0
Letters to the Editor   |    
M. Miles Braun, MD, MPH; Craig E. Zinderman, MD, MPH; Jennifer J. Wood, PhD, MPH; Mark A. Malek, MD, MPH; Frank J. Frassica, MD; Jacquelyn A. Polder, BSN, MPH; Timothy R. Coté, MD, MPH
View Disclosures and Other Information
These letters originally appeared, in slightly different form, on jbjs.org. They are still available on the web site in conjunction with the article to which they refer.

The Journal of Bone and Joint Surgery, Incorporated
J Bone Joint Surg Am, 2006 Nov 01;88(11):2539-2539
5 Recommendations (Recommend) | 3 Comments | Saved by 3 Users Save Case

Extract

M.M. Braun, C.E. Zinderman, J.J. Wood, M.A. Malek, F.J. Frassica, J.A. Polder, and T.R. Cote reply:We appreciate the correspondence of Ms. Budri and colleagues and that of Drs. Gooding and Bentley as well as the opportunity to address the common questions they raise regarding the interpretation of adverse event reports derived from spontaneous (also called passive) reporting systems.Budri et al. suggest that the active nature of the Cartilage Repair Registry would minimize underreporting. In a qualitative sense, this seems a reasonable assertion; however, the quantitative importance of the Cartilage Repair Registry depends at least in part on the numbers of patients enrolled (as a proportion of all Carticel-treated patients) as well as on the duration and completeness of their follow-up—data that Budri et al. did not provide. Provision of these data would allow better estimation of the significance of the underreporting that we acknowledged to be inherent in our study design and that Budri et al. downplay. Given the lack of such data, we refrained from comparing infectious complication rates following Carticel treatment with other procedures, and we wonder on what quantitative basis Budri et al. make such comparisons. They also note that our finding about total knee replacement as an adverse event following Carticel treatment was not novel, since a report of this had preceded our paper; however, that report was published subsequent to the submission of our paper to The Journal of Bone and Joint Surgery. This underscores the fact that knowledge of product safety evolves over time and that we should be vigilant, particularly with novel products.
Figures in this Article

    First Page Preview

    View Large
    />
    First page PDF preview
    Sign In to Your Personal ProfileSign In To Access Full Content
    Not a Subscriber?
    Get online access for 30 days for $35
    New to JBJS?
    Sign up for a full subscription to both the print and online editions
    Register for a FREE limited account to get full access to all CME activities, to comment on public articles, or to sign up for alerts.
    Register for a FREE limited account to get full access to all CME activities
    Have a subscription to the print edition?
    Current subscribers to The Journal of Bone & Joint Surgery in either the print or quarterly DVD formats receive free online access to JBJS.org.
    Forgot your password?
    Enter your username and email address. We'll send you a reminder to the email address on record.

     
    Forgot your username or need assistance? Please contact customer service at subs@jbjs.org. If your access is provided
    by your institution, please contact you librarian or administrator for username and password information. Institutional
    administrators, to reset your institution's master username or password, please contact subs@jbjs.org

    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.
    CME Activities Associated with This Article
    Submit a Comment
    Please read the other comments before you post yours. Contributors must reveal any conflict of interest.
    Comments are moderated and will appear on the site at the discretion of JBJS editorial staff.

    * = Required Field
    (if multiple authors, separate names by comma)
    Example: John Doe





    Related Content
    JBJS Case Connector
    Related Audio and Videos
    Clinical Trials
    Readers of This Also Read...
    JBJS Jobs
    12/04/2013
    NY - Icahn School of Medicine at Mount Sinai
    02/10/2014
    IL - The University of Chicago's Department of Orthopaedic Surgery and Rehabilitation Medicine
    04/02/2014
    IL - Hinsdale Orthopaedics
    02/05/2014
    OR - The Center - Orthopedic and Neurosurgical Care and Research