Using Intraoperative Measurements to Predict Postoperative Outcomes of TKA

描述（由申请人提供）：拟定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）后的患者功能和临床结局相关，TKA是一种用于治疗退行性关节疾病（如骨关节炎）的常见手术。据估计，2003年在美国进行了300，000例TKA，预计到2030年，每年约有348万例手术。全膝关节置换术的成功取决于许多因素，包括假体部件的对线和膝关节周围软组织的管理（或“平衡”）。 虽然全膝关节置换术在恢复功能和改善生活质量方面通常是成功的，但那些不能进行日常生活基本活动的人，如舒适地爬楼梯的人，与那些可以回到他们喜欢的活动，如远足，高尔夫球或打网球的人之间仍然存在很大的差距。TKA后的患者存在年龄匹配对照组中未观察到的功能挑战，例如爬楼梯更慢、膝关节僵硬步态、股四头肌无力和膝关节运动学异常。全膝关节置换术后的异常运动学和临床结局变异性的来源仍然未知。尽管手术技术被认为对TKA的结局很重要，但关键的术中决策是主观和定性的，这代表了当前手术知识的显著差距。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局的研究通常缺乏对患者特定手术技术或关节术前状况的测量。虽然外科医生显然对什么是“好的”和“不可接受的”手术技术有着敏锐的感觉，但他们在手术过程中的行为的细微差异如何影响术后结果仍然是未知的。 该基金将确定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局相关。目标1将使用导航系统和新型测量设备，通过可重复的、客观的实验性手术，在全膝关节置换术前后对关节稳定性进行术中表征。目标2将在步态实验室中，使用患者的术前步态作为分析中的协变量，将关节稳定性和被动膝关节运动学的术中测量值与患者在6个月和2年随访检查期间行走和爬楼梯的关节力矩相关联。目标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年临床结局相关，如SF-36和KOOS自我评估通过3项功能测量确定的：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，患者在相同临床检查中的术前评分将用作分析中的协变量。 本研究代表了通过对关节的术中状况及其对术后关节生物力学和功能临床结局的影响进行全面和严格的研究来改善术后结局的重要第一步。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.