Objectives: Comparison of fracture healing with two different implants: a conventional Dynamic Compression Plate (DCP) and a new internal Point Contact Fixator (PC-Fix).
Design: Randomized, prospective study in experimental animals. Observation times: 12, 24, 48 and 96 weeks, with six sheep per group.
Setting: Following surgery, animals were kept with unrestricted weight-bearing in individual stalls for 12 weeks, thereafter in groups.
Animals: 56 adult Swiss mountain sheep.
Intervention: A standardized oblique fracture of the sheep tibia was reduced and compressed by a lag screw and "neutralized" with one of the implants.
Main outcome measurements: Standard radiographs were used for callus size measurements. After sacrifice the implant was removed and both the treated bone and the contralateral bone were tested for static strength in bending with the plate side under tension. Broken bones were processed for histological evaluation.
Results: In the DCP group all six bones failed through the original fracture at 12 weeks. At 24 and 48 weeks two out of six, at 96 weeks one out of six bones failed through the original fracture, others through one of the screw holes. In the PC-Fix group there were no failures through the original fracture with a single exception at 96 weeks. The strength values in the PC-Fix groups of 12 and 96 weeks were significantly higher then in the corresponding DCP groups.
Conclusions: Healing of simple diaphysial fractures treated by PC-Fix was superior to that achieved by conventional plating. The histological evaluation suggested that the observed differences can be accounted for by the absence of implant-related cortical necrosis and by the circumferentially uninterrupted (if smaller) callus in the PC-Fix group.