Background: Standard open reduction and internal fixation techniques have been successful in restoring osseous alignment for bicondylar tibial plateau fractures; however, surgical morbidity, especially soft-tissue infection and wound necrosis, has been reported frequently. For this reason, several investigators have proposed minimally invasive methods of fracture reduction followed by circular external fixation as an alternative approach. To our knowledge, there has been no direct comparison of the two operative approaches. Methods: We performed a multicenter, prospective, randomized clinical trial in which standard open reduction and internal fixation with medial and lateral plates was compared with percutaneous and/or limited open fixation and application of a circular fixator for displaced bicondylar tibial plateau fractures (Schatzker types V and VI and Orthopaedic Trauma Association types C1, C2, and C3). Eighty-three fractures in eighty-two patients were randomized to operative treatment (forty-three fractures were randomized to circular external fixation and forty to open reduction and internal fixation). Follow-up consisted of obtaining a history, physical examination, and radiographs; completion of the Hospital for Special Surgery (HSS) knee score, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), and the Short Form-36 (SF-36) General Health Survey; and recording of complication and reoperation rates. Results: There were no significant differences between the groups in terms of demographic variables, mechanism of injury, or fracture severity and/or displacement. However, patients in the circular fixator group had less intraoperative blood loss than those in the open reduction and internal fixation group (213 mL and 544 mL, respectively; p = 0.006) and spent less time in the hospital (9.9 days and 23.4 days, respectively; p = 0.024). The quality of osseous reduction was similar in the groups. There was a trend for patients in the circular fixator group to have superior early outcome in terms of HSS scores at six months (p = 0.064) and the ability to return to preinjury activities at six months (p = 0.031) and twelve months (p = 0.024). These outcomes were not significantly different at two years. There was no difference in total arc of knee motion, and the WOMAC scores at two years after the injury were not significantly different between the groups with regard to the pain (p = 0.923), stiffness (p = 0.604), or function (p = 0.827) categories. The SF-36 scores at two years after the injury were significantly decreased compared with the controls for both groups (p = 0.001 for the circular fixator group and p = 0.014 for the open reduction and internal fixation group), although there was less impairment in the circular fixator group in the bodily pain category (a score of 46) compared with the open reduction and internal fixation group (a score of 35) (p = 0.041). Seven (18%) of the forty patients in the open reduction and internal fixation group had a deep infection. The number of unplanned repeat surgical interventions, and their severity, was greater in the open reduction and internal fixation group (thirty-seven procedures) compared with the circular fixator group (sixteen procedures) (p = 0.001). Conclusions: Both techniques provide a satisfactory quality of fracture reduction. Because percutaneous reduction and application of a circular fixator results in a shorter hospital stay, a marginally faster return of function, and similar clinical outcomes and because the number and severity of complications is much higher with open reduction and internal fixation, we believe that circular external fixation is an attractive option for these difficult-to-treat fractures. Regardless of treatment method, patients with this injury have substantial residual limb-specific and general health deficits at two years of follow-up. Level of Evidence: Therapeutic Level I. See Instructions to Authors for a complete description of levels of evidence. Copyright � 2006 by The Journal of Bone and Joint Surgery, Incorporated.
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