Using Intraoperative Measurements to Predict Postoperative Outcomes of TKA

描述(申请人提供)：拟议工作的目的是确定外科技术，特别是初始软组织平衡和被动运动学，是否以及如何与患者在全膝关节置换术(TKA)后的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年在美国进行了30万次TKA，预计到2030年每年将进行约348万次手术。全膝关节置换术的成功取决于许多因素，包括假体的对齐和膝关节周围软组织的管理(或“平衡”)。虽然TKA在恢复功能和改善生活质量方面总体上是成功的，但那些不能在家中舒适地爬楼梯等基本日常生活活动的人与那些可以回到他们喜欢的活动如徒步旅行、打高尔夫球或打网球的人仍然存在很大的差距。全膝关节置换术后的患者面临着与年龄匹配的对照组中没有的功能挑战，如爬楼梯更慢，膝关节步态僵硬，股四头肌无力，以及膝关节运动学异常。全膝关节置换术后运动学异常的来源和临床结果的可变性仍不清楚。尽管手术技术被认为对全膝关节置换术的结果很重要，但关键的术中决定是主观和定性的，这代表了目前对该手术的认识存在显著差距。由于缺乏客观和定量的术中关键测量，很难对不同的患者始终如一地应用相同的技术。对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有的手术技术或手术前关节状况的测量。虽然外科医生显然对什么是“好的”和“不能接受的”外科技术有着敏锐的感觉，但他们在手术过程中的细微差异如何影响手术后的结果仍然是未知的。这笔赠款将确定手术中被动运动学和初始软组织平衡的客观和定量测量是否以及如何与术后结果相关。目标1将使用导航系统和新的测量设备，通过可重复的、客观的实验程序，在手术中表征全膝关节置换术前后的关节稳定性。目的2以患者的术前步态为协变量，将术中关节稳定性和被动膝关节运动学的测量与患者在步态实验室6个月和2年的随访中行走和爬楼梯的关节瞬间联系起来。AIM 3将把术中关节稳定性和被动膝关节运动学的测量与SF-36和Koos通过3种功能测量确定的6个月和2年的临床结果相关联：定时楼梯攀登试验、6分钟步行试验和定时起跳试验。对于这些临床评估，患者在相同临床测试中的术前得分将被用作分析中的协变量。这项研究是通过全面而严格地研究术中关节状况及其对术后关节生物力学和功能性临床结果的影响，朝着改善术后结果迈出的重要的第一步。这些结果将使外科医生能够做出更知情、更循证的术中决定；物理治疗师将能够个性化康复计划；患者将对自己的具体结果获得现实的期望。

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.