Abstract
BACKGROUND: Spinal fusion surgeries remain a successful treatment for degenerative disc disease. While autograft is considered the gold standard bone graft, synthetic bone void fillers are increasingly used to limit donor site morbidity while giving sufficient graft volume. METHODS: This retrospective clinical study evaluates MagnetOs Easypack Putty(TM) as a standalone graft without autograft in interbody fusion. An independent radiologist blinded to the clinical status provided evaluation of computed tomography (CT) images obtained at 12 months and graded each treated level based on the Brantigan-Steffee-Fraser (BSF) Classification. Twenty subjects were enrolled in the study. A total of 36 spinal levels were treated with an average of 1.8 levels per subject (L2-L3 to L5-S1). RESULTS: The primary endpoint of CT-based fusion was 94.4% (34/36 levels) based on the presence of bridging bone or locked pseudoarthrosis at 12 months. The high fusion rate was accompanied by consistent improvement in pain scores. Visual analogue scale (VAS) pain scores decreased an average of 25% from 5.3/10 pre-operatively to 2.8/10 at 12 months post-operative, and all subjects who reported pre-operative back or leg pain reported improved pain post-operatively. Although the patient population included risk factors and comorbidities, the fusion rate remained high, and no device-related adverse events (AEs) were observed. CONCLUSIONS: The high fusion rate and favorable safety profile support the performance of MagnetOs Easypack Putty for standalone use without autograft in interbody fusion procedures.