39 research outputs found
Percutane schroeffixatie voor osteoporotische sacrumfracturen bij oudere patiënten
Abstract:
In older patients, pubic rami fractures resulting from low-impact falls are generally
considered to be stable and treated non-operatively. An associated sacral fracture is easily missed on plain radiography but can result in debilitating pain. The objective of this report is to present our experience with percutaneous sacro-iliac screw fixation in 2 elderly patients with (missed) osteoporotic sacral fractures. We conclude that "isolated" pubic rami fractures in elderly patients should prompt careful investigation to rule out an associated sacral fracture particularly in patients with lower back or sacral pain. In the presence of a sacral fracture, early percutaneous sacro-iliac screw fixation to allow rapid mobilization should be considered in selected patients
Plate fixation or intramedullary fixation of humeral shaft fractures: An updated meta-analysis
Background The optimal approach to operative treatment of humeral shaft fractures remains debatable. Previously published trials have been limited in size and have been inconclusive regarding important patient outcome variables following treatment with either intramedullary nails or plates. We conducted a meta-analysis of available trials comparing treatment of humeral shaft fractures
Early mobilisation versus plaster immobilisation of simple elbow dislocations: Results of the FuncSiE multicentre randomised clinical trial
Background/aim To compare outcome of early mobilisation and plaster immobilisation in patients with a simple elbow dislocation. We hypothesised that early mobilisation would result in earlier functional recovery. Methods From August 2009 to September 2012, 100 adult patients with a simple elbow dislocation were enrolled in this multicentre randomised controlled trial. Patients were randomised to early mobilisation (n=48) or 3 weeks plaster immobilisation (n=52). Primary outcome measure was the Quick Disabilities of the Arm, Shoulder, and Hand (Quick-DASH) score. Secondary outcomes were the Oxford Elbow Score, Mayo Elbow Performance Index, pain, range of motion, complications and activity resumption. Patients were followed for 1 year. Results Quick-DASH scores at 1 year were 4.0 (95% CI 0.9 to 7.1) points in the early mobilisation group versus 4.2 (95% CI 1.2 to 7.2) in the plaster immobilisation group. At 6 weeks, early mobilised patients reported less disability (Quick-DASH 12 (95% CI 9 to 15) points vs 19 (95% CI 16 to 22); p<0.05) and had a larger arc of flexion and extension (121° (95% CI 115° to 127°) vs 102° (95% CI 96° to 108°); p<0.05). Patients returned to work sooner after early mobilisation (10 vs 18 days; p=0.020). Complications occurred in 12 patients; this was unrelated to treatment. No recurrent dislocations occurred. Conclusions Early active mobilisation is a safe and effective treatment for simple elbow dislocations. Patients recovered faster and returned to work earlier without increasing the complication rate. No evidence was found supporting treatment benefit at 1 year
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)
Central coordination as an alternative for local coordination in a multicenter randomized controlled trial: the FAITH trial experience
Contains fulltext :
110505.pdf (publisher's version ) (Open Access)BACKGROUND: Surgeons in the Netherlands, Canada and the US participate in the FAITH trial (Fixation using Alternative Implants for the Treatment of Hip fractures). Dutch sites are managed and visited by a financed central trial coordinator, whereas most Canadian and US sites have local study coordinators and receive per patient payment. This study was aimed to assess how these different trial management strategies affected trial performance. METHODS: Details related to obtaining ethics approval, time to trial start-up, inclusion, and percentage completed follow-ups were collected for each trial site and compared. Pre-trial screening data were compared with actual inclusion rates. RESULTS: Median trial start-up ranged from 41 days (P25-P75 10-139) in the Netherlands to 232 days (P25-P75 98-423) in Canada (p = 0.027). The inclusion rate was highest in the Netherlands; median 1.03 patients (P25-P75 0.43-2.21) per site per month, representing 34.4% of the total eligible population. It was lowest in Canada; 0.14 inclusions (P25-P75 0.00-0.28), representing 3.9% of eligible patients (p < 0.001). The percentage completed follow-ups was 83% for Canadian and Dutch sites and 70% for US sites (p = 0.217). CONCLUSIONS: In this trial, a central financed trial coordinator to manage all trial related tasks in participating sites resulted in better trial progression and a similar follow-up. It is therefore a suitable alternative for appointing these tasks to local research assistants. The central coordinator approach can enable smaller regional hospitals to participate in multicenter randomized controlled trials. Circumstances such as available budget, sample size, and geographical area should however be taken into account when choosing a management strategy. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00761813
Dutch Prospective Observational Study on Prehospital Treatment of Severe Traumatic Brain Injury: The BRAIN-PROTECT Study Protocol
Background: Severe traumatic brain injury (TBI) is associated with a high mortality rate and those that survive
commonly have permanent disability. While there is a
broad consensus that appropriate prehospital treatment is
crucial for a favorable neurological outcome, evidence to
support currently applied treatment strategies is scarce. In
particular, the relationship between prehospital treatments
and patient outcomes is unclear. The BRAIN-PROTECT
study therefore aims to identify prehospital treatment
strategies associated with beneficial or detrimental outcomes. Here, we present the study protocol. Study
Protocol: BRAIN-PROTECT is the acronym for BRAin
INjury: Prehospital Registry of Outcome, Treatments and
Epidemiology of Cerebral Trauma. It is a prospective
observational study on the prehospital treatment of
patients with suspected severe TBI in the Netherlands.
Prehospital epidemiology, interventions, medication strategies, and nonmedical factors that may affect outcome are
studied. Multivariable regression based modeling will be
used to identify confounder-adjusted relationships
between these factors and patient outcomes, including
mortality at 30 days (primary outcome) or mortality and
functional neurological outcome at 1 year (secondary outcomes). Patients in whom severe TBI is suspected during
prehospital treatment (Glasgow Coma Scale score 8 in
combination with a trauma mechanism or clinical findings
suggestive of head injury) are identified by all four helicopter emergency medical services (HEMS) in the
Netherlands. Patients are prospectively followed up in 9
participating trauma centers for up to one year. The
manuscript reports in detail the objectives, setting, study
design, patient inclusion, and data collection process.
Ethical and juridical aspects, statistical considerations, as
well as limitations of the study design are discussed.
Discussion: Current prehospital treatment of patients
with suspected severe TBI is based on marginal evidence,
and optimal treatment is basically unknown. The BRAINPROTECT study provides an opportunity to evaluate and
compare different treatment strategies with respect to
patient outcomes. To our knowledge, this study project is
the first large-scale prospective prehospital registry of
patients with severe TBI that also collects long-term follow-up data and ma
Factors Associated with Revision Surgery after Internal Fixation of Hip Fractures
Background: Femoral neck fractures are associated with high rates of revision surgery after management with internal fixation. Using data from the Fixation using Alternative Implants for the Treatment of Hip fractures (FAITH) trial evaluating methods of internal fixation in patients with femoral neck fractures, we investigated associations between baseline and surgical factors and the need for revision surgery to promote healing, relieve pain, treat infection or improve function over 24 months postsurgery. Additionally, we investigated factors associated with (1) hardware removal and (2) implant exchange from cancellous screws (CS) or sliding hip screw (SHS) to total hip arthroplasty, hemiarthroplasty, or another internal fixation device. Methods: We identified 15 potential factors a priori that may be associated with revision surgery, 7 with hardware removal, and 14 with implant exchange. We used multivariable Cox proportional hazards analyses in our investigation. Results: Factors associated with increased risk of revision surgery included: female sex, [hazard ratio (HR) 1.79, 95% confidence interval (CI) 1.25-2.50; P = 0.001], higher body mass index (fo
A Retrospective Study of Five Clinical Criteria and One Age Criterion for Selective Prehospital Spinal Immobilization
Full spinal immobilization of blunt trauma victims is a widely accepted prehospital measure, applied in order to prevent (further) damage to the spinal cord. However, looking at the marginal evidence that exists for the effectiveness of spinal immobilization, and the growing evidence for the negative effects following immobilization, a more selective protocol might be able to reduce possible morbidity and mortality as good as the present prehospital immobilization protocol. In a retrospective study, the sensitivity of a selective prehospital immobilization protocol that adds an age criterion to five clinical spine clearance criteria is examined. Based on ICD-9 codes, all patients admitted to the trauma center diagnosed with spinal fractures with or without spinal damage were identified. The sensitivity of the combination of five clinical criteria (reduced awareness, evidence of intoxication, neurological deficit, pain of the spine on palpation, (significant) distracting injury) and an age criterion (65 years or older at time of accident) was determined. If one or more criteria were positive, standard full immobilization would be indicated. The other patients would not have been immobilized. A total of 238 blunt trauma victims primarily admitted to the trauma center were included for this study. Median age of the included patients was 39 years (range 5-98), with 32.8% female. A total of 236 had at least one positive criterion (sensitivity 99.2%). The two missed patients were male, 40 and 41 years old. Radiology showed a small fissure in the arch of C2, and a transverse process fracture of L3, respectively. Both patients were discharged the next day without complications or medical interventions. In this retrospective study, a selective protocol based on clinical criteria instead of trauma mechanism showed 99.2% sensitivity for spinal fractures with or without spinal cord damage. Based on this study and the current controversy surrounding spinal immobilization, a prospective study should be considered to evaluate the five clinical criteria and one age criterion in the prehospital settin
Trauma and psychiatric disorders: A systematic review
Suicide is currently a topic of high priority for policy-makers, researchers and clinicians. The World Health Organization estimated 804,000 suicide deaths worldwide in 2012. Some studies that focused on patients with self-inflicted injury revealed that mortality in this group is higher than for patients who sustain unintentional injury. However little is known about the impact of psychiatric disorders on health care resources including length of hospital stay. To determine whether trauma patients with a psychiatric disorder or after attempting suicide are at higher risk of a complicated course than patients without a psychiatric disorder or accidental cause. The secondary objective was to provide an overview of the current literature on the same group of trauma patients with psychiatric comorbidity in regard to mortality rate, length of stay, hospital costs and quality of life. Our primary outcome measure, complicated course, was found to be most clinically relevant. We searched PubMed, Embase and PsycInfo electronic databases. All searches were updated to March 2016. The methodological quality was assessed using the QUIPS tool. Our search identified 9284 articles (PubMed 3660, Embase 2590, PsycInfo 3034). Of these, 18 articles were included. Four studies investigated the association between psychiatric disorders and a complicated course after trauma, three found a significant higher risk of complications. Mortality was reviewed in 14 studies, of which seven showed significant higher risk of in-hospital mortality for trauma patients with psychiatric disorder. Eight of nine studies found significant prolonged length of stay for these patients. Patients who have a psychiatric disorder or who have attempted suicide are at higher risk of increased in-hospital mortality and prolonged length of stay after sustaining injuries. These patients also tend to be at higher risk of complications after severe trauma, however future research is needed to confirm these potentially important implications. Systematic review, level II