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Extracorporeal Shock-Wave Therapy Compared with Surgery for Hypertrophic Long-Bone Nonunions
Angelo Cacchio, MD1; Lucio Giordano, MD2; Olivo Colafarina, MD1; Jan D. Rompe, MD3; Emanuela Tavernese, MD2; Francesco Ioppolo, MD4; Stefano Flamini, MD1; Giorgio Spacca, MD1; Valter Santilli, MD4
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@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
View Disclosures and Other Information
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.
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

The Journal of Bone and Joint Surgery, Inc.
J Bone Joint Surg Am, 2009 Nov 01;91(11):2589-2597. doi: 10.2106/JBJS.H.00841
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Abstract

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/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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    References

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    These activities have been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint sponsorship of the American Academy of Orthopaedic Surgeons and The Journal of Bone and Joint Surgery, Inc. The American Academy of Orthopaedic Surgeons is accredited by the ACCME to provide continuing medical education for physicians.
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    Angelo Cacchio, MD
    Posted on April 05, 2010
    Dr. Cacchio responds to Drs. Chisena and Lane
    "San Salvatore" Hospital of L'Aquila, L'Aquila, Italy

    We thank Dr. Chisena for his comments regarding our article (1). We will agree with the conclusions of Dr. Chisena that the pressure exerted by a cast or brace may be a positive factor influencing the healing of a nonunion, when randomized, double-blind, controlled, clinical trials, with an adequate number of patients, confirm the data from his preliminary study. Furthermore, our article was published in November 2009, while the article of Dr. Chisena and colleagues was published in February 2010. Thus it was impossible for us to have, and discuss, this information at the time of writing our manuscript.

    Reference

    1. Cacchio A, Giordano L, Colafarina O, Rompe JD, Tavernese E, Ioppolo F, Flamini S, Spacca G, Santilli V. Extracorporeal shock-wave therapy compared with surgery for hypertrophic long-bone nonunions. J Bone Joint Surg Am. 2009;91:2589-97.

    Ernest C. Chisena, MD, MS
    Posted on March 11, 2010
    Letter to the Editor
    Huntington Hospital, St Catherine of Siena, New York

    To the Editor:

    I read the interesting article "Extracorporeal Shock-Wave Therapy Compared with Surgery for Hypertrophic Long-Bone Nonunions", by Cacchio et al. (1). In this paper, three study groups were compared. Both in Group 1 and Group 2, the nonunions were treated with electromagnetic extracorporeal shock-wave. The authors claim that the treatment promotes bone-healing by creating micro-fractures that induce a healing reaction as occurs during the natural bone-healing process. As stated, the limb in those groups was immobilized in a plaster cast or a brace for six weeks to three months after the therapy.

    In Group 3, patients had surgical revisions of the nonunion (refreshing the fracture site). The only mention of post surgical immobilization is in the section "Adverse Effects". A patient with a radial nerve neuropraxia had been treated with an inappropriately applied cast.

    In a recent study (2), it was shown that local soft tissue compression enhanced fracture healing in a rabbit fibula. Granted this was a pilot study, nevertheless, it suggests that studies of fracture healing should control the pressure applied to the soft tissues over the fracture.

    It could be assumed that, in Groups 1 and 2, some unknown pressure was applied to the soft tissue over the fracture site by the cast or brace. The pressure applied may have had a positive effect on the healing of the nonunions with newly created micro-fractures. Similarly, it was not reported whether the surgically treated patients had any post operative immobilization that could apply pressure to the soft tissues over the fracture. This data should be available. Local soft tissue pressure may be a confounding variable, therefore future studies should control the pressure applied to the soft tissues at the fracture site, to be certain shock-wave therapy alone has the claimed positive effect.

    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.

    References

    1. Cacchio A, Giordano L, Colafarina O, Rompe JD, Tavernese E, Ioppolo F, Flamini S, Spacca G, Santilli V. Extracorporeal shock-wave therapy compared with surgery for hypertrophic long-bone nonunions. J Bone Joint Surg Am. 2009;91:2589-97.

    2. Morr S, Chisena EC, Tomin E, Mangino M, Lane JM. Local soft tissue compression enhances fracture healing in a rabbit fibula. HSS J. 2010;6:43-8.

    Angelo Cacchio, MD
    Posted on January 11, 2010
    Dr. Cacchio responds to Dr. Salas
    "San Salvatore" Hospital of L'Aquila, L'Aquila, Italy

    We thank Dr. Salas for his comment regarding our article (1), and we agree with him. A mistake occurred during the revision process and we are preparing an "erratum" for the Editor. In Table 1, ulna and radius must be grouped and humerus should replace ulna. On page 2591, first paragraph, “a long leg cast for the tibial and femoral fractures and a plaster cast for the ulnar and radial fractures” should be replaced with, “a long leg cast for the tibial and femoral fractures and a plaster cast for the ulnar and radial and humeral fractures”.

    Reference

    1. Cacchio A, Giordano L, Colafarina O, Rompe JD, Tavernese E, Ioppolo F, Flamini S, Spacca G, Santilli V. Extracorporeal shock-wave therapy compared with surgery for hypertrophic long-bone nonunions. J Bone Joint Surg Am. 2009;91:2589-97.

    Arturo E. Salas, MD
    Posted on December 30, 2009
    Extracorporeal Shock-Wave Therapy
    Sociedad Chilena de Ortopedia y Traumatologia, Santiago, Chile

    To the Editor:

    I read the very useful and interesting paper by Cacchio et al (1). I would like to know whether the method can be used for nonunions of the shaft of the humerus because, among the long bones in Table I, I could only see "femur, tibia, ulna and radius". Humeral nonunion is not included in the exclusion critera. Moreover, the x-ray film of one of those nonunions is shown in page 2594. Does that patient belong to the randomized group or is this just an illustrative case?

    The author did not receive any outside funding or grants in support of his research for or preparation of this work. Neither he nor a member of his immediate family 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 author, or a member of his immediate family, is affiliated or associated.

    Reference

    1. Cacchio A, Giordano L, Colafarina O, Rompe JD, Tavernese E, Ioppolo F, Flamini S, Spacca G, Santilli V. Extracorporeal shock-wave therapy compared with surgery for hypertrophic long-bone nonunions. J Bone Joint Surg Am. 2009;91:2589-97.

    Angelo Cacchio, MD
    Posted on December 23, 2009
    Dr. Cacchio responds to Dr. McKee
    "San Salvatore" Hospital of L'Aquila, L'Aquila, Italy

    We thank Dr. McKee for its comments regarding our article (1).

    With regard to the first question, we would like to specify that all the patients were treated 6 months or more after their injury. The results reported in Table I derive from a normal statistic elaboration of a numerical sequence. For greater clarity, here we report the numerical sequence from which was drawn the datum reported in Table I, related to group 3.

    (Months:6,8,12,6,7,8,8,9,10,6,12,6,6,7,22,7,23,6.5,21,17,7,21,7,6,6,7,6,17,6,7,7,9,21,26,6,7.5,6,6,6,7,23,10. Mean = 10.2 mo; SD = 6.1 mo).

    With regard to the second question, we agree with Dr. McKee. A mistake occurred during the revision process and we are preparing a "erratum" for the Editor. In Table 1, ulna and radius fractures should be grouped together and "humerus" should replace "ulna". A plaster cast was used for all ulnar and radial and humeral fractures.

    Reference

    1. Cacchio A, Giordano L, Colafarina O, Rompe JD, Tavernese E, Ioppolo F, Flamini S, Spacca G, Santilli V. Extracorporeal shock-wave therapy compared with surgery for hypertrophic long-bone nonunions. J Bone Joint Surg Am. 2009;91:2589-97.

    Michael D. McKee, MD, FRCSC
    Posted on December 09, 2009
    Excellent Study
    St. Michael's Hospital, Toronto, Ontario, Canada

    To the Editor:

    I would like to congratulate Dr. Cacchio and colleagues on their excellent study, “Extracorporeal Shock-Wave Therapy Compared with Surgery for Hypertrophic Long-Bone Nonunions” (1). A randomized trial of this nature is certainly a much-needed study that helps the practicing clinician determine the role of this non-operative modality (ESWT) in the treatment of established long bone nonunion. I have two specific questions regarding their data:

    1. The data in Table I on “Duration of nonunion” would suggest (i.e. Group 3, Mean 10.2 months +/- 6.1 months) that some patients were treated earlier than 6 months following their injury whereas the Materials and Methods section states that nonunion was defined at a minimum of 6 months post-treatment. This information is important and would have some influence on an orthopaedic surgeon’s decision as to when this treatment is best initiated.

    2. The data in Table I and the information in the Materials and Methods section states that there were no humeral nonunions included in the study, yet Figure 3 shows a humeral nonunion and the “Adverse Effects” section discusses a complication following the treatment of a distal humeral nonunion. The applicability (or lack thereof) of ESWT to humeral nonunions would be of interest to practicing clinicians.

    The author did not receive any outside funding or grants in support of his research for or preparation of this work. Neither he nor a member of his immediate family 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 author, or a member of his immediate family, is affiliated or associated.

    Reference

    1. Cacchio A, Giordano L, Colafarina O, Rompe JD, Tavernese E, Ioppolo F, Flamini S, Spacca G, Santilli V. Extracorporeal shock-wave therapy compared with surgery for hypertrophic long-bone nonunions. J Bone Joint Surg Am. 2009;91:2589-97.

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