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We have studied the progression of healing in 103 unstable fractures of the tibia. In 76 patients we removed the external fixator once the stiffness had reached 15 Nm/° in the sagittal plane. Deformity at the site of the fracture subsequently occurred in four patients. In a further 27, we measured stiffness in several planes and removed the fixator only when the stiffness reached 15 Nm/° in each. We found that stiffness in two orthogonal planes may differ widely (maximum difference 9.0 Nm/°, mean 4.1 Nm/°). There were no failures in the second group. We advocate that fracture stiffness be measured in two orthogonal planes when assessing tibial healing and suggest that values above 15 Nm/° in two planes give an indication that it is safe to remove the fixator.

This paper presents a new design for a device to monitor the motion of fracture fragments in diaphyseal tibial fractures. The device measures the motion that occurs at the fracture site when loaded by gait or by manipulation. It has undergone rigorous calibration and acceptance trials. The device has been used in ethically approved research clinics held at the North Staffordshire Hospital (40 patients). The paper presents a selection of results obtained using the new device. The results demonstrate several new ways of assessing fracture healing by examining fracture site motion. The following conclusions were drawn: 1. If fracture monitoring devices are to be attached to bone screws, it is essential to minimize bone screw errors. To do this, each patient must have similar bone screw lengths, orientations, alignment and siting. This is only achievable using a peroperative reduction device. 2. If fracture stiffness is to be used as a measure of fracture healing, load rate should be controlled; at the very least strain rate should be controlled. 3. It is imperative that fracture stiffness be measured in more than one plane by a biplanar device so that asymmetry may be accommodated. 4. Fracture stiffness, on its own, is probably not a sufficiently rigorous measure of healing end-point. The quantifiably viscoelastic properties of healing callus should be taken into account.

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A widely used method of treatment for unstable tibial shaft fractures is unilateral external fixation. The majority of fixators act as three distinct devices: an intra-operative reduction device, a device to maintain fracture alignment during healing and an aid to healing by allowing movement at the fracture site. Conventional operative techniques require the surgeon to manipulate a number of degrees of freedom at once, making reduction of the fracture difficult, and results in the fixator being out of alignment with the long axis of the bone. An operative method has been developed that separates reduction and fixation. A dedicated device has been designed to improve the per-operative control of fracture fragments during fracture reduction. The device has been used in clinical trials for the reduction of 22 diaphyseal tibial fractures. Compared with previous operative techniques there has been a saving of 53 per cent in fracture reduction time and an overall saving of 10 per cent in operating time. Fracture alignment has been improved compared with reductions achieved with a fixator which potentially improves healing and lowers the rate of malunion. In each case the fixator has been applied in alignment with the bone, improving dynamization and reducing the likelihood of malunion due to fixator cam slippage.