Biomechanical and biological considerations relating to the clinical use of the Point Contact-Fixator--evaluation of the device handling test in the treatment of diaphyseal fractures of the radius and/or ulna.

The Point Contact-Fixator (PC-Fix) was designed as part of the developmental evolution of more biological devices for internal fixations. It is a device characterized by minimal contact to the underlying periosteum and bone, hereby minimizing potential damage to perfusion. A multicentre handling test was conducted in 1993 and 1994 in six hospitals to assess its performance. A total of 83 fractured forearm bones (34 radii and 49 ulnae) in 52 patients were stabilized with a PC-Fix. The mean age of the patients was 37 years. There were 24 AO type A, 24 type B and 5 type C fractures. Nine fractures were open. Mean follow-up was 15.6 months; follow-up was 100%. All 21 surgeons involved considered the use of the PC-Fix self-explanatory and relatively easy. Handling difficulties were mainly related to insertion of the monocortical screws. In particular, the precision required for insertion, the inability to incline the screw and the inability to pull the plate to the bone using the screw were considered hard to deal with. Stripping of the hexagonal slot was a problem at removal of the implant, possibly related to overtightening of the screws at insertion. In 76 of 83 bones (49 of 53 forearms), the fractures united without additional surgery. The healing pattern typically showed early callus formation bridging the fracture, followed by progressive mineralization of the central radiolucent line. Complications included one infection, one late displacement and four delayed unions, all requiring revision surgery. In 8 forearms, plate removal was performed after a mean of 10.3 months. Two refractures occurred after removal of the implant 6 and 7 months postoperatively. In conclusion, the practical handling of the new implant was straightforward and easily learnt. The treatment failures observed were related to technical and strategic errors. We consider that, when using devices with a locking compression principle, a minimum number of three screws should be placed on each side of the fracture, that interfragmentary compression of simple fractures is desirable in order to increase stability and that, contrary to in vivo animal studies, early plate removal is not indicated. The trend in fracture fixation is to improve the biomechanical and biological properties of operating technique and the devices used. The PC-Fix has proven a useful step in the right direction in this evolutionary process.