Abstract
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
Highlights
The 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 bone articulates with 5 surrounding bones in the wrist and has an essential role in functionality of the wrist, acting as a pivot
Summary
Fractures of the scaphoid, which is the most commonly fractured of the carpal bones, represent 2-6% of all fractures and typically occur in young, active patients aged 15 to 40 [1]. This study is the first double blind randomized, placebo controlled trial to investigate the effect of pulsed electromagnetic fields on the healing of fresh fractures of the scaphoid and investigate the effects of this treatment on consolidation and complications of treatment. To determine whether the use of bone-growth stimulation by means of pulsed electromagnetic fields in acute scaphoid fractures will accelerate healing both clinically and radiologically. Follow up will take place at six, nine, twelve, twenty-four and fifty-two weeks after diagnosis of the fractured scaphoid At these times the cast will be removed and physical and radiological examination will be performed to determine fracture consolidation. The research question for the economic evaluation is: Is the use of PEMF for fresh scaphoid fractures potentially cost-effective when compared with care as usual from a societal point of view? All patients have to provide written informed consent before participation in the study
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