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[全膝关节置换术中患者特异性器械的应用。一项前瞻性随机研究的一年结果]

[Use of Patient Specific Instruments at Total Knee Arthroplasty. One-Year Results of a Prospective Randomised Study].

作者信息

Musil D, Stehlík J, Abrman K, Held M, Sadovský P

机构信息

Nemocnice České Budějovice, a.s., Ortopedické oddělení, České Budějovice.

出版信息

Acta Chir Orthop Traumatol Cech. 2016;83(3):175-81.

Abstract

UNLABELLED

PURPOSE OF THE STUDY The aim of this prospective study was to evaluate, at one year of follow-up, radiographic and clinical results of total knee arthroplasty (TKA) performed with use of Zimmer® Patient Specific Instruments (PSIs) which allow for planning and customising each patient's TKA. MATERIAL AND METHODS Of the patients with knee arthritis who were eligible for joint replacement, 23 were randomly selected and included in this study. There were 11 men and 12 women, with 11 right and 12 left knee joints. On the basis of pre-operative CT scans, PSI custom-made pin guides, which conformed to the individual patient's anatomy, were produced and then used in the THA surgery involving a NexGen (CR) system. All patients were examined before surgery and at 1 year after THA. The evaluation at a follow-up visit included standing full-length radiographs (antero-posterior and lateral), Knee Score results, range of motion (ROM), patient's satisfaction report, and post-operative complications. The X-ray views were examined for mechanical leg axis alignment, TKA alignment in antero-posterior and lateral projection and signs of potential loosening. RESULTS At 1 post-operative year, the average Knee Society Score (KSS) was 85.5 points and the average functional score was 82.6 point. The satisfaction rate was 94% and, on a school rating system, the average mark was 1.3. The average postoperative ROM value was 116°. All patients were willing to undergo the surgery again. The only complication was thrombosis in one patient. Radiographic findings of knee alignment were optimal in 18, correct (up to 3° deviation) in three and incorrect (above 3° deviation) in two patients. Radiographic signs of loosening were not recorded. DISCUSSION Correct knee alignment is one of the requirements for achieving a good TKA outcome. Various techniques are used to improve the total knee process (computer-aided surgery, customised guides). Zimmer Patient Specific Instruments provide advanced pre-operative planning and more accurate implant sizing and alignment. An experienced surgeon can achieve the same good results with conventional planning under standard conditions but the use of PSIs is clearly more beneficial in patients with extra-articular deformities and in patients in whom femoral intramedullary guides cannot be employed. To produce a custom-made pin guide requires a CT scan of the whole leg and is also associated with additional paperwork. The PSIs simplify the total knee process from start to finish and surgeons have complete flexibility to make fine-tuning adjustments during the procedure. CONCLUSIONS Zimmer Patient Specific Instruments allow for exact alignment of both the femoral and the tibial component in a TKA process. Under standard circumstances, clinical and radiographic outcomes are comparable with those of conventional planning. However, the use of PSIs is clearly more beneficial in patients with extra-articular deformities and in patients in whom femoral intramedullary guides cannot be employed.

KEY WORDS

total knee arthroplasty, TKA, Patient Specific Instruments, PSIs.

摘要

未标注

研究目的 本前瞻性研究的目的是在随访一年时评估使用Zimmer®患者特异性器械(PSI)进行全膝关节置换术(TKA)的影像学和临床结果,该器械可用于规划和定制每位患者的TKA。材料与方法 从符合关节置换条件的膝关节炎患者中随机选取23例纳入本研究。其中男性11例,女性12例,右膝关节11个,左膝关节12个。根据术前CT扫描结果,制作符合个体患者解剖结构的PSI定制销钉导向器,然后用于涉及NexGen(CR)系统的THA手术。所有患者在手术前和THA术后1年接受检查。随访时的评估包括站立位全长X线片(前后位和侧位)、膝关节评分结果、活动范围(ROM)、患者满意度报告和术后并发症。检查X线片以评估机械性下肢力线对齐情况、TKA在前后位和侧位投影中的对齐情况以及潜在松动迹象。结果 术后1年时,膝关节协会平均评分(KSS)为85.5分,平均功能评分为82.6分。满意度为94%,在学校评分系统中,平均分数为1.3。术后ROM平均数值为116°。所有患者均愿意再次接受该手术。唯一的并发症是1例患者发生血栓形成。膝关节对齐的影像学检查结果在18例患者中为最佳,3例患者正确(偏差达3°),2例患者不正确(偏差超过3°)。未记录到松动的影像学迹象。讨论 正确的膝关节对齐是实现良好TKA结果的要求之一。各种技术用于改善全膝关节手术过程(计算机辅助手术、定制导向器)。Zimmer患者特异性器械提供了先进的术前规划以及更准确的植入物尺寸确定和对齐。经验丰富的外科医生在标准条件下使用传统规划也能取得同样好的结果,但在关节外畸形患者和无法使用股骨髓内导向器的患者中,使用PSI显然更有益。制作定制销钉导向器需要对整条腿进行CT扫描,并且还涉及额外的文书工作。PSI从始至终简化了全膝关节手术过程,外科医生在手术过程中具有完全的灵活性进行微调。结论 Zimmer患者特异性器械可使TKA过程中股骨和胫骨部件精确对齐。在标准情况下,临床和影像学结果与传统规划相当。然而,在关节外畸形患者和无法使用股骨髓内导向器的患者中,使用PSI显然更有益。关键词:全膝关节置换术;TKA;患者特异性器械;PSI

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