J Korean Neurosurg Soc.  2022 Nov;65(6):825-833. 10.3340/jkns.2021.0296.

Comparative Analysis of ABM/P-15, Bone Morphogenic Protein and Demineralized Bone Matrix after Instrumented Lumbar Interbody Fusion

• Sathe A
• Lee SH
• Kim SJ
• Eun SS
• Choi YS
• Lee Sm
• Seuk JW
• Lee YS
• Shin SH
• Bae J

• KMID: 2535842
• DOI: http://doi.org/10.3340/jkns.2021.0296

Abstract

Objective
: ABM/P-15 (anorganic bone matrix/15-amino acid peptide fragment) is a commercially available synthetically manufactured P-15 collagen peptide fragment, that is adsorbed on ABM. This study was done to investigate the efficacy of ABM/ P-15 in achieving fusion in the lumbar spine and comparing it with that of recombinant bone morphogenic protein-2 (rhBMP-2) and demineralized bone matrix (DBM).
Methods
: A retrospective observational study of prospectively collected data of 140 patients who underwent lumbar spinal fusion surgeries in a single specialty spine hospital between 2016 and 2020, with a minimum 6-month follow-up was conducted. Based on the material used for the augmentation of the bone graft at the fusion site, the patients were divided into three categories namely ABM/P-15, rhBMP-2, and DBM group.
Results
: ABM/P-15, rhBMP-2, and DBM were used in 46, 44, and 50 patients, respectively. Patient characteristics like age, gender, bone mineral density, smoking history, and presence of diabetes mellitus were comparable amongst the three groups. Average follow-up was 16.0±5.2, 17.9±9.8, and 26.2±14.9 months, respectively in ABM/P-15, rhBMP-2, and DBM groups. The fusion was achieved in 97.9%, 93.2%, and 98% patients while the average time-to-union was 4.05±2.01, 10±4.28, and 9.44±3.49 months (p<0.001), respectively for ABM/P-15, rhBMP-2, and DBM groups. The average pre-operative Visual analogue scale score was 6.93±2.42, 7.14±1.97, 7.01±2.14 (p=0.900) for ABM/P-15, rhBMP-2 and DBM groups, respectively, which reduced to 1.02±0.80, 1.21±0.96, and 0.54±0.70 (p=0.112), respectively at the last follow up. Pre-operative Oswestry disability index scores were 52.7±18.02, 55.4±16.8, and 53.56±19.6 (p=0.751) in ABM/P-15, rhBMP-2, and DBM groups, which post-operatively reduced to 33.77±15.52, 39.42±16.47, and 38.3±15.89 (p=0.412) and further to 15.74±8.3, 17.41±10.45, and 16.76±9.81 (p=0.603), respectively at the last follow-up.
Conclusion
: ABM/P-15 appears to achieve union significantly earlier than rhBMP-2 and DBM in lumbar spinal fusion cases while maintaining a comparable clinical and complication profile.

Keyword

Lumbar vertebrae; Spinal fusion; Demineralized bone matrix; rhBMP-2; Anorganic bone matrix/15-amino acid peptide fragment

Figure

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  Fig. 1. Box plot showing the number of patients achieving union. There is a clear time advantage for the ABM/P-15 group as compared to rhBMP-2 and DBM group. ABM/P-15 : anorganic bone matrix/15-amino acid peptide fragment, rhBMP-2 : recombinant bone morphogenic protein-2, DBM : demineralized bone matrix.

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  Fig. 2. Case presentation of a 62-year-old female patient who underwent anterior lumbar interbody fusion with percutaneous pedicle screw fixation at the L4-5 and L5-S1 level using ABM/P-15 mixed with allograft as bone graft substitute. Postoperative lateral radiographs (A) and sagittal reconstructed CT scan (B) at 3-months follow-up bony bridging between the endplates of L4-L5 and L5-S1. Twelve-month follow-up sagittal CT (C) showing thickened bone-bridge. ABM/P-15 : anorganic bone matrix/15-amino acid peptide fragment, CT : computed tomography.

• 

  Fig. 3. Case presentation of a 60-year-old male patient who underwent lateral lumbar interbody fusion with percutaneous pedicle screw fixation at the L2-3 and L3-4 level using rhBMP-2 mixed with allograft. Postoperative lateral radiographs on 3-month (A), 6-month (B), 12-month (D) showing the progression of bony union. The solid union was achieved on a 12-month follow-up. Sagittal reconstructed computed tomography scan on 6-month (C) shows ingrowth of bone-bridge into the disc space. rhBMP-2 : recombinant bone morphogenic protein-2.

• 

  Fig. 4. Case presentation of a 60-year-old female patient who underwent anterior lumbar interbody fusion with percutaneous pedicle screw fixation at the L3-4 and L4-5 level using DBM mixed with allograft. Postoperative lateral radiographs on 3-month (A), 9-month (B), and sagittal reconstructed computed tomography scan on 9-month (C) showing union was achieved on 9-month follow-up. DBM : demineralized bone matrix.

Reference

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