Hemiarthroplasty versus angle-stable locking compression plate osteosynthesis in the treatment of three- and four-part fractures of the proximal humerus in the elderly: design of a randomized controlled trial

ABSTRACT: BACKGROUND: The optimal surgical management of dislocated three- and four-part fractures of the proximal humerus in elderly patients remains unclear. Most used techniques are hemiarthroplasty and angle-stable locking compression plate osteosynthesis. In the current literature there is no evidence available presenting superior results between hemiarthroplasty and angle-stable locking compression plate osteosynthesis in terms of speed of recovery, pain, patient satisfaction, functional outcome, quality of life or complications. METHODS/DESIGN: A randomized controlled multicenter trial will be conducted. Patients older than 60 years of age with a dislocated three- or four-part fracture of the proximal humerus as diagnosed by X-rays and CT-scans will be included. Exclusion criteria are a fracture older than 14 days, multiple comorbidity, multitrauma, a pathological fracture, previous surgery on the injured shoulder, severely deranged function caused by a previous disease, "head-split" proximal humerus fracture and unwillingness or inability to follow instructions. Participants will be randomized between surgical treatment with hemiarthroplasty and angle-stable locking compression plate osteosynthesis. Measurements will take place preoperatively and 3 months, 6 months, 9 months, 12 months and 24 months postoperatively. Primary outcome measure is speed of recovery of functional capacity of the affected upper limb using the Disabilities of Arm, Shoulder and Hand score (DASH). Secondary outcome measures are pain, patient satisfaction, shoulder function, quality of life, radiological evaluation and complications. Data will be analyzed on an intention-to-treat basis, using univariate and multivariate analyses. DISCUSSION: Both hemiarthroplasty and angle-stable locking compression plate osteosynthesis are used in the current treatment of dislocated three-and four-part fractures of the proximal humerus. There is a lack of level-1 studies comparing these two most-used surgical treatment options. This randomized controlled multicenter trial has been designed to determine which surgical treatment option provides the fastest recovery of functional capacity of the affected upper limb, and will provide better outcomes in pain, satisfaction, shoulder function, quality of life, radiological evaluation and complications. TRIAL REGISTRATION NUMBER: The trial is registered in the Netherlands Trial Registry (NTR2461)

Efeito do extrato aquoso de Sida cordifolia na regeneração hepática após hepatectomia parcial

Introdução: O uso de plantas medicinais para o tratamento de patologias humanas tem aumentado em todo mundo. Muitas delas são usadas por administração oral, e após a absorção podem afetar muitos órgãos. Objetivo: Esse estudo, tem como objetivo verificar o efeito do extrato aquoso de Sida cordifolia, popularmente conhecida no Brasil como “malva-branca”, na regeneração hepática. Métodos: Vinte ratos foram divididos em 4 grupos: controle, Sida 100, Sida 200 e Sida 400. Os animais foram submetidos a administração oral de água destilada, 100, 200 e 400 mg/kg de extrato aquoso de Sida cordifolia, respectivamente. Imediatamente após, foi realizada hepatectomia parcial 67%. Vinte quatro horas após, os fígados foram removidos. A regeneração hepática foi avaliada por imunohistoquímica (PCNA), usando o anticorpo monoclonal PC-10. Resultados: Os grupos Sida100 e Sida200 mostraram índices de regeneração hepática maiores que o grupo controle (p<0.001 e p<0.05, respectivamente). Conclusão: O extrato aquoso de Sida cordifolia estimula a regeneração hepática após hepatectomia parcial a 67% em ratos. _________________________________________________________________________________________ ABSTRACT: Purpose: The use of medicinal plants for the treatment of human diseases has increased worldwide. Many of them are used by oral administration and, after absorption, may affect many organs. Therefore, this study aimed at assessing the effects of the aqueous extract of Sida cordifolia leaves, popularly known in Brazil as “malva-branca”, on liver regeneration. Methods: Twenty rats were divided into four groups: control, Sida100, Sida200 and Sida400 groups. All animals were submitted to oral administration of distilled water, 100, 200 and 400 mg/kg of the aqueous extract of Sida cordifolia, respectively. Immediately after this, they underwent 67% partial hepatectomy. Twenty four hours later, their livers were removed. Hepatic regeneration was assessed by immunohistochemical staining for proliferating cell nuclear antigen (PCNA) using the PC-10 monoclonal antibody. Results: Sida100 and Sida200 groups disclosed higher liver regeneration indices than control group (p<0.001 and p<0.05, respectively). Conclusion: The aqueous extract of Sida cordifolia stimulates liver regeneration after 67% partial hepatectomy in rats