inSWing – results of biomechanical and preclinical tests; premises for clinical assessment

The aim of the study: assessment of the lumbar spine interspinous stabilization method with inSWing (inSWing: interspinous Spacer with Wings) and its stabilizer in the aspect of biomechanical properties, biotolerance and implantation procedure in connection with the effects in the treatment of intervertebral space dysfunctions. Material and methods: The tests were performed on a bearing-tensioning spinal implant made of three different types of biomaterials, whose construction is adjusted to fit the geometry of the intervertebral space and which secures low surgical invasiveness. Model and strength analyses were performed based on computer simulations, including the finite elements method (FEM) and biomechanical tests. The assessment of therapeutic possibilities, i.e., implantability, functionality, and safety of use, was performed on animal specimens as well as on live animals (goats) simulating real conditions for the use of an interspinous implant . Results: A high usefulness (of the inSWing method and the stabilizer was shown as far as the installation procedure, biotolerance, biomechanical properties are concerned. The effect of surgical technique and selection of an appropriate implant (size, shape) on the quality of bio-stabilization was revealed.. It was shown that apart from the importance of the bearing function of an implant, the geometry of the interspinous space, in which the implant is placed, is of great significance as well as tension of the band which in a long-term affects the rebuilding of the intervertebral space geometry. Conclusions: Interdisciplinary research points to the high usefulness of the inSWing method for the treatment of lumbar spine dysfunctions localized in the intervertebral space. The assumed therapeutic possibilities with the use of the new interspinous “non-fusion” stabilizer and its applicability for the treatment of spinal diseases were confirmed. At the same time, the method secures a higher level of safety both for the patient and the surgeon. It was shown that it is indispensable to carry out a multicenter, wide-scale research in order to refine and assess the new treatment methods of the osteo-neuro-muscular system with implants and implantation techniques.