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Ethics in Practice   |    
The Ethics of Sham Surgery in Clinical Orthopaedic Research
Samir Mehta, MD1; Thomas G. Myers, MD2; Jess H. Lonner, MD3; G. Russell Huffman, MD, MPH4; Brian J. Sennett, MD4
1 Department of Orthopaedics and Sports Medicine, Harborview Medical Center, 325 9th Avenue, Box 359798, Seattle, WA 98104. E-mail address: samir.mehta@uphs.upenn.edu
2 Department of Orthopaedic Surgery, University of Pittsburgh, Kaufmann Medical Building, 3461 Fifth Avenue, Pittsburgh, PA 15213
3 Booth Bartolozzi Balderston Orthopaedics, Pennsylvania Hospital, 800 Spruce Street 3B Orthopaedics, Philadelphia, PA 19107
4 Division of Sports Medicine, Department of Orthopaedic Surgery, University of Pennsylvania, Penn Sports Medicine Center, Weightman Hall, 235 South 33rd Street, Philadelphia, PA 19104
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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.

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2007 Jul 01;89(7):1650-1653. doi: 10.2106/JBJS.F.00563
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While other surgical specialties, such as neurosurgery and thoracic surgery, have already broached the ethical discussion surrounding sham surgery as a research method, published discussion regarding the use of the sham orthopaedic model has been limited1. One solution in orthopaedics would be to open up the debate and the decision-making process to the surgeons, as there is no current forum or body to do this2. An essential question in the debate on the ethics of sham surgery concerns resolving the tension between the highest standard of research design (the double-blind, randomized, placebo-controlled trial) and the highest standard of ethics (to do no harm to the patient)3.
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    Samir Mehta, M.D.
    Posted on September 21, 2007
    Dr. Mehta responds to Dr. Means
    Hospital of the University of Pennsylvania, Philadelphia, PA

    Dr. Means' recommendations regarding the re-naming of "sham" surgery as "placebo" surgery is very appropriate. While we, as orthopaedic surgeons, may not want to admit it, our explanation of a condition or disease to a patient or the goals of surgery can bias a patient's decision. Even inclusion in a "sham" or "placebo" trial can give the patient a "therapeutic misconception."

    In addition to merely changing the terminology, physician-researchers should and will need to follow strict guidelines when embarking on such studies. "Placebo" surgery has a role in our profession as we move forward.

    Kenneth R Means, Jr., M.D.
    Posted on September 07, 2007
    Placebo Surgery Instead of Sham Surgery
    Curtis National Center, Union Memorial Hospital, Baltimore, MD

    To The Editor:

    I think we would all agree that Prospective Randomized Controlled Trials (PRCTs) are the best way for us to determine standards of care in the practice of evidence based medicine. The article by Mehta et al.(1) was an excellent review of the ethics involving, and need for, so called sham surgery. Perhaps one small way to decrease resistance to the concept of sham surgery would be a simple name change. I imagine that IRBs and our patients are reluctant to consider something with such a negative connotation as "sham".

    A PubMed(2) text search of "sham surgery" vs. "placebo surgery" reveals nearly 40 times as many results for the former (1277 vs. 33). Using "placebo surgery" instead, as Moseley et al.(3) did, may be helpful in allowing us, our patients, and the general public to more open-mindedly consider the option.

    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 .

    References:

    1. Samir Mehta, Thomas G. Myers, Jess H. Lonner, G. Russell Huffman, and Brian J. Sennett. The Ethics of Sham Surgery in Clinical Orthopaedic Research. J Bone Joint Surg Am 2007; 89: 1650-1653.

    2. http://www.ncbi.nlm.nih.gov/sites/entrez

    3. Moseley JB, O'Malley K, Petersen NJ, Menke TJ, Brody BA, Kuykendall DH, Hollingsworth JC, Ashton CM, Wray NP. A controlled trial of arthroscopic surgery for osteoarthritis of the knee. N Engl J Med. 2002;347:81-88.

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