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© 1998 The Journal of Bone and Joint Surgery, Inc.
CorrespondenceTO THE EDITOR: I was dismayed on reading "Editorial. The Prospective, Randomized, Double-Blind Clinical Trial in Orthopaedic Surgery" (79-A: 1119–1120, Aug. 1997) by Clark. From this editorial, it would appear that the first and only paper to address a clinical problem in orthopaedics with use of the so-called gold standard of a randomized, controlled trial was that by Barrack et al.2. The editorial ignored the fact that, four years ago, my research group used the randomized, controlled trial design to study whether a tourniquet is beneficial in the operative treatment of fractures of the distal aspect of the fibula12. This omission is even more difficult to understand given the fact that the article was published in The Journal. Furthermore, my research group has performed several other randomized, controlled trials in orthopaedics, the results of which have been published in other peer-reviewed journals4,5,8,9,11. While we are well aware that randomized, controlled trials are difficult to conceive, perform, and implement in our operative specialty as well as in others3, there is a concerted effort on my side of the Atlantic to address clinical problems with use of this study design10. Orthopaedic surgeons only have to search through Medline to realize that randomized, controlled trials, although still rare, are being performed with increasing frequency by their colleagues all over the world.
Nicola Maffulli, M.D., M.S., Ph.D., F.R.C.S.(Orth): Department of Orthopaedic Surgery, University of Aberdeen Medical School, Polwarth Building, Foresterhill, Aberdeen AB25 2ZD, Scotland
Dr. Clark replies: Maffulli et al. did indeed perform a prospective, randomized study that was published in The Journal12 as well as several others that have been published in other journals4,5,8,9,11. Consequently, I would have expected Dr. Maffulli to be a firm supporter of this editorial. Perhaps he misunderstood the intent of the editorial. As I pointed out, most reports in the orthopaedic literature relating to operative procedures are retrospective reviews of series of patients. As Barrack et al.2 had prepared a report for the August 1997 issue of The Journal regarding a prospective, randomized, double-blind study, I believed that it was important to highlight this type of clinical study. In no way did I intend to suggest that this was the first such report to have been published in The Journal, as I am familiar with the report by Maffulli et al.12 as well as with several other reports of this type that have appeared in the orthopaedic literature1,6,7,9. However, the number of prospective, randomized, double-blind clinical trials in the field of orthopaedic surgery pales in comparison with the number of retrospective reviews. Consequently, I wished to highlight the features of the article by Barrack et al. to stress the importance of such studies and to encourage investigators to consider this methodology when planning future investigations. It would not have been realistic to reference all of the previous prospective, randomized clinical trials that have been published in The Journal. My intent was not to overlook these but rather to stress the importance of such studies, which were highlighted by Barrack et al.2. Maffulli et al. are to be congratulated for performing such clinical studies, and I trust that they will continue to do so in the future.
Charles R. Clark, M.D.: Department of Orthopaedic Surgery, University of Iowa Hospitals and Clinics, 200 Hawkins Drive, Iowa City, Iowa 52242
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