First clinical experience with posterior lumbar interbody fusion using a thermal-sprayed silver-containing hydroxyapatite-coated cage

BACKGROUND: To investigate the possibility of silver (Ag)-induced adverse events and the degree of bone fusion in posterior lumbar interbody fusion surgery using an Ag-containing hydroxyapatite (HA) lumbar interbody cage. METHODS: An Ag-HA cage consisting of highly osteoconductive HA interfused with Ag was developed, and we applied it clinically at three university-affiliated hospitals from April 2020 to December 2020. During the 12-month postoperative observation period, Ag-related adverse events, neuropathy, and postoperative complications were investigated as indicators of safety, while clinical improvement and the fusion status were investigated as indicators of efficacy. Clinical improvement was defined as improvement beyond the minimum clinically important difference (MCID) in the numerical rating scale (NRS; 1.6) for low back and lower limb pain and the Oswestry Disability Index (ODI; 12.8). RESULTS: We performed lumbar interbody fusion using an Ag-HA cage for 48 patients (female, n = 25; mean age, 67.5 years). The mean preoperative NRS was 6.4 (standard deviation, 1.9), while the mean preoperative ODI was 44 [12]. No adverse effects (i.e., argyria) were identified during the 12-month observation period. Surgical site infection occurred in one case, although the implant was preserved via immediate debridement. In total, 39 (81%) participants showed clinical improvement beyond MCID for both NRS and ODI. Bone fusion was achieved at 45 levels (88%) at 6 months and 48 levels (91%) at 12 months postoperatively. CONCLUSIONS: The results of this study suggest that Ag-HA cages can be safely used in spinal fusion procedures and have the potential to prevent postoperative infections, prevent deterioration of the quality of life, and result in favorable outcomes. Larger-scale and longer-term follow-up studies will be required to corroborate these conclusions. Trial registration UMIN 000039964 (date: April 01, 2020).