Application of bone repair materials containing recombinant human bone morphogenetic protein-2 in anterior cervical discectomy and fusion

doi:10.3969/j.issn.2095-4344.2014.43.001

Abstract

Abstract:

BACKGROUND: The anterior cervical discectomy and fusion with autologous bone is the standard surgical treatment for cervical spondylosis, but there are more complications occurring during the harvesting of autologous iliac bone. To find suitable alternative materials used in bone repair surgery has been a research focus.
OBJECTIVE: To analyze the clinical and radiographic outcomes in patients undergoing anterior cervical discectomy with fusion using polyetheretherketone cages packed with bone repair material containing recombinant human bone morphogenetic protein-2.
METHODS: A total of 40 consecutive patients with cervical spinal degenerative disease who underwent anterior cervical discectomy and fusion were enrolled. We retrospectively reviewed anterior cervical discectomy with fusion using polyetheretherketone cages packed with bone repair material containing recombinant human bone morphogenetic protein-2 and autologous osteophyte in 21 cases and with autologous iliac crest in 19 cases. These patients had sequential radiographs before and after surgery, and at 1 year. The anterior disc height, interbody height, segmental Cobb angle, complication, and fusion rate were assessed based on radiographs including flexion/extension radiographs and CT scan. The neurologic outcomes were evaluated using the visual
analog scale score for neck and arm pain and the Japanese Orthopedic Association scoring system for myelopathy.
RESULTS AND CONCLUSION: At the last follow-up, solid fusion appeared to have been achieved in patients of both groups. Lordosis was increased significantly in both groups after surgery (P < 0.05), and was maintained up until 1 year without a difference between groups. Both the anterior disc height and interbody height were significantly increased after surgery (P < 0.05), without a significant difference between groups. At the last follow-up, the Cobb angle in the test group was significantly higher than that in the control group (P < 0.05), but there was no significant difference in both the visual analog scale score and the Japanese Orthopedic Association scores between the two groups at the last follow-up. Bone repair materials containing recombinant human bone morphogenetic protein-2 can achieve higher fusion rates, restore and maintain up of lordosis and disc space height. Therefore, the ongoing use of the polyetheretherketone cage packed with bone repair material containing recombinant human bone morphogenetic protein-2 and autologous osteophyte in anterior cervical discectomy with fusion is a safe and effective alternative to the gold standard of autologous iliac bone grafts.

中国组织工程研究杂志出版内容重点：生物材料；骨生物材料; 口腔生物材料; 纳米材料; 缓释材料; 材料相容性；组织工程

全文链接：

Key words: bone morphogenetic proteins, cervical vertebrae, spinal fusion

CLC Number:

R318

Xu Yun, Jin Yao, Shi Yong, Jiang Wei-min, Tang Tian-si. Application of bone repair materials containing recombinant human bone morphogenetic protein-2 in anterior cervical discectomy and fusion[J]. Chinese Journal of Tissue Engineering Research, 2014, 18(43): 6889-6895.

Figures/Tables 5

2.1 参与者数量分析 40例患者均完成12个月随访，进入结果分析。 2.2 基线资料比较两组患者在年龄、性别、颈椎病类型、手术节段分布等方面比较差异均无显著性意义(P > 0.05)，见表1。 2.3 术后影像学指标测量结果 6个月左右大部分病例获得满意的骨性融合，无假关节形成。颈椎前凸(Cobb角)的变化：术前两组颈Cobb角比较差异无显著性意义(P=0.061)。术后两组Cobb角均较术前显著增加(P < 0.001)。随着随访时间的延长，两组颈椎前凸均有逐渐的丢失，末次随访时试验组Cobb角大于对照组(P=0.026)，表明试验组对颈椎前凸的维持优于对照组；并且末次随访时，两组Cobb角仍然大于术前(P=0.016，P=0.001)，见表2，3。椎间高度的变化：术前两组融合节段椎间隙前缘高度比较差异无显著性意义(P=0.061)。术后两组前缘高度均较术前显著增加，两组间比较差异无显著性意义(P=0.903)。随着随访时间的延长，融合节段前缘高度逐渐丢失，至末次随访时，试验组融合节段前缘高度稍高于对照组，但差异无显著性意义(P=0.148)。融合节段高度的变化趋势与融合节段前缘高度大致相同，见表2，3。融合率：试验组29个融合节段，对照组26个融合节段。随访6个月时，试验组融合率为100%，对照组融合率96%，至末次随访两组病例全部获得骨性融合，见表4。 2.4 两组临床疗效评价术后两组患者颈部及上肢疼痛麻木症状及脊髓压迫受损JOA评分均有不同程度改善，见表5。 JOA评分：术前两组JOA评分比较差异无显著性意义(P=0.599)。术后24-48 h两组JOA评分较术前稍有改善，两组之间比较差异无显著性意义(P=0.957)。至末次随访时，两组JOA评分均有明显改善，两组之间比较差异无显著性意义(P=0.186)。颈部目测类比评分：两组术前均有不同程度的颈部疼痛不适，两组术前目测类比评分差异无显著性意义(P=0.800)。术后24-48 h，两组目测类比评分均明显低于术前(P < 0.001)，两组间比较差异无显著性意义(P=0.128)。至末次随访时，两组间比较差异无显著性意义(P=0.100)。上肢目测类比评分：两组术前上肢疼痛麻木程度情况相当(P=0.182)。术后24-48 h，两组目测类比评分均较术前均有不同程度改善(P < 0.001)。末次随访时，两组间比较差异无显著性意义(P=0.087)。 2.5 手术情况及相关并发症试验组与对照组手术时间分别为(107.76±18.24)，(114.63±24.31) min，两组间比较差异无显著性意义(P=0.316)。试验组与对照组术中出血量分别为(122.86±53.02)，(186.32±74.03) mL，组间差异有显著性意义(P=0.003)。试验组未发生严重的颈前软组织水肿，气道阻塞而致的呼吸困难。试验组有2例、对照组有3例出现一过性咽部不适或吞咽困难，但症状较轻，术后3 d后均自行缓解。两组各有1例术中发生硬脊膜破裂，以明胶海绵填塞、抬高床尾、减低颅内压、减少脑积液分泌药物治疗，均未出现严重的脑脊液漏。对照组有2例出现cage塌陷下沉，其中1例形成颈椎反曲，无脊髓及神经根受压症状，临床症状恢复好。试验组无cage下沉并发症出现。术后7个月随访X射线检查发现对照组有1例出现螺钉松动，但手术节段已牢固融合，"

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