Swelling Management after Total Knee Arthroplasty
Swelling Management after Total Knee Arthroplasty
批准号:
10732720
负责人:
Michael J Bade
金额:
$20.17万
依托单位国家:
美国
项目类别:
财政年份:
2023
资助国家:
美国
项目状态:
未结题
起止时间:
2023-08-02 至 2026-06-30
关键词:
AcuteAddressArticular Range of MotionAtrophicClinicalClinical TrialsCohort StudiesCompression StockingDeep Vein ThrombosisDegenerative polyarthritisEffectivenessElasticityElderlyEquilibriumGait speedHealthIndividualInfectionInterventionJointsKneeKnee OsteoarthritisLaboratoriesLifeLimb structureMediatingOperative Surgical ProceduresOutcomePainParticipantPathway interactionsPatient Outcomes AssessmentsPerformancePhysical FunctionPositioning AttributePostoperative PeriodRecommendationRehabilitation therapyResearchRoleSample SizeStandardizationSwellingTestingThromboembolismTraumaWestern Ontario and McMaster Universities Arthritis Indexattenuationcomparison controlcost effective interventiondesigndisabilityfall riskfunctional declinefunctional lossfunctional outcomesimprovedin vivoinsightknee replacement arthroplastypain reductionpatient populationpreventprimary endpointprimary outcomeprogramsquadriceps musclerandomized, controlled studystandard of caretheories
中文摘要
项目总结
尽管全膝关节置换术(TKA)在减轻终末期骨关节炎(OA)疼痛方面是有效的,但
关节的急性创伤加剧了骨性关节炎常见的潜在的虚弱和残疾,
导致长期萎缩和进一步的残疾。这种力量和功能的急剧丧失的衰减可以
带来更好的长期结果。减少这种急性失血的关键是有效的术后管理。
膝盖肿胀。全膝关节置换术后膝关节肿胀是严重的,理论上是这种急性力量的主要驱动因素。
和功能丧失。这种术后早期的力量丧失是由自愿激活的缺陷推动的
严重限制了康复的潜力,并导致长期的萎缩和残疾。传统干预措施
例如弹性压缩袜子(例如,血栓栓塞症威慑[TED]软管)具有最小
TKA术后消肿效果观察。我们已经在一项初步研究中证明,
可调压缩服可使术后早期肿胀减轻50%。然而,有必要
正式评估这件衣服对所有结果的初步影响,以便为样本量计算提供参考
进行更大规模的审判。此外,迄今为止关于股四头肌激活和肿胀的大部分研究都依赖于
在实验室诱导的肿胀方面,这项试验将独特地定位于探索体内的机制关系
在肿胀变化和股四头肌激活之间。因此,我们提出一项随机对照研究。
58名接受全膝关节置换术的老年参与者,以确定一件无弹性可调压缩服装
(INCOM)对术后肿胀的改善作用强于弹性TED软管(对照组)。两组人都将穿着
TKA后前3周的服装分配,并在TKA后参加标准化的康复计划
TKA。结果将在手术前和手术后第1、3周(停止使用服装)、12周进行评估
和26岁。这项研究将使我们能够确定(目标1)INCOM是否导致外科肢体肿胀的改善
对照术后TKA(主要结局)与对照(AIM 2)的初步疗效比较
INCOM关于股四头肌力量、疼痛、活动范围、身体功能和患者报告的结果
与对照组相比,全膝关节置换术的结果。此外,我们还将探索(探索性目标)
肿胀对全膝关节置换术预后的中介作用。这项研究有很高的潜力预防急性强度和
数以百万计的老年人将在短期内丧失功能并改善长期健康
TKA每年一次。这项研究将独一无二地提供关于肿胀和
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
提供对许多其他具有显著股四头肌的患者群体的管理的见解
活动缺陷(膝盖骨关节炎)或肢体肿胀(手术后或创伤后)。
英文摘要
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).
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