Pitzen Tobias R, Chrobok Jiri, Stulik Jan, Ruffing Sabine, Drumm Joerg, Sova Laurentius, Kucera Roman, Vyskocil Tomas, Steudel Wolf Ingo
SRH Waldklinikum Gera gGmbH, Strasse des Friedens 122, Gera, Germany.
Spine (Phila Pa 1976). 2009 Apr 1;34(7):641-6. doi: 10.1097/BRS.0b013e318198ce10.
Prospective, controlled, randomized, multicenter study.
To analyze implant complications and speed.
Rigid plate designs, in which the screws are locked to the plate, are in common use and thought to provide more fixation than dynamic designs, in which the screws may glide when the graft is settling. The aim of the study is to analyze (1) implant complications, (2) speed of fusion, (3) loss of lordosis, and (4) clinical outcome in both types of plates.
One hundred thirty-two patients were included and assigned by randomization to one of the groups in which they received a routine anterior cervical discectomy and autograft fusion with either a dynamic plate (ABC, study group) or a rigid plate (CSLP, control group). At discharge, after 3 and 6 months and finally after 2 years, implant complications, segmental mobility, absence of radiolucencies, absence of bone sclerosis, evidence of bridging trabecular bone, loss of lordosis, Visual Analog Scale (VAS) and Neck Disability Score were recorded. All radiographic measurements were performed by an independent radiologist.
There have been 4 patients with implant complications within the control group and no implant complications within the study group, P = 0.045. Mean segmental mobility before discharge for the study group was 1.7 mm, 1.4 mm after 3 months, 0.8 mm after 6 months, and 0.4 mm after 2 years. For the control group, these values were 1.0, 1.8, 1.6, and 0.5 mm. The difference at 6 months between both groups was significant (P = 0.024). Neither absence of radiolucencies, nor absence of sclerosis, nor evidence of bridging bone showed significant differences between the 2 groups through the postoperative follow-up (P > 0.05). The loss of segmental lordosis for the study group with respect to intraoperative radiograph was 1.3 degrees at discharge and 4.3 degrees after 2 years. For the control group, these values were 0.9 degrees , 0.7 degrees . The difference at 2 years was significant (P = 0.003). Clinical postoperative outcome (VAS and ODI) was not different between the 2 groups through the postoperative follow-up (P > 0.05).
Dynamic cervical plate designs provide less implant complications (no patient) compared with rigid plate designs (4 patients). Speed of fusion was faster in the presence of a dynamic plate. However, loss of segmental lordosis is significantly higher if dynamic plates are used, which did not result in differences regarding clinical outcome between dynamic and constrained plates after 2 years. Thus, dynamic plates should be considered to be the preferred treatment option because of the lower risk for implant failure-related revision surgery.
前瞻性、对照、随机、多中心研究。
分析植入物并发症及速度。
螺钉锁定于钢板的刚性钢板设计应用广泛，且被认为比动态钢板设计提供更强的固定，动态钢板设计中植骨沉降时螺钉可能会滑动。本研究旨在分析（1）植入物并发症，（2）融合速度，（3）颈椎前凸丧失，（4）两种钢板的临床结局。
纳入132例患者，随机分为两组，分别接受常规颈椎前路椎间盘切除及自体骨移植融合术，一组使用动态钢板（ABC，研究组），另一组使用刚性钢板（CSLP，对照组）。在出院时、3个月后、6个月后及最终2年后，记录植入物并发症、节段活动度、无透亮区、无骨质硬化、小梁骨桥接证据、颈椎前凸丧失、视觉模拟评分（VAS）及颈部功能障碍评分。所有影像学测量均由一名独立放射科医生进行。
对照组有4例患者出现植入物并发症，研究组无植入物并发症，P = 0.045。研究组出院前平均节段活动度为1.7mm，3个月后为1.4mm，6个月后为0.8mm，2年后为0.4mm。对照组相应数值分别为1.0、1.8、1.6及0.5mm。两组在6个月时的差异具有统计学意义（P = 0.024）。在术后随访期间，两组间在无透亮区、无骨质硬化及小梁骨桥接证据方面均无显著差异（P > 0.05）。研究组相对于术中X线片的节段颈椎前凸丧失在出院时为1.3度，2年后为4.3度。对照组相应数值分别为0.9度、0.7度。两组在2年后的差异具有统计学意义（P = 0.003）。在术后随访期间，两组间临床术后结局（VAS和ODI）无差异（P > 0.05）。
与刚性钢板设计（4例患者）相比，动态颈椎钢板设计的植入物并发症更少（无患者）。使用动态钢板时融合速度更快。然而，如果使用动态钢板，节段颈椎前凸丧失显著更高，2年后动态钢板与限制性钢板在临床结局方面无差异。因此，由于与植入物失败相关的翻修手术风险较低，动态钢板应被视为首选治疗方案。
