Pulsed electromagnetic fields in the treatment of fresh scaphoid fractures. Clinical and radiological outcome. A multi centre, prospective, double-blind, placebo controlled, randomized trial.

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. In
addition impaired consolidation of scaphoid fractures results in longer
immobilization and more days lost at work with significant psychosocial and
financial consequences.
Studies showed that even uncomplicated healing leads to a mean employment
interruption of 155 days. Furthermore patient population mainly consist of
young, active men and women aged 15 to 40 and therefore economic consequences
of temporary or even permanent disability are substantial.
Current treatment strategies are unable to deal with this problem since exact
outcome after scaphoid union, non-union and other complications such as
avascular necrosis remains unclear. Even after operative treatment results are
variable. Furthermore operative treatment for complicated healing of scaphoid
fractures (eg delayed or non-union) is often initiated in a late fase, most
often months after the fracture occured.
Initially PEMF (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 non-union within 12 weeks
after initiation of therapy.
We therefore want to investigate whether the use of PEMF in fresh scaphoid
fractures accelerates consolidation of this fracture and whether the use of
PEMF reduces the incidence of disabling wrist conditions like scaphoid
non-union or osteonecrosis.

The objective of this study is:

1.To determine whether the use of bone-growth stimulation by means of pulsed
electromagnetic fields (PEMF) in fresh scaphoid fractures will accelerate
healing both clinically and radiologically.

2.To determine whether the use of PEMF in fresh scaphoid fractures will
decrease the incidence of non-unions and avascular necrosis of the scaphoid and
therefore the number of secondary surgical interventions.

3.To investigate the effect of PEMF in scaphoid fractures on functional outcome.

4.To investigate the potential cost-effectiveness of PEMF from a societal
perspective when compared with care as usual.

This is a multi centre, prospective, double-blind, placebo controlled,
randomized trial.
Study parameters are clinical consolidation, radiological consolidation by
means of CT scanning, functional status of the wrist, including the patient
rated wrist evaluation (PRWE) and quality of life, measured by SF-36 health
survey questionnaire.

All patients having a proven scaphoid fracture are treated with cast
immobilisation and a small PEMF device placed on the cast. Half of the PEMF
devices will be disabled at random in the factory. The patients as well as the
investigators will be unaware of the device's functionality.
The small PEMF device will be placed on the cast within five days after
diagnosing the fracture and will be applied for 24 hours a day continuously.
Dependant on fracture consolidation, the device will be removed after six to
twelve weeks.
Follow up will take place acoording to a fixed protocol.

All patients will be subjected to two or three extra visits to the outpatient
clinic. These visits will take 10 to 15 minutes extra. Furthermore they will be
asked to fill out two questionnaires, the PRWE and the SF-36 questionnaire. Two
or three extra CT-scans of the wrist will be made. Benefit for the patients is
that all patients will have substantial better control of the healing of their
fracture.
No negative effects of treatment with the PEMF device have been reported.
Concerning safety of the diagnostic interventions, the amount of additional
generated radiation is very low. The average amount of generated radiation when
performing a CT scan of the wrist is 0.045 mSv. The average amount of radiation
from artificial sources used in medicine each person is exposed to in the
Netherlands is 0.7 mSv each year. The total amount of received radiation is 2
to 2.7 mSv annually in the Netherlands. When concerning these numbers, the
added amount of radiation is negligible.