Clinical Outcomes of Anorganic Bone Matrix Combined With a P-15 Osteogenic Cell-Binding Peptide (ABM/P-15) in One- and Two-Level Transforaminal Lumbar Interbody Fusion (TLIF): A Propensity-Matched Comparison

TL;DR

This study compares the effectiveness and safety of a new bone graft material in spinal fusion surgeries, finding it as effective as existing options.

Contribution

First direct comparison of ABM/P-15 with rhBMP-2 in TLIF surgeries, showing similar outcomes and costs.

Findings

ABM/P-15 achieved 84% fusion rate, comparable to rhBMP-2 and autograft bone.

Postoperative complication rates were similar across all groups.

Patient-reported outcomes improved significantly in all groups after 12 months.

Abstract

Objective: This retrospective observational cohort study evaluated the efficacy and safety of anorganic bone matrix combined with a P-15 osteogenic cell-binding peptide (ABM/P-15) in one- to two-level transforaminal lumbar interbody fusion (TLIF), compared with recombinant human bone morphogenetic protein-2 (rhBMP-2) or local autograft bone.

Background: ABM/P-15 is a relatively new peptide-based bone graft substitute that promotes new bone formation. While its safety and efficacy have been demonstrated in randomized trials of anterior cervical fusion, evidence supporting its use in lumbar fusion remains limited, and clinical outcomes have not been well described.

Methods: We retrospectively reviewed 318 patients who underwent one- or two-level TLIF. Patients lacking complete patient-reported outcome measures (PROMs) or 12-month radiographic evaluations were excluded. Patients were categorized into three groups based on graft material: ABM/P-15, rhBMP-2, and local autograft bone. Each ABM/P-15 patient was matched to a rhBMP-2 and local autograft patient based on demographics, number of levels fused, and graft dose/kit size. Postoperative complications, PROMs, and fusion rates were compared among the groups.

Results: Each group consisted of 38 patients after matching. The mean ABM/P-15 volume was 4.4 ± 1.3 cc (cost: $2,432.3 ± 714.4), and the mean rhBMP-2 dose was 3.0 ± 1.1 mg (cost: $2,316.6 ± 843.0). At 12 months, PROMs improved significantly in all groups, with no significant differences among them. Fusion was achieved in 84% of the ABM/P-15 group, 79% in the rhBMP-2 group, and 82% in the autograft group (p = 0.265). Complication rates, including postoperative radiculopathy, were also comparable (p = 0.725).

Conclusion: To the best of our knowledge, this is the first study to directly compare ABM/P-15 and rhBMP-2 in patients undergoing TLIF. ABM/P-15 demonstrated comparable fusion and complication rates to rhBMP-2 in one- or two-level TLIF procedures, at a similar cost.