Occurrence of ectopic ossification around the surgical site after using of ABM/P-15 in anterior cervical discectomy and fusion.

Abstract

PURPOSE: Since receiving FDA approval in 2016, iFBG has been highlighted in several clinical studies as an innovative alternative to conventional bone graft materials. However, in our study, ectopic ossification occurred around the surgical site in the majority of cases using the iFBG. The aim of this study to describe the incidence of ectopic ossification following ACDF using i-FACTOR bone graft (iFBG) in comparison with other bone graft materials such as DBM, and to assess its influence on both clinical and radiologic outcomes. METHODS: We enrolled 153 patients and were compared clinical and radiologic data based on the presence of ectopic ossification, and multiple logistic regression was performed to determine risk factors for longitudinal dural or posterior longitudinal ligament ossification (LDPO) among patients with ectopic calcification following iFBG use. RESULTS: Ectopic ossification occurred only in the iFBG group, with an incidence of 61.6%, while no cases were observed in the DBM group. LDPO was also confined to the iFBG group but occurred in only eight patients. Age and preoperative cervical lordosis angle were significantly associated with LDPO. Fusion rates were similar between the groups (DBM: 87.7%, iFBG: 88.9%). CONCLUSIONS: iFBG use in ACDF was associated with ectopic ossification, likely due to graft migration; however, clinical outcomes and fusion rates at one year were comparable to DBM. LDPO occurred only in the iFBG group, but its cause remains unclear and requires further study.