Injury
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Randomized Controlled Trial Comparative Study
Fragility fractures of the ankle in the elderly: Open reduction and internal fixation versus tibio-talo-calcaneal nailing: Short-term results of a prospective randomized-controlled study.
The management of ankle fractures in the elderly remains unpredictable, secondary to their various co-morbidities. Although tibiotalocalcaneal (TTC) nailing has been an effective option for ankle arthrodesis due to ankle arthritis or Charcot arthropathy there are few reports regarding the use of TTC nail for the treatment of ankle fractures. ⋯ We believe that TTC nailing is a safe and effective method of treatment of unstable ankle fractures in the elderly because it has a low risk of complications and restores function and mobility allowing an immediate return to full weight-bearing.
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Randomized Controlled Trial Comparative Study
Fixation of intra-articular fractures of the distal radius using intramedullary nailing: a randomized trial versus palmar locking plates.
Proposed benefits of intramedullary techniques include limited soft tissue dissection while affording sufficient stability to allow early wrist motion. The primary null hypothesis of this randomized trial was that there is no significant difference with respect to functional outcome, pain and disability between patients treated with either 2.4-mm volar locking plate fixation or intramedullary nail fixation of intra-articular fractures of the distal radius. ⋯ The present study suggests that intramedullary nail fixation is a reasonable alternative to volar plate fixation for the treatment of intra-articular distal radius fractures and both techniques can yield reliably good results.
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Randomized Controlled Trial Comparative Study
A prospective randomised non-blinded comparison of conventional and Dorgan's crossed pins for paediatric supracondylar humeral fractures.
Closed reduction and percutaneous pinning are the preferred treatment of displaced supracondylar humeral fractures in children. The purpose of this study is to evaluate the non-standard Dorgan's method and compare its results with those of the standard percutaneous cross pinning method in treatment of unstable or irreducible Gartland type II and III supracondylar humeral fractures in children. ⋯ Two laterally inserted crossed pins provide adequate stability with good functional and cosmetic outcome for most unstable paediatric supracondylar humeral fractures with no risk of iatrogenic ulnar nerve injury.
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Assessing protocol adherence in a clinical trial with ordered treatment regimens: Quantifying the pragmatic, randomized optimal platelet and plasma ratios (PROPPR) trial experience.
Medication dispensing errors are common in clinical trials, and have a significant impact on the quality and validity of a trial. Therefore, the definition, calculation and evaluation of such errors are important for supporting a trial's conclusions. A variety of medication dispensing errors can occur. In this paper, we focus on errors in trials where the intervention includes multiple therapies that must be given in a pre-specified order that varies across treatment arms and varies in duration. ⋯ Overall, PROPPR adherence to blood transfusion order pre-specified in the protocol was high, and the required order of transfusions for the 1:1:2 group was more difficult to achieve. The approaches proposed in this manuscript were useful in evaluating the PROPPR adherence and are potentially useful for other trials where a specific treatment orders with varying durations must be maintained.
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Randomized Controlled Trial Multicenter Study
Is distal locking with short intramedullary nails necessary in stable pertrochanteric fractures? A prospective, multicentre, randomised study.
We investigated whether a proximal femoral nail can be implanted without a distal locking screw in AO/OTA 31-A1 and 31-A2 pertrochanteric stable femur fractures. A multicentre, randomised study was conducted in six level-two trauma centres in our area (Puglia, Italy). A total of 333 patients received their allocated intervention (162 in the locking group [LG] and 171 in the unlocking group [UG]) and 266 patients were included in the final analysis at 1year. ⋯ There were also no statistically significant differences between groups for mortality and length of hospital stay. Conversely, the UG was associated with shorter operation and fluoroscopy times, shorter surgical incision length, and less blood loss and residual thigh pain. Pertrochanteric stable fractures (31-A1, 31-A2) can be treated successfully with intramedullary nails without distal locking, reducing patient and clinical personnel radiation exposure and sanitary costs (surgery time and screws costs).