Experimental Study of a Newly Developed Prosthesis and Its Initial Clinical Use in Microvascular Decompression Surgery

抄録

This study aimed to develop a new, refined, and easy-to-use microvascular decompression surgical prosthesis and report its processability, uniformity, stability, and clinical safety.

In an experimental study, the processing time required to create five slings and five balls from a prototype clump (0.010 ± 0.001 grams) was measured. Similarly, the processing time to form a clump (0.01 ± 0.001 grams) by plucking an equivalent amount of fibers from commercial polytetrafluoroethylene felt was measured. After approval from the Pharmaceuticals and Medical Devices Agency, the new prosthesis was used in 39 consecutive microvascular decompression surgeries.

The handling time to make slings and balls from the refined polytetrafluoroethylene material was shorter than that from polytetrafluoroethylene felt (60.5 ± 4.81 versus 155 ± 6.59 seconds, p-value < 0.001 and 84.0 ± 8.51 versus 141.1 ± 7.02 seconds, p-value < 0.001). The tensile study showed that the prototype was significantly stronger than the slings conventionally made from polytetrafluoroethylene felt (6.2 ± 2.12 Newtons versus 1.56 ± 0.647 Newtons, p-value = 0.012). The adhesion study showed an equivalent adhesive strength to the conventional one (0.137 ± 0.05 Newtons versus 0.108 ± 0.05 Newtons, p-value = 0.40). The 39 microvascular decompression surgeries (trigeminal neuralgia, 13 cases; hemifacial spasm, 26 cases) showed no adverse events related to the materials (follow-up period: 9 months-3 years 9 months, mean: 2 years 9 months).

The new Pharmaceuticals and Medical Devices Agency-approved, refined polytetrafluoroethylene material, which is easier to handle and less time-consuming, exhibited uniform characteristics, excellent manipulability, sufficient strength, and clinical reliability for prostheses. It may serve as valuable additional option for prostheses in microvascular decompression surgery.