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. Issue 7 (September 2022)

• Record Type: Journal Article
• Authors: Loenen, Arjan C. Y.; Connor, Jerome; Johnson, Scott; Davis, Katherine; Hannigan, Nolan; Barnes, Tristan; Arts, Jacobus J.; van Rietbergen, Bert
• Is Part Of: Global spine journal. Volume 12:Issue 7(2022)
• Page Start: 1330
• Page End: 1337
• Publication Date: 2022-09
• Subjects: lumbar interbody fusion -- ovine -- bone graft substitute -- p-15 peptide -- morphological analysis; Spine -- Diseases -- Periodicals; Spine -- Diseases -- Treatment -- Periodicals; Spine -- Abnormalities -- Periodicals; Spine -- Surgery -- Periodicals; 616.73
• DOI: 10.1177/2192568220979839
• Languages: English
• ISSNs: 2192-5682

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.