Department of Orthopaedic Surgery, Martini Hospital, van Swietenplein 1, 9728NT, Groningen, The Netherlands.
BMC Musculoskelet Disord. 2009 Sep 30;10:119. doi: 10.1186/1471-2474-10-119.
Prosthetic design for the use in primary total knee arthroplasty has evolved into designs that preserve the posterior cruciate ligament (PCL) and those in which the ligament is routinely sacrificed (posterior stabilized). In patients with a functional PCL the decision which design is chosen depends largely on the favour and training of the surgeon.The objective of this study is to determine whether the patient's perceived outcome and speed of recovery differs between a posterior cruciate retaining total knee arthroplasty and a posterior stabilized total knee arthroplasty.
METHODS/DESIGN: A randomized controlled trial will be conducted. Patients who are admitted for primary unilateral TKA due to primary osteoarthrosis are included when the following inclusion criteria are met: non-fixed fixed varus or valgus deformity less than 10 degrees, age between 55 and 85 years, body mass index less than 35 kg/m(2) and ASA score (American Society of Anaesthesiologists) I or II. Patients are randomized in 2 groups. Patients in the posterior cruciate retaining group will receive a prosthesis with a posterior cut-out for the posterior cruciate ligament and relatively flat topography. In patients allocated to the posterior stabilized group, in which the posterior cruciate ligament is excised, the design may substitute for this function by an intercondylar tibial prominence that articulates with the femur in flexion. Measurements will take place preoperatively and 6 weeks, 3 months, 6 months and 1 year postoperatively.At all measurement points patient's perceived outcome will be assessed using the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC). Secondary outcome measures are quality of life (SF-36) and physician reported functional status and range of motion as determined with the Knee Society Clinical Rating System (KSS).
In the current practice both posterior cruciate retaining and posterior stabilized designs for total knee arthroplasty are being used. To date no studies have been performed determining whether there is a difference in patient's perceived outcome between the two designs. Additionally, there is a lack of studies determining the speed of recovery in both designs as most studies only determine the final outcome. This randomised controlled study has been designed to determine whether the patient's perceived outcome and speed of recovery differs between a posterior cruciate retaining total knee arthroplasty and a posterior stabilized total knee arthroplasty.
The trial is registered in the Netherlands Trial Registry (NTR1673).
用于初次全膝关节置换术的假体设计已经发展到保留后交叉韧带（PCL）的设计和常规切除韧带（后稳定）的设计。在有功能 PCL 的患者中，选择哪种设计取决于外科医生的偏好和培训。本研究的目的是确定保留后交叉韧带的全膝关节置换术和后稳定的全膝关节置换术之间，患者的感知结果和恢复速度是否存在差异。
方法/设计：将进行一项随机对照试验。当满足以下纳入标准时，将纳入因原发性骨关节炎而接受初次单侧 TKA 的患者：非固定性内翻或外翻畸形小于 10 度，年龄在 55 至 85 岁之间，体重指数小于 35kg/m²和 ASA 评分（美国麻醉医师协会）I 或 II。患者随机分为 2 组。在后交叉韧带保留组中，患者将接受一种带有后交叉韧带后切迹和相对平坦的假体。在后稳定组中，切除了后交叉韧带，设计可能通过与股骨在屈曲时关节的髁间胫骨突起来替代这个功能。测量将在术前以及术后 6 周、3 个月、6 个月和 1 年进行。在所有测量点，患者的感知结果将使用西安大略和麦克马斯特大学骨关节炎指数（WOMAC）进行评估。次要结果测量包括生活质量（SF-36）和医生报告的功能状态和膝关节学会临床评分系统（KSS）确定的运动范围。
在当前的实践中，后交叉韧带保留和后稳定设计都被用于全膝关节置换术。迄今为止，还没有研究确定两种设计之间患者感知结果是否存在差异。此外，由于大多数研究仅确定最终结果，因此缺乏确定两种设计中恢复速度的研究。这项随机对照研究旨在确定保留后交叉韧带的全膝关节置换术和后稳定的全膝关节置换术之间，患者的感知结果和恢复速度是否存在差异。
该试验在荷兰试验注册处（NTR1673）注册。
