Chinese Journal of Tissue Engineering Research ›› 2021, Vol. 25 ›› Issue (30): 4863-4869.doi: 10.12307/2021.275
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Gu Honglin, Zheng Xiaoqing, Liang Changxiang, Zeng Shixing, Zhan Shiqiang, Chang Yunbing
Received:
2021-02-09
Revised:
2021-02-19
Accepted:
2021-03-18
Online:
2021-10-28
Published:
2021-07-29
Contact:
Chang Yunbing, MD, Chief physician, Department of Spine Surgery, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510080, Guangdong Province, China
About author:
Gu Honglin, MD, Attending physician, Department of Spine Surgery, Guangdong Provincial People’s Hospital, Guangdong Academy of Medical Sciences, Guangzhou 510080, Guangdong Province, China
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CLC Number:
Gu Honglin, Zheng Xiaoqing, Liang Changxiang, Zeng Shixing, Zhan Shiqiang, Chang Yunbing. Long-term survival rate and reoperation of Wallis interspinous dynamic stabilization system for treatment of lumbar degenerative disc disease[J]. Chinese Journal of Tissue Engineering Research, 2021, 25(30): 4863-4869.
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2.2 患者基线资料及一般手术指标分析 103患者例随访92-144个月,平均随访(124.43±11.44)个月;共包括男62例,女41例;年龄19-77岁,平均年龄(43.12±11.51)岁;术前诊断腰椎管狭窄症9例,腰椎间盘突出症46例,腰椎管狭窄症合并腰椎间盘突出症41例,腰椎滑脱症7例。在103例患者中腰椎间盘切除伴/不伴椎管减压者87例(术前诊断为腰椎间盘突出症或腰椎管狭窄症合并腰椎间盘突出症),未行腰椎间盘切除者16例(术前诊断腰椎管狭窄症者或腰椎滑脱症),其中行椎管减压者12例,仅行Wallis植入撑开者4例。共植入Wallis装置107枚,其中单节段植入89例,双节段植入4例,置于融合相邻节段作为Topping-off 10例。手术固定节段:L2/3节段2例,L3/4节段9例,L4/5节段94例,L5/S1节段(均为骶椎腰化)2例。单节段手术时间60-95 min,平均手术时间(73.61±12.07) min;双节段手术时间90-100 min,平均手术时间(94.85±4.81) min;出血量50- 200 mL,平均出血量(70.89±15.30) mL。 2.3 患者临床指标及满意度情况分析 所有患者术后末次随访时目测类比评分、JOA评分及ODI评分均较术前明显改善 (P < 0.05),见表2。"
患者末次随访时总体满意度为93.2%。 2.4 患者术后并发症情况分析 共15例患者出现术中及术后并发症,见表3。并发症发生率为14.5%(15/103),术后并发症发生的平均时间为1-82个月,平均时间(30.79±29.83)个月。15例患者均行腰椎间盘切除术伴/不伴椎管减压,行椎间盘切除患者并发症发生率为17.2%(15/87),而未行椎间盘切除的16例患者均无并发症情况。 根据是否与Wallis装置相关分为内固定相关并发症及非内固定相关并发症。其中内固定相关并发症(9例):3例为Wallis手术节段椎间盘突出复发,均为L4/5节段,其中1例24岁男性术后51个月后出现,行Wallis取出+L4/5减压椎间融合内固定术;1例49岁男性术后1个月后出现,经保守治疗后症状好转,未行手术;另外1例L3/4,L4/5双节段Wallis植入,术后6年再次出现右下肢疼痛,经腰椎磁共振确认为L4/5椎间盘突出复发,使用椎间孔镜摘除突出椎间盘后症状缓解,但2个月后再发右下肢疼痛,行磁共振及椎间盘造影确定为L4/5椎间盘突出再次复发,保守治疗无效,行L3/4,L4/5 Wallis取出,L4/5椎间融合;4例为手术邻近节段椎间盘突出复发或再发狭窄:其中2例行椎间孔镜下椎间盘髓核摘除,2例行减压融合;1例36岁女性患者于术后68个月复查X射线片时发现棘突骨折,未行手术,佩戴腰围制动后骨折愈合;1例术中植入过程中假体爆裂,予更换假体。非内固定相关并发症(6例):1例术后1个月出现伤口浅部感染,经清创及抗感染治疗后治愈;1例术后7个月出现伤口深部感染,经腰椎MRI检查及穿刺活检明确为椎间盘炎,予深部清创、Wallis取出及自体髂骨植入椎间融合,术后继续抗感染治疗后症状好转,随访7年患者无不适症状;4例出现术后不明原因腰痛,经实验室检查及影像学检查排除感染、假体及椎管内因素,最终经骶管、小关节封闭或止痛治疗后好转。 根据术后并发症出现的时间,可分为术后早期并发症及术后中远期并发症。其中术后早期并发症(7例):出现在1年内,包括1例手术节段腰椎间盘突出复发,2例手术部位感染,4例术后不明原因腰痛,发生时间为1-10个月,平均发生时间为(3.57±3.55)个月。术后中远期并发症(7例):出现在术后3年以上,包括2例手术节段腰椎间盘突出复发,4例手术邻近节段腰椎间盘突出或再狭窄,1例棘突骨折,发生时间为39-82个月,平均发生时间(58.00±13.70)个月。 2.5 患者术后再手术情况分析 15例患者出现并发症,有8例患者行二次手术,再手术率为7.8%(8/103),其中装置相关并发症的再手术率为5.8%(6/103)。二次手术距首次手术时间为1-82个月,平均时间(43.25±27.09)个月。有3例行装置移除,装置移除的时间为7-82个月,(46.67±37.69)个月,其中2例为腰椎间盘突出复发,均行内固定拆除+融合手术,1例为伤口深部感染。有5例未移除装置:包括1例伤口浅部感染行伤口清创、4例手术邻近节段椎间盘突出复发或再发狭窄行椎间孔镜或融合手术。患者男7例,女1例,男性再手术率为11.3%,女性再手术率为2.4%,男性患者再手术率略高于女性,但无显著差异(P=0.205);再手术患者平均年龄为(42.00±11.90)岁,未再手术患者平均年龄为(43.31±11.50)岁,两者之间无显著差异(P=0.686)。 "
2.6 患者装置存留率情况 103例患者的Wallis总体5年装置存留率为98.1%(101/103),10年存留率为97.1%(100/103)。装置移除的3例患者术前均诊断为腰椎间盘突出症,腰椎间盘突出症患者5年的装置存留率为95.7%(44/46),10年装置存留率为93.5%(43/46)。腰椎管狭窄症、腰椎管狭窄症合并腰椎间盘突出症,以及腰椎滑脱症患者5年及10年装置存留率均为100%(Log Rank,P > 0.05),见图2。而对于不同手术方式,行椎间盘切除术患者5年及10年的装置存留率分别为97.7%(85/87)及96.6%(84/87),未行椎间盘切除术患者5年及10年装置存留率均为100%(Log Rank P > 0.05)。经Cox回归分析,患者年龄、性别、手术节段、手术方式及术前诊断均非影响装置存留率的危险因素(P=0.496,0.965,0.176,0.983,0.952)。"
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