P-15 Peptide Enhanced Bone Graft in Lumbar Spine Surgery for Degenerative Disc Disease: Radiological and Clinical Outcomes from a Canadian Prospective Multicenter Study.

Introduction: Transforaminal Lumbar Interbody Fusion (TLIF) and Posterior Lumbar Interbody Fusion (PLIF) are common surgical techniques. Successful arthrodesis is critical to favorable outcomes. P-15 Peptide Enhanced Bone Graft (ABM/P-15 Matrix), is a composite bone graft incorporating P-15, a synthetic peptide that mimics the cell-binding domain of Type I collagen. This abstract reports the early outcomes associated with the use of ABM/P-15 Matrix in TLIF or PLIFs in a multi-center clinical trial.

Methods: A prospective on-label study was conducted in six hospitals in Canada. Adults requiring lumbar spinal fusion with TLIF/Posterolateral Fusion (PLF) or PLIF/PLF, between levels L1-S1, were included. Neurological status, relevant clinical history, Oswestry Disability Index (ODI), 12-Item Short Form Survey (SF-12), and Numeric Pain Rating Scale (NRS) were collected at baseline, 6-months, 12-months and 24-months. Active smoking, obesity (BMI >30) and diabetes were considered high-risk factors. A thin-cut ( < 1mm) CT was acquired at 12-months and assessed for fusion status by an independent core-lab. Fusion status was reported at both the segmental and participant levels. Adverse events and reinterventions at the index level were recorded.

Results: : A total of 94 participants (116 operative levels) were included and received either TLIF or PLIF procedures combined with PLF. 60.6% of patients presented with 1 or more high-risk comorbidities. Of the 52 TLIF/PLF participants with data available, 80.7% were either fully (n=33) or partially (n=9) fused. Additionally, 98.4% of the 61 TLIF/PLF segments were either fully (n=46) or partially (n=14) fused. Of the 17 PLIF/PLF participants, 88.2% were either fully (n=13) or partially (n=2) fused. Additionally, 95.0% of 20 PLIF/PLF segments were either fully (n=17) or partially (n=2) fused. Mean improvement for TLIF/PLF at 12 months was noted in ODI, SF-12 mental and physical scores, NRS back and leg scores. Mean improvement for PLIF/PLF at 12 months was noted in ODI, SF-12 mental score), NRS back and leg scores.

Conclusion : High fusion rates at 12-months in lumbar arthrodesis were observed with P-15 peptide enhanced bone graft, even in a population where a majority of the patients were considered high risk. No evidence of graft related complications and no index level re-operations were identified.