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- Goldhahn, Jörg, et al.
(författare)
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Clinical evaluation of medicinal products for acceleration of fracture healing in patients with osteoporosis
- 2008
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Ingår i: Bone. - : Elsevier BV. - 8756-3282 .- 1873-2763. ; 43:2, s. 343-347
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Tidskriftsartikel (refereegranskat)abstract
- Pre-clinical studies indicate that pharmacologic agents can augment fracture union. If these pharmacologic approaches could be translated into clinical benefit and offered to patients with osteoporosis or patients with other risks for impaired fracture union (e.g. in subjects with large defects or open fractures with high complication rate), they could provide an important adjunct to the treatment of fractures. However, widely accepted guidelines are important to encourage the conduct of studies to evaluate bioactive substances, drugs, and new agents that may promote fracture union and subsequent return to normal function. A consensus process was initiated to provide recommendations for the clinical evaluation of potential therapies to augment fracture repair in patients with meta- and diaphyseal fractures. Based on the characteristics of fracture healing and fixation, the following study objectives of a clinical study may be appropriate: a) acceleration of fracture union, b) acceleration of return to normal function and c) reduction of fracture healing complications. The intended goal(s) should determine subsequent study methodology. While an acceleration of return to normal function or a reduction of fracture healing complications in and of themselves may be sufficient primary study endpoints for a phase 3 pivotal study, acceleration of fracture union alone is not. Radiographic evaluation may either occur at multiple time points during the healing process with the aim of measuring the time taken to reach a defined status (e.g. cortical bridging of three cortices or disappearance of fracture lines), or could be obtained at a single pre-determined timepoint, were patients are expected to reach a common clinical milestone (i.e. pain free full weight-bearing in weight-bearing fracture cases). Validated Patient Reported Outcomes (PRO's) measures will need to support the return to normal function co-primary endpoints. If reduction of complication rate (e.g. non-union) is the primary objective, the anticipated complications must be defined in the study protocol, along with their possible associations with the specified fracture type and fixation device. The study design should be randomized, parallel, double-blind, and placebo-controlled, and all fracture subjects should receive a standardized method of fracture fixation, defined as Standard of Care. © 2008 Elsevier Inc. All rights reserved.
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| 2. |
- Grandjean, Philippe, et al.
(författare)
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The faroes statement : human health effects of developmental exposure to chemicals in our environment.
- 2008
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Ingår i: Basic & Clinical Pharmacology & Toxicology. - : Wiley. - 1742-7835 .- 1742-7843. ; 102:2, s. 73-5
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Tidskriftsartikel (refereegranskat)abstract
- The periods of embryonic, foetal and infant developmentare remarkably susceptible to environmental hazards. Toxicexposures to chemical pollutants during these windows ofincreased susceptibility can cause disease and disability ininfants, children and across the entire span of human life.Among the effects of toxic exposures recognized in the pasthave been spontaneous abortion, congenital malformations,lowered birthweight and other adverse effects. These outcomesmay be readily apparent. However, even subtle changes causedby chemical exposures during early development may leadto important functional deficits and increased risks ofdisease later in life. The timing of exposure during early lifehas therefore become a crucial factor to be considered intoxicological assessments.During 20–24 May 2007, researchers in the fields of environmentalhealth, environmental chemistry, developmentalbiology, toxicology, epidemiology, nutrition and paediatricsgathered at the International Conference on Fetal Programmingand Developmental Toxicity, in Tórshavn, FaroeIslands. The conference goal was to highlight new insightsinto the effects of prenatal and early postnatal exposure tochemical agents, and their sustained effects on the individualthroughout the lifespan. The conference brought togetherresearchers to focus on human data and the translationof laboratory results to elucidate the environmental risks tohuman health.
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| 3. |
- Kakar, Sanjeev, et al.
(författare)
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Technical considerations in the operative management of femoral neck fractures in elderly patients : a multinational survey.
- 2007
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Ingår i: The Journal of trauma, injury, infection, and critical care. - : Ovid Technologies (Wolters Kluwer Health). - 1079-6061 .- 0022-5282. ; 63:3, s. 641-646
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To identify current opinions among orthopedic traumatologists relating to technical aspects of internal fixation and arthroplasty for patients with femoral neck fractures. METHODS: We developed and administered a survey to orthopedic surgeons who were members of the Orthopedic Trauma Association and European clinics affiliated with AO International (Davos, Switzerland). Surgeons reported preferences in specific aspects of the surgical technique for internal fixation as well as arthroplasty. Each surgeon received either a mailed package (7-page survey, a personalized cover letter, and a stamped return envelope) or an email with a link to the same survey on the Internet with an identification code. At 6 weeks, 12 weeks, and 18 weeks after the initial mailing, we remailed the questionnaire to all nonresponders. RESULTS: Of the 442 surgeons who were sent the questionnaire, 298 (68%) responded. The typical respondent was a North American aged more than 40 years, in academic practice, supervised residents, had fellowship training in trauma, and worked in a low-volume center. Among surgeons who treated displaced femoral neck fractures with arthroplasty, significant disparities existed in terms of the type of anesthesia (51% preferring general anesthesia), surgical approach (47% used posterior approach), and placement of unipolar implants (50%). Surgeons tended to agree on the use of cement fixation (69%), repairing the capsule (80%), and not using a drain postoperatively (68%). Surgeons who preferentially treated hip fractures with internal fixation tended to have a lack of consensus in terms of what constituted acceptable surgical delays (43% allowing greater than 48 hours) and which screw configuration to use, with more than half using a triangle with base inferior construct. Surgeons tended to agree on the use of closed fracture reduction techniques (69%), three cannulated screws (73%), and did not routinely perform a capsulotomy (80%) or aspirate the fracture hematoma (90%). Within both treatment groups (internal fixation and arthroplasty), surgeons tended to agree on the use of perioperative antibiotics (>92%), thromboprophylaxis (98%), and postoperative weight bearing status (>87%). CONCLUSIONS: A general lack of consensus exists among orthopedic trauma surgeons in the management of displaced femoral neck fractures. With an ever-growing emphasis upon the practice of evidence-based medicine, we have demonstrated several disparities in the technical aspects of fixation and perioperative care likely caused by a general lack of available evidence. We recommend the need for future research and large collaborative efforts.
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