Injury
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Multicenter Study
Do design adaptations of a trochanteric nail make sense for Asian patients? Results of a multicenter study of the PFNA-II in Japan.
Asian patients with osteoporosis suffer from an increased incidence of hip fracture and a potentially increased risk of fixation failure due to anatomical differences compared to Caucasians. To cope with these differences, an Asian size- and geometry-adapted Proximal Femoral Nail Antirotation (PFNA-II) was developed. The objective of this prospective multicenter study was to assess the risk of fracture fixation complications (FFCs), the occurrence of mismatch and the quality of life status of patients treated with the PFNA-II. ⋯ The reported complication risks and mismatches are reasonable for this patient cohort. The geometry- and size-adapted PFNA-II is relatively safe but requires standardized assessment in a larger target cohort.
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Randomized Controlled Trial Multicenter Study Pragmatic Clinical Trial
Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial: Design, rationale and implementation.
Forty percent of in-hospital deaths among injured patients involve massive truncal haemorrhage. These deaths may be prevented with rapid haemorrhage control and improved resuscitation techniques. The Pragmatic Randomized Optimal Platelet and Plasma Ratios (PROPPR) Trial was designed to determine if there is a difference in mortality between subjects who received different ratios of FDA approved blood products. This report describes the design and implementation of PROPPR. ⋯ PROPPR is the largest randomized study to enrol severely bleeding patients. This study showed that rapidly enrolling and successfully providing randomized blood products to severely injured patients in an EFIC study is feasible. PROPPR was able to achieve these goals by utilizing a collaborative structure and developing successful procedures and design elements that can be part of future trauma studies.
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Multicenter Study
A clinical evaluation of alternative fixation techniques for medial malleolus fractures.
Medial malleolus fractures have traditionally been managed using partially threaded screws and/or Kirschner wire fixation. Using these conventional techniques, a non-union rate of as high as 20% has been reported. In addition too many patients complaining of prominent hardware as a source of pain post-fixation. This study was designed to assess the outcomes of medial malleolar fixation using a headless compression screw in terms of union rate, the need for hardware removal, and pain over the hardware site. ⋯ Headless compression screws provide effective compression of medial malleolus fractures and result in good clinical outcomes. The headless compression screw is a beneficial alternative to the conventional methods of medial malleolus fixation.
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Multicenter Study Observational Study
Decompressive craniectomy for severe traumatic brain injury: The relationship between surgical complications and the prediction of an unfavourable outcome.
To assess the impact that injury severity has on complications in patients who have had a decompressive craniectomy for severe traumatic brain injury (TBI). ⋯ Mechanical complications after decompressive craniectomy including herniation of the brain outside the skull bone defects, subdural effusion, and hydrocephalus requiring ventriculo-peritoneal shunt were more common in patients with a more severe form of TBI when quantified by the CRASH predicted risk of unfavourable outcome. The CRASH predicted risk of unfavourable outcome represents a useful baseline characteristic of patients in observational and interventional trials involving patients with severe TBI requiring decompressive craniectomy.
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Multicenter Study
Trends in moderate to severe paediatric trauma in Central Netherlands.
Trend analyses of hospital discharge data can raise signals for prevention policies, but are often flawed by changes in health care consumption. This is a trend analysis of the clinical incidence of paediatric trauma that used international criteria to overcome this bias. The objective is to describe trends in clinical incidence of moderate to severe paediatric trauma, and to identify target groups for prevention activities. ⋯ The incidence of paediatric trauma in the centre of the Netherlands increased since 2001. Trend analyses on moderate and severe injuries may identify target groups for prevention in a trauma region.