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1.
J Clin Med ; 12(16)2023 Aug 18.
Artigo em Inglês | MEDLINE | ID: mdl-37629413

RESUMO

Perioperative myocardial injury (PMI) is a common cardiac complication. Recent guidelines recommend its systematic screening using high-sensitivity cardiac troponin (hs-cTn). However, there is limited evidence of local screening programs. We conducted a prospective, single-center study aimed at assessing the feasibility and outcomes of implementing systematic PMI screening. Hs-cTn concentrations were measured before and after surgery. PMI was defined as a postoperative hs-cTnT of ≥14 ng/L, exceeding the preoperative value by 50%. All patients were followed-up during the hospitalization, at one month and one year after surgery. The primary outcome was the incidence of death and major cardiovascular and cerebrovascular events (MACCE). The secondary outcomes focused on the individual components of MACCE. We included two-thirds of all eligible high-risk patients and achieved almost complete compliance with follow-ups. The prevalence of PMI was 15.7%, suggesting a higher presence of cardiovascular (CV) antecedents, increased perioperative CV complications, and higher preoperative hs-cTnT values. The all-cause death rate was 1.7% in the first month, increasing up to 11.2% at one year. The incidence of MACCE was 9.5% and 8.6% at the same time points. Given the observed elevated frequencies of PMI and MACCE, implementing systematic PMI screening is recommendable, particularly in patients with increased cardiovascular risk. However, it is important to acknowledge that achieving optimal screening implementation comes with various challenges and complexities.

2.
Int Orthop ; 46(7): 1539-1545, 2022 07.
Artigo em Inglês | MEDLINE | ID: mdl-35411436

RESUMO

PURPOSE: To determine the correlation between the assessment computed tomography osteochondral allograft (ACTOCA) scoring system and clinical outcomes scores. The hypothesis was that the ACTOCA score would show sufficient correlation to support its use in clinical practice. METHODS: We prospectively collected data from all consecutive patients who underwent cartilage restitution with fresh osteochondral allograft (FOCA) transplantation for osteochondral lesions of the knee and had a minimum follow-up of two years. CT scans were performed at three, six and 24 months post-operatively. A musculoskeletal radiologist blinded to the patients' medical history evaluated the scans using the ACTOCA scoring system. Clinical outcomes collected preoperatively and at three, six and 24 months postoperatively were evaluated using the International Knee Documentation Committee (IKDC), Kujala, the Western Ontario Meniscal Evaluation Tool (WOMET), and the Tegner Activity Scale. RESULTS: The mean total ACTOCA score showed a statistically significant correlation with the clinical outcome. The correlation was optimal at 24 months. We found a high negative correlation with the IKDC, Kujala and Tegner (- 0.737; - 0.757, and - 0.781 respectively), and a moderate negative correlation with WOMET (- 0.566) (p < 0.001). IKDC, Kujala, WOMET, and Tegner scores showed a significant continuous improvement in all scores (p < 0.001). CONCLUSION: The mean total ACTOCA score showed a linear correlation with clinical results in IKDC, Kujala, WOMET, and Tegner scores, being the highest at 24 months post-surgery. This finding supports the use of ACTOCA to standardize CT scan reports following fresh osteochondral allograft transplantation in the knee.


Assuntos
Cartilagem Articular , Fraturas Intra-Articulares , Aloenxertos , Transplante Ósseo/métodos , Cartilagem Articular/diagnóstico por imagem , Cartilagem Articular/cirurgia , Seguimentos , Humanos , Articulação do Joelho/diagnóstico por imagem , Articulação do Joelho/cirurgia , Tomografia Computadorizada por Raios X
3.
Clin Pharmacokinet ; 61(1): 83-95, 2022 01.
Artigo em Inglês | MEDLINE | ID: mdl-34255299

RESUMO

BACKGROUND: Tranexamic acid (TXA), an antifibrinolytic drug, is usually administered intravenously; however, intra-articular administration has recently been proven to be as effective as intravenous administration. Limited information regarding the pharmacokinetics (PK) of TXA after intra-articular administration has been reported. AIMS: The aim of this study was to develop a population PK model of TXA administered as a single intra-articular dose and as two intravenous doses, and to study the sources of interindividual variability (IIV) in the PK processes of TXA. The developed model was used to simulate PK profiles of TXA at different dosage regimens and in patients with renal impairment. METHODS: Patients who underwent primary unilateral total knee replacement (TKR) received 1 g/10 mL (concentration of 100 mg/mL) of TXA applied directly to the surgical field before wound closure, or 2 g (two doses of 1 g) of intravenous TXA. A population PK model was developed using a nonlinear mixed-effects approach and sources of IIV, such as sex, age, body weight, height, body mass index (BMI), preoperative haemoglobin, preoperative haematocrit, and creatinine clearance. RESULTS: Twenty-four patients were included, 12 in each group. Twenty patients were female, mean age (standard deviation) was 73.7 years (5.6). The disposition of TXA was best described as a two-compartment model with clearance dependent on creatinine clearance. Bootstrap results indicated that the model was stable and robust. The estimated bioavailability for intra-articular administration was 81%. Simulations indicated that 100% of patients would have plasma concentrations associated with partial fibrinolysis at 8 h post-administration with the dosages and routes of administration used in the present study. Intra-articular administration would produce complete inhibition of fibrinolysis in only 12% of patients compared with 72.5% with intravenous administration. No adverse events were reported. CONCLUSIONS: This population PK model demonstrated that a single dose of high-concentration, low-volume intra-articular TXA can achieve antifibrinolytic plasma concentrations of the drug for 8 h, providing both local and systemic effects in patients undergoing TKR. TXA administration to the surgical field could be an alternative to the intravenous; route for patients undergoing TKR; however, clinical studies are needed to assess the toxic local effects of TXA. TRIAL REGISTRATION: Spanish Clinical Studies Registry Number: 2017-004059-22. Date of registration: 12 April 2018.


Assuntos
Antifibrinolíticos , Artroplastia do Joelho , Ácido Tranexâmico , Administração Intravenosa , Idoso , Antifibrinolíticos/uso terapêutico , Perda Sanguínea Cirúrgica , Transfusão de Sangue , Feminino , Humanos , Injeções Intra-Articulares
4.
Int Orthop ; 45(5): 1191-1197, 2021 05.
Artigo em Inglês | MEDLINE | ID: mdl-33416905

RESUMO

AIM OF THE STUDY: To describe a new semiquantitative computed tomography (CT) scoring system for multi-feature analysis of cartilage defect repair by osteochondral allografts for the knee and to assess its intra-observer and inter-observer variability. METHOD: A semiquantitative assessment CT osteochondral allograft (ACTOCA) scoring system was designed based on fresh osteochondral allograft transplantations for the knee. The system includes five CT features: density relative to host bone, integration at the host-graft junction, surface percentage with a discernible cleft at the host-graft junction, cystic changes, and intra-articular fragments. Inter-observer variability was calculated by three observers blinded to the patient's medical history and treatment. Intra-observer variability was also determined. RESULTS: Inter-observer agreement was moderate to substantial for all CT score components and intra-observer agreement was moderate to almost perfect for all CT score components (κ > 0.5, p < 0.05). CONCLUSION: The ACTOCA score is a reliable tool to evaluate integration of osteochondral allograft transplantations. It provides an accurate evaluation of bone changes and may help to standardize CT scan reports following osteochondral allograft transplantation for the knee.


Assuntos
Cartilagem Articular , Aloenxertos , Transplante Ósseo , Cartilagem Articular/diagnóstico por imagem , Cartilagem Articular/cirurgia , Humanos , Articulação do Joelho/diagnóstico por imagem , Articulação do Joelho/cirurgia , Variações Dependentes do Observador , Tomografia , Tomografia Computadorizada por Raios X
5.
Acta Orthop Traumatol Turc ; 53(2): 115-119, 2019 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-30638780

RESUMO

OBJECTIVE: The aim of this study was to evaluate the outcomes of open reduction and internal fixation (ORIF) in hamate hook fractures and review the literature on this surgical procedure. METHODS: We report the outcomes of ORIF of hamate hook fractures in 13 consecutive patients (12 men and 1 woman; mean age: 32 years (range, 22-48 years)). In eight patients (61%) the fracture was associated with ulnar nerve neuritis in Guyon's canal. We assessed the following clinical data: age, sex, mechanism of injury, side of the injured hand and associated lesions, fracture classification, average time from injury to correct diagnosis, surgical technique, complications, and length of follow-up. All patients underwent radiological imaging, including standard radiographs in two planes (anteroposterior and lateral projections), and a CT study. Functional outcomes evaluated were pain, range of motion, grip strength, Disabilities of the arm, shoulder and hand (DASH) and Mayo wrist score. RESULTS: The mean follow-up was 36 months (range, 12-144 months). All 13 cases were treated with ORIF of the hook of the hamate. Mean VAS pain score was 5 preoperatively (4-9) and 1 (0-2) postoperatively. All patients returned to pre-injury level and only one patient felt pain on activity. Preoperative modified Mayo wrist score was 51 and the postoperative value was 94. All outcomes scores improved significantly from preoperative values. The patients who participated in sports postoperatively were able to do so at or near pre-injury levels. Postoperative average range of wrist motion was 76° in extension, 71° in flexion, 14° in ulnar deviation, and 21° in radial deviation. Mean grip strength in the hand with the hook fracture was 58 kg compared with 53 Kg in the unaffected hand. All patients returned to their pre-injury level of functioning after 10-12 weeks and there were no complications. Analysis of grip strength revealed values comparable with the unaffected hand. CONCLUSION: ORIF of hamate hook fractures is a safe and effective technique to restore normal grip strength and return to pre-injury level. In cases of ulnar nerve neuritis, neurolysis of the deep palmar branch is mandatory. LEVEL OF EVIDENCE: Level IV, Therapeutic study.


Assuntos
Fixação Interna de Fraturas , Hamato , Força da Mão , Adulto , Feminino , Fixação de Fratura/efeitos adversos , Fixação de Fratura/métodos , Fixação Interna de Fraturas/efeitos adversos , Fixação Interna de Fraturas/métodos , Hamato/diagnóstico por imagem , Hamato/lesões , Hamato/cirurgia , Humanos , Masculino , Avaliação de Processos e Resultados em Cuidados de Saúde , Radiografia/métodos , Amplitude de Movimento Articular , Traumatismos do Punho/diagnóstico , Traumatismos do Punho/fisiopatologia , Traumatismos do Punho/cirurgia , Articulação do Punho/fisiopatologia
6.
Contemp Clin Trials ; 61: 16-22, 2017 10.
Artigo em Inglês | MEDLINE | ID: mdl-28687347

RESUMO

BACKGROUND: Several hemostatic treatments intended to reduce the bleeding associated to total knee arthroplasty have been investigated with varying degrees of success. TT-173 is a new topical agent based on recombinant tissue factor that activates the extrinsic pathway of coagulation. This trial aim is to evaluate the efficacy and safety of TT-173 in total knee arthroplasty. METHODS/DESIGN: This is a phase II/III, sequential, simple blind, randomized, multicenter, placebo controlled and parallel clinical trial that will recruit 189 evaluable patients. Those randomized to treatment group will receive 2mg of TT-173 over the surgical surfaces of the knee. Control patients will receive physiologic saline. The follow up will consist in 6 visits during a period of 35 (±7) days. Primary endpoints will be the total blood loss and the incidence and severity of adverse events. Secondary and exploratory endpoints will include drainage production, decrease in hemoglobin level, transfusion ratio, analytical alterations, pain intensity, motion range, immunogenicity of TT-173 and the occurrence of systemic absorption. At the end of phase II, results will be evaluated by an independent committee that will recommend the continuation or the discontinuation of the trial. DISCUSSION: The design proposed maximizes the safety of the participants, avoids the risk of bias derived from the limitations of masking and enable the eventual discontinuation of the trial if this is recommended by the Interim Analysis Committee. If TT-173 proves its efficacy and safety in this indication, it would become a useful tool to improve the bleeding control in total knee arthroplasty. TRIAL REGISTRATION: ClinicalTrials.gov identifier: NCT02687399. Registered the 9th of February 2016.


Assuntos
Artroplastia do Joelho/métodos , Hemostasia Cirúrgica/métodos , Hemostáticos/uso terapêutico , Tromboplastina/uso terapêutico , Humanos , Projetos de Pesquisa , Método Simples-Cego
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