Yang Xi, Song Yueming, Kong Qingquan, Gong Quan, Pei Fuxing, Tu Chongqi
Department of Orthopedics, West China Hospital, Sichuan University, Chengdu Sichuan, 610041, P R China.
Zhongguo Xiu Fu Chong Jian Wai Ke Za Zhi. 2012 Dec;26(12):1425-9.
To evaluate the short-term effectiveness of nano-hydroxyapatite/polyamide-66 (n-HA/PA66) intervertebral cage for lumbar interbody fusion in the patients with lower lumbar degenerative diseases.
Between January and October 2011, 20 patients with lower lumbar degenerative diseases underwent transforaminal lumbar interbody fusion with n-HA/PA66 intervertebral cage. There were 8 males and 12 females, aged 22-80 years (mean, 51 years). The disease duration was 1 to 24 months (mean, 4 months). L4,5 fusion was performed in 8 cases, L5, S1 fusion in 9 cases, and L4-S1 fusion in 3 cases. Among 20 cases, 3 were diagnosed as having recurrent lumbar disc protrusion, 5 as having lumbar degenerative spondylolisthesis, 9 as having lumbar isthmic spondylolisthesis, and 3 as having lumbar spinal stenosis. The intervertebral height and lordosis were measured on X-ray film to assess the surgical correction and postoperative sustain while osseous fusion was observed on 3-dimensional CT. The Oswestry disability index (ODI) and short-form 36 health survey scale (SF-36) scores were obtained to assess the status of clinical recovery.
All patients had incision healing by first intention. The pain and numb were relieved in varying degrees after operation. No cerebrospinal leakage, nerve root injury, or wound infection was occurred. All patients were followed up 6-9 months (mean, 7 months). No cage displacement or collapse was found. The intervertebral height and lordosis of single fusion segment were significantly improved at 3 days and 3, 6 months after operation when compared with those at preoperation (P < 0.01); there was no significant difference among each time point after operation (P > 0.05). The fusion rate was 74% at 3 months after operation and 96% at 6 months after operation, with an average of 4 months (range, 3-9 months) for interbody fusion. The ODI and SF-36 scores were significantly improved at 3 days and 6 months after operation when compared with the scores at preoperation (P < 0.01); there was no significant difference among each time point after operation (P > 0.05).
The interbody fusion with n-HA/PA intervertebral cage is effective and safe to treat the lower lumbar degenerative diseases. The n-HA/PA66 intervertebral cage is an ideal device of interbody fusion with high fusion rate, low subsidence rate, and high transmission X-ray, but the long-term effectiveness need further observation.
评估纳米羟基磷灰石/聚酰胺-66（n-HA/PA66）椎间融合器用于下腰椎退变性疾病患者腰椎椎间融合术的短期疗效。
2011年1月至10月，20例下腰椎退变性疾病患者接受了经椎间孔腰椎椎间融合术并植入n-HA/PA66椎间融合器。其中男性8例，女性12例，年龄22 - 80岁（平均51岁）。病程1至24个月（平均4个月）。L4、5融合8例，L5、S1融合9例，L4 - S1融合3例。20例中，3例诊断为复发性腰椎间盘突出症，5例为腰椎退变性滑脱，9例为腰椎峡部裂性滑脱，3例为腰椎管狭窄症。通过X线片测量椎间高度和腰椎前凸以评估手术矫正情况及术后维持情况，同时通过三维CT观察骨融合情况。采用Oswestry功能障碍指数（ODI）和36条目简明健康调查量表（SF - 36）评分评估临床恢复状况。
所有患者切口均一期愈合。术后疼痛和麻木均有不同程度缓解。未发生脑脊液漏、神经根损伤或伤口感染。所有患者均获随访6 - 9个月（平均7个月）。未发现融合器移位或塌陷。与术前相比，单节段融合术后3天及3、6个月时椎间高度和腰椎前凸均显著改善（P < 0.01）；术后各时间点间差异无统计学意义（P > 0.05）。术后3个月融合率为74%，6个月时为96%，椎间融合平均时间为4个月（范围3 - 9个月）。与术前相比，术后3天及6个月时ODI和SF - 36评分均显著改善（P < 0.01）；术后各时间点间差异无统计学意义（P > 0.05）。
应用n-HA/PA椎间融合器行椎间融合术治疗下腰椎退变性疾病有效且安全。n-HA/PA66椎间融合器是一种理想的椎间融合器械，融合率高、下沉率低、X线透射性好，但长期疗效有待进一步观察。
