April 2002 Bulletin

Letters

Write to The Editor, AAOS Bulletin, 6300 North River Road, Rosemont, Ill. 60018-4262

Joint registry

I would like to share some personal experiences with Medical Registries and make some suggestions concerning the article "National Joint Registry Explored," published in the February 2002 issue of the Bulletin.

While serving as Chairman of the Committee on Injuries of the Academy in the mid-1970s, I proposed to the Board of Directors the establishment of a Fracture Registry. A pilot project was funded after we had agreed that such a major undertaking must be initiated in a very moderate scale, and only gradually expanded. Five institutions in different parts of the country were to participate in the initial project. The fractured femur, which had the common denominator of always being treated in a hospital, was chosen to be the first fracture in the study. The effort failed. The submission of data was often incomplete and delayed; and more importantly follow-up data was very poor.

During the years of 1976 and 1977, I served as President of the Hip Society, which at that time had less than 30 members; and the number of different Total Hip Implants on the market probably did not exceed half a dozen. One of my highest priorities was the creation of a Total Joint Registry. Despite the devotion of considerable amount of time and effort to the project it failed. Big egos, concerned over the possibility of losing their own fledging systems of evaluation, prevailed. A few years later Clement Sledge, MD, ascended to the presidency of the Society and made a comparable effort, with equally unhappy results.

I am keenly aware that comparisons between the current AAOS project and the above mentioned attempts must be carefully made. Today’s computer sophistication and our ability to communicate between institutions are superior. These are two important factors. However, the human elements have remained essentially unchanged. As a matter of fact the obstacles they are likely to present may be even more serious. To rely too heavily on the success of the Swedish Registry as an example of the feasibility of an American Registry may be wrong. Sweden has a small, homogeneous, stable and disciplined population. Its registry has included a small number of implants, while in this country there are, according to published reports, over 300 different total hip prostheses.

The necessarily limited length of this letter does not permit my indulging in details. Let it suffice to say that the following points must be seriously considered before embarking in this worthwhile adventure.

  1. Will all 300 different prostheses be included in the Registry? Since it is likely this will not be the case, then which ones will be chosen? How will the "managers" of the Registry determine the ones to be included? How will the "exclusions" be justified to the participating orthopaedic community? If only a few implants are chosen, this action will be considered by some as tantamount to recognition of their superiority and therefore a condemnation of the excluded ones.
  2. Will only institutions where large numbers of arthroplasties are performed be selected to participate? Will that be fair? How will surgeons, who have large practices and their "own" prostheses, be handled? What about the surgeons who have their own manufacturing facilities?
  3. The manufacturing Industry of prosthetic implants–in order to successfully compete in a most competitive market–release with frequency their "new and improved" implants. Will every new modification be included in the Registry? How will industrial concerns respond to being excluded? Until now Industry, because of it awesome economic power, has managed to reign supreme in the field. Will it quietly accept an unfavorable verdict?
  4. Will the above potential issues create a political battleground where industry and unhappy excluded surgeons will fight against the registry claiming unfair discrimination?
  5. How will the accuracy of reporting of data be guaranteed? Is it possible that some unscrupulous surgeons, concerned over the fact that their results will be public knowledge, will "fudge" their results to insure the maintenance of their reputations?

If the sole purpose of the Registry is to develop a mechanism that allows earlier identification of "failed implants," then success is within reach. But only if all implants, those manufactured in the United States and in Europe, Latin America and the Orient are included, since many hip prostheses implanted in America are made overseas.

A comprehensive registry, comparable to the Swedish or Canadian registries, will face obstacles that might prove to have been insurmountable. I suggest to the Academy to withhold plans to move rapidly into this venture, and to consider very carefully the questions I have raised, as well as the ones that others are likely to voice in the near future. Voices that will come from people, who like myself, wish the Academy success in all of its activities.

Augusto Sarmiento, MD

Coral Gables, FL

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