聚氨基酸/纳米羟基磷灰石/硫酸钙椎间融合器植骨融合治疗下腰椎退行性疾病的中期临床随访

背景:在经椎间孔腰椎椎间融合术(TLIF)治疗下腰椎退行性疾病中,聚醚醚酮(PEEK)椎间融合器是临床首选的融合材料。其促植骨融合能力有限,且价格昂贵。一种新型聚氨基酸/纳米羟基磷灰石/硫酸钙(PAA/n-HA/CS)椎间融合器的早期临床效果良好。目的:评价PAA/n-HA/CS融合器行TLIF治疗下腰椎退行性疾病的中期疗效。方法:本研究为前瞻性随机对照试验。纳入2014年3月至9月在我科接受单节段TLIF治疗的30例下腰椎退行性疾病患者。随机分为试验组和对照组。试验组术中植入PAA/n-HA/CS融合器,对照组植入PEEK融合器。试验组1例患者术后1年失访,其余患者均获36个月随访。试验组:男10例,女9例;年龄28~70岁,平均48.6岁。其中腰椎滑脱症14例,椎间盘突出伴椎管狭窄症5例;手术节段:L4-L5 9例,L5-S1 10例。对照组:男3例,女7例;年龄36~68岁,平均48.0岁。其中腰椎滑脱症6例,椎间盘突出伴椎管狭窄症3例,腰椎间盘突出髓核摘除术后复发1例;病变节段:L4-L5 5例,L5-S1 5例。术前及术后随访均行X线及三维CT检查,测量患者融合节段椎间隙高度和前凸曲度评价手术效果,观察植骨融合情况。采用Oswestry功能障碍指数(ODI)下腰痛评分评价患者症状改善情况。结果:两组患者术后随访各时间点融合节段椎间隙高度、融合节段前凸曲度及ODI评分等均较术前显著改善(P<0.05)。术前及术后随访各时间点,两组各参数比较,差异无统计学意义(P>0.05)。术后12个月和36个月,试验组植骨融合率分别为95%、100%,对照组分别为90%、100%。两组植骨融合情况对比,差异无统计学意义(P>0.05)。结论:PAA/n-HA/CS融合器能够有效恢复并维持融合节段的生理高度及曲度,显著促进植骨融合,其应用于经后路椎间融合术治疗下腰椎退行性疾病患者的中期随访效果较为满意。

Effectiveness of polyaminoacid/nano-hydroxyapatite/calcium sulfate cage for lumbar interbody fusion in patients with lower lumbar degenerative diseases:a mid-term study

Background: At present, polyether ether ether ketone(PEEK) cage is still the first choice in the treatment of lower lumbar degenerative diseases by transforaminal lumbar interbody fusion(TLIF). However, its ability of promoting bone fusion is limited and its price is expensive. It has been proven that the polyaminoacid/nano-hydroxyapatite/calcium sulfate(PAA/nHA/CS) cage developed by our research team has good early clinical outcomes. Objective: To evaluate the mid-term effectiveness of PAA/n-HA/CS cage for TLIF in patients with lower lumbar degenerative diseases. Methods: Thirty eligible patients with lower lumbar degenerative diseases treated by single segment TLIF between March 2014 and September 2014 were enrolled in this randomized controlled trial. They were randomly divided into trial group(with PAA/n-HA/CS cage) and control group(with PEEK cage). All the patients were followed up for 36 months except one was lost at one year after surgery. Eventually, there were 10 males and 9 females with an average age of 48.6 years(range, 28-70 years) in the trial group, including 14 cases with spondylolisthesis and 5 cases with lumbar disc herniation with spinal canal stenosis. Operative segment: L4/5 in 9 patients and L5/S1 level in the other 10 patients. There were 3 males and 7 females with an average age of 48.0 years(range,36-68 years) in the control group, including 6 cases with spondylolisthesis, 3 cases with lumbar disc herniation with stenosis and one with recurrent lumbar disc herniation. Operative segment: L4/5 in 5 patients and L5/S1 in the other 5 patients. The intervertebral height and lordosis were measured on X-film to assess the surgical correction and postoperative sustaining. Osseous fusion was observed on 3-dimensional CT. The Oswestry disability index(ODI) scores were obtained to assess the clinical recovery. Results: The intervertebral height and lordosis angle of fused segments, and ODI scores at each time point at followup were significantly improved when compared to preoperative ones(P<0.05). There was no significant difference in the abovementioned parameters between groups at different time points(P>0.05). The fusion rate was 95% and 100%, respectively, at 12 months and 36 months postoperatively in the trial group. It was 90% and 100%, respectively, in the control group. There was no significant difference in the fusion rate between two groups(P>0.05). Conclusions: PAA/n-HA/CS cage can effectively restore and maintain the disc height of the fusion segment with a high rate of graft fusion. The mid-term clinical results of TLIF with this cage for the patients with lower lumbar degenerative diseases are well content.