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.