Multicenter Randomized Controlled Clinical Trial to Compare the Safety and Performance of Two Bone Flap Fixation Systems.

Background And Objectives: Polymeric clamp-like devices present potential advantages regarding plates and screws to close craniotomies; however, no clinical research has provided enough evidence to compare them. This randomized controlled trial compares the clinical safety and performance of clamp-like devices with the standard of care for craniotomy closure: titanium plates and screws (P&S).

Methods: A prospective, double-arm, multicenter randomized controlled trial was performed at 3 sites, recruiting 60 patients undergoing neurosurgical interventions requiring craniotomy.