Muller S D, Deehan D J, Holland J P, Outterside S E, Kirk L M G, Gregg P J, McCaskie A W
Department of Orthopaedics, Freeman Hospital, Freeman Road, High Heaton, Newcastle upon Tyne, UK.
J Bone Joint Surg Br. 2006 Dec;88(12):1596-602. doi: 10.1302/0301-620X.88B12.17695.
The role of modular tibial implants in total knee replacement is not fully defined. We performed a prospective randomised controlled clinical trial using radiostereophotogrammetric analysis to compare the performance of an all-polyethylene tibia with a metal-backed cruciate-retaining condylar design, PFC-Sigma total knee replacement for up to 24 months. There were 51 patients who were randomised into two treatment groups. There were 10 subsequent withdrawals, leaving 21 all-polyethylene and 20 metal-backed tibial implants. No patient was lost to follow-up. There were no significant demographic differences between the groups. At two years one metal-backed implant showed migration > 1 mm, but no polyethylene implant reached this level. There was a significant increase in the SF-12 and Oxford knee scores after operation in both groups. In an uncomplicated primary total knee replacement the all-polyethylene PFC-Sigma tibial prosthesis showed no statistical difference in migration from that of the metal-backed counterpart. There was no difference in the clinical results as assessed by the SF-12, the Oxford knee score, alignment or range of movement at 24 months, although these assessment measures were not statistically powered in this study.
模块化胫骨植入物在全膝关节置换中的作用尚未完全明确。我们进行了一项前瞻性随机对照临床试验,采用放射立体摄影测量分析,比较全聚乙烯胫骨与金属背衬保留交叉韧带髁设计的PFC-Sigma全膝关节置换长达24个月的性能。51例患者被随机分为两个治疗组。随后有10例退出,剩余21例全聚乙烯胫骨植入物和20例金属背衬胫骨植入物。无患者失访。两组之间在人口统计学上无显著差异。两年时,1例金属背衬植入物出现迁移>1 mm,但无聚乙烯植入物达到此水平。两组术后SF-12和牛津膝关节评分均显著提高。在无并发症的初次全膝关节置换中,全聚乙烯PFC-Sigma胫骨假体与金属背衬假体在迁移方面无统计学差异。在24个月时,通过SF-12、牛津膝关节评分、对线或活动范围评估的临床结果无差异,尽管这些评估指标在本研究中未达到统计学效力。