Effect of component alignment on soft tissue conditions during total knee replacement

摘要 虽然全膝关节置换术(TKR)在翻修方面被认为是相当成功的手术 死亡率(10年存活率为95%)，约25%的患者仍然对他们的治疗结果不满意。 做手术。此外，近一半的早期TKR修复被认为是可以预防的，如果手术技术可以的话 可靠地提供适当的部件对齐和韧带平衡。考虑到将军澳支线的数量 预计到2030年，美国每年将超过430万人，这相当于数百万不满意的患者 临床结果不令人满意。众所周知，稳定的TKR功能是成功的关键 病人的结果。在TKR手术中，外科医生进行手动评估以检测关节不稳定和 通过调整TKR对齐和平衡周围软组织的张力来进行矫正 那家大麻店。不幸的是，几乎没有证据可以指导外科医生确定何时对齐和软组织。 张力是足够的。长期以来，人们一直推测软组织张力曲线可能是TKR的预测指标 将临床结果与组件对齐进行比较。根据我们发表的临床研究，这是我们的科学 前提是对齐会影响患者感觉到的软组织张力和稳定性，从而导致不良反应 临床评分。然而，目前还没有足够的方法来测量活体软组织张力，而且内部 人工全膝关节置换术后膝关节的力学环境不明确。我们的长期目标是开发一种经过验证的 建立TKR的有限元模型，确定9个单侧软组织的张力分布 跨越膝关节的结构和建立部件对齐、软化之间的定量关系 组织张力和TKR患者的临床结果。我们假设i)组件对齐会影响软 TKR期间的组织张力状况；以及ii)这些软组织状况是临床的重要预测指标 TKR术后转归。我们建议使用一种独特的实验来解决这些知识和技术差距 和计算建模方法。我们确定了以下具体目标：1)采用有限元模型 自然膝关节评价TKR软组织张力；2)确定TKR对软组织的影响 张力；以及3)确定张力曲线对TKR体内临床结果的影响。成功 这项建议的完成将：i)展示术中膝关节测量的实际应用 用于确定FE TKR模型中的软张力轮廓的被动运动范围(ROM)中的运动学和；ii) 确定与假体对齐和软组织张力相关的不良功能结局的潜在预测因素； 以及三)确定潜在的可检测事件，为技术创新提供信息，以便更有意义地利用 术中监测软组织张力和膝关节运动。该项目将为我们未来的R01提案提供信息 临床可接受软组织张力的大小及不同TKR设计的影响 软组织张力的外科技术。

SUMMARY While total knee replacement (TKR) is regarded as a reasonably successful procedure in terms of revision rates (95% survivorship at 10 years), about 25% of patients remain dissatisfied with the outcome of their surgery. Moreover, nearly half of early TKR revisions are considered preventable if surgical techniques could reliably provide for proper component alignment and ligament balance. Considering that the number of TKR in the USA is projected to exceed 4.3 million annually by 2030, this equates to millions of dissatisfied patients with unsatisfactory clinical outcomes. It is well-established that stable TKR function is critical for successful patient outcomes. During TKR surgery, surgeons perform manual evaluations to detect joint instability and proceed to correct it by adjusting the TKR alignment and balancing the tension in the soft tissues surrounding the joint. Unfortunately, there is little evidence to guide surgeons in determining when alignment and soft tissue tension are adequate. It has long been speculated that soft tissue tension profiles could be a predictor of TKR clinical outcome compared to component alignment. Based on our published clinical studies, it is our scientific premise that alignment impacts soft tissue tension and the stability perceived by the patients, contributing to poor clinical scores. However, adequate methods for measuring soft tissue tension in vivo do not exist and the internal mechanical environment in the knee after TKR is poorly defined. Our long-term goal is to develop a validated finite element (FE) model of TKR and use it to determine the tension profiles of nine individual soft tissue structures crossing the knee joint and to establish quantitative relationships between component alignment, soft tissue tension, and clinical outcome in TKR patients. We hypothesize that i) component alignment affects soft tissue tension conditions during TKR; and ii) these soft tissue conditions are significant predictors of clinical outcomes after TKR. We propose to address these knowledge and technical gaps using a unique experimental and computational modeling approach. We identify the following specific aims: 1) adapt a finite element model of the natural knee to evaluate soft tissue tension in TKR; 2) determine the effect of TKR alignment on soft tissue tension; and 3) determine the effect of tension profiles on in vivo clinical outcomes of TKR. Successful completion of this proposal will: i) demonstrate the practical use of intra-operative measurements of knee kinematics during passive range of motion (ROM) for determining soft-tension profiles in FE TKR models and; ii) identify potential predictors of poor functional outcomes related to component alignment and soft tissue tension; and iii) identify potential detectable events that could inform technology innovation for more meaningful use of intra-operative sensing of soft tissue tension and knee motions. This project will inform our future R01 proposals addressing the magnitude of clinically acceptable soft tissue tension and the influence of different TKR designs and surgical techniques on soft tissue tension.