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Extra-corporeal shock wave therapy in patients with tennis elbow and painful heel.. Extracorporal shock wave application – an effective treatment for patients with chronic and therapy-re

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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-mary treatment method Beutler et al (19 9 9 )

reported 11 out of 27 patients healed (41 %) 3

months after SWT with two times 2000

impulses at 18 kv Schaden (2000)

demon-strates a success rate of 75.4 % in 49

nonuni-ons and of 75 % in 15 infected nonuninonuni-ons 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

a success parameter because of the wide range of interobserver variability in its assess-ment It was thought that if cortical consolida-tion had not appeared after 9months 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

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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 Nonunions

70

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