ORTHOUNION is a multicentre, open, comparative, three-arm, randomized clinical trial (EudraCT number 2015-000431-32) to compare the efficacy, at one and two years, of autologous human bone marrow-derived expanded mesenchymal stromal cell (hBM-MSC) treatments versus iliac crest autograft (ICA) to enhance bone healing in patients with diaphyseal and/or metaphysodiaphyseal fracture (femur, tibia, and humerus) status of atrophic or oligotrophic nonunion (more than 9 months after the acute fracture, including recalcitrant cases after failed treatments). The primary objective is to determine if the treatment with hBM-MSCs combined with biomaterial is superior to ICA in obtaining bone healing. If confirmed, a secondary objective is set to determine if the dose of 100 × 106 hBM-MSCs is noninferior to that of 200 × 106 hBM-MSCs. The participants (n = 108) will be randomly assigned to either the experimental low dose (n = 36), the experimental high dose (n = 36), or the comparator arm (n = 36) using a central randomization service. The trial will be conducted in 20 clinical centres in Spain, France, Germany, and Italy under the same clinical protocol. The confirmation of superiority for the proposed ATMP in nonunions may foster the future of bone regenerative medicine in this indication. On the contrary, absence of superiority may underline its limitations in clinical use.
Well-differentiated liposarcomas of the extremities are one of the most frequent types of malignant soft tissue tumors in adults. These tumors are typically locally aggressive and show a tendency to recurrence after surgical excision even though they do not metastasize and very rarely dedifferentiate. Its clinical presentation is generally a progressively growing mass causing aesthetic, functional, or compressive symptoms depending on the tumor's size and localization. Several authors recommend a wide excision with free margins in order to minimize the risk of recurrence, while others report good results and a low rate of recurrence with more conservative or even marginal excision thereby avoiding complications due to surgical site morbidity. We present a retrospective study of 11 patients with a large-sized well-differentiated liposarcoma of the lower limb with a mean follow-up of 3.2 years. The mean size was 22 × 19 × 17 cm, and a marginal resection was made, respecting the affected neurovascular structures, in all cases. Only one recurrence was found and the functional results were 81.6% according to the MSTS functional scale 1 year after surgery. We believe that the marginal excision is a good alternative when the tumor is located near vascular or nerve structures, and as to our experience, it is not associated with elevated recurrences.
Currently, there is a wide awareness of the high degree of functional impairment and morbimortality associated with hip fractures in the elderly, and efforts are being made to improve outcomes. As age rises, physiological reserves decline, and more severe complications occur. Simultaneous bilateral extracapsular hip fractures in the setting of low-energy trauma in the elderly are rare but deserve special attention with treatment strategies that are in between those for unilateral hip fractures and elderly patients with multiple injuries. Adequate initial assessment, a multidisciplinary approach to trauma care, and the integration of medical and orthopaedic surgical attention are paramount. Furthermore, there is a need for early single-stage surgical fixation in medically stable patients and optimization of patients who are unfit. Despite some variations from unilateral cases, the main objective remains to achieve painless hips and stable fixation for early mobilization with the lowest morbidity and mortality rates. General anesthesia for intramedullary nailing using short nonreamed nails for stable fracture patterns and minimal reaming when long nails are used may be regarded as the best option. Physicians should be cautious of the higher risk of complications such as blood loss, fat embolism syndrome, and adult respiratory distress syndrome. Orthogeriatric management and multidisciplinary teams may also improve outcomes, as demonstrated for unilateral hip fractures. Secondary prevention of fractures is promoted through the prescription of antiosteoporotic treatment, nutritional assessment, and skills training. This literature review aims to help optimize the management of patients with simultaneous bilateral extracapsular hip fractures, outlining the differential concerns with respect to unilateral cases.
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