Comparison of Radiographic Alignment of Image less Computer-Assisted Surgery vs Conventional Instrumentation in Primary Total Knee Arthroplasty
Comparison of Radiographic Alignment of Image less Computer-Assisted Surgery vs Conventional Instrumentation in Primary Total Knee Arthroplasty
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DOI：
10.1016/j.arth.2011.04.037
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发表时间：
2011-12-01
影响因子：
3.5
通讯作者：
Fisher, David A.
中科院分区：
文献类型：
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作者：
Barrett, William P.;Mason, J. Bohannon;Fisher, David A.
一项多中心、前瞻性、随机、机构审查委员会批准的研究共入组了208例患者，该研究比较了使用计算机辅助手术（CAS）植入的初次全膝关节置换术（TKA）与传统TKA器械的术前手术计划与术后二维影像学对线，该对线由设盲审查员测量。结果表明，冠状面胫骨部件对线有统计学显著改善（P <0.03），机械轴、股骨冠状面/矢状面和胫骨矢状面对线无统计学显著改善。在所有术后时间间隔，两个治疗组之间的膝关节协会评分、膝关节和功能评分以及6分钟步行试验均相等。CAS膝关节的皮肤-皮肤时间（P <0.0001）和首次截骨时间（P <0.0001）与植入传统内固定器械的膝关节相比有统计学显著增加。与传统TKA相比，在高容量中心进行的这项随机临床试验中使用CAS在术后对线、临床、功能或安全性结局方面没有提供具有临床意义的改善。
A total of 208 patients were enrolled in a multicenter, prospective randomized, institutional review board approved study that compared preoperative surgical plan to postoperative 2-dimensional radiographic alignment measured by a blinded reviewer for primary total knee arthroplasty (TKA) implanted using computer-assisted surgery (CAS) compared with conventional TKA instrumentation. The results demonstrated a statistically significant improvement in the coronal tibial component alignment (P < .03) and failed to demonstrate a statistically significant improvement in the mechanical axis, femoral coronal/sagittal, and tibial sagittal alignment. Knee Society Score knee and function scores and 6-minute walk test were equivalent between the 2 treatment groups at all postoperative intervals. There was a statistically significant increase in the skin-skin time (P < .0001) and the time until first bone cut (P < .0001) for the CAS knees compared with those implanted with conventional instrumentation. The use of CAS in this randomized clinical trial conducted at high-volume centers did not offer a clinically meaningful improvement in postoperative alignment, clinical, functional, or safety outcomes compared with conventional TKA.