Injury
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Multicenter Study Comparative Study
Long-term outcomes after open reduction and internal fixation of bicondylar tibial plateau fractures.
To establish normative data, long-term patient-reported functional outcome and health-related quality of life (HrQoL) after operative treatment of bicondylar tibial plateau fractures. Secondly, to identify risk factors associated with functional outcome and HrQoL. ⋯ Therapeutic Level III.
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Multicenter Study
Validation of a long bone fracture non-union healing score after treatment with mesenchymal stromal cells combined to biomaterials.
The available scores to clinically evaluate fracture consolidation encounter difficulties to interpret progression towards consolidation in long-bone non-union, particularly when incorporating biomaterials in the surgical treatment. The aims of this study were to validate the REBORNE bone healing scale in tibia, humerus and femur non-unions treated by a combination of mesenchymal stromal cells (MSCs) and biomaterials, through the interclass correlation (ICC) among raters, and to define reliability and concordance in anteroposterior and lateral radiographs, compared to computed tomography (CT).
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In 2040 the estimated number of people with a hip fracture in the Netherlands will be about 24,000. The medical care for this group of patients is complicated and challenging. Multidisciplinary approaches aim to improve clinical outcome. Quality indicators that gain insight in the treatment and outcome of hip fracture patients may help to optimize and monitor the standard of medical care. The Dutch Hip Fracture Audit (DHFA) is a new multidisciplinary quality indicator that is implemented in the Dutch hospitals in 2017. ⋯ Implementation of the DHFA quality indicator does have a positive non-significant trend on 30-day mortality, but showed no impact on length of hospital stay and time until surgery. More research on relevant quality indicators seems therefore mandatory.
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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.