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临床试验/NCT07159945
NCT07159945已完成不适用

Controlling Nutritional Status as a Superior Predictor of Fixation Failure in Intertrochanteric Fractures: Development and Validation of a Multicentre Nomogram

First Affiliated Hospital of Fujian Medical University1 个研究点 分布在 1 个国家目标入组 1,296 人开始时间: 2020年1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
1,296
试验地点
1
主要终点
The CONUT score

研究概览

简要总结

A multicentre retrospective cohort study was conducted within the Department of Orthopaedics at the First Affiliated Hospital of Fujian Medical University. This study reviewed 1,296 patients who underwent internal fixation treatment with ITF at the institution between 2020 and 2024. This study employed three distinct nutritional assessment tools for preoperative nutritional evaluation: CONUT, PNI, and NPS. By comparing the prevalence of malnutrition across these three scales and their relationship with FIF-ITF, an optimal predictive model combining INST with clinical factors was established.

详细描述

A multicentre retrospective cohort study was conducted within the Department of Orthopaedics at the First Affiliated Hospital of Fujian Medical University. This study reviewed 1,296 patients who underwent internal fixation treatment with ITF at the institution between 2020 and 2024. Detailed documentation of patient information, including age, gender, affected side, bone mineral density (BMD), age-adjusted Charlson Comorbidity Index (aCCI), fracture type, internal fixation method, haematological parameters, implant-related complications (INSTs), and reasons for failure. This study employed three distinct nutritional assessment tools for preoperative nutritional evaluation: CONUT, PNI, and NPS. By comparing the prevalence of malnutrition across these three scales and their relationship with FIF-ITF, an optimal predictive model combining INST with clinical factors was established.

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

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

排除标准

  • 1. 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; and
  • Missing postoperative follow-up.

结局指标

主要结局

The CONUT score

时间窗: Before surgery

The PNI score

时间窗: Before surgery

The NPS score

时间窗: Before surgery

次要结局

  • serum albumin(Before surgery)
  • fracture type(Before surgery)
  • total cholesterol(Before surgery)
  • lymphocyte count(Before surgery)
  • age(Before surgery)
  • osteoporosis(Before surgery)

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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