Nutton R W, Wade F A, Coutts F J, van der Linden M L
Royal Infirmary Edinburgh, Orthopaedics Department, 51 Little France Crescent, Edinburgh EH16 4SA, UK.
J Bone Joint Surg Br. 2012 Aug;94(8):1051-7. doi: 10.1302/0301-620X.94B8.28828.
This prospective randomised controlled double-blind trial compared two types of PFC Sigma total knee replacement (TKR), differing in three design features aimed at improving flexion. The outcome of a standard fixed-bearing posterior cruciate ligament-preserving design (FB-S) was compared with that of a high-flexion rotating-platform posterior-stabilised design (RP-F) at one year after TKR. The study group of 77 patients with osteoarthritis of the knee comprised 37 men and 40 women, with a mean age of 69 years (44.9 to 84.9). The patients were randomly allocated either to the FB-S or the RP-F group and assessed pre-operatively and at one year post-operatively. The mean post-operative non-weight-bearing flexion was 107° (95% confidence interval (CI) 104° to 110°)) for the FB-S group and 113° (95% CI 109° to 117°) for the RP-F group, and this difference was statistically significant (p = 0.032). However, weight-bearing range of movement during both level walking and ascending a slope as measured during flexible electrogoniometry was a mean of 4° lower in the RP-F group than in the FB-S group, with 58° (95% CI 56° to 60°) versus 54° (95% CI 51° to 57°) for level walking (p = 0.019) and 56° (95% CI 54° to 58°) versus 52° (95% CI 48° to 56°) for ascending a slope (p = 0.044). Further, the mean post-operative pain score of the Western Ontario and McMaster Universities Osteoarthritis Index was significantly higher in the RP-F group (2.5 (95% CI 1.5 to 3.5) versus 4.2 (95% CI 2.9 to 5.5), p = 0.043). Although the RP-F group achieved higher non-weight-bearing knee flexion, patients in this group did not use this during activities of daily living and reported more pain one year after surgery.
这项前瞻性随机对照双盲试验比较了两种全膝关节置换术（TKR）中使用的PFC Sigma产品，这两种产品在旨在改善膝关节屈曲的三个设计特点上有所不同。将标准的保留后交叉韧带的固定平台设计（FB-S）的效果与高屈曲旋转平台后稳定设计（RP-F）在全膝关节置换术后一年的效果进行了比较。该研究组由77例膝关节骨关节炎患者组成，其中男性37例，女性40例，平均年龄69岁（44.9至84.9岁）。患者被随机分配到FB-S组或RP-F组，并在术前和术后一年进行评估。FB-S组术后平均非负重屈曲角度为107°（95%置信区间（CI）104°至110°），RP-F组为113°（95%CI 109°至117°），这一差异具有统计学意义（p = 0.032）。然而，在柔性电子测角仪测量中，RP-F组在平路行走和上坡时的负重活动范围平均比FB-S组低4°，平路行走时分别为58°（95%CI 56°至60°）和54°（95%CI 51°至57°）（p = 0.019），上坡时分别为56°（95%CI 54°至58°）和52°（95%CI 48°至56°）（p = 0.044）。此外，RP-F组术后西安大略和麦克马斯特大学骨关节炎指数的平均疼痛评分显著更高（分别为2.5（95%CI 1.5至3.5）和4.2（95%CI 2.9至5.5），p = 0.043）。尽管RP-F组实现了更高的非负重膝关节屈曲，但该组患者在日常生活活动中并未使用这一优势，且术后一年报告的疼痛更多。
