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临床试验/CTRI/2025/11/098189
CTRI/2025/11/098189尚未招募不适用

Frailty as a predictor of post operative outcomes in elderly patients undergoing total knee arthroplasty A Prospective Observational Study

Devidas T U1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2025年12月24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
66
试验地点
1

研究概览

简要总结

This prospective observational study aims to evaluate how preoperative frailty affects postoperative outcomes in elderly patients undergoing Total Knee Arthroplasty (TKA). Frailty is a clinical syndrome characterized by reduced physiological reserve and increased vulnerability to stress, and it is considered an independent predictor of surgical risk.

Rationale

Although TKA is effective for severe knee osteoarthritis, many elderly candidates are frail. Frail patients tend to have:

• Higher rates of postoperative complications

• Delayed recovery and prolonged hospital stay

• Increased need for post-discharge rehabilitation facilities

However, frailty assessment is not routinely done in preoperative evaluation. This study intends to bridge this gap.

Study Objectives

Primary Objectives:

  1. Assess preoperative frailty in patients scheduled for TKA.

  2. Analyze postoperative complications and recovery patterns.

Secondary Objective:

• Determine the relationship between frailty level and length of hospital stay.

Methodology

• Study Setting: Three hospitals under Kasturba Medical College, Mangalore.

• Participants: Patients aged 60–85 years, ASA Grade I–III, undergoing TKA.

• Sample Size: 83 participants determined based on prevalence data.

• Study Tool: FRAIL Scale, assessing fatigue, resistance, ambulation, illness burden, and weight loss.

• Follow Up: Postoperative assessments at 24 hrs, day 7, 6 weeks, and 3 months.

Outcomes Measured

  1. Pain (VAS score)

  2. Postoperative complications (classified using Clavien-Dindo system)

  3. Recovery time and functional improvement

  4. Length of hospitalization

Data Analysis

Statistical tests (paired t-test, chi-square, ANOVA) will be used with significance set at p < 0.05.

Expected Impact

Preoperative frailty screening will help:

• Identify high-risk patients early,

• Guide personalized care and rehabilitation plans,

• Improve surgical decision-making and patient counseling

研究设计

研究类型
Observational

入排标准

年龄范围
60.00 Year(s) 至 85.00 Year(s)(—)
性别
All

入选标准

  • Patients undergoing total knee arthroplasty ASA 1 2 3 Age 60 years-85 years.

排除标准

  • Patients under ASA 4 5 6 Patients who are not willing to participate in the study.

研究者

发起方
Devidas T U
申办方类型
Other [nil]
责任方
Principal Investigator
主要研究者

Devidas T U

Kasturba Medical College Mangalore

研究点 (1)

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