JBJS | Article

The Journal of Bone & Joint Surgery, Volume 80, Issue 6

Correspondence | June 01, 1998

Correspondence

Nicola Maffulli, M.D., M.S., Ph.D., F.R.C.S.(Orth); Charles R. Clark, M.D.

The Journal of Bone & Joint Surgery. 1998; 80:923-923

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Introduction

Introduction | References

TO 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 journals^4,5,8,9,11.

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 journals^4,5,8,9,11. 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 literature^1,6,7,9. 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

References

Introduction | References

Badner, N. H.; Bourne, R. B.; Rorabeck, C. H.; MacDonald, S. J.; and Doyle, J. A.: Intra-articular injection of bupivacaine in knee-replacement operations. Results of use for analgesia and for preemptive blockade. J. Bone and Joint Surg.,78-A: 734-738, May 1996.78-A734 1996

Barrack, R. L.; Wolfe, M. W.; Waldman, D. A.; Milicic, M.; Bertot, A. J.; and Myers, L.: Resurfacing of the patella in total knee arthroplasty. A prospective, randomized, double-blind study. J. Bone and Joint Surg.,79-A: 1121-1131, Aug. 1997.79-A1121 1997

Bell, P. R.: Surgical research and randomized trials. British J. Surg.,84: 737-738, 1997.84737 1997

Capasso, G.; Testa, V.; Maffulli, N.; and Barletta, L.: Molded arthroplasty and transfer of extensor hallucis brevis tendon. A modification of Keller-Lelievre operation. Clin. Orthop.,308: 43-49, 1994.30843 1994 [PubMed]

Capasso, G.; Testa, V.; Maffulli, N.; and Bifulco, G.: Aprotinin, corticosteroids and normosaline in the management of patellar tendinopathy in athletes: a prospective randomized study. Sports, Exerc. and Injury,3: 111-115, 1997.3111 1997

Grontvedt, T.; Engebretsen, L.; Benum, P.; Fasting, O.; Molster, A.; and Strand, T.: A prospective, randomized study of three operations for acute rupture of the anterior cruciate ligament. Five-year follow-up of one hundred and thirty-one patients. J. Bone and Joint Surg.,78-A: 159-168, Feb. 1996.78-A159 1996

Heckman, J. D.; Ryaby, J. P.; McCabe, J.; Frey, J. J.; and Kilcoyne, R. F.: Acceleration of tibial fracture-healing by non-invasive, low-intensity pulsed ultrasound. J. Bone and Joint Surg.,76-A: 26-34, Jan. 1994.76-A26 1994

Lee, E. W.; Maffulli, N.; Li, C. K.; and Chan, K. M.: Pulsed magnetic and electromagnetic fields in experimental Achilles tendonitis in the rat: a prospective randomized study. Arch. Phys. Med. and Rehab.,78: 399-404, 1997.78399 1997

Liem, M. S.; van der Graaf, Y.; and van Vroonhoven, T. J.: CONSORT, randomized trials and the surgical scientific community. British J. Surg.,84: 769-770, 1997.84769 1997

Klosok, J. K.; Pring, D. J.; Jessop, J. H.; and Maffulli, N.: Chevron or Wilson metatarsal osteotomy for hallux valgus. A prospective randomised trial. J. Bone and Joint Surg.,75-B(5): 825-829, 1993.75-B(5)825 1993

Maffulli, N.; Pintore, E.; and Petricciuolo, F.: Arthroscopy wounds: to suture or not to suture. Acta Orthop. Belgica,57: 154-156, 1991.57154 1991

Maffulli, N.; Testa, V.; and Capasso, G.: Use of a tourniquet in the internal fixation of fractures of the distal part of the fibula. A prospective, randomized trial. J. Bone and Joint Surg.,75-A: 700-703, May 1993.75-A700 1993

Bell, P. R.: Surgical research and randomized trials. British J. Surg.,84: 737-738, 1997.84737 1997

Liem, M. S.; van der Graaf, Y.; and van Vroonhoven, T. J.: CONSORT, randomized trials and the surgical scientific community. British J. Surg.,84: 769-770, 1997.84769 1997

Maffulli, N.; Pintore, E.; and Petricciuolo, F.: Arthroscopy wounds: to suture or not to suture. Acta Orthop. Belgica,57: 154-156, 1991.57154 1991

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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Nicola Maffulli, Charles R. Clark; Correspondence. The Journal of Bone & Joint Surgery. 1998 Jun;80(6):923-923.

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