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Specialty Update   |    
What's New in Sports Medicine
Kimberly A. Turman, MD1; Mark D. Miller, MD1
1 Department of Orthopaedic Surgery, University of Virginia, 400 Ray C. Hunt Drive, Suite 330, Charlottesville, VA 22908-0159. E-mail address for M.D. Miller: mdm3p@virginia.edu
View Disclosures and Other Information
Specialty Update has been developed in collaboration with the Council of Musculoskeletal Specialty Societies (COMSS) of the American Academy of Orthopaedic Surgeons.
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, Inc.
J Bone Joint Surg Am, 2008 Jan 01;90(1):211-222. doi: 10.2106/JBJS.G.01428
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Extract

This update is based on the scientific and investigational activities in the specialty of sports medicine from September 2006 to August 2007. It includes a review of pertinent research and articles published in the three premier journals of our specialty, namely, The Journal of Bone and Joint Surgery (American Volume), The American Journal of Sports Medicine, and Arthroscopy. It also takes into account the scientific presentations of the annual and Specialty Day meetings of the American Academy of Orthopaedic Surgeons (AAOS), the American Orthopaedic Society for Sports Medicine (AOSSM), and the Arthroscopy Association of North America (AANA).
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    References

    Accreditation Statement
    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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    Mark D Miller, M.D.
    Posted on February 24, 2008
    Dr. Miller et al. respond to Dr. Davidson
    Department of Orthopaedic Surgery, University of Virginia, Charlottesville, VA

    We are pleased to have the opportunity to respond to Dr. Davidson's letter. The focus of the specialty update is to concisely review the published literature over the course of the previous year, in this case September 2006 to August 2007.

    While we acknowledge that there are several commercially available products to aid in the allograft sterilization process, we are unaware of any peer-reviewed studies regarding this issue published during this time period. As such, it was not included in our review. We apologize if we have left the impression that there are no products or techniques available to aid in efforts to reduce disease transmission with allograft use. We are also keenly aware of the need to ensure that there is no potential for a conflict of interest in presenting this information. As new studies and peer reviewed literature become available documenting the effectiveness of these products, they will certainly be included in future updates and reviews.

    Philip A. Davidson, M.D.
    Posted on January 31, 2008
    Allografts for Knee Reconstruction Can Be Safe and Sterile
    Medical Director, Clearant, Inc.

    To The Editor:

    This letter is in reference to the article published in the recent edition of JBJS, "What's New in Sports Medicine,"(1). As Medical Director of Clearant (TM), I would like to comment on a key omission pertaining to the subject of allograft safety and sterility for ligament reconstruction.

    The authors accurately comment on the risk of disease transmission associated with allografts, but neglected to mention the capacity for allograft tissue sterilization. There are a variety of modalities capable of rendering the tissues "sterile". In the Clearantâ„¢ tissue processing method, sterility is attained at the SAL (sterility assurance level) of 10-6(2). The Clearant process entails pre-treatment of the grafts in a protective solution (propylene glycol, dimethyl sulfoxide, mannitol, and trehalose) and the controlled application of ultra cold temperatures. These measures mitigate against tissue damage from freezing and serve to scavenge the free radicals associated with high dose gamma radiation (50KGy), collectively protecting the tissue integrity. Using this method, the same degree of sterility is achieved as that mandated for orthopedic metallic implants. Complete inactivation is attained for bacterial and viral contaminants and/or pathogens. A study has shown the efficacy of Clearantâ„¢ with processed ACL grafts successfully replicating outcomes of ACL reconstruction with otherwise untreated, non-sterile, ligament grafts(3). Furthermore, it has been demonstrated that this process does not denigrate the mechanical integrity of these grafts(4). In cases where allografts are used for ligament reconstruction, Clearantâ„¢ sterile processed grafts allow for enhanced safety with efficacy equal to non- sterile grafts.

    In support of their research for or preparation of this work, one or more of the authors received, in any one year, outside funding or grants in excess of $10,000 from Clearant, Inc. In addition, one or more of the authors or a member of his or her immediate family received, in any one year, payments or other benefits in excess of $10,000 or a commitment or agreement to provide such benefits from a commercial entity (Clearant Inc.). 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. Turman KA, Miller MD. What's new in sports medicine. J Bone Joint Surg Am. 2008;90:211-222.

    2. Davis K.W., Strawderman W.E. & Whitby, J.L., The rationale and a computer evaluation of a gamma irradiation sterilization dose determination method for medical devices using substerilization incremental dose sterility test protocol, J. Applied Bacteriology, 1984, 57, 31-50.

    3. Davidson P.A., Endean T. , Towcimak N. Clinical Performance of Soft Tissue Allografts Sterilized Using Controlled High Dose Gamma Irradiation; AATB Annual Meeting, 2006.

    4. McAllister D.R., Joyce M.J., Mann B.J., and Vangsness, Jr C.T. Allograft Update: The Current Status of Tissue Regulation, Procurement, Processing, and Sterilization Am. J. Sports Med., Dec 2007; 35: 2148 - 2158.

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