To determine if force measured using a strain gauge in circular external fixation frames is different for 1) different simulated stages of bone healing, and for 2) fractures clinically deemed either united or un-united. In a laboratory study, 3 similar Ilizarov frame constructs were assembled using a Perspex bone analogue. Constructs were tested in 10 different clinical situations simulating different stages of bone healing including with the bone analogue intact, with 1,3 and 50mm gaps, and with 6 materials of varying stiffness's within the 50mm gap. A Bluetooth strain gauge was inserted across the simulated fracture focus, replacing one of the 4 threaded rods used to construct the frame. Constructs were loaded to 700N using an Instron testing machine and maximum force during loading was measured by the strain gauge. Testing was repeated with the strain gauge replacing each of the 4 threaded rods in turn, with measurements being repeated 3 times, across all 3 frame constructs for all 10 simulated clinical situations (n=360). Force measurements between the situations were compared using a Kruskal-Wallis test (KW) and a post-hoc Steel test was used for multiple comparison against control (intact bone model). Additionally, a pilot study has been initiated to assess clinical efficacy of the strain gauge measurement in patients with circular frames. The strain gauge replaced the anterior rod across the fracture focus for each patient. Patients were asked to step on a weighing scale with their affected limb, and maximum weight transfer through the limb and maximal force measured in the frame were recorded. This was repeated 3 times and a mean ratio of force to weight through affected limb was calculated for each patient. The clinical situation at each measurement was designated as united or un-united by one of the senior authors for analysis. Force measurements between the situations were compared using a Wilcoxon-Mann-Whitney test.Abstract
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