagenarians returned to their own home and more than half regained their prefracture level of mobility. Given these findings, prevention strategies for hip fracture and adverse events during hospital stay that focus particularly on frail nonagenarians are highly recommended.

More than half of hip fracture patients do not regain mobility in the first postoperative year.

AIM: To measure functional recovery and determine risk factors for failure to return to the prefracture level of mobility of hip fracture patients 1 year postoperatively. METHODS: A prospective cohort follow-up study of 390 hip fracture patients aged 65 years and older was carried out. Patients were stratified in categories based on prefracture mobility: mobile without aid, with aid in- and outdoors, or only mobile indoors. Immobile patients were excluded. Risk factors for not regaining prefracture mobility were identified. RESULTS: Nearly half of all patients regained their prefracture level of mobility after 1 year. Mobile patients without an aid were less likely to return to their prefracture mobility level compared with patients who were mobile with aid or mobile indoors. After 1 year, 18.7% of all patients had become immobile. Most important independent risk factors for failure to return to the prefracture level of mobility were a limited prefracture level of activities of daily living and a delirium during admission. CONCLUSIONS: The risk not to regain prefracture mobility is highest in mobile patients without an aid. The risk of becoming immobile is higher in those having a lower prefracture mobility. Activities of daily living dependence and delirium were the main risk factors for not regaining mobility.

Re-displacement of stable distal both-bone forearm fractures in children: a randomised controlled multicentre trial.

INTRODUCTION: Displaced metaphyseal both-bone fractures of the distal forearm are generally reduced and stabilised by an above-elbow cast (AEC) with or without additional pinning. The purpose of this study was to find out if re-displacement of a reduced stable metaphyseal both-bone fracture of the distal forearm in a child could be prevented by stabilisation with Kirschner wires. METHODS: Consecutive children aged <16 years with a displaced metaphyseal both-bone fracture of the distal forearm (n = 128) that was stable after reduction were randomised to AEC with or without percutaneous fixation with Kirschner wires. The primary outcome was re-displacement of the fracture. RESULTS: A total of 67 children were allocated to fracture reduction and AEC and 61 to reduction of the fracture, fixation with Kirschner wires and AEC. The follow-up rate was 96% with a mean follow-up of 7.1 months. Fractures treated with additional pinning showed less re-displacement (8% vs. 45%), less limitation of pronation and supination (mean limitation 6.9 (± 9.4)° vs. 14.3 (± 13.6)°) but more complications (14 vs. 1). CONCLUSIONS: Pinning of apparent stable both-bone fractures of the distal forearm in children might reduce fracture re-displacement. The frequently seen complications of pinning might be reduced by a proper surgical technique.

Contralateral hip fractures and other osteoporosis-related fractures in hip fracture patients: incidence and risk factors. An observational cohort study of 1,229 patients.

PURPOSE: To report risk factors, 1-year and overall risk for a contralateral hip and other osteoporosis-related fractures in a hip fracture population. METHODS: An observational study on 1,229 consecutive patients of 50 years and older, who sustained a hip fracture between January 2005 and June 2009. Fractures were scored retrospectively for 2005-2008 and prospectively for 2008-2009. Rates of a contralateral hip and other osteoporosis-related fractures were compared between patients with and without a history of a fracture. Previous fractures, gender, age and ASA classification were analysed as possible risk factors. RESULTS: The absolute risk for a contralateral hip fracture was 13.8 %, for one or more osteoporosis-related fracture(s) 28.6 %. First-, second- and third-year risk for a second hip fracture was 2, 1 and 0 %. Median (IQR) interval between both hip fractures was 18.5 (26.6) months. One-year incidence of other fractures was 6 %. Only age was a risk factor for a contralateral hip fracture, hazard ratio (HR) 1.02 (1.006-1.042, p = 0.008). Patients with a history of a fracture (33.1 %) did not have a higher incidence of fractures during follow-up (16.7 %) than patients without fractures in their history (14 %). HR for a contralateral hip fracture for the fracture versus the non-fracture group was 1.29 (0.75-2.23, p = 0.360). CONCLUSION: The absolute risk of a contralateral hip fracture after a hip fracture is 13.8 %, the 1-year risk was 2 %, with a short interval between the 2 hip fractures. Age was a risk factor for sustaining a contralateral hip fracture; a fracture in history was not.

Below-elbow cast for metaphyseal both-bone fractures of the distal forearm in children: a randomised multicentre study.

INTRODUCTION: Minimally displaced metaphyseal both-bone fractures of the distal forearm in children are often treated with an above-elbow cast (AEC). Treatment with a below-elbow cast (BEC) could give more comfort, but might lead to fracture displacement reducing pronation and supination. Because this has not been systematically investigated, we set up a randomised multicentre study. The purpose of this study was to find out whether BEC causes equal limitation of pronation and supination but with higher comfort level, compared with AEC. PATIENTS AND METHODS: In four hospitals, consecutive children aged<16 (mean 7.1) years with a minimally displaced metaphyseal both-bone fracture of the distal forearm were randomised to 4 weeks BEC (n=35) or 4 weeks AEC (n=31). Primary outcome was limitation of pronation and supination 6 months after initial trauma. The secondary outcomes were cast comfort, limitation of flexion/extension of wrist/elbow, complications, cosmetics, complaints, and radiological assessment. RESULTS: A group of 35 children received BEC and 31 children received AEC. All children attended for the final examination at a mean follow-up of 7.0 months (range 5.0-11.6 months). Limitation of pronation and supination 6 months after initial trauma showed no significant difference between the two groups [4.4° (± 5.8) for BEC and 5.8° (± 9.8) for AEC]. Children treated with BEC had significantly higher cast comfort on a visual analogue scale [5.6 (± 2.7) vs. 8.4 (± 1.4)] and needed significantly less help with dressing (8.2 days vs. 15.1 days). Six complications occurred in the BEC group and 14 in the AEC group. Other secondary outcomes were similar between the two groups. CONCLUSIONS: Children with minimally displaced metaphyseal both-bone fractures of the distal forearm should be treated with a below-elbow cast.

Risk factors for failure to return to the pre-fracture place of residence after hip fracture: a prospective longitudinal study of 444 patients.

INTRODUCTION: Long-term place of residence after hip fracture is not often described in literature. The goal of this study was to identify risk factors, known at admission, for failure to return to the pre-fracture place of residence of hip fracture patients in the first year after a hip fracture. METHODS: This is a prospective longitudinal study of 444 consecutive admissions of hip fracture patients aged ≥ 65 years. Place of residence prior to admission, at discharge, after 3 and 12 months was registered. Patients admitted from a nursing home (n = 49) were excluded from statistical analysis. Multivariable logistic regression analysis was performed, using age, gender, presence of a partner, ASA-score, dementia, anaemia at admission, type of fracture, pre-fracture level of mobility and level of activities of daily living (ADL) as possible risk factors. RESULTS: Two hundred eighty-nine patients lived in their own home, 31.8% returned at discharge, 72.9% at 3 months and 72.8% at 12 months. Age, absence of a partner, dementia, and a lower pre-fracture level of ADL or mobility were independent contributors to failure to return to their own home at discharge, 3 or 12 months. 106 patients lived in a residential home; 33.3% returned at discharge, 68.4% at 3 months and 64.4% at 12 months. Age was an independent contributor to failure to return to a residential home. CONCLUSIONS: Age, dementia and a lower pre-fracture level of ADL were the main significant risk factors for failure to return to the pre-fracture residence. As the 3- and 12-month return-rates were similar, 3-month follow-up might be used as an endpoint in future research.

Outcome in hip fracture patients related to anemia at admission and allogeneic blood transfusion: an analysis of 1262 surgically treated patients.

BACKGROUND: Anemia is more often seen in older patients. As the mean age of hip fracture patients is rising, anemia is common in this population. Allogeneic blood transfusion (ABT) and anemia have been pointed out as possible risk factors for poorer outcome in hip fracture patients. METHODS: In the timeframe 2005-2010, 1262 admissions for surgical treatment of a hip fracture in patients aged 65 years and older were recorded. Registration was prospective from 2008 on. Anemic and non-anemic patients (based on hemoglobin level at admission) were compared regarding clinical characteristics, mortality, delirium incidence, LOS, discharge to a nursing home and the 90-day readmission rate. Receiving an ABT, age, gender, ASA classification, type of fracture and anesthesia were used as possible confounders in multivariable regression analysis. RESULTS: The prevalence of anemia and the rate of ABT both were 42.5%. Anemic patients were more likely to be older and men and had more often a trochanteric fracture, a higher ASA score and received more often an ABT. In univariate analysis, the 3- and 12-month mortality rate, delirium incidence and discharge to a nursing home rate were significantly worse in preoperatively anemic patients.In multivariable regression analysis, anemia at admission was a significant risk factor for discharge to a nursing home and readmission < 90 days, but not for mortality. Indication for ABT, age and ASA classification were independent risk factors for mortality at all moments, only the mortality rate for the 3-12 month interval was not influenced by ABT. An indication for an ABT was the largest negative contributor to a longer LOS (OR 2.26, 95% CI 1.73-2.94) and the second largest for delirium (OR 1.67, 95% CI 1.28-2.20). CONCLUSIONS: This study has demonstrated that anemia at admission and postoperative anemia needing an ABT (PANT) were independent risk factors for worse outcome in hip fracture patients. In multivariable regression analysis, anemia as such had no effect on mortality, due to a rescue effect of PANT. In-hospital, 3- and 12-month mortality was negatively affected by PANT, with the main effect in the first 3 months postoperatively.

Delirium risk screening and haloperidol prophylaxis program in hip fracture patients is a helpful tool in identifying high-risk patients, but does not reduce the incidence of delirium.

BACKGROUND: Delirium in patients with hip fractures lead to higher morbidity and mortality. Prevention in high-risk patients by prescribing low dose haloperidol is currently under investigation. METHODS: This prospective cohort surveillance assessed hip fracture patients for risk of developing a delirium with the Risk Model for Delirium (RD) score. High-risk patients (score ≥ 5 points) were treated with a prophylactic low-dose of haloperidol according to hospital protocol. Primary outcome was delirium incidence. Secondary outcomes were differences between high- and low-risk patients in delirium, length of stay (LOS), return to pre-fracture living situation and mortality. Logistic regression analysis was performed with age, ASA-classification, known dementia, having a partner, type of fracture, institutional residence and psychotropic drug use as possible confounders. RESULTS: 445 hip fracture patients aged 65 years and older were admitted from January 2008 to December 2009. The RD-score was completed in 378 patients, 173 (45.8%) high-risk patients were treated with prophylactic medication. Sensitivity was 71.6%, specificity 63.8% and the negative predictive value (NPV) of a score < 5 was 85.9%.Delirium incidence (27.0%) was not significantly different compared to 2007 (27.8%) 2006 (23.9%) and 2005 (29.0%) prior to implementation of the RD- protocol.Logistic regression analysis showed that high-risk patients did have a significant higher delirium incidence (42.2% vs. 14.1%, OR 4.1, CI 2.43-7.02). They were more likely to be residing at an alternative living situation after 3 months (62.3% vs. 17.0%, OR 6.57, CI 3.23-13.37) and less likely to be discharged from hospital before 10 days (34.9% vs. 55.9%, OR 1.63, CI 1.03-2.59). Significant independent risk factors for a delirium were a RD-score ≥ 5 (OR 4.13, CI 2.43-7.02), male gender (OR 1.93, CI 0.99-1.07) and age (OR 1.03, CI 0.99-1.07). CONCLUSIONS: Introducing the delirium prevention protocol did not reduce delirium incidence.The RD-score did identify patients with a high risk to develop a delirium. This high-risk group had a longer LOS and returned to pre-fracture living situation less often.The NPV of a score < 5 was high, as it should be for a screening instrument. Concluding, the RD-score is a useful tool to identify patients with poorer outcome.

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.

[Cost] effectiveness of withdrawal of fall-risk increasing drugs versus conservative treatment in older fallers: design of a multicenter randomized controlled trial (IMPROveFALL-study).

BACKGROUND: Fall incidents represent an increasing public health problem in aging societies worldwide. A major risk factor for falls is the use of fall-risk increasing drugs. The primary aim of the study is to compare the effect of a structured medication assessment including the withdrawal of fall-risk increasing drugs on the number of new falls versus 'care as usual' in older adults presenting at the Emergency Department after a fall. METHODS/DESIGN: A prospective, multi-center, randomized controlled trial will be conducted in hospitals in the Netherlands. Persons aged ≥65 years who visit the Emergency Department due to a fall are invited to participate in this trial. All patients receive a full geriatric assessment at the research outpatient clinic. Patients are randomized between a structured medication assessment including withdrawal of fall-risk increasing drugs and 'care as usual'. A 3-monthly falls calendar is used for assessing the number of falls, fallers and associated injuries over a one-year follow-up period. Measurements will be at three, six, nine, and twelve months and include functional outcome, healthcare consumption, socio-demographic characteristics, and clinical information. After twelve months a second visit to the research outpatient clinic will be performed, and adherence to the new medication regimen in the intervention group will be measured. The primary outcome will be the incidence of new falls. Secondary outcome measurements are possible health effects of medication withdrawal, health-related quality of life (Short Form-12 and EuroQol-5D), costs, and cost-effectiveness of the intervention. Data will be analyzed using an intention-to-treat analysis. DISCUSSION: The successful completion of this trial will provide evidence on the effectiveness of withdrawal of fall-risk increasing drugs in older patients as a method for falls reduction. TRIAL REGISTRATION: The trial is registered in the Netherlands Trial Register (NTR1593).

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).

Demographics and functional outcome of toe fractures.

Toe fractures are common; however, there are few data on demographics and functional outcome. We studied outcomes in 339 consecutive patients with toe fractures treated between January 2006 and September 2008. Two hundred and sixty-four patients, aged 16 to 75, were mailed an outcome questionnaire, and overall subjective satisfaction with the outcome of treatment was measured using a visual analog scale (VAS). Most frequently affected were the first (38%) and fifth (30%) toes, and most (75.6%) of the fractures were caused by stubbing or crush injury. More than 95% of the fractures were displaced less than 2 mm, and all of the fractures were treated conservatively. The questionnaire was returned by 141 (53%) patients with a median follow-up of 27 months. Respondents were female in 57.4% of cases and had a median age of 45 years. The median AOFAS score was 100 (P(25), P(75) = 93,100) points; the median VAS was 10 (P(25), P(75) = 8, 10) points. Univariate regression analysis revealed no statistically significant associations between outcome and the particular toe or phalanx involved, number of fractured toes, fracture type and location, articular involvement, gender, age, body mass index, smoking habits, and the presence of diabetes mellitus. Satisfaction VAS was dependent on age (P = .047) and gender (P = .049) in the multivariate analysis. The AOFAS midfoot score was not influenced by any of the covariates. This is the first epidemiological investigation using 2 outcome-scoring systems to determine function and satisfaction following treatment of toe fractures.