Swelling Management after Total Knee Arthroplasty

全膝关节置换术后的肿胀管理

基本信息

  • 批准号:
    10732720
  • 负责人:
  • 金额:
    $ 20.17万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2023
  • 资助国家:
    美国
  • 起止时间:
    2023-08-02 至 2026-06-30
  • 项目状态:
    未结题

项目摘要

PROJECT SUMMARY Although total knee arthroplasty (TKA) is effective at reducing pain from end-stage osteoarthritis (OA), it is an acute trauma to the joint which exacerbates the underlying weakness and disability common with OA, leading to long-term atrophy and further disability. Attenuation of this acute loss of strength and function can lead to improved long-term outcomes. Key to attenuating this acute loss is effectively managing postoperative knee swelling. Knee swelling after TKA is profound and is theorized to be a major driver of this acute strength and functional loss. This early postoperative strength loss is driven by a deficit in voluntary activation that acutely limits rehabilitation potential and leads to long-term atrophy and disability. Traditional interventions such as elastic compression stockings (e.g., thromboembolism-deterrent [TED] hose) have minimal effectiveness in reducing swelling after TKA. We have demonstrated in a preliminary study that an inelastic, adjustable compression garment can decrease early postoperative swelling by 50%. However, there is a need to formally evaluate the preliminary effects of this garment on all outcomes to inform sample size calculations for a larger trial. Additionally, as a majority of research to date on quadriceps activation and swelling has relied on laboratory induced swelling, this trial will be uniquely positioned to explore in-vivo mechanistic relationships between changes in swelling and quadriceps activation. Therefore, we propose a randomized controlled study of 58 older adult participants undergoing TKA to determine if an inelastic adjustable compression garment (INCOM) improves postoperative swelling more than elastic TED hose (CONTROL). Both groups will wear the assigned garments for the first 3 weeks after TKA and participate in a standardized rehabilitation program after TKA. Outcomes will be assessed preoperatively and postoperatively at weeks 1, 3 (end of garment use),12 and 26. This study will enable us to determine (AIM 1) if INCOM results in improved surgical limb swelling control after TKA (primary outcome) compared to CONTROL and (AIM 2) to explore the preliminary efficacy of INCOM on the outcomes of quadriceps strength, pain, range of motion, physical function, and patient reported outcomes after TKA compared to CONTROL. Additionally, we will explore (EXPLORATORY AIM) the mediating role of swelling on outcomes after TKA. This study has high potential to prevent acute strength and functional losses in the short-term and improve long-term health of the millions of older adults who will undergo TKA annually. This study will uniquely provide insights into 1) causal relationships between swelling and strength/functional outcomes and 2) mechanisms for quadriceps activation deficits. Study findings will also provide insights into the management of numerous other patient populations with significant quadriceps activation deficits (knee OA) or extremity swelling (post-surgical or trauma).
项目摘要 尽管全膝关节置换术(TKA)在减轻终末期骨关节炎(OA)疼痛方面有效,但 关节急性创伤,加剧了OA常见的潜在虚弱和残疾, 导致长期萎缩和进一步残疾。这种力量和功能的急性丧失的减轻可以 从而改善长期结果。减少这种急性流失的关键是有效地管理术后 膝盖肿胀。TKA后膝关节肿胀严重,理论上是这种急性强度的主要驱动因素 功能丧失。这种术后早期力量损失是由自主激活的缺陷驱动的, 严重限制了康复潜力,并导致长期萎缩和残疾。传统干预措施 例如弹性压缩袜(例如,血栓栓塞威慑[TED]软管)具有最小的 减少TKA术后肿胀的有效性。我们已经在一项初步研究中证明, 可调式加压衣可使术后早期肿胀减轻50%。但有必要 正式评估该服装对所有结果的初步影响,以告知样本量计算 进行更大规模的审判此外,由于迄今为止关于股四头肌激活和肿胀的大多数研究都依赖于 在实验室诱导肿胀方面,该试验将独特地定位于探索体内机制关系 肿胀和股四头肌活动之间的联系因此,我们建议进行一项随机对照研究, 58名接受TKA的老年人参与者,以确定无弹性可调节加压衣 (INCOM)比弹性TED软管(对照)更能改善术后肿胀。两组都将穿着 在TKA后的前3周内分配服装,并在术后参加标准化康复计划。 全膝关节置换术将在术前和术后第1、3(服装使用结束)、12周评估结局 和26.本研究将使我们能够确定(AIM 1)INCOM是否会改善手术肢体肿胀 TKA后的对照(主要结局)与对照和(AIM 2)进行比较,以探索 关于股四头肌力量、疼痛、活动度、身体功能和患者报告结局的INCOM 与对照组相比,TKA后的结局。此外,我们将探索(探索目标) 肿胀对TKA术后结局的介导作用。这项研究具有很高的潜力,以防止急性强度和 在短期内减少功能丧失,并改善数百万老年人的长期健康, 每年一次TKA。这项研究将提供独特的见解,1)肿胀之间的因果关系, 力量/功能结果和2)股四头肌激活缺陷的机制。研究结果还将 提供了对许多其他具有显著股四头肌的患者人群的管理的见解 激活缺陷(膝关节OA)或肢体肿胀(手术后或创伤)。

项目成果

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