Objective:

ABM/P-15 is a commercially available synthetically manufactured P-15 collagen peptide fragment, that is adsorbed on anorganic bone matrix. 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 bone morphogenic protein (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 2016-2020, with a minimum 6-months 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 11.65±3.57, 18.34±9.87, 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 VAS-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, 0.54±0.70 (p=0.112) respectively at the last follow up. Pre-operative ODI scores were 52.7±18.02, 55.4±16.8, 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, 38.3±15.89 (p:<0.001) and further to 15.74±8.3, 17.41±10.45, 16.76±9.81 (p=.002) respectively at the last follow-up.

Conclusions:

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.