Articles: fractures-therapy.
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Multicenter Study
Early efficacy evaluation of mesenchymal stromal cells (MSC) combined to biomaterials to treat long bone non-unions.
Advanced therapy medicinal products (ATMP) frequently lack of clinical data on efficacy to substantiate a future clinical use. This study aims to evaluate the efficacy to heal long bone delayed unions and non-unions, as secondary objective of the EudraCT 2011-005441-13 clinical trial, through clinical and radiological bone consolidation at 3, 6 and 12 months of follow-up, with subgroup analysis of affected bone, gender, tobacco use, and time since the original fracture. ⋯ Bone consolidation was efficaciously obtained with the studied expanded hBM-MSCs combined to biomaterials, by clinical and radiological evaluation, and confirmed by bone biopsies, with lower consolidation scores in smokers.
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Eur J Trauma Emerg Surg · Aug 2019
Multicenter Study Comparative StudyRib fixation versus non-operative treatment for flail chest and multiple rib fractures after blunt thoracic trauma: a multicenter cohort study.
Over the years, a trend has evolved towards operative treatment of flail chest although evidence is limited. Furthermore, little is known about operative treatment for patients with multiple rib fractures without a flail chest. The aim of this study was to compare rib fixation based on a clinical treatment algorithm with nonoperative treatment for both patients with a flail chest or multiple rib fractures. ⋯ No advantage could be demonstrated for operative fixation of rib fractures. Future studies are needed before rib fixation is embedded or abandoned in clinical practice.
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ORTHO-1 is a European, multicentric, first in human clinical trial to prove safety and feasibility after surgical implantation of commercially available biphasic calcium phosphate bioceramic granules associated during surgery with autologous mesenchymal stromal cells expanded from bone marrow (BM-hMSC) under good manufacturing practices, in patients with long bone pseudarthrosis. ⋯ EU-FP7-HEALTH-2009, REBORNE Project (GA: 241876).
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Health Technol Assess · Dec 2018
Multicenter Study Pragmatic Clinical TrialNegative-pressure wound therapy versus standard dressings for adults with an open lower limb fracture: the WOLLF RCT.
Open fractures of the lower limb occur when a broken bone penetrates the skin and is exposed to the outside environment. These are life-changing injuries. The risk of deep infection may be as high as 27%. The type of dressing applied after surgical debridement could potentially reduce the risk of infection in the open-fracture wound. ⋯ Future work should investigate alternative strategies to reduce the incidence of infection and improve outcomes for patients with an open fracture of the lower limb. Two specific areas of potentially great benefit are (1) the use of topical antibiotic preparations in the open-fracture wound and (2) the role of orthopaedic implants with antimicrobial coatings when fixing the associated fracture.
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Eur J Trauma Emerg Surg · Oct 2018
Multicenter Study Observational StudyDiagnostics and early treatment in prehospital and emergency-room phase in suspicious pelvic ring fractures.
Testing for mechanical stability in pelvic ring fractures is advocated for the initial assessment and management of pelvic ring fractures. A survey among trauma surgeons showed that 91% agree with this recommendation. The aim of the present study was to describe the actual workup of patients with a high risk for unstable pelvic fractures in daily routine. ⋯ Testing of mechanical stability of the pelvic ring was carried out less often and with lower consequences for the actual management than expected. It seems worthwhile to rather put on a pelvic binder at earliest occasion based on trauma mechanism or clinical findings to reduce the risk of serious pelvic bleeding.