The long-term outcomes and the quality of life were studied in patients who had had an open fracture of the tibial shaft with severe soft-tissue loss. Limb salvage with a free flap was attempted in twenty-seven patients (sixteen of whom had a successful procedure and were examined personally by us), while eighteen patients were managed concurrently with an early below-the-knee amputation. Soft-tissue coverage was successful in all but one patient in whom limb salvage had been attempted. Ultimately, however, five extremities were amputated, with an infection at the site of a non-union being the most common reason for amputation. The patients who had had limb salvage had more complications (p < 0.001), more operative procedures (p < 0.001), and a longer stay in the hospital (p < 0.05) than the patients who had had an early below-the-knee amputation. The long-term functional results for sixteen patients who had had a successful limb-salvage procedure (average duration of follow-up, thirty-five months) were compared with those for eighteen patients who had had a below-the-knee amputation (average duration of follow-up, forty-four months). The patients who had had a successful limb-salvage procedure took significantly more time to achieve full weight-bearing (p < 0.05), were less willing or able to work (p < 0.01), and had higher hospital charges (p < 0.006) than the patients who had been managed with an early below-the-knee amputation. They also had a significant decrease in motion at the ankle and subtalar joint in the injured leg compared with the contralateral leg (p < 0.001). A quality-of-life evaluation was possible for only thirteen of the patients who had had a successful limb-salvage procedure and for sixteen of the patients who had had a below-the-knee amputation. The two groups were similar in terms of their responses, but significantly more patients who had had limb salvage considered themselves severely disabled (p < 0.05). They also had more problems with the performance of occupational and recreational activities (p < 0.05). This study confirmed the reliability of modern microvascular free tissue techniques for the coverage of large soft-tissue defects associated with tibial fractures. It also showed that complications and difficulties in the restoration of osseous union are common and may be directly related to the less satisfactory functional, occupational, recreational, and quality-of-life outcomes that are seen in many patients who have had limb salvage.(ABSTRACT TRUNCATED AT 400 WORDS)