A prospective randomised controlled trial of operative versus non-operative management of fractures of the humeral diaphysis: the HUmeral Shaft Fracture FIXation (HU-FIX) Study protocol.
Trials
; 20(1): 475, 2019 Aug 05.
Article
em En
| MEDLINE
| ID: mdl-31383027
ABSTRACT
BACKGROUND:
Humeral shaft fractures constitute around 1% of adult fractures in the UK, with an annual incidence of approximately 13 per 100,000 population. Historically, these injuries have been primarily managed non-operatively, with operative fixation reserved for specific indications. Although some recent retrospective studies have suggested there are potential benefits of operative fixation over humeral bracing, there is a deficiency in level 1 evidence to support operative management as the primary treatment for humeral shaft fractures. METHODS/DESIGN:
This single-centre prospective randomised controlled trial aims to recruit 70 adult patients with an isolated closed fracture of the humeral diaphysis into one of two treatment arms operative (n = 35) or non-operative (n = 35). The operative arm will undergo open reduction and internal fixation (ORIF) of the fracture using a standard fixation technique (plate and screws). The non-operative arm will be fitted with a prefabricated humeral brace until fracture union. All patients will be followed up for 1 year post-intervention. The primary outcome measure will be the Disabilities of the Arm, Shoulder and Hand (DASH) score at 3 months post-intervention. Secondary outcome measures will include pain, treatment complications, return to work or sporting activities, shoulder and elbow range of motion, radiographic assessment, EuroQol (EQ-5D) Health Outcome score and 12-item Short Form (SF-12) Health Survey score. A health economic analysis will be performed to compare the cost implications of each treatment strategy.DISCUSSION:
This randomised controlled trial will provide level 1 evidence comparing a standard ORIF technique against functional bracing for isolated closed humeral shaft fractures. The investigators hope that the study results will assist surgeons in their decision-making when managing patients with these injuries. TRIAL REGISTRATION ClinicalTrials.gov, NCT03689335 . Registered on 28 September 2018 (retrospectively).Palavras-chave
Texto completo:
1
Eixos temáticos:
Pesquisa_clinica
Base de dados:
MEDLINE
Assunto principal:
Ensaios Clínicos Controlados Aleatórios como Assunto
/
Fixação Interna de Fraturas
/
Fraturas do Úmero
Tipo de estudo:
Clinical_trials
/
Observational_studies
/
Prognostic_studies
/
Risk_factors_studies
Limite:
Adult
/
Humans
Idioma:
En
Ano de publicação:
2019
Tipo de documento:
Article