Peptide Enhanced Bone Graft Substitute Presents Improved Short-Term Increase in Bone Volume and Construct Stiffness Compared to Iliac Crest Autologous Bone in an Ovine Lumbar Interbody Fusion Model

Abstract

Study design: Preclinical ovine model. Objective: To assess the in vivo efficacy and safety of the P-15 L bone graft substitute and compare its performance to autologous iliac crest bone graft (ICBG) for lumbar interbody fusion indications. Methods: Thirty skeletally mature sheep underwent lumbar interbody fusion surgery. Half of the sheep received autologous ICBG and the other half the peptide enhanced bone graft substitute (P-15 L). Following termination at 1, 3, and 6 months after surgery, the operated segments were analyzed using micro computed tomography (µCT), histology, and destructive mechanical testing. Additional systemic health monitoring was performed for the P-15 L group. Results: One month after surgery, there was only minor evidence of bone remodeling and residual graft material could be clearly observed within the cage. There was active bone remodeling between 1 and 3 months after surgery. At 3 months after surgery significantly denser and stiffer bone was found in the P-15 L group, whereas at 6 months, P-15 L and ICBG gave similar fusion results. The P-15 L bone graft substitute did not have any adverse effects on systemic health. Conclusions: The drug device combination P-15 L was demonstrated to be effective and save for lumbar interbody fusion as evidenced by this ovine model. Compared to autologous ICBG, P-15 L seems to expedite bone formation and remodeling but in the longer-term fusion results were similar.

Early bone ingrowth and segmental stability of a trussed titanium cage versus a polyether ether ketone cage in an ovine lumbar interbody fusion model

“…Implementation of the exact 3D geometry of the cage would resolve these issues and yield more accurate FE analyses. The distance between consecutive histological sections (300 µm) was considered suitable for characterizing the 3D structure of trabecular bone since it is in the same order of magnitude as the trabecular thickness and separation of bone from an interbody fusion zone [36,37].…”

The Osteogenic Peptide P-15 for Bone Regeneration: A Narrative Review of the Evidence for a Mechanism of Action

“…After three months, sheep treated with ABM/P-15 exhibited significantly more mature, denser and thicker trabecular bone structures. After six months, the P-15 and autograft groups exhibited similar bone growth outcomes, indicating that P-15 can expedite bone formation without any evidence of adverse effects on systemic health [ 52 ].…”