Pulsed Electromagnetic Fields in the treatment of fresh scaphoid fractures. A multicenter, prospective, double blind, placebo controlled, randomized trial

BMC Musculoskeletal Disorders

Study Protocol

Andries J Werre¹  Kevin WA Göttgens²  Martijn Poeze²  Pascal Hannemann²  Peter RG Brink²  Bob J van Wely³  Karel A Kolkman⁴ 

[1] Department of surgery, Canisius Wilhelmina Hospital, Weg door Jonkerbos 100, 6532 SZ, Nijmegen, The Netherlands;Department of surgery, Maastricht University Medical Center, PO box 5800, 6226 AZ, Maastricht, The Netherlands;Department of surgery, Radboud University Nijmegen Medical Center, Geert Groteplein zuid 10, 6525 GA, Nijmegen, The Netherlands;Department of surgery, Rijnstate Hospital, Alysis Group, 6815 AD, Wagnerlaan55, Arnhem, The Netherlands;

关键词: Avascular Necrosis;    Scaphoid Fracture;    Total Treatment Cost;    Pulse Electromagnetic Field;    Fresh Fracture;   

DOI  :  10.1186/1471-2474-12-90

 received in 2011-03-30, accepted in 2011-05-06,  发布年份 2011

来源: Springer

【 摘 要 】

BackgroundThe scaphoid bone is the most commonly fractured of the carpal bones. In the Netherlands 90% of all carpal fractures is a fracture of the scaphoid bone. The scaphoid has an essential role in functionality of the wrist, acting as a pivot. Complications in healing can result in poor functional outcome. The scaphoid fracture is a troublesome fracture and failure of treatment can result in avascular necrosis (up to 40%), non-union (5-21%) and early osteo-arthritis (up to 32%) which may seriously impair wrist function. Impaired consolidation of scaphoid fractures results in longer immobilization and more days lost at work with significant psychosocial and financial consequences.Initially Pulsed Electromagnetic Fields was used in the treatment of tibial pseudoarthrosis and non-union. More recently there is evidence that physical forces can also be used in the treatment of fresh fractures, showing accelerated healing by 30% and 71% reduction in nonunion within 12 weeks after initiation of therapy. Until now no double blind randomized, placebo controlled trial has been conducted to investigate the effect of this treatment on the healing of fresh fractures of the scaphoid.Methods/DesignThis is a multi center, prospective, double blind, placebo controlled, randomized trial. Study population consists of all patients with unilateral acute scaphoid fracture. Pregnant women, patients having a life supporting implanted electronic device, patients with additional fractures of wrist, carpal or metacarpal bones and pre-existing impairment in wrist function are excluded. The scaphoid fracture is diagnosed by a combination of physical and radiographic examination (CT-scanning).Proven scaphoid fractures are treated with cast immobilization and a small Pulsed Electromagnetic Fields bone growth stimulating device placed on the cast. Half of the devices will be disabled at random in the factory.Study parameters are clinical consolidation, radiological consolidation evaluated by CT-scanning, functional status of the wrist, including assessment by means of the patient rated wrist evaluation (PRWE) questionnaire and quality of life using SF-36 health survey questionnaire.Primary endpoint is number of scaphoid unions at six weeks, secondary endpoints are time interval to clinical and radiological consolidation, number of non-unions, functional status at 52 weeks and non-adherence to the treatment protocol.Trial registrationNetherlands Trial Register (NTR): NTR2064

【 授权许可】

CC BY   
© Hannemann et al; licensee BioMed Central Ltd. 2011