Zero-P implant versus traditional interbody fusion with titanium plate in the repair of nerve root cervical spondylosis: 2-year follow-up of efficacy and imaging

doi:10.3969/j.issn.2095-4344.2014.48.009

Abstract

Abstract:

BACKGROUND: Anterior interbody fusion has been used to treat cervical degenerative diseases for more than 50 years, but the standardization of its technique remains controversial. The major disadvantages of alone use of interbody fusion cage are instant poor stability and fusion subsidence. The main disadvantages of interbody fusion with anterior titanium plate are dysphagia in the plate region and heterotopic ossification around the operated intervertebral disc side.
OBJECTIVE: To compare clinical and radiological efficacies of new implant Zero-P and traditional fusion with titanium plate for treatment of nerve root cervical spondylosis.
METHODS: We retrospectively analyzed clinical data of 56 patients with nerve root type cervical spondylosis undergoing anterior cervical decompression and fusion fixation. They were divided into two groups according to fixation scheme. Zero-P group contained 25 patients with 31 segments. Traditional group (traditional intervertebral fusion device + locking titanium plate) contained 31 patients with 40 segments. There were no significant differences in age, gender and operated regions between above two groups. Cervical dysfunction index, the incidence of dysphagia, Cobb C angle, Cobb S angle, vertebral height, vertebral stability and heterotopic ossification degree were compared between the two groups.
RESULTS AND CONCLUSION: Cervical dysfunction index was significantly lower at 24 months after fixation than before fixation in both groups (P < 0.05). Patient’s symptoms were obviously improved after fixation. One patient affected dysphagia in early stage after fixation in the Zero-P group. Symptoms disappeared during 24-month follow-up. Two patients experienced dysphagia in the traditional group after fixation. No significant difference in the incidence of dysphagia was detected between the two groups (P > 0.05). No significant differences in Cobb C angle and vertebral height of surgical segment were detectable before and after fixation in the two groups (P > 0.05). Cobb S angle apparently increased in the Zero-P group from pre-fixation to post-fixation (i.e., surgical procedures). The maximum appeared in the first rechecking after fixation. In the traditional group, Cobb S angle slowly increased from pre-fixation to 6 weeks post-fixation, and peaked at 6 weeks post-fixation. Solid bony fusion was visible in the fusion segment in all cases of the Zero-P group, but solid body fusion was found in 30 cases of the traditional group, with a stable rate of 97%. In 24-month follow-up, the incidence of heterotopic ossification was 25% in the Zero-P group, but 44% in the traditional group. The rate of heterotopic ossification was significantly lower in the Zero-P group than that in the traditional group at 24 months after fixation (P < 0.05). These data suggested that compared with traditional pegboard system, Zero-P implant for treatment of nerve root cervical spondylosis has a certain advantage, and deserves to be used in the clinic.

中国组织工程研究杂志出版内容重点：人工关节；骨植入物；脊柱；骨折；内固定；数字化骨科；组织工程

全文链接：

Key words: cervical vertebrae, internal fixators, deglutition disorders, follow-up studies

CLC Number:

R318

Hu Wei, Li Lei, Liu Yan-lu, Wu Yan-sheng, Huang Yi-fei, Zhang Bin. Zero-P implant versus traditional interbody fusion with titanium plate in the repair of nerve root cervical spondylosis: 2-year follow-up of efficacy and imaging[J]. Chinese Journal of Tissue Engineering Research, 2014, 18(48): 7757-7762.

Figures/Tables 4

2.1 参与者数量分析按意向性处理，纳入行颈椎前路内固定患者56例，根据内固定方案分为两组，Zero-P组25例，传统组31例。全部进入结果分析，无脱落。 2.2 基线资料比较两组患者基线资料比较差异无显著性意义(P > 0.05)，具有可比性，见表1。 2.3 两组患者内固前、内固定后观测指标比较 Zero-P组共25例患者共计31个手术处理节段，传统组共31例患者共计40个手术处理节段。两组患者手术节段均位于C4-C7，所有患者手术过程顺利、无异常情况发生，两组患者内固前及内固定后24个月的颈椎功能障碍指数比较差异均有显著性意义(P < 0.00 1)，内固定治疗效果良好(见表2)；Zero-P组内固定后早期均发现1例吞咽困难患者，内固定后24个月随访时症状消失，吞咽困难发生率为4%；传统组内固定后发生吞咽困难有2例，内固定后24个月随访时仍有1例觉吞咽不适，其发生率为7%；两组术后吞咽困难发生率差异无显著性意义(P > 0.05)。内固前及内固定后行X射线片检查，测量结果显示：Zero-P组与传统组在内固前及内固定后各个时间点，Cobb C角均较低，同时，Zero-P组内固前及内固定后(3个月)随访测得的Cobb C角未见明显变化(P=0.062)，随着时间的延长(24个月时)Cobb C也未证明有所变化(P=0.083)；Zero-P组患者在内固定后3个月时Cobb C角值增至最大，然后逐渐降低至内固前水平；Zero-P组患者Cobb S角在内固前至内固定后(即手术过程时间)呈明显增加趋势，最大值出现在内固定后第1次复查时，后逐渐下降、稳定；而传统组内固前至内固定后6周时Cobb S角呈缓慢增加趋势，内固定后6周左右Cobb S角达到最大值，后逐渐下降、稳定；两组手术节段在内固前及内固定后各个时间点椎体高度差异无显著性意义(P > 0.05)，两组手术节段椎体高度随时间延长逐渐下降，但降幅度较小；内固定后24个月时复查椎体高度值仍是内固前的95%左右，未见明显椎体高度变化；Cobb C、Cobb S及椎体高度在各个时间点的变化情况见表3。 2.4 两组内固定后骨性愈合及异位骨化情况比较内固定后24个月随访检查显示：Zero-P组患者手术节段均达到了牢固骨性融合(稳定)，稳定率为100%，而传统组31例患者中有30例达到牢固骨性融合(稳定)，仅有1例为可能稳定，稳定率为97%，两组内固定后24个月时手术节段稳定情况比较差异无显著性意义(P > 0.05)。内固定后24个月，Zero-P组手术处理节段上下共有5个1级、3个2级异位骨化，异位骨化发生率为25%，其中上位节段发生率12%，下位阶段发生率为13%，重度异位骨化(2级或3级)率为9%；而传统组手术处理节段上下共有7个1级、7个2级和3个3级异位骨化，异位骨化发生率为"

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