颈椎形状记忆椎管成形固定器的研制及基础研究
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摘要
本研究以Ni-Ti记忆合金为材料研制一种颈椎形状记忆椎管成形固定器(CSMLP)应用于颈椎椎管扩大成形术的固定系统。方法采用颈椎后路椎管成形山羊动物模型,通过X线、CT、组织形态学、生物力学对该固定器进行评价。结果CSMLP的环抱支尖端最大应力值为25.40±1.33Mpa,其尖端回弹力为119.86±7.59N,在30℃回弹力最大,在温度达到26℃时到达平台期。CSMLP不增加手术出血量和手术时间,可提高椎管成形术后即刻屈伸活动的稳定性,骨质愈合良好,可促进椎板再造,椎管再塑形。结论CSMLP可促进椎管成形术后铰链侧的骨愈合程度;对椎板再生有支架作用,新生骨可沿其生长。CSMLP可恢复颈椎椎管的完整性,增加颈椎椎管成形术后早期颈椎的稳定性,术中可以自行抱夹、撑开椎板,其安装简便,固定牢靠,用于颈椎椎管扩大成形术是安全、快速、有效的,即时椎管扩大效果明显,CSMLP有进一步研究的价值。
To design and manufacture a new kind of cervical spinal shape memory alloy laminoplasty system. Method Evaluate the basic character of the CSMLP with electric measurement assessment and encircle strength of holding part. Establish laminoplasty animal model, two group,ODL group (9 goats) and CSMLP group (9 goats), undergoing C4-C6 laminoplasty in ODL group and the other open-door laminoplasty with CSMLP fixation. Lateral cervical spine radiographs and cervical spine CT scan were obtained preoperatively and at 1week and 12 week post-operation. After 3 goats in each group were killed at 12 weeks post-operation, histomorphological observation were performed. After 6 goats in each group were killed at 24 weeks post-operation, biomechanical testing (range of motion in flexion-extension, lateral flexion and axial rotation) was performed using pure moment loading on 30 intact cervical spinal columns, blank group(6 goats)、instant post-laminoplasty(6 goats) and instant post-laminoplasty with CSMLP fixation (6 goats). Result The maximum Stress of the CSML's holding part was 25.40±1.33Mpa, encircle strength was 119.86±7.59N. The hinged side of All specimen in CSMLP group were fused and 7of 9 in ODL group were fused also. Newly formed bone grew along CSMLP which was a frame. CSMLP could promote lamina regeneration. Instant flexion-extension range of post-operation was larger than the control group(p<0.05). Conclusions .CSMLP can open and cramp lamina automatically. It was easy to be performed and the fixation effect was stably. IThe instant cervical spine curvature and cervical spine curvature 24 weeks post-operation decreased significantly. The healing of hinged side was good by using CSMLP. Instant range of flexion- extension decreased after laminoplasty. laminoplasty increase unsteadiness at the early time post-operation. CSMLP can improve the instant stability in flexion-extension post-operation by increase the antibending section modulus. Laminoplasty did not change instant lateral flexion and axial rotation post-operation in the condition of weather use CSMLP or not. The range of motion decreased significantly medium or long period after laminoplasty in the condition of weather use CSMLP or not.
引文
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