Sathe Ashwin, Lee Sang-Ho, Kim Shin-Jae, Eun Sang Soo, Choi Yong Soo, Lee Shih-Min, Seuk Ju-Wan, Lee Yoon Sun, Shin Sang-Ha, Bae Junseok
Department of Neurological Surgery, Wooridul Spine Hospital, Seoul, Korea.
Department of Orthopedic Surgery, Wooridul Spine Hospital, Seoul, Korea.
J Korean Neurosurg Soc. 2022 Nov;65(6):825-833. doi: 10.3340/jkns.2021.0296. Epub 2022 May 16.
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).
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.
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.
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.
ABM/P - 15（无机骨基质/15氨基酸肽片段）是一种市售的合成制造的P - 15胶原肽片段，吸附于无机骨基质上。本研究旨在调查ABM/P - 15在腰椎融合术中实现融合的疗效，并将其与重组骨形态发生蛋白-2（rhBMP - 2）和脱矿骨基质（DBM）进行比较。
对一家专科医院2016年至2020年间140例行腰椎融合手术患者的前瞻性收集数据进行回顾性观察研究，至少随访6个月。根据融合部位用于增强骨移植的材料，将患者分为ABM/P - 15、rhBMP - 2和DBM三组。
分别有46、44和50例患者使用了ABM/P - 15、rhBMP - 2和DBM。三组患者的年龄、性别、骨密度、吸烟史和糖尿病患病情况等特征具有可比性。ABM/P - 15组、rhBMP - 2组和DBM组的平均随访时间分别为16.0±5.2、17.9±9.8和26.2±14.9个月。ABM/P - 15组、rhBMP - 2组和DBM组的融合成功率分别为97.9%、93.2%和98%，平均融合时间分别为4.05±2.01、10±4.28和9.44±3.49个月（p<0.001）。ABM/P - 15组、rhBMP - 2组和DBM组术前视觉模拟量表评分分别为6.93±2.42、7.14±1.97、7.01±2.14（p = 0.900），末次随访时分别降至1.02±0.80、1.21±0.96和0.54±0.70（p = 0.112）。ABM/P - 15组、rhBMP - 2组和DBM组术前Oswestry功能障碍指数评分分别为52.7±18.02、55.4±16.8和53.56±19.6（p = 0.751），术后分别降至33.77±15.52、39.42±16.47和38.3±15.89（p = 0.412），末次随访时进一步降至15.74±8.3、17.41±10.45和16.76±9.81（p = 0.603）。
在腰椎融合病例中，ABM/P - 15似乎比rhBMP - 2和DBM显著更早实现融合，同时保持了相当的临床和并发症情况。
