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临床试验/NCT07208968
NCT07208968已完成不适用

Metal Artifact Reduction Sequence MRI for Surgical Decision-Making in Infected Unicompartmental Knee Arthroplasty

First Affiliated Hospital of Fujian Medical University1 个研究点 分布在 1 个国家目标入组 28 人开始时间: 2017年6月1日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
28
试验地点
1
主要终点
Infection control or not according to the MSIS criteria

研究概览

简要总结

A single-center retrospective cohort study was conducted in the Department of Orthopedics of Fujian Medical University Affiliated First Hospital. This study reviewed 28 patients who received unicompartmental prosthetic joint infection (uPJI) treatment at this institution from 2017 to 2023. The personal information of the patients, including age, gender, affected side, age-adjusted Charles Syndrome Index (aCCI), inflammation markers, lesion range on magnetic resonance angiography (MARS-MRI), lesion range observed directly during surgery and surgical methods, were recorded in detail. The study evaluated the clinical decision-making of a standardized MARS-MRI-guided treatment protocol for uPJI by reviewing the clinical outcomes of uPJI patients in a single PJI center.

详细描述

A single-center retrospective cohort study was conducted in the Department of Orthopedics of Fujian Medical University Affiliated First Hospital. This study reviewed 28 patients who received unicompartmental prosthetic joint infection (uPJI) treatment at this institution from 2017 to 2023. The personal information of the patients, including age, gender, affected side, age-adjusted Charles Syndrome Index (aCCI), inflammation markers, lesion range on magnetic resonance angiography (MARS-MRI), lesion range observed directly during surgery and surgical methods, were recorded in detail. The study evaluated the clinical decision-making of a standardized MARS-MRI-guided treatment protocol for uPJI by reviewing the clinical outcomes (infection control and functional recovery) of uPJI patients in a single PJI center.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Diagnosis of uPJI on the basis of medical history, symptoms, imaging data, etc.;
  • Treatment by internal fixation surgery;
  • Normal cognitive function;
  • Informed consent obtained from the patient or family.

排除标准

  • Significant missing data: In accordance with the Transparent Reporting of a Multivariate Prediction Model for Individual Prognosis or Diagnosis (TRIPOD) statement, only cases with complete key variables (missing rate <5%) were included;
  • Severe preoperative systemic comorbidities (e.g., decompensated liver/renal failure, active pneumonia, malignancy, and cachexia) and/or a history of mental illness;
  • Missing postoperative follow-up.

结局指标

主要结局

Infection control or not according to the MSIS criteria

时间窗: preoperative and two-year follow-up

According to the Musculoskeletal Infection Society (MSIS) criteria, infection control was defined as no local inflammation, infection/aseptic revision, or uPJI-related death within 1 year of the initial surgery.

The Hospital for Special Surgery Knee Score (HSS) score

时间窗: preoperative and two-year follow-up

The Hospital for Special Surgery Knee Score (HSS) is a patient-reported questionnaire specific to the knee joint, with a total score of 100 points. It comprises six scoring components: pain (30 points), function (22 points), range of motion (18 points), muscle strength (10 points), knee deformity (10 points) and stability (10 points). Additional points are deducted for the use of assistive devices, extension lag and varus deformity: up to 3 points for assistive device use, up to 5 points for extension lag and 1 point deducted for every 5 degrees of varus deformity. The scores are classified as follows: ≥ 85 as "Excellent", 70-84 as "Good", 60-69 as "Fair", and \< 60 as "Poor". The HSS score is widely praised for its perceived ease of use and quick recording and has been shown to be an effective and reliable measure for assessing the efficacy of TKA.

次要结局

  • Range of motion(preoperative and two-year follow-up)
  • Visual Analogue Scale (VAS) score(preoperative and two-year follow-up)
  • Pathogens Type(preoperative and two-year follow-up)
  • SF-12 score(preoperative and two-year follow-up)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xinyu Fang

Deputy chief physician

First Affiliated Hospital of Fujian Medical University

研究点 (1)

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