颈椎前路低切迹钛板系统的研制和初步临床应用

The design and preliminary clinical application of anterior cervical low-profile plate system

目的对自行研制的颈椎前路低切迹钛板系统(anterior cervical low-profile plate system, ACLPS)进行临床应用评价。方法颈椎前路低切迹钛板系统由医用钛合金材料制成,组件包括钛板、锁固片、固定螺钉及挽救螺钉,切迹低平、锁固简捷、规格多样,并以松质骨螺纹自攻螺钉单皮质固定为特点。临床应用治疗颈椎疾患37例,男23例,女14例;年龄35～74岁,平均50.7岁。颈椎病8例,颈椎间盘突出症12例,颈椎骨折和(或)脱位伴截瘫14例,颈椎转移性肿瘤伴截瘫3例。均行颈前路减压、植骨融合及ACLPS内固定术。单间隙融合22例,双间隙15例。单纯自体髂骨块植骨29例40个间隙,结合椎间融合器植骨8例12个间隙。钛板固定椎体最高为C3,最低达T1。结果37例均获随访,随访时间6～12个月,平均9.6个月。全部病例术后均无颈部异物感,舒适度满意。未发生切口感染、血肿、窒息、神经损伤、硬脊膜破裂及脑脊液漏、切口渗液不愈合等现象。全部病例均获骨性融合,根据JOA评分术后总有效率94.6%,优良率83.8%。术后影像学资料显示无植骨块脱出或塌陷、椎间高度明显丢失、钛板或螺钉断裂、螺钉松动脱落及钛板螺钉整体松动等并发症。结论ACLPS具有较高的强度和紧固能力,能够提供较好的生物力学稳定作用,且操作简便,可以满足颈椎前路固定的需要。

Objective To evaluate the clinical results of self-designed anterior cervical low-profile plate system (ACLPS). Methods The anterior cervical plate system, composed of one plate, two locking caps and two types of screws. The system was made of medical titanium alloy possessing the following characteristics: low profile, instant locking, versatile use and unicortical screw fixation. 37 patients with cervical disorders were fixed with ACLPS after anterior spinal decompression and interbody fusion. The diagnosis included spondylosis in 8 cases, cervical intervertebral disk protrusion in 12, fracture and /or dislocation with paralysis in 14 and metastatic tumor in 3. The fusion were performed with autologous iliac crest bone graft for 29 patients while the others with cages. The fixed levels ranged from C3 to T1. Results 37 cases were followed-up for an average of 9.6 months, ranging from 6 to 12 months. Postoperatively all patients felt comfortable in neck without any foreign body sensation. No obvious complications such as wound infection, hematoma, asphyxia, nerve injury, laceration of spinal cord dura, leakage of cerebrospinal fluid, bleeding and nonhealing of the wound were observed. Solid interbody fusion were achieved in all cases. According to JOA scores, the total effective rate was 94.6% while the good rate was 83.8%. The radiograph confirmed that there was no dislocation or subsidence of graft, no obvious loss of intervertebral height, no loosening or failure of implant. Conclusion In regard to the high rigidity, good bony purchasing and easy handling, ACLPS is able to provide sufficient biomechanical stability and is an optional choice for clinical use.