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

全膝关节置换术中组件对准对软组织状况的影响

• 批准号: 10244922
• 负责人: Melinda Harman
• 金额: $ 23.95万
• 依托单位: CLEMSON UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-15 至 2023-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10244922
• 关键词: Address; Affect; Anterior; Archives; Biomechanics; Cadaver; Centers of Research Excellence; Clinical; Clinical Research; Communities; Computer Models; Data; Devices; Elements; Environment; Equilibrium; Evaluation; Event; Experimental Models; Future; Goals; Hand; Health; Implant; Individual; Joint Instability; Joints; Knee; Knee joint; Knowledge; Lateral; Ligaments; Limb structure; Manuals; Measurement; Measures; Mechanics; Medial; Methods; Modeling; Motion; Musculoskeletal; Operative Surgical Procedures; Outcome; Passive Range of Motion function; Patient-Focused Outcomes; Patients; Plant Roots; Posterior Cruciate Ligament; Procedures; Prosthesis; Publishing; Research Design; Specimen; Structure; Surgeon; Techniques; Technology; Tendon structure; Testing; Torque; Translational Research; base; capsule; collateral ligament; design; experimental study; functional outcomes; improved; in vivo; innovation; kinematics; knee replacement arthroplasty; open source; predict clinical outcome; prosthetic alignment; repository; restraint; soft tissue; success; survivorship; tool

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.

概括 虽然总膝盖置换（TKR）被视为在修订方面相当成功的程序 率（10年的95％生存率），大约25％的患者对其结果不满意 外科手术。此外，如果手术技术可以使用，将近一半的TKR修订被认为可以预防 可靠地提供了适当的组件对齐和韧带平衡。考虑到TKR的数量 预计到2030年，美国每年将超过430万，这相当于数百万不满意的患者 临床结果不令人满意。稳定的TKR功能对成功至关重要，这是良好的 患者的结果。在TKR手术期间，外科医生进行手动评估以检测关节不稳定和 继续调整TKR对齐并平衡周围软组织的张力来纠正它 关节。不幸的是，几乎没有证据指导外科医生确定何时对齐和软组织 紧张是足够的。长期以来，人们一直猜测软组织张力轮廓可能是TKR的预测因子 与组件比对相比，临床结果。根据我们发表的临床研究，这是我们的科学 对准会影响软组织张力和患者所感知的稳定性的前提，导致不良 临床分数。但是，不存在体内软组织张力的足够方法，并且内部 TKR后膝盖的机械环境的定义很差。我们的长期目标是开发经过验证的 TKR的有限元（Fe）模型，并使用它来确定九个单独软组织的张力曲线 越过膝关节并建立组件比对之间的定量关系的结构 TKR患者的组织张力和临床结局。我们假设i）组件对齐会影响软 TKR期间的组织张力条件； ii）这些软组织条件是临床的重要预测指标 TKR之后的结果。我们建议使用独特的实验来解决这些知识和技术差距 和计算建模方法。我们确定以下特定目的：1）调整有限元模型 自然膝盖评估TKR中软组织张力； 2）确定TKR比对对软组织的影响 紧张; 3）确定张力谱对TKR体内临床结果的影响。成功的 该提案的完成将：i）证明膝盖术内测量的实际使用 被动运动范围（ROM）的运动学，用于确定Fe TKR模型中的软张感应轮廓和； ii） 确定与组件比对和软组织张力相关的功能性不良结果的潜在预测因素； iii）确定可能可检测的事件，这些事件可以为技术创新提供信息，以更有意义地使用 软组织张力和膝关节运动的术内感应。该项目将告知我们未来的R01建议 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 和软组织张力上的手术技术。