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Extracorporeal Shock-Wave Therapy Compared with Surgery for Hypertrophic Long-Bone Nonunions

¹ Department of Physical Medicine and Rehabilitation (A.C. and G.S.) and Division of Orthopaedic Surgery, Department of Surgery (O.C. and S.F.), "San Salvatore" Hospital of L'Aquila, via L. Natali 1, 67100 L'Aquila, Italy. E-mail address for A. Cacchio: angelo.cacchio{at}tin.it
² Physical Medicine and Rehabilitation Center, Nomentana Hospital, L.go N. Berloco 60, 00010 Fontenuova, Rome, Italy
³ OrthoTrauma Evaluation Center, Oppenheimer Strasse 70, D-55130 Mainz, Germany
⁴ Department of Physical Medicine and Rehabilitation, School of Medicine, "La Sapienza" University of Roma, p.le A. Moro 5, 00185 Rome, Italy

Investigation performed at the Department of Physical Medicine and Rehabilitation and the Division of Orthopaedic Surgery, Department of Surgery, "San Salvatore" Hospital of L'Aquila; the Physical Medicine and Rehabilitation Center, Nomentana Hospital, Rome; and the Department of Physical Medicine and Rehabilitation, School of Medicine, "La Sapienza" University, Rome, Italy

A commentary by J. Lawrence Marsh, MD, is available at www.jbjs.org/commentary and as supplemental material to the online version of this article.

Disclosure: The authors did not receive any outside funding or grants in support of their research for or preparation of this work. Neither they nor a member of their immediate families received payments or other benefits or a commitment or agreement to provide such benefits from a commercial entity. No commercial entity paid or directed, or agreed to pay or direct, any benefits to any research fund, foundation, division, center, clinical practice, or other charitable or nonprofit organization with which the authors, or a member of their immediate families, are affiliated or associated.

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/mm² (Group 1) or 0.70 mJ/mm² (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.

Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence.

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