Choi Un Yong, Kim Kyoung-Tae, Kim Kwang Gi, Lim Sang Heon, Kim Young Jae, Sohn Seil, Sheen Seung Hun, Heo Chan Yeong, Han Inbo
Department of Neurosurgery, CHA Bundang Medical Center, CHA University, Seongnam-si 13496, Korea.
Department of Neurosurgery, School of Medicine, Kyungpook National University, Daegu 41944, Korea.
Cells. 2020 Oct 8;9(10):2250. doi: 10.3390/cells9102250.
The rates of pseudarthrosis remain high despite recent advances in bone graft substitutes for spinal fusion surgery. The aim of this single center, non-randomized, open-label clinical trial was to determine the feasibility of combined use of stromal vascular fraction (SVF) and β-tricalcium phosphate (β-TCP) for patients who require posterior lumbar interbody fusion (PLIF) and pedicle screw fixation. Two polyetheretherketone (PEEK) cages were inserted into the intervertebral space following complete removal of the intervertebral disc. The PEEK cage (SVF group) on the right side of the patient was filled with β-TCP in combination with SVF, and the cage on the left side (control group) was filled with β-TCP alone. Fusion rate and cage subsidence were assessed by lumbar spine X-ray and CT at 6 and 12 months postoperatively. At the 6-month follow-up, 54.5% of the SVF group (right-sided cages) and 18.2% of the control group (left-sided cages) had radiologic evidence of bone fusion ( = 0.151). The 12-month fusion rate of the right-sided cages was 100%, while that of the left-sided cages was 91.6% ( = 0.755). Cage subsidence was not observed. Perioperative combined use of SVF with β-TCP is feasible and safe in patients who require spinal fusion surgery, and it has the potential to increase the early bone fusion rate following spinal fusion surgery.
尽管脊柱融合手术中骨移植替代物有了最新进展，但假关节发生率仍然很高。这项单中心、非随机、开放标签的临床试验的目的是确定对于需要后路腰椎椎间融合术（PLIF）和椎弓根螺钉固定的患者，联合使用基质血管成分（SVF）和β-磷酸三钙（β-TCP）的可行性。在完全切除椎间盘后，将两个聚醚醚酮（PEEK）椎间融合器植入椎间隙。患者右侧的PEEK椎间融合器（SVF组）填充β-TCP与SVF的混合物，左侧的椎间融合器（对照组）仅填充β-TCP。在术后6个月和12个月通过腰椎X线和CT评估融合率和椎间融合器下沉情况。在6个月随访时，SVF组（右侧椎间融合器）有54.5%、对照组（左侧椎间融合器）有18.2%有骨融合的影像学证据（P = 0.151）。右侧椎间融合器12个月的融合率为100%，而左侧椎间融合器为91.6%（P = 0.755）。未观察到椎间融合器下沉。对于需要脊柱融合手术的患者，围手术期联合使用SVF和β-TCP是可行且安全的，并且有可能提高脊柱融合手术后的早期骨融合率。
