| Objective: To developed a safe and feasible gunsight which can assist in percutaneous pedicle one-way locking screw on the locking axial lumbosacral interbody fusion. we evaluate the safety and feasibility through the locking axial lumbosacral interbody fusion experiment on adult specimens at the same time.Methods:(1)According to the data and characteristics which comes from the research on radiographic research,biomechanics testing and finite element analysis of the locking axial lumbosacral interbody fusion.On the basis of the design of the man-machine engineering specification and humanized design basic requirements, developed a safe and feasible gunsight for axial lumbar 5 sacral 1(L5/S1) internal fixation fixed percutaneous pedicle unilateral Locking which can assist in percutaneous pedicle one-way locking screw on the locking axial lumbosacral interbody fusion.(2) Choose 8 specimens of adult corpse, all contain the pelvis to the L4 vertebral body. Divided it into the control group(group unarmed lock) and experimental group(equipment auxiliary), each group contain 4 specimens.Each set of the specimens make eight locking experiments in the left and right sides respectively.Compared the success rate of lock and the accuracy of locking nail, the differences on the number of lock time-consuming and number of perspective between the 2 groups.Results:(1)We developed the gunsight for axial lumbar 5 sacral 1(L5/S1) internal fixation fixed percutaneous pedicle unilateral locking preliminarily. It mainly comprise axial fixed and alignment two major parts in vivo and in vitro, including axial fixed link, alignment arm, porous, aiming tube, T lock wrench and open cone etc.(2) In the locking experiments, the experimental group(group equipment auxiliary) compared to the control group(group unarmed lock), the success rate of lock and the accuracy of locking nail improved, the lock time-consuming shortened, the number of perspective reduced, and the differences have statistically significant(all P < 0.05).Conclusions: The gunsight for axial Lumbar 5 Sacral 1(L5/S1) internal fixation fixed percutaneous pedicle unilateral locking has reached the ergonomics of the basic design requirement specification and humanized design. Namely, rational design, structural optimization, convenient and practical theoretically. It is a reasonable, safe and feasible surgical instruments in the operation of axial Lumbar 5 Sacral 1(L5/S1) internal fixation fixed percutaneous pedicle unilateral locking.But, as a result of the fewer experimental specimen cases and it has not been used in clinical trials, its clinical application remains to be further in-depth study. At the same time, we can make it further perfection and improvement through other relevant research and further clinical experimental applications in order to apply it to clinical successfully. |