BACKGROUND: The authors of several studies have recommended extracorporeal shock-wave therapy as an alternative to surgical treatment for long-bone nonunions. This study was performed to compare the results of extracorporeal shock-wave therapy produced by two different devices with those of surgical treatment in the management of long-bone nonunions. METHODS:One hundred and twenty-six patients with a long-bone nonunion were randomly assigned to receive either extracorporeal shock-wave therapy (Groups 1 and 2) or surgical treatment (Group 3). The patients in the shock-wave groups received four treatments with 4000 impulses of shock waves with an energy flux density of 0.40 mJ/mm(2) (Group 1) or 0.70 mJ/mm(2) (Group 2). The patients in the three groups had similar demographic characteristics, durations of nonunion, and durations of follow-up. Radiographic results (the primary outcome) and clinical results (the secondary outcomes) were determined before and three, six, twelve, and twenty-four months after treatment. RESULTS: The radiographic findings did not differ among the three groups of patients. At six months, 70% of the nonunions in Group 1, 71% of the nonunions in Group 2, and 73% of the nonunions in Group 3 had healed. Three and six months after treatment, the clinical outcomes in the two shock-wave groups were significantly better than those in the surgical group (p < 0.001). However, at both twelve and twenty-four months after treatment, there were no differences among the three groups, with the exception of the DASH score, which differed significantly between Groups 1 and 3 (p = 0.038) and between Groups 2 and 3 (p = 0.021) at twelve months. CONCLUSIONS:Extracorporeal shock-wave therapy is as effective as surgery in stimulating union of long-bone hypertrophic nonunions and yields better short-term clinical outcomes.
RCT Entities:
BACKGROUND: The authors of several studies have recommended extracorporeal shock-wave therapy as an alternative to surgical treatment for long-bone nonunions. This study was performed to compare the results of extracorporeal shock-wave therapy produced by two different devices with those of surgical treatment in the management of long-bone nonunions. METHODS: One hundred and twenty-six patients with a long-bone nonunion were randomly assigned to receive either extracorporeal shock-wave therapy (Groups 1 and 2) or surgical treatment (Group 3). The patients in the shock-wave groups received four treatments with 4000 impulses of shock waves with an energy flux density of 0.40 mJ/mm(2) (Group 1) or 0.70 mJ/mm(2) (Group 2). The patients in the three groups had similar demographic characteristics, durations of nonunion, and durations of follow-up. Radiographic results (the primary outcome) and clinical results (the secondary outcomes) were determined before and three, six, twelve, and twenty-four months after treatment. RESULTS: The radiographic findings did not differ among the three groups of patients. At six months, 70% of the nonunions in Group 1, 71% of the nonunions in Group 2, and 73% of the nonunions in Group 3 had healed. Three and six months after treatment, the clinical outcomes in the two shock-wave groups were significantly better than those in the surgical group (p < 0.001). However, at both twelve and twenty-four months after treatment, there were no differences among the three groups, with the exception of the DASH score, which differed significantly between Groups 1 and 3 (p = 0.038) and between Groups 2 and 3 (p = 0.021) at twelve months. CONCLUSIONS: Extracorporeal shock-wave therapy is as effective as surgery in stimulating union of long-bone hypertrophic nonunions and yields better short-term clinical outcomes.