We reviewed the literature to determine the clinical outcomes of the treatment of closed fractures of the tibial shaft with immobilization in a cast, open reduction with internal fixation, or fixation with an intramedullary rod. We reviewed 2372 reports of comparative trials and uncontrolled studies of series of patients published between 1966 and 1993. Nineteen reports, involving six controlled trials and twenty-seven groups of patients, met our inclusion criteria. A structured questionnaire was used to assess the quality of the literature in terms of the experimental design and the method of assessment of outcome. Outcomes from controlled trials were summarized with odds ratios and risk differences, and outcomes from case series were summarized by the medians of the reported results. The studies that were reviewed generally had few subjects and were poorly designed. The comparative trials showed treatment with a cast to be associated with a lower rate of superficial infection than open reduction and internal fixation (mean difference, -5.81 per cent; p = 0.02) and open reduction and internal fixation to be associated with a higher rate of union by twenty weeks than treatment with a cast (mean difference, -18.07 per cent; p = 0.008). There were no other significant associations. There were insufficient data for us to evaluate any aspect of functional status, level of pain, or other patient- reported outcomes of any of the methods of treatment. The results of the present review suggest that the data from the published literature are inadequate for decision-making with regard to the treatment of closed fractures of the tibia.