Arthroscopic-assisted tibial plateau fixation (AATPF) vs. Open reduction internal fixation (ORIF): A multicenter randomized controlled trial
Arthroscopic-assisted tibial plateau fixation (AATPF) vs. Open reduction internal fixation (ORIF): A multicenter randomized controlled trial
批准号:
10723527
负责人:
Mai P Nguyen
金额:
$17.61万
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
项目状态:
未结题
起止时间:
2023-09-07 至 2025-08-31
关键词:
AccelerationArticular Range of MotionCenters for Disease Control and Prevention (U.S.)ClassificationClinicalCollaborationsCommittee MembersComplicationDataDissectionDocumentationElectronicsEligibility DeterminationEnrollmentEnsureFellowshipFractureFracture FixationFundingFutureGoalsGrantInfectionInformation SystemsInstitutional Review BoardsInterdisciplinary StudyInternationalJointsKneeKnee jointLateralLeadershipLevel of EvidenceLimb structureLongevityManualsMeasurementMeasuresMethodsMinnesotaModelingMonitorOperative Surgical ProceduresOrthopedic SurgeryOrthopedicsOutcomePainParticipantPatient Outcomes AssessmentsPatient-Focused OutcomesPatientsPhasePostoperative PeriodPreparationProtocols documentationRandomizedRandomized, Controlled TrialsRecording of previous eventsRecoveryRepeat SurgeryReportingResearchResearch InfrastructureResearch PersonnelRiskSafetySample SizeSecondary toSiteSocietiesSpecialistSportsSurfaceSurgeonSurgical Wound InfectionSurgical complicationTestingTimeTrainingTraumaTraumatic ArthropathyUniversitiesVisualVisualizationWeight-Bearing stateWith lateralityadjudicationanalogclinical research sitecost efficientdata managementdesignevidence basefollow-uphealth related quality of lifehospital readmissioninterestknee painknee replacement arthroplastyminimally invasiveoperationpostoperative recoveryprescription opioidpreservationprimary outcomeradiological imagingrecruitsample fixationsoft tissuestandard caresurgical risktimelinetrial comparingwound
中文摘要
关节镜辅助胫骨平台固定(AATPF)与切开复位内固定的比较
(ORIF):一项多中心随机对照试验
项目总结/摘要
目前标准治疗方法为胫骨平台骨折内固定、切开复位内固定
(ORIF)具有显著的局限性,包括手术部位感染、疼痛、僵硬和
长时间的非承重限制。ORIF的大型软组织剥离是
与手术部位感染风险增加和关节可视化有限相关
这种手术入路的减少与未来全膝关节置换的风险增加有关。
继发于创伤后骨关节炎的关节置换术。1 -6关节镜辅助胫骨平台
固定(AATPF)提供了关节面的直接可视化,具有最小的侵入性,
加速术后恢复,并保持关节长寿。7,8几项研究
报告了AATPF治疗胫骨外侧平台的良好结局和低并发症发生率
结论9,10然而,没有I级证据比较AATPF和
传统的ORIF方法。我们设计了一项随机对照试验(RCT)
比较胫骨外侧骨折患者的患者报告、临床和影像学结局,
使用AATPF与ORIF治疗的平台骨折,为以下方面提供高水平的循证数据:
临床医生建议的R34预研究规划期对于成功
启动并完成RCT。
英文摘要
Arthroscopic-assisted tibial plateau fixation (AATPF) vs. Open reduction internal fixation
(ORIF): A multicenter randomized controlled trial
Project Summary/Abstract
The current standard treatment for tibial plateau fracture fixation, open reduction internal fixation
(ORIF), has significant limitations including surgical site infections, pain, stiffness, and a
prolonged period of non-weight bearing restrictions. The large soft tissue dissection for ORIF is
associated with an increased risk of surgical site infections, and limited visualization of joint
reduction in this surgical approach is associated with an increased risk of future total knee
arthroplasty secondary to post-traumatic osteoarthritis.1-6 Arthroscopic-assisted tibial plateau
fixation (AATPF) provides direct visualization of the articular surface with minimal invasiveness,
accelerated post-operative recovery, and preserves joint longevity.7,8 Several studies have
reported good outcomes with low complication rates of AATPF for lateral tibial plateau
fractures.9,10 However, there is no Level I evidence comparing outcomes of AATPF and outcomes
of the traditional ORIF approach. We have designed a randomized controlled trial (RCT)
comparing patient-reported, clinical, and radiographic outcomes of patients with lateral tibial
plateau fractures treated with AATPF vs. ORIF to provide high level evidence-based data for
clinicians. The proposed R34 pre-study planning period is essential to successfully
initiate and complete the RCT.
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