Scientific Evaluation of a New Alignment Method for Total Knee Arthroplasty

全膝关节置换术新对位方法的科学评估

• 批准号: 1067527
• 负责人: Maury Hull
• 金额: $ 34.8万
• 依托单位: University of California-Davis
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-09-01 至 2015-08-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1067527&HistoricalAwards=false
• 关键词: Scientific; Evaluation; New; Alignment; Method

PI: Hull, Maury L.Proposal Number: 1067527Goals and Objectives: The general aim of the proposed research is to use in vitro testing to determine whether kinematic alignment, which is a controversial new method of aligning components in total knee arthroplasty (TKA), gives better knee function than mechanical alignment, which is the traditional method of alignment. The two alignment methods will be assessed by determining which better restores the kinematic axes of the tibiofemoral joint to normal, the passive envelopes of motion to normal, more evenly balances and centers the medial and lateral contact forces on the tibial component. These four general categories of dependent variables are important determinates of knee function, which must be tested in vitro because the use of instrumentation with this level of sophistication in vivo is not possible. The proposed research will test the following four hypotheses: 1) Kinematically aligned TKA restores the position and orientation of both the transverse axis in the femur about which the tibia flexes and extends and the longitudinal rotational axis in the tibia about which the tibia internally and externally rotates closer to normal than mechanically aligned TKA. 2) Kinematically aligned TKA restores the neutral and bidirectional limits of the passive envelopes of motion of flexion-extension, varus-valgus, and internal-external rotations and anterior-posterior translation closer to normal than mechanically aligned TKA. 3) Kinematically aligned TKA better balances the contact forces in the medial and lateral compartments than mechanically aligned TKA. 4) Kinematically aligned TKA better centers the contact forces in the medial and lateral compartments than mechanically aligned TKA. Our research group is uniquely able to perform these studies because we have developed a new method for determining the axes of motion, we have experience using our custom built six degree-of-freedom load application knee testing system, and we have extensive developmental and clinical experience with kinematically and mechanically aligned TKAs. Intellectual Merit: The method of aligning a TKA is of keen interest to the patient and surgeon because alignment determines knee motion, stability, pain relief, patient satisfaction, durability, and revision rate. Mechanically aligned TKA, which strives to achieve a 0° mechanical axis, has good long-term durability, but several studies have shown that 20-25% of patients are less than satisfied due to persistent unexplained pain, stiffness, and instability. One reason for the less than satisfied outcome is that aligning the limb to a 0º mechanical axis changes the kinematics of the knee. The change in kinematics requires ligament releases to restore motion, which can cause instability. Kinematic alignment is a controversial but exciting new method that strives to restore the kinematics of the knee to normal in which case ligament releases are not required. Kinematically aligned TKA has increased patient satisfaction, shortened surgery, reduced transfusions, and quickened recovery compared to mechanically aligned TKA. The in vitro assessment of axes of motion, passive envelopes of motion, and contact forces will provide quantifiable explanations for the differences in clinical results between methods. Broader Impact: Total knee arthroplasty (TKA) is a surgical procedure used to reduce pain, restore joint function, and improve the quality of life of patients suffering from osteoarthritis (OA) of the knee. In 2006, 542,000 TKA procedures were performed in the US, and it has been projected that by 2030, 3.48 million TKA procedures will be performed annually. Because 20-25% of patients are less than satisfied [5, 45], there is a need to improve the clinical outcome and a need to reduce the morbidity and expense associated with revision surgery. If the proposed in vitro cadaveric study determines that kinematically aligned TKA better restores the transverse axis in the femur, passive envelopes of motion, distribution of contact forces, and better centers the contact forces, then the use of this alignment technique in vivo would be further justified. The broad impact of the increased use of kinematically TKA would likely translate into improved clinical outcome, a reduction in the revision rate, and reduction in the social and medical costs for the tens of millions of patients that will undergo TKA in the next two decades.

主要研究者：船体，Maury L.提案编号：1067527目标和目的：拟议研究的总体目的是使用体外测试来确定运动对线（全膝关节置换术（TKA）中对线部件的一种有争议的新方法）是否比机械对线（传统的对线方法）提供更好的膝关节功能。将通过确定哪种方法更好地将胫股关节的运动轴恢复至正常、被动运动包络恢复至正常、更均匀地平衡胫骨部件上的内侧和外侧接触力并使其居中，来评估两种对线方法。这四类因变量是膝关节功能的重要决定因素，必须在体外进行测试，因为在体内使用这种复杂程度的器械是不可能的。拟议的研究将测试以下四个假设：1）运动学对准的TKA恢复了股骨中胫骨屈曲和伸展所围绕的横轴和胫骨中胫骨内部和外部旋转所围绕的纵轴的位置和方向，比机械对准的TKA更接近正常。2)与机械对线TKA相比，运动对线TKA恢复了屈曲-伸展、内翻-外翻、内外旋转和前后平移的被动运动包络的中立和双向限制，更接近正常。3)与机械对线TKA相比，运动对线TKA能更好地平衡内侧和外侧间室的贴靠力。4)与机械对线TKA相比，运动对线TKA可更好地将贴靠力集中在内侧和外侧间室。我们的研究小组是唯一能够进行这些研究的，因为我们已经开发了一种确定运动轴的新方法，我们有使用定制的六自由度载荷应用膝关节试验系统的经验，我们有运动学和机械对准TKA的广泛开发和临床经验。智力优势：TKA的对线方法是患者和外科医生非常感兴趣的，因为对线决定了膝关节活动、稳定性、疼痛缓解、患者满意度、耐久性和翻修率。机械对线TKA力求实现0°机械轴，具有良好的长期耐久性，但多项研究表明，20-25%的患者由于持续的不明原因疼痛、僵硬和不稳定而不太满意。结果不太令人满意的一个原因是将肢体与0º机械轴对齐会改变膝关节的运动学。运动学的变化需要韧带松解来恢复运动，这可能导致不稳定。运动学对线是一种有争议但令人兴奋的新方法，它致力于恢复膝关节的运动学，在这种情况下不需要韧带松解。与机械对线TKA相比，运动对线TKA提高了患者满意度，缩短了手术时间，减少了输血，并加快了恢复。运动轴、被动运动包络和贴靠力的体外评估将为方法间临床结果的差异提供可量化的解释。更广泛的影响：全膝关节置换术（TKA）是一种用于减轻疼痛、恢复关节功能并改善膝关节骨关节炎（OA）患者生活质量的外科手术。 2006年，美国进行了542，000例TKA手术，预计到2030年，每年将进行348万例TKA手术。由于20-25%的患者不太满意[5，45]，因此需要改善临床结局，并需要降低与翻修手术相关的发病率和费用。如果拟定的体外尸体研究确定，运动学对线TKA能够更好地恢复股骨的横轴、被动运动包络、贴靠力分布，并更好地使贴靠力居中，则该对线技术在体内的使用将得到进一步证明。运动学TKA使用增加的广泛影响可能会转化为临床结局的改善、翻修率的降低以及未来20年将接受TKA的数千万患者的社会和医疗成本的降低。