Knee Arthrosis after ACL Reconstruction: A Long-term Cohort Study with Matched Controls
Knee Arthrosis after ACL Reconstruction: A Long-term Cohort Study with Matched Controls
批准号:
10159846
负责人:
Braden C Fleming
金额:
$30.92万
依托单位:
依托单位国家:
美国
项目类别:
财政年份:
2019
资助国家:
美国
项目状态:
已结题
起止时间:
2019-05-10 至 2023-04-30
关键词:
AnteriorAnterior Cruciate LigamentAutologous TransplantationCaringClinicalClinical ResearchClinical TrialsContralateralControl GroupsDataDegenerative polyarthritisDevelopmentDiagnostic radiologic examinationEconomic BurdenEnrollmentEpidemicFemaleFemurFrequenciesFundingFutureHealthImageIncidenceInjuryJointsKneeKnee InjuriesKnee OsteoarthritisKnee jointLong-Term EffectsLongitudinal StudiesLongitudinal cohort studyLongterm Follow-upMeasuresMechanicsMedialModificationMonitorOperative Surgical ProceduresOutcomeOutcome MeasurePatientsPopulationProcessProtocols documentationRandomizedRandomized Controlled TrialsReconstructive Surgical ProceduresReportingRiskRisk FactorsRoentgen RaysSex DifferencesSex FactorsStructureTechniquesTimeTraumatic ArthropathyUnited States National Institutes of HealthWidthWorkanterior cruciate ligament injuryanterior cruciate ligament reconstructionbasecartilage degradationcohortcontrol trialdesignfollow-upfunctional outcomesfunctional restorationgraft failurehigh riskimaging modalitymalenovelpatient orientedpreventprimary outcomereconstructionrecruitretention ratesample fixationsecondary outcomesextibiatreatment grouptreatment guidelinestrendtrial comparing
中文摘要
项目摘要/摘要
这项纵向结果研究的目的是评估创伤后的进展。
前十字韧带重建术后的骨关节炎(PTOA)
女性患者在手术后15年,并确定最初的张力是否适用于移植物时
手术和性别是否会影响与关节病相关的长期结果。前交叉韧带断裂是一种常见的损伤
这通常需要手术重建来恢复功能和预防PTOA。“最初的移植物张力”
手术时应用可调节关节接触力学,进而可能促进PTOA。然而,
低和高初始移植物张力对PTOA发展的影响尚不清楚。人们还知道,性行为
是前交叉韧带损伤和随后移植物失败的危险因素。因此,女性患癌症的风险很可能增加。
术后PTOA。拟议的工作将利用一组重建前交叉韧带的患者,这些患者
之前参加了一项随机对照试验,以研究初始移植物张力的影响。病人,他们是
接受自体移植重建前交叉韧带的候选人被随机分为两个治疗组之一:1)
初始移植张力设定使重建膝关节的前后松弛程度与重建膝关节的松弛程度相等。
对侧正常膝关节(“低张力”治疗;n=46),2)初始移植物张力设定以减少AP
膝关节相对对侧膝关节松弛2 mm(“高张力”治疗;n=44)。一项额外的
无膝关节损伤证据的受试者组(n=60)作为非损伤对照组。在
在之前的资金周期中,我们发现两者在几个结果指标上开始出现差异
最初的移植物紧张组在7年的随访期,在3年的随访期没有出现。在这项提案中,
该患者队列及其匹配对照组的随访将延长至15年,这一时间点将
使我们能够清楚地识别那些既有放射学表现又有症状性PTOA的患者。这个
第一个假设是“高张力”组重建膝关节的胫股关节间隙宽度
与对照组持平,而低血压组的血压低于对照组
前交叉韧带重建后15年组。第二个假设是内侧关节间隙宽度减小
女性患者前交叉韧带重建率高于男性患者。综合布景
将使用的结果包括监测PTOA发展的成像方式和其他经过验证的患者-
报告的、临床的和功能的测量。关节间隙宽度的X射线测量被认为是唯一
膝关节临床试验中PTOA进展的验证指标,并将作为主要结果
为拟议研究采取的措施。关节健康的放射学评估(OARSI评分)和基于MR的
关节健康(蠕虫)的测量将作为次要成像结果。膝骨性关节炎
结果评分(KOOS)将被用来确定哪些患者有症状性PTOA。全面的
一组结果将使我们能够确定最初移植物张力的长期影响,并系统地
评价性别对前交叉韧带重建术后PTOA发展的影响。建议的研究是
新的前交叉韧带重建队列包括当时单侧前交叉韧带损伤的患者
包括评估这些患者PTOA发展所需的长期随访,以及
包括一个匹配的对照组,以比较未受伤人群的关节发育情况。
英文摘要
PROJECT SUMMARY/ABSTRACT
The objectives of this longitudinal outcome study are to evaluate the progression of post-traumatic
osteoarthritis (PTOA) following surgical reconstruction of the anterior cruciate ligament (ACL) in male and
female patients 15 years after surgery, and to determine if the initial tension applied to the graft at the time of
surgery and if sex influences long-term outcomes related to arthrosis. Disruption of the ACL is a common injury
that usually requires surgical reconstruction to restore function and prevent PTOA. The “initial graft tension”
applied at the time of surgery modulates joint contact mechanics, which in turn, may promote PTOA. However,
the effects of low- and high-initial graft tensions on PTOA development are unknown. It is also known that sex
is a risk factor for ACL injury and subsequent graft failure. Thus, it is likely that females are at increased risk for
PTOA following surgery. The proposed work will leverage a cohort of ACL reconstructed patients that were
previously enrolled in a randomized control trial to study the effects of initial graft tension. Patients, who were
candidates for ACL reconstruction with an autograft, were randomized into one of two treatment groups: 1)
initial graft tension set such that the anterior-posterior (AP) laxity of the reconstructed knee was equal to that of
the contralateral normal knee (the “low-tension” treatment; n=46), and 2) initial graft tension set to reduce AP
knee laxity by 2 mm relative to that of the contralateral knee (the “high-tension” treatment; n=44). An additional
group of subjects without evidence of knee injury (n=60) was recruited to serve as an uninjured control. In the
previous funding cycle, we found differences in several outcome measures starting to emerge between the two
initial graft tension groups at 7-year follow-up that were not present at 3-year follow-up. In this proposal, the
follow-up of this patient cohort and its matched control group will be extended to 15 years, a time point that will
enable us to clearly identify those patients who present with both radiographic and symptomatic PTOA. The
first hypothesis is that tibiofemoral joint space width of the reconstructed knees of the “high-tension” cohort will
be equal to that of the control group, while that of the “low-tension” cohort will be less than that of the control
group 15 years after ACL reconstruction. The second hypothesis is that decreases in medial joint space width
after ACL reconstruction will be greater in female patients compared to male patients. The comprehensive set
of outcomes to be used include imaging modalities to monitor PTOA development and other validated patient-
reported, clinical, and functional measures. X-ray measures of joint space width are considered the only
validated indicator of PTOA progression for clinical trials of the knee, and will serve as the primary outcome
measure for the proposed study. Radiographic assessment of joint health (OARSI score) and a MR-based
measure of joint health (WORMS) will serve as secondary imaging outcomes. The Knee Osteoarthritis
Outcome Score (KOOS) will be used to identify which patients have symptomatic PTOA. The comprehensive
set of outcomes will allow us to establish the long-term effects of initial graft tension, and to systematically
evaluate the effects of sex on PTOA development following ACL reconstruction surgery. The proposed study is
novel as the ACL reconstructed cohort is comprised of patients with isolated unilateral ACL injuries at the time
of injury, includes the long-term follow-up required to assess PTOA development in these patients, and
includes a matched control group in order to compare arthrosis development in the uninjured population.
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Knee Arthrosis after ACL Reconstruction: A Long-term Cohort Study with Matched Controls
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批准号:10424422
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项目类别:
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资助金额:$31.56万
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财政年份:2019
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批准号:8928046
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资助金额:$56.98万
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财政年份:2014
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负责人:Braden C Fleming
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依托单位:
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批准号:8759439
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项目类别:
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资助金额:$56.27万
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财政年份:2014
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Non-invasive assessment of ligament healing in vivo
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批准号:9136641
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资助金额:$57.04万
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财政年份:2014
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RI COBRE: BIOENGINEERING CORE
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批准号:8360473
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项目类别:
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资助金额:$19.63万
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财政年份:2011
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负责人:Braden C Fleming
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依托单位:
RI COBRE: BIOENGINEERING CORE
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批准号:8168033
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资助金额:$18.78万
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财政年份:2010
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负责人:Braden C Fleming
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Biologically Enhanced Healing of Autograft ACL Reconstruction.
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批准号:8020913
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资助金额:$35.77万
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财政年份:2009
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负责人:Braden C Fleming
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Biologically Enhanced Healing of Autograft ACL Reconstruction.
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批准号:8213690
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资助金额:$33.01万
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财政年份:2009
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资助金额:$13.88万
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财政年份:2009
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负责人:Braden C Fleming
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依托单位:
Biologically Enhanced Healing of Autograft ACL Reconstruction
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批准号:7807720
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资助金额:$149.18万
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财政年份:2009
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负责人:Braden C Fleming
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批准号:7572237
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项目类别:
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资助金额:$53.44万
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财政年份:2009
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依托单位:
Biologically Enhanced Healing of Autograft ACL Reconstruction.
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批准号:7763917
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项目类别:
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资助金额:$51.04万
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财政年份:2009
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负责人:Braden C Fleming
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依托单位:
Bio-enhanced ACL Repair as a Modular of Post-traumatic Osteoarthritis
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批准号:9338118
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项目类别:
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资助金额:$42.31万
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财政年份:2009
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负责人:Braden C Fleming
-
依托单位:
RI COBRE: BIOENGINEERING CORE
-
批准号:7721004
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项目类别:
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资助金额:$14.61万
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财政年份:2008
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-
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依托单位:
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批准号:6931565
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资助金额:$38.96万
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依托单位:
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批准号:8519304
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项目类别:
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负责人:Braden C Fleming
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海外基金