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临床试验/CTRI/2024/02/062403
CTRI/2024/02/062403尚未招募不适用

Satisfaction After Total Knee Arthroplasty In India - Analysis Of Functional Outcomes: A Multicenter National Study (SATISFY)

Society of Knee Surgeons of India (SKI)4 个研究点 分布在 1 个国家目标入组 20,000 人开始时间: 2024年5月1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
20,000
试验地点
4
主要终点
Satisfaction Analysis following TKA surgery

研究概览

简要总结

While TKA surgery has proven to alleviate pain, restore function and improve quality of life in patients with advanced degenerative arthritis of the knee, a sizable portion of the population is dissatisfied with their outcome. Numerous papers, mainly from the West, have shown this cohort to be about 18%. Factors such as associated low back pain, history of mental health problems, use of a fixed-bearing insert, and poor post-operative function have been shown to influence post-surgery outcomes negatively. However, most of these data are from western developed countries, and very few are from developing countries like India. Many factors are variable in patients from India who undergo TKA compared with patients from the West. Unlike the West, where a central healthcare system governs the modalities and delivery of healthcare, India has a multi-payer healthcare model paid for by a combination of private and public health insurance funds. Hence the factors responsible for dissatisfaction will be different for patients from India. Unlike the West, only 18% of total outpatients and 44% of inpatient care are in the public health sector. Variation in utilization of services across of the country also results in wide practice preferences among surgeons in surgeries like TKA.

Analysis of satisfaction outcomes following in TKA in India on a national scale will enable researchers analyse causes of dis-satisfaction, and also aim to improve outcomes in future. This multicentre observational study will help us analyse the satisfaction following TKA, across India.

研究设计

研究类型
Observational

入排标准

年龄范围
35.00 Year(s) 至 90.00 Year(s)(—)
性别
All

入选标准

  • Primary Tricompartmental Osteoarthritis of Knees undergoing TKA surgery Degenerative Osteoarthritis of Knees undergoing TKA surgery.

排除标准

  • Inflammatory arthritis of knees Infection in the same limb Patients not willing to participate Unicompartmental arthritis of knee.

结局指标

主要结局

Satisfaction Analysis following TKA surgery

时间窗: 6 months and 12 months

次要结局

  • Causes of dis-satisfaction following TKA surgery(6 months and 12 months)

研究者

发起方
Society of Knee Surgeons of India (SKI)
申办方类型
Other [SKI is a society of professionals involved in the management of knee diseases]
责任方
Principal Investigator
主要研究者

Raja Bhaskara Kanakeshwar Rajasekaran

Ganga Medical Center

研究点 (4)

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