跳至主要内容
临床试验/CTRI/2025/07/091343
CTRI/2025/07/091343尚未招募不适用

Evaluation Of Quality of Life using EURO-5D5L Questionnaire for patients following surgically treated proximal femur fracture– After 1 year in Sri Ramakrishna hospital

K.Sowndarya1 个研究点 分布在 1 个国家目标入组 94 人开始时间: 2025年7月30日最近更新:

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
94
试验地点
1
主要终点
Euro quality of life 5D 5L

研究概览

简要总结

The cross sectional study was to be conducted on patients, who met the inclusion criteria after acquiring the approval of the institutional committee and the approval from MD and Orthopedic surgeon. The data must be collected from the Medical Record Department for patients sustaining Intertrochanteric fractures. All consecutive patients from Jan 2024 to Jan 2025 at Sri Ramakrishna Hospital with radiologically confirmed Proximal femur fracture of cases aging from 60 to 75 years regardless of gender. An expert orthopedic hip surgeon determined the type of fracture according to AO OTA classification of proximal femur fracture. Data were collected from medical records of the patients as well as in person interview of the patient and their relatives. Patient’s data  before and after surgery from post operative day 1 demographic data, past medical history and information pertaining to the surgery and type of fracture will be documented. And after completion of 1 year from the month of surgery. Study procedure is explained to the patient. The informed consent must be obtained from the patients. EQ 5D 5L questionnaire must be carried out by a written consent from the patients and families.

研究设计

研究类型
Observational

入排标准

年龄范围
60.00 Year(s) 至 75.00 Year(s)(—)
性别
All

入选标准

  • Age group from 60 to 75 years of age.
  • Both male and female.
  • Patient who completed 1 year after the surgical intervention of proximal femur fracture Patients who are co-operative/ Willing to participate Patients who are available for around 30kms surrounding Sri Ramakrishna Hospital after discharge.
  • Those without linguistic barriers that would prohibit them from understanding the questionnaires Minimum education level of 4th grade of elementary education.

排除标准

  • Participation in another surgical intervention or drug study during the study period.
  • Patients completed surgery more than 1 year 6 months of duration Known metastatic disease.
  • Duration between fracture and admission to the hospital being more than three days.
  • Bilateral proximal femoral fractures.
  • Surgery delayed for any medical reasons.

结局指标

主要结局

Euro quality of life 5D 5L

时间窗: baseline

次要结局

  • EuroQol 5D 5L(baseline)

研究者

发起方
K.Sowndarya
申办方类型
Other [Principal investigator]
责任方
Principal Investigator
主要研究者

Sowndarya Kumar

Master of Physiotherapy in Orthopedics

研究点 (1)

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