A critique of the methodologies used in clinical studies of hip-joint arthroplasty published in the English-language orthopaedic literature.

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Abstract
In a search of the English-language orthopaedic literature that was published from 1960 through 1986, only four papers that reported on prospective studies of hip-joint arthroplasty were found. In the study presented here, the standard epidemiological methods that are applicable to the design and performance of prospective clinical trials in medicine were reviewed, and the identified papers were evaluated with respect to the use of these methods. In all four papers, grave deficiencies were identified. Finally, the effects of some controlled clinical trials in other surgical disciplines were briefly reviewed. On the basis of the findings in this study, it was concluded that adequate surgical trials should be completed before new procedures or new designs of prostheses, such as those used in hip-joint arthroplasty, are made available for general use.

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