We reviewed all 717 manuscripts published in the 1997 issues of the British
and American volumes of the Journal of Bone and Joint Surgery and in Clini
cal Orthopaedics and Related Research, from which 33 randomised, controlled
trials were identified. The results and sample sizes were used to calculat
e the statistical power of the study to distinguish small (0.2 of standard
deviation), medium (0.5 of standard deviation), and large (0.8 of standard
deviation) effect sizes.
Of the 33 manuscripts analysed, only three studies (9%) described calculati
ons of sample size. To perform post-hoc power assessments and estimations o
f deficiencies of sample size, the standard effect sizes of Cohen (small, m
edium and large) were calculated. Of the 25 studies which reported negative
results, none had adequate power (beta < 0.2) to detect a small effect siz
e and 12 (48%) lacked the power necessary to detect a large effect size. Of
the 25 studies which did not have an adequate size of sample to detect sma
ll differences, the average used was only 10% of the required number.
Our findings suggest that randomised, controlled trials in clinical orthopa
edic research utilise sample sizes which are too small to ensure statistica
l significance for what may be clinically important results.