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

Arjan C.Y. Loenen, Jerome Connor, Scott Johnson, Katherine Davis, Nolan Hannigan, Tristan Barnes, Jacobus J. Arts, Bert van Rietbergen (Corresponding author)

Research output: Contribution to journalArticleAcademicpeer-review

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.

Original languageEnglish
JournalGlobal Spine Journal
VolumeXX
Issue numberXX
Early online date7 Jan 2021
DOIs
Publication statusE-pub ahead of print - 7 Jan 2021

Keywords

  • bone graft substitute
  • lumbar interbody fusion
  • morphological analysis
  • ovine
  • p-15 peptide

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