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临床试验/CTRI/2021/06/034398
CTRI/2021/06/034398尚未招募4 期

Comparison of diagnostic accuracy of Hip Fracture Multidimensional Frailty Score (HF-MFS) with American Society of Anesthesiologists (ASA) grading for prediction of post-operative outcomes in hip fracture patients

Department of Anaesthesia and Intensive Care GMCH Chandigarh1 个研究点 分布在 1 个国家目标入组 85 人开始时间: 2021年1月7日最近更新:

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
85
试验地点
1
主要终点
To compare the diagnostic accuracy of HF-MFS with ASA grading for prediction of post-operative outcomes.

研究概览

简要总结

Hip Fractures are one of the most common fractures seen in the age group 50-99 years, and cause significant morbidity and mortality, along with a high-risk of post-operative complications. These complications can include incomplete recovery due to age, permanent disability, post-operative infections, ICU admissions, re-operation risk, and mortality. In this study, patients will be studied pre-operatively using the HF-MFS system and ASA grading, to classify them on the basis of surgical risk and chances of occurrence of post-operative complications. This study will then aim to determine the predictive value of the multidimensional frailty score (HF-MFS), which uses a combination of clinical, anthropometric and laboratory parameters, as compared to ASA grading, to predict 90-day post-operative outcomes in patients undergoing hip surgeries in an Indian healthcare setting.

研究设计

研究类型
Observational

入排标准

年龄范围
50.00 Year(s) 至 99.00 Year(s)(—)
性别
All

入选标准

  • Age ≥50 years
  • Patients with hip fractures (intra- and extra-capsular)
  • ASA Grade II-III patients
  • Patients posted for surgery between March 2021 and September 2022.

排除标准

  • Age < 50 years
  • Non-hip fractures
  • Moribund patients or patients unfit for surgery (ASA Grade IV-V)
  • Patients managed conservatively
  • Patients who refused surgery or died before surgery
  • Patients with end-stage or active malignancy with metastasis; multiple fractures; polytrauma
  • Patients unable to be contacted for outcome evaluation.

结局指标

主要结局

To compare the diagnostic accuracy of HF-MFS with ASA grading for prediction of post-operative outcomes.

时间窗: 24 hours, 1 week, 1 month, 2 months and 3 months after surgery

次要结局

  • 1. To compare the diagnostic accuracy of HF-MFS with modified frailty index (mFI-11)(2. To determine if Hip-Fracture Multidimensional Frailty Score (HF-MFS) is able to predict post-operative mortality after hip surgery with 90 days after surgery.)

研究者

发起方
Department of Anaesthesia and Intensive Care GMCH Chandigarh
申办方类型
Government medical college

研究点 (1)

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