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1.
J Orthop Res ; 42(3): 500-511, 2024 Mar.
Artículo en Inglés | MEDLINE | ID: mdl-38069631

RESUMEN

In vitro and in vivo studies are critical for the preclinical efficacy assessment of novel therapies targeting musculoskeletal infections (MSKI). Many preclinical models have been developed and applied as a prelude to evaluating safety and efficacy in human clinical trials. In performing these studies, there is both a requirement for a robust assessment of efficacy, as well as a parallel responsibility to consider the burden on experimental animals used in such studies. Since MSKI is a broad term encompassing infections varying in pathogen, anatomical location, and implants used, there are also a wide range of animal models described modeling these disparate infections. Although some of these variations are required to adequately evaluate specific interventions, there would be enormous value in creating a unified and standardized criteria to animal testing in the treatment of MSKI. The Treatment Workgroup of the 2023 International Consensus Meeting on Musculoskeletal Infection was responsible for questions related to preclinical models for treatment of MSKI. The main objective was to review the literature related to priority questions and estimate consensus opinion after voting. This document presents that process and results for preclinical models related to (1) animal model considerations, (2) outcome measurements, and (3) imaging.


Asunto(s)
Proyectos de Investigación , Animales , Humanos , Consenso , Modelos Animales
2.
Injury ; 54 Suppl 6: 110776, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37221112

RESUMEN

PURPOSE: Cement augmentation is considered to improve the bone-implant construct stability in hip fragility fractures, additionally biomechanical studies show that cement augmentation improves the pull-out strength and increases resistance to failure. Thus far, the advantage of these technique used in a clinical scenario is yet to be determined METHODS: a randomized, multicenter, single-blinded clinical trial was conducted in patients aged 65 years or older who were admitted to two level I trauma centers with a fragility intertrochanteric hip fracture during September 2015 and December 2017. Patients were stratified into 2 groups: patients between 65 and 85 years and older than 85 years. A balanced block randomization was performed using blocks of 6 patients: 3 patients assigned to the control group (no augmentation) and 3 patients to the intervention group. Follow-up visits were done at 1, 3, 6 and 12 postoperative months documenting the tip-apex distance (TAD) as well as followed up after 5 to 7 years of surgical procedure documenting EQ5D, Parker Mobility Score and mortality rates at these different time points. RESULTS: A total of 90 patients were included but only 53 patients completed a one-year follow up. The mean immediate postoperative and one-year follow up TAD measurement from the whole cohort (20.99 mm vs 21.3 mm, respectively) showed no statistical significance (P = 0.18). For patients in the control group, the difference of TAD measurements from the immediate postoperative and one-year follow-up was -0.25 mm (P = 0.441). For patients included in the intervention group, the difference of TAD measurement from the immediate postoperative and 1-year follow up was -0.48 mm (P = 0.383). No statistical difference was found when stratified by age (p = 0.78). One patient from the control group had an implant failure after 1-month postoperative. Readmission after 30 days showed no statistical difference between both groups (7 vs. 7 patients, p = 0.754). Augmentation did not show a difference in most of the functional outcomes nor quality of life after 5 to 7 years of surgical procedure. CONCLUSIONS: The use of augmentation can be considered a safe procedure for the fixation of fragility hip fractures.


Asunto(s)
Fijación Intramedular de Fracturas , Fracturas de Cadera , Humanos , Estudios de Seguimiento , Resultado del Tratamiento , Calidad de Vida , Cementos para Huesos/uso terapéutico , Fijación Intramedular de Fracturas/métodos , Clavos Ortopédicos
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