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
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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
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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.
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