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. 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