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

总结 虽然全膝关节置换术（TKR）被认为是一种相当成功的翻修手术， 虽然10年生存率为95%，但仍有约25%的患者对治疗结果不满意。 手术此外，如果手术技术能够 可靠地提供适当的部件对准和韧带平衡。考虑到土耳其难民的数量， 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 临床效果不理想。众所周知，稳定的TKR功能是成功的关键 患者结局。在TKR手术期间，外科医生进行手动评估以检测关节不稳定性， 通过调整TKR对线和平衡周围软组织的张力来进行矫正 接头。不幸的是，几乎没有证据可以指导外科医生确定何时对线和软组织 张力是足够的。长期以来，人们一直认为软组织张力分布可以预测TKR 与部件对线相比的临床结局。根据我们已发表的临床研究， 前提是对线会影响软组织张力和患者感知的稳定性，导致不良 临床评分。然而，用于测量体内软组织张力的适当方法不存在，并且内部张力测量不需要任何测量。 TKR后膝关节的机械环境定义不明确。我们的长期目标是开发一种经过验证的 TKR的有限元（FE）模型，并使用它来确定9个个体软组织的张力分布 通过膝关节的结构，并建立部件对线、软组织和关节软骨之间的定量关系， TKR患者的组织张力和临床结局。我们假设i）组件对齐影响软 TKR期间的组织张力状况;和ii）这些软组织状况是临床 TKR后的结果。我们建议使用一种独特的实验方法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，以评估TKR中的软组织张力; 2）确定TKR对线对软组织的影响 张力; 3）确定张力曲线对TKR体内临床结局的影响。成功 完成本提案将：i）证明膝关节术中测量的实际用途 被动活动范围（ROM）期间的运动学，用于确定FE TKR模型中的软张力曲线; ii） 识别与部件对线和软组织张力相关的不良功能结局的潜在预测因素; 和iii）识别潜在的可检测事件，这些事件可以为技术创新提供信息，以便更有意义地使用 软组织张力和膝关节运动的术中感测。该项目将为我们未来的R 01提案提供信息 解决临床上可接受的软组织张力的大小和不同TKR设计的影响 和外科技术对软组织张力的影响

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.