Tests were done on 10 intact specimen and the process included the initial drilling and final placement of an osteosynthetic screw. Postoperative placement was controlled with a 3-D scan. Results concerning a defined optimal screw positioning and drill failures attempts were done by another independent surgeon.
The 3-D imaging modality allows a direct control of the reduction and screw placement intraoperatively. Our tests did not include simulated fracture conditions, a general use of our new technique can now only be implemented to non displaced fracture types, while clinical and further laboratory tests have to improve our findings for all types of scaphoid fractures.
The validation was performed in two steps: Step 1. Comparison of standard dynamic pedography (three trials, walking, third step, three trials, mid stance force pattern), static pedography in standing position (three trials) and pedography with KIOP in healthy volunteers (three trials, total force 400 N).. Step 2. Comparison between pedography in standing position, pedography with KIOP in awake and anaesthesized patients (three trials, total force 400 N). A randomized prospective controlled study comparing treatment with and without intraoperative pedography has started on November 1, 2005. The subjects are randomized into two groups,
a) use of intraoperative pedography, versus b) no use of intraoperative pedography. One-year-follow-up including standard dynamic pedography is planned. The following scores are used: American Orthopaedic Foot and Ankle Society (AOFAS), Visual-Analogue-Scale Foot and Ankle (VAS FA), Short-Form 36 (SF36, standardized to 100-point-maximum). Intraoperative consequences after the use of intraoperative pedography were recorded.
Conclusion: Since no statistical significant differences were found between the measurements of intraoperative pedography in anaesthesized individuals and the standard static pedography, the introduced method can be considered to be valid for intraoperative static pedography. During the clinical use, in 44% of the cases a modification of the surgical correction were made after intraoperative pedography in the same surgical procedure.