Applications in Musculoskeletal Disorders - part 9 potx

mation was observed without bony consolida-
tion. They concluded that high-energy ESWT
was an excellent noninvasive treatment for
pseudarthrosis and should be used as a pri-
marytreatmentmethod.Beutleretal.(1999)
reported 11 out of 27 patients healed (41%) 3
months after SWT with two times 2000
impulses at 18 kv. Schaden (2000) demon-
stratesasuccessrateof75.4%in49nonuni-
ons and of 75% in 15 infected nonunions. He
suggestes that shock waves had a stimulating
effect on osteoformation. In 2001, Schaden et
al. had treated 115 patients with nonunions or
delayed fracture healing. In 87 of the patients
a single SWT resulted in bony consolidation.
Wang and co-workers (2001) applied 6000
impulses at 28 kV for posttraumatic nonuni-
ons of the femur and tibia, 3000 impulses at
28 kV for nonunions of the humerus, 2000
impulses at 24 kV for nonunions of the radius
and ulna, and 1000 impulses at 20 kV for
nonunions of the metatarsal bones. Alto-
gether, 72 patients underwent SWT. The rate
of bony unions was described as 40% at 3
months, 60.9 % at 6 months, and 80 % at 12
months. The least effectiveness was seen in
atrophic nonunions.
The current observational cohort study
focused on the treatment of nonunions of
femur or tibia, being defined as a fracture or
osteotomy in which no radiological signs of

cortical bridging occurred for at least 9
months after the last operative intervention.
Stringent exclusion criteria were applied, SWT
was standardized, and adjunct treatment
remained unchanged. The decision whether
bony healing had occurred was made by an
independent observer. Radiological success
was seen in 72% of the patients, and a clear
connection with a positive tracer uptake in
the mineralization phase of bone scintigraphy.
Therefore, patients with a scintigraphically
inactive pseudarthrosis are excluded. Six out
of eight patients with an inactive pseudar-
throsis and subsequent treatment failure after
ESWT smoked, each more than 20 cigarettes
per day. In the knowledge of a possible direct
relationship between the development of a
nonunion and the presence of nicotine (Silcox
et al. 1995) we recommended our patients
stop smoking before starting with high-
energy ESWT.
Several weak points of the current study
deserve attention. Firstly, the suggestions of
the Food and Drug Administration panel of
the United Stated Department of Health and
Human Services of 1986 (Taylor 1992) for the
definition of a pseudarthrosis were only par-
tially adopted: the determination of visible
progressive signs of healing for 3 months
were excluded because according to the

radiological department involved in the cur-
rent study this criterion should not be used as
asuccessparameterbecauseofthewide
range of interobserver variability in its assess-
ment. It was thought that if cortical consolida-
tion had not appeared after 9 months in long
bones, spontaneous union had to be regarded
as improbable, even in hypertrophic, hyper-
vascular nonunions as shown in Figure 8.3.
One may wonder whether the nonunion
would have united spontaneously. However,
in this case, as in all the others, it was an inde-
pendent observer who diagnosed a nonunion,
and operative revision could have been sug-
gested at this point.
Secondly, the author attempted to select a
homogenous group of patients. But it is evi-
dent that there may be differences between
healing times of posttraumatic and postosteo-
tomy nonunions. With the small number of
patients available, an individual statistical
comparison of the two groups would have
given no adequate statistical information.
Nevertheless, better results were observed
after postosteotomy than after postfracture
nonunions.
Thirdly, there is no control group. Naturally,
whenever a new method of treatment is sug-
gested it must be compared with an adequate
set of controls. A study design with a placebo

control had been dismissed as unethical. The
alternative must be the comparison of high-
energy ESWT and a standardized operative or
conservative procedure. The author strongly
favors a multicenter study. Given the small
number of our patients available in one
department, an additional subdivison into
Discussion 69
two treatment groups would have given no
adequate information from a statistical point
of view.
Beyond the preliminary clinical studies, the
author is not aware of any other studies that
document the effectiveness of high-energy
ESWT in the treatment of pseudarthrosis. The
author thinks that additional clinical corrobo-
ration of the stimulation of bone healing with
use of standardized high-energy extracorpo-
real shock waves is highly recommended, and
may lead to useful application of shock waves
in the treatment of pseudarthroses, and a
determination of the total energy most likely
to accomplish healing.
8 Extracorporeal Shock Wave Application in the Treatment of Nonunions70
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