Using Intraoperative Measurements to Predict Postoperative Outcomes of TKA

描述（由申请人提供）：拟议工作的目的是确定手术技术，特别是初始软组织平衡和被动运动学，是否以及如何与全膝关节置换术（TKA）后患者功能和临床结果相关，TKA是一种用于治疗退行性关节疾病（如骨关节炎）的常见外科手术。据估计，2003年美国实施了30万例tka手术，预计到2030年每年将实施约348万例tka手术。TKA的成功取决于许多因素，包括假体部件的对齐和膝关节周围软组织的管理（或“平衡”）。虽然TKA在恢复功能和提高生活质量方面通常是成功的，但那些不能进行基本日常生活活动的人（比如在家里舒服地爬楼梯）和那些能回到他们喜欢的活动（比如远足、打高尔夫球或打网球）之间仍然存在很大的差距。TKA患者会出现与年龄匹配的对照组所没有的功能挑战，如爬楼梯更慢、膝关节僵硬、股四头肌无力和膝关节运动异常。全膝关节置换术后异常运动学的来源和临床结果的可变性仍然未知。尽管手术技术被认为对TKA的结果很重要，但关键的术中决定是主观和定性的，这表明目前对该手术的了解存在重大差距。由于缺乏客观和定量的关键术中测量，使得难以一致地将相同的技术应用于不同的患者。TKA术后患者体内功能和临床结果的研究通常缺乏对患者特异性手术技术或关节术前状况的测量。虽然外科医生显然对“好”和“不接受”的手术技术有敏锐的感觉，但他们在手术过程中行为的细微差异如何影响术后结果仍不得而知。这项拨款将确定术中被动运动学和初始软组织平衡的客观定量测量是否以及如何与术后结果相关联。目的1将使用导航系统和具有可重复、客观、实验程序的新型测量设备，在全膝关节置换术前后术中表征关节稳定性。目的2将在步态实验室进行为期6个月和2年的随访检查，将术中关节稳定性和被动膝关节运动学测量与患者行走和爬楼梯的关节力矩联系起来，使用患者术前步态作为分析中的协变量。目的3将关节稳定性和被动膝关节运动学的术中测量与6个月和2年的临床结果联系起来，由SF-36和oos自我评估确定，通过3种功能测量：定时爬楼梯测试、6分钟步行测试和定时起身和行走测试。对于这些临床评估，患者在相同临床测试中的术前评分将被用作分析中的协变量。本研究通过对关节术中状况及其对术后关节生物力学和功能临床结果的影响进行全面而严格的研究，为改善术后预后迈出了重要的第一步。这些结果将使外科医生能够做出更明智的、基于证据的术中决策；物理治疗师个性化康复方案；患者也会对自己的具体结果产生现实的期望。

DESCRIPTION (provided by applicant): The purpose of the proposed work is to determine if and how surgical technique, specifically initial soft tissue balance and passive kinematics, relates to patient functional and clinical outcomes following total knee arthroplasty (TKA), a common surgical procedure used to treat degenerative joint diseases such as osteoarthritis. An estimated 300,000 TKAs were performed in the United States in 2003, and approximately 3.48 million annual procedures are expected by the year 2030. The success of TKA depends on many factors including the alignment of the prosthetic components and the management (or "balancing") of soft tissues around the knee. While TKA is generally successful at restoring function and improving quality of life, a wide gap still separates those who cannot perform basic activities of daily living like comfortably climbing the stairs within their homes to those who can go back to activities they love such as hiking, golfing, or playing tennis. Patients following TKA have functional challenges that are not seen in aged-matched controls, such as climbing stairs more slowly, stiff-knee gait, quadriceps weakness, and abnormal knee kinematics. The source of the abnormal kinematics and the variability in clinical outcomes following total knee arthroplasty remains unknown. Even though surgical technique is believed to be important to the outcome of a TKA, key intra-operative decisions are subjectively and qualitatively performed, representing a significant gap in the current knowledge of the procedure. This lack of objective and quantitative key intra-operative measurements make it difficult to consistently apply the same technique to different patients. Studies of in-vivo function and clinical outcomes of patients following TKA have typically lacked the measurements of patient-specific surgical technique or the pre-operative condition of the joint. While surgeons obviously have a keen sense of what is "good" and "unacceptable" surgical technique, it remains unknown how subtle differences in their actions during surgery influence post-operative outcome. This grant will determine if and how objective and quantitative intra-operative measurements of passive kinematics and initial soft tissue balance are associated with post-operative outcomes. Aim 1 will intra- operatively characterize joint stability before and after total knee arthroplasty with a navigation system and novel measurement equipment with a repeatable, objective, experimental procedure. Aim 2 will relate intra- operative measurements of joint stability and passive knee kinematics to patient's joint moments walking and climbing stairs during 6-month and 2-year follow-up examinations in a gait laboratory, using a patient's pre- operative gait as a covariate in the analysis. Aim 3 will relate intra-operative measurements of joint stability and passive knee kinematics to 6-month and 2-year clinical outcomes, as determined by SF-36 and KOOS self- administered assessments by 3 functional measures: a timed Stair Climbing Test, a 6 Minute Walk Test, and a Timed Up and Go test. For these clinical assessments, a patient's pre-operative scores on the same clinical tests will be used as a covariate in the analysis. This study represents an important first step toward improving post-operative outcomes through a comprehensive and rigorous study of intra-operative conditions of the joint and their influence on post- operative joint biomechanics and functional clinical outcomes. These results will enable surgeons to make more informed, evidence-based, intra-operative decisions; physical therapists to individualize rehabilitation programs; and patients will gain realistic expectations of their own specific outcomes.