• Chris Christou, Tamara Varcoe, Georgia Williams, Todd Heil, Sarah Leifeld, Hyeon Park, Steve Peckham, David Stewart, John Greenbaum, Tian Wang, Matthew Pelletier, William Walsh, and Luis Alvarez.
• South Australia Health and Medical Research Institute, Preclinical, Imaging & Research Laboratories (SAHMRI-PIRL), Gilles Plains, SA.
• Spine. 2024 Oct 1; 49 (19): 138113901381-1390.

Study DesignAssessment of bone formation in an ovine interbody fusion study.ObjectiveTo compare OsteoAdapt SP, which consists of AMP-2, a modified variant of recombinant human bone morphogenetic protein (rhBMP-2) bound to a tricalcium phosphate-containing carrier, to autologous iliac crest bone graft (ICBG) in a lumbar interbody fusion model.Summary Of Background DataTreatment of lumbar disk degeneration often involves spinal fusion to reduce pain and motion at the affected spinal segment by insertion of a cage containing bone graft material. Three graft materials were compared in this study-ICBG and OsteoAdapt SP (low or high dose).MethodsThe sheep underwent lateral lumbar fusion surgery with PEEK or Titanium interbody cages packed with OsteoAdapt SP (low or high dose) or ICBG. Outcomes were evaluated at 8-, 16- and 26- weeks. Newly formed bone quality, bone mineralization, and fusion were assessed by manual palpation, qualitative and semi-quantitative histopathology, histomorphometry, computed tomography (CT), and micro-CT (mCT) analysis.ResultsOsteoAdapt SP was implanted into 43 animals and ICBG into 21 animals (L3-L4). No group showed evidence of systemic toxicity by multiple assessments. All levels were fused by manual palpation at 26 weeks. Serial CT scans showed increasing fusion scores over time. Both doses of OsteoAdapt SP resulted in robust new bone formation and progression of fusion in the interbody cage. Range of motion tests for treatment groups was lower compared with ICBG at 8- and 16 weeks. Similarly, histology at eight weeks demonstrated more robust new bone formation for both OsteoAdapt SP groups compared to autograft.ConclusionWe have demonstrated the preclinical safety and efficacy of OsteoAdapt SP in a clinically relevant large animal model, supporting faster and more robust new bone formation within the interbody cage, comparable to or better than the gold standard, ICBG, in all measures.Copyright © 2024 The Author(s). Published by Wolters Kluwer Health, Inc.

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