Treatment of diaphyseal fractures of the forearm using the Point Contact Fixator (PC-Fix): results of 387 fractures of a prospective multicentric study (PC-Fix II).

Fractures of the forearm are considered to be a very good indication for plating. Conventional plating is still technically demanding. Extensive animal studies show that there is potential for improvement. The method consists of using an internal fixator that minimizes implant contact to the bone to reduce biological damage. Furthermore, foregoing the need for precise reduction and interfragmental compression makes it easier to use and, therefore, it should be safer. The goal of the study was to observe handling qualities, healing, and complications. For this purpose the study was designed to yield a very high follow-up in clinics with adequate experience and with a number of different surgeons performing the internal fixation. The study was designed as a prospective multicentre investigation in 16 trauma centres worldwide. To test the new approach to internal fixation, diaphyseal fractures of the forearm were stabilized surgically with the PC-Fix (Point-Contact Fixator) system, namely, 387 fractured bones involving 277 forearms in 272 patients. Internal fixation was performed using 387 PC-Fixators. 21% of the fractures were open and 25% occurred in polytraumatized patients. The rate of follow-up was 97%. 355 fractured bones healed uneventfully within four months. Overall, there were 32 complications before bone union occurred; 27 of these bones required re-operation (27 of 387, 7%). All of them subsequently healed without further complications. There were 15 delayed or non-unions and seven implant loosenings, two of which were associated with infection. Two superficial (0.6%) and two deep infections (0.6%) occurred in 306 closed fractures. Deep infection developed in one of 81 osteosyntheses of open fractures (1.2%). Other complications included one synostosis, fractures with the implant in situ with adequate trauma involving three bones, and two secondary correction procedures for postoperative malalignment. There were seven refractures occurring at a mean of three weeks after the removal of 150 PC-Fixators (4.7%). This study demonstrated that the technique of using an internal fixator is a simple one for the fixation of forearm fractures, resulting in shorter duration of surgery with a low rate of complications compared with the data reported in the literature on conventional techniques for forearm fracture stabilization.