A Prospective, Randomized, Multicenter Study Comparing Silicated Calcium Phosphate versus BMP-2 Synthetic Bone Graft in… (2024)

https://doi.org/10.1097/brs.0000000000002678 ·

Journal: Spine, 2018, №15, p.E860-E868

Publisher: Ovid Technologies (Wolters Kluwer Health)

Authors:

Marc Coughlan
Mark Davies
Adriaan K. Mostert
Dharmin Nanda
Paul C. Willems
Geoffrey Rosenberg
Richard Ferch

Abstract

<jats:sec> Study Design. A prospective, Phase IV, multicenter, randomized study. </jats:sec> <jats:sec> Objective. The aim of this study was to compare vertebral fusion success rates following posterolateral fusion [(PLF)/posterolateral intertransverse fusion (PITF)] surgery. The surgical procedure combined posterior lumbar interbody fusion (PLIF) and PLF with internal fixation over one or two levels using silicated calcium phosphate (SiCaP) or bone morphogenetic protein (BMP)-2 as graft material in patients with a degenerative disorder of the lumbar spine. </jats:sec> <jats:sec> Summary of Background Data. Few controlled trials have evaluated the bone graft materials available to surgeons treating patients with spinal disorders, including degenerative disc disease, spondylolisthesis, and disc herniation. </jats:sec> <jats:sec> Methods. Following randomization, the surgical procedure consisting of PLIF and PLF with internal fixation over one or two levels was performed using SiCaP or BMP-2. No other osteoconductive/osteoinductive graft materials were permitted. Spinal fusion was assessed radiographically at ≤24 months. Clinical outcomes (pain on visual analog scale, Oswestry Disability Index, SF-36) and adverse events (AEs) were monitored. </jats:sec> <jats:sec> Results. One hundred three patients were enrolled. At 12 months, fusion was achieved in 25 of 35 (71.4%) of the SiCaP and 20 of 27 (74.1%) of the BMP-2 group, respectively (<jats:italic toggle="yes">P = 1.000). At 24 months, the fusion rate was 78.6% and 84.8% for SiCaP and BMP-2, respectively (<jats:italic toggle="yes">P = 0.5613). Clinical outcomes improved similarly in both groups over time. AEs were consistent with this surgical population. </jats:sec> <jats:sec> Conclusion. SiCaP was safe and well tolerated in patients with degenerative spinal disorders requiring PLF and provided fusion rates similar to BMP-2. Level of Evidence: 2 </jats:sec>

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