Comparison of Silicate-Substituted Calcium Phosphate (Actifuse) with Recombinant Human Bone Morphogenetic Protein-2 (Infuse) in Posterolateral Instrumented Lumbar Fusion

摘要

>Study Design Randomized controlled trial. >Objective The aim of this study was to assess the efficacy of the bone grafting substitute silicate-substituted calcium phosphate (SiCaP) compared with recombinant human bone morphogenetic protein 2 (rhBMP-2) and to evaluate the clinical outcomes over a period of 2 years. >Methods Patients undergoing PLF surgery for DDD at a single center were recruited and randomized to one of two groups: SiCaP (n = 9) or rhBMP-2 (n = 10). One patient withdrew prior to randomization and another from the rhBMP-2 group after randomization. The radiologic and clinical outcomes were examined and compared. Fusion was assessed at 12 months with computed tomography and plain radiographs. Clinical outcomes were evaluated by recording measures of pain, quality of life, disability, and neurologic status from 6 weeks to 2 years postoperatively. >Results In the SiCaP and rhBMP-2 groups, fusion was observed in 9/9 and 8/9 patients, respectively. Pain and disability scores were reduced and quality of life increased in both groups. Leg pain, disability, and satisfaction scores were similar between the groups at each postoperative point; however, back pain was less at 6 weeks and quality of life was higher at 6 months in the SiCaP group than the rhBMP-2 group. >Conclusions SiCaP and rhBMP-2 were comparable in terms of achieving successful bone growth and fusion. Both groups achieved similar alleviation of pain and improved quality of life and neurologic, satisfaction, and return to work outcomes following PLF surgery.