The monitoring of fracture healing is a complex process. Typically, successive radiographs are performed and an emerging calcification of the fracture area is evaluated. The aim of this study was to investigate whether different bone healing patterns can be distinguished using a telemetric instrumented femoral internal plate fixator. An electronic telemetric system was developed to assess bone healing mechanically. The system consists of a telemetry module which is applied to an internal locking plate fixator, an external reader device, a sensor for measuring externally applied load and a laptop computer with processing software. By correlation between externally applied load and load measured in the implant, the elasticity of the osteosynthesis is calculated. The elasticity decreases with ongoing consolidation of a fracture or nonunion and is an appropriate parameter for the course of bone healing. At our centre, clinical application has been performed in 56 patients suffering nonunion or fracture of the femur.Objectives
Materials and Methods
In an interdisciplinary project involving electronic
engineers and clinicians, a telemetric system was developed to measure
the bending load in a titanium internal femoral fixator. As this
was a new device, the main question posed was: what clinically relevant
information could be drawn from its application? As a first clinical
investigation, 27 patients (24 men, three women) with a mean age
of 38.4 years (19 to 66) with femoral nonunions were treated using the
system. The mean duration of the nonunion was 15.4 months (5 to
69). The elasticity of the plate-callus system was measured telemetrically
until union. Conventional radiographs and a CT scan at 12 weeks
were performed routinely, and healing was staged according to the
CT scans. All nonunions healed at a mean of 21.5 weeks (13 to 37).
Well before any radiological signs of healing could be detected,
a substantial decrease in elasticity was recorded. The relative
elasticity decreased to 50% at a mean of 7.8 weeks (3.5 to 13) and
to 10% at a mean of 19.3 weeks (4.5 to 37). At 12 weeks the mean
relative elasticity was 28.1% (0% to 56%). The relative elasticity
was significantly different between the different healing stages
as determined by the CT scans. Incorporating load measuring electronics into implants is a promising
option for the assessment of bone healing. Future application might
lead to a reduction in the need for exposure to ionising radiation
to monitor fracture healing.