Evaluation of the efficacy of combined vitamin D3 and K2 therapy in reducing implant-associated complication risk and improving spinal fusion stability

In the last decade, the use of implants in spinal surgery has significantly increased, particularly interbody devices and transpedicular fixators. This trend has necessitated refining approaches aimed at preventing intra- and postoperative complications. A key factor influencing the effectiveness of stabilization procedures is bone mineral density (BMD). Objective: To investigate the relationship among vitamin D levels, BMD, and the incidence of implant-related failures in patients who have undergone stabilization procedures on the spine, as well as to evaluate the role of postoperative correction of vitamin D₃ and K2 deficiencies in enhancing fixation stability and reducing complication risks. Materials and Methods: A retrospective single-center cohort study was conducted in specialized departments of Romodanov Neurosurgery Institute NAMS of Ukraine, from January 2023 to December 2024. A total of 250 patients who underwent spinal surgery with the use of transpedicular screws and/or interbody implants were analyzed with respect to their age, sex, body mass index, serum vitamin D (25-(OH)D₃) levels, and BMD (according to computed tomography data). Original grading scales were used to evaluate implant-related complications. Postoperative correction of vitamin D deficiency was carried out using “Solemax®” (vitamin D₃, vitamin K2, and ω-3 polyunsaturated fatty acids). Results: A high prevalence of vitamin D deficiency and reduced BMD was recorded among patients undergoing elective stabilization surgeries on the spine. A significant correlation was detected between 25-(OH)D₃ levels and bone tissue status. After 4 months of “Solemax®” administration, all patients achieved reference 25-(OH)D3 levels, indicating the effectiveness of the therapy. In the correction group, an increase in BMD was observed, whereas in the comparison group, BMD values decreased. The incidence of implant-related complications was statistically reduced: the risk of screw loosening decreased by 69.84% over the first 6 months and by 85.06% over one year, while the risk of interbody implant migration declined by 56.2% and 64.7%, respectively. Conclusions: The stability of spinal fusion is more contingent upon the adaptive response of bone tissue to implantation than on absolute BMD values. The use of a balanced combination of vitamins D₃ and K2 contributes to enhanced fixation stability and a lower risk of postoperative complications.